annual report 2009 - fagg
TRANSCRIPT
Federal Agency for Medecines and Health Products
Victor Hortaplein - Place Victor Horta 40/401060 Bruxellestel. 0032 2 524 80 00fax 0032 2 524 80 01www.afmps.be
THE FAMHP MOVES UP A GEARAnnual Report 2009
Federal Agency for Medecines and Health Products
LIST OF A NUMBER OF DEFINITIONS AND USED ABBREVIATIONS
IA variations
Type IA variations are changes to an MA that have minimal or no effect on the quality, safety or efficacy of the medicinal product.
IB variations
Type IB variations are all changes to an MA that are not defined as a Type IA variation, a Type II variation or a line extension, and that cannot have any significant effect on the quality, safety or efficacy of the medicinal product.
@ctua Electronic newsletter of the FAMHP to its stakeholders
@ctua Express
Electronic newsletter of the FAMHP to the stakeholders, used to communicate specific or urgent reports
A/H1N1v A new human virus of mixed genetic origin, being a reassortment of swine, avian, and human influenza viruses. This virus was identified in Mexico at the end of March 2009.
a.o. Among others
APB The coordinating federation of the Belgian professional associations of independent retail pharmacies
ASMF Active Substance Master File - File concerning the active ingredient only. It consists of an “open part” and a “closed part”. The “open part” can be part of an MA application or a variation to an MA.
ASR Annual Safety Report
B&Mc Budget and Management control
BCFI-CBIP Belgian Centre for Pharmacotherapeutic Information, non-profit association
BCGH-CBPH Belgian Centre for Pharmacovigilance for medicines for human use, within the FAMHP
BEMA Benchmarking European Medicines Agencies
B.S.-M.B. Belgian journal of acts, orders and decrees
BUM Proper use of medicines
BVK-SBP Belgian Association for Paediatric Medicine
CAT Committee for Advanced Therapies
CE Marking that companies are required to display on products falling within the scope of the New Approach Directives - European conformity marking
CHMP Committee for Medicinal Products for Human Use (ex CPMP)
CIBE Public sector tailored communication
CKG-CMP Evaluation commission for traditional herbal medicines for human use
Class labelling
Stipulations(s) in the PIL and the SPC concerning the safety in use of all medicinal products within one class, or of all medicines with the same active substance
CMD Certificate for Medical Device
CMDh Coordination Group for Mutual Recognition and Decentralised Procedures, human
CODA-CERVA
Veterinary Agrochemical Research Centre
COMMnet The network of federal staff members working in communication. It comprises some six hundred people from some sixty federal services for MA.
CP Centralised Procedure for MA
CTA Clinical Trial Application
CTFG Clinical Trial Facilitation Group - A collaborative group established to facilitate and harmonise the organisation of clinical trials in Europe
CVMP Committee for Medicinal Products for Veterinary Use
DCP Decentralised Procedure for MA
DG Directorate-General
(e)CTD (electronic) Common Technical Document - File format for the application for (changes to) MA for medicines for human use
EDQM European Directorate for the Quality of Medicines & HealthCare - European bureau (Council of Europe) for the evaluation of the quality of medicines and healthcare
e-Health Secure platform for electronic data exchange within the Belgian healthcare sector
EMA European Medicines Agency
EORTC European Organisation for Research and Treatment of Cancer - International non-profit organisation promoting and coordinating clinical laboratory cancer research throughout Europe. The mission of the EORTC is to raise cancer treatment standards, and to facilitate the transition between experimental discoveries and brand new treatments.
EU European Union
Eudra-Vigilance
Central EMA database including reports of adverse reactions of human and veterinary medicines approved within the EU, with data provided by European medicines authorities and pharmaceutical companies
FAGG-AFMPS
Federal Agency for Medicines and Health Products, FAMHP
FAMHP Federal Agency for Medicines and Health Products = FAGG-AFMPS
FANC-AFCN Federal Agency for Nuclear Control
Farmaka A non-profit association whose mission is to contribute, by means of research and projects, to the rational use of medicines and medical devices and to place this knowledge at the service of healthcare professionals, consumers and the competent authorities
FAVV-AFSCA Federal food agency
Fedict Federal Public Service for Information and Communication Technology
FEDLAND Consultation platform of the FAMHP’s Precursors Unit together with Customs, the Federal Police and the Justice Department
FIOD-ECD Tax Information and Investigation Department - Economic Control Department - Dutch Tax Investigation Service
FPS Federal Public Service
Fr French
FUSL Schools of Saint-Louis University
GAP analysis
Method for comparison between an actual and a desired situation
GCP Good Clinical Practices
GDP Good Distribution Practices
GMO Genetically Modified Organism
GMP Good Manufacturing Practices
HCG-HCM Evaluation commission for homeopathic medicines for human and veterinary use
HMA Heads of Medicines Agencies - Network of European medicines authorities
HMM Homeopathic Manufacturing Methods
HMPC Committee on Herbal Medicinal Products
HMPWG Homeopathic Medicinal Products Working Group
HR Human Resources
ICH International Conference on Harmonisation
ICI-CII Interministerial Commissariat for Influenza
ICT Information and communication technology
IMP Investigational Medicinal Product
IMPACT International Medical Products Anti-Counterfeiting Taskforce - WHO initiative in the fight against counterfeit medicines
INCB International Narcotics Control Board
IT Information technology
IWP Immunologicals Working Party
R.D. Royal Decree
KCE Belgian Health Care Knowledge Centre
SME Small to medium-sized enterprise
KPI Key Performance Indicator
LUSS A non-profit association of users, patients and citizens interested in health matters
MA Marketing Authorisation
MAH Marketing Authorisation Holder
M.D. Ministerial Decree
Mdeon Mdeon is a non-profit association, the common professional ethics platform set up by doctors’, pharmacists’, veterinarians’ and nurses’ associations and the pharmaceutical and medical devices industry associations.
MeSeA Medicines electronic Submission and electronic Approval
MHRA Medicines and Healthcare Products Regulatory Agency - The British medicines authority
MRP Mutual Recognition Procedure for MA
N-1 Mandate holder - Management position of Director-General
NAT Nucleic Acid Amplification Test - a blood test
NeeS Non eCTD Electronic Submission
Nl Dutch
NIMP Non Investigational Medicinal Product
NOE National Investigation Unit of the FAVV-AFSCA
NP National procedure for MA
NTA Working Group Notice to Applicants - Working group for the development of specific guidelines for the filing of MA applications
OIVO User Associations Research/Investigation Centre
OLAF European Anti-Fraud Office
OPHACO Belgian professional association of cooperative retail pharmacies
P&O Personnel and organisation
PDCO Paediatric Committee
PFIPC Permanent Forum on International Pharmaceutical Crime
pharma.be General association of the Pharmaceutical Industry (AVGI), a non-profit association established to promote the interests of the pharmaceutical industry in Belgium
Pharm-pack
Regulatory proposal submitted at the end of 2008 by the European Commission to the Parliament and the Council, concerning pharmacovigilance, the imitation and counterfeiting of medicines, and patient information
PhVWP PharmacoVigilance Working Party
PIC(/s) Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S)- International cooperation scheme for pharmaceutical inspections
PIL Patient Information Leaflet
PIP Paediatric Investigation Plan
PMO Program Management Office
PSUR Periodic Safety Update Report
PUMP The Public Management Programme is a “training sabbatical”, an intensive government management training programme for Federal civil servants.
R&D Research and Development
RAS Rapid Alert System - System of warnings and urgent information reports concerning medicines and health products;
RECIP-E Pilot project for electronic prescription of medicines in the outpatient sector
Referral Arbitration procedure for MA applications
RIZIV-INAMI National institute for sickness and invalidity insurance
RMS Reference Member State
RQ Five-yearly renewal
SAWP Scientific Advice Working Party
SAWP-V Scientific Advice Working Party, Veterinary
Selor Government recruitment agency
SPC Summary of Product Characteristics
SMF Site Master File - Document drawn up by the manufacturer and containing specific GMP and factual information concerning pharmaceutical industry production and/or controls, the activities carried out at the designated site, and the closely integrated activities in adjacent and neighbouring buildings
SOE-USE Special Investigation Unit of the FAMHP
SOP Standaard Operating Procedure - A series of instructions to be performed in sequential order
SPOC Single Point Of Contact
STA Scientific-Technical Advice
TGV-ATU Authorisation for temporary use
TMF-FTM Therapeutic Magistral Formularium
TOR Technical consultation platform for registration
TQM Total Quality Management
TSE Transmissible Spongiform Encephalopathy
TU Traditional Use - Traditional use of plant based medicines as stipulated in Article 43 of the R.D. of 14 December 2006
UCL Catholic University of Louvain - French-language university
UGent Ghent University
ULB Free University of Brussels - French-language university
ULg Liège University
UNO United Nations Organization
VET Veterinary (animal health)
VET-TOR Technical consultation platform for registration for medicinal products for veterinary use
Vit@ The FAMHP’s monthly internal, electronic newsletter
Vit@ Express
Internal, electronic newsletter for urgent reports
Vit@ MeSeA The FAMHP’s internal, electronic newsletter for all MeSeA reports
Vitruvius A leadership development programme of the FPS P&O
VUB Free University of Brussels - Dutch-language university
VWP Vaccine Working Party
vzw-asbl Non-profit association
WGEO Working Group of Enforcement Officers - Working group for consultation in matters concerning the fight against pharmaceutical crime
WHO World Health Organisation
WIV-ISP Scientific Institute of Public Health
FAMHPOnce again this year I have been granted the opportunity and the privilege to preview the annual report of the Federal Agency for Medicines and Health Products, entitled “The FAMHP moves up a gear. Annual Report 2009.”
As you know, as far as Public Health was concerned, 2009 was the year of the influenza pandemic. In this context, the Agency played an important role in, among other aspects, medicines logistics and surveillance of the vaccine and the antivirals used in Belgium. In addition, the Agency also succeeded in duly carrying out its tasks and in introducing its new organisation chart. A number
of other projects were also productively completed, and are described in this annual report.
Thus, in 2009 the FAMHP success- fully launched its first general public information campaign. The purpose of this campaign was to increase the public’s awareness of the risks connected with illegal purchases of medicinal products via the Internet.
The year 2009 also saw the coming into effect of the long awaited new regulation for retail pharmacists in conjunction with the good pharmaceutical practices, as well as a review of the regulations concerning human tissue material, with
reinforced rules concerning ethics, quality and vigilance; this also resulted in new competences being assigned to the Agency.
In 2009 the Agency also devoted additional attention to eliminating the backlog in the processing of applications, achieving distinctly positive results. The accumulated backlog has been substantially reduced, and in the future the FAMHP will ensure that all applications are processed within the set deadlines.
The FAMHP is in constant evolution. You will undoubtedly notice this in the numerous
achievements discussed in this third annual report of the FAMHP, which more than ever before chose consultation with its partners in order to help fulfil its mission.
“The FAMHP moves up a gear. Annual Report 2009.” provides a clear overview of the results for 2009 in the form of articles, interviews and figures, using the Agency’s new organisation chart as a starting point.
Before I let you form your own opinion, I would like to highlight the fantastic work of our still relatively “young” medicinal products agency (created in 2007). For the future,
Dear Reader,
I would like to encourage the Agency to continue its Public Health protection work with the same professionalism and energy, so as to provide a high quality public service for both healthcare professionals and the community.
I hope you will enjoy reading this report.
Laurette OnkelinxDeputy Prime Minister and Minister for Social Affairs and Public Health, in charge of Social IntegrationMinister responsible for the FAMHP
June 2010
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Deputy Prime Minister and Minister for Social Affairs and Public Health, in charge of Social Integration Minister responsible for the FAMHP 1
Chief Executive Officer of the FAMHP 5
Mission, role and values 7
“New” iN 2009 9
A new website for the FAMHP 10
New regulations for retail pharmacists promulgated with the R.D. of 21 January 2009 12
Agency’s new organisation chart now operational 15
Belgian network for paediatric clinical research 18
A/H1N1v influenza: the role of the FAMHP in the management of the crisis 20
Quota system 22
Communication in relation to experiments 23
Implementation of the new Scientific-Technical Advice (STA) within the FAMHP 24
First campaign: “Medicines via the internet? Don’t surf with your health!”. 26
Operation Pangea II or the Belgian participation in an international operation to fight online sale of counterfeit and other illegal medicinal products 28
Project Backlog – 2009 trends 30
FAMPH communication optimisation project 32
CoNteNtSConte
nts2
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Annual Report 2009
Chief Executive Officer’s services 80
Communication Division 80
PMO Unit - Program Management Office 81
International Relations Unit 82
The three committees of the FAMHP 84
Scientific Committee 84
Consultative Committee 85
Transparency Committee 85
The four spearheads of the FAMHP 86
ONCOLOGY spearhead 86
VACCINES spearhead 88
PROACTIVE VIGILANCE spearhead 91
EARLY PHASE DEVELOPMENT spearhead 93
FAMHP representatives at national and international level 94
International representation 94
National representation 98
Contact 109
Some useful information 109
Legal context of the FAMHP 110
Publication information 116
2009 “ReSultS” 35
Pillar 1, the DG PRE authorisation, or all activities prior to approval of the first marketing authorisation for a medicine or health product 36
R&D Division (human) 38
Marketing Authorisation Division (human) 40
Medicines for Veterinary Use Division 45
Assessors Division 46
Pillar 2, the DG POST authorisation, or all activities following approval of the first marketing authorisation for a medicine or health product 48
Marketing Authorisation Division – Variations & Renewals 50
Vigilance Division (pharmaco, materio, haemo, bio) 52
Health Products Division 54
Proper Use Division 56
Pillar 3, the DG INSPECTION or all inspection and control activities 60
Control Policy Division 62
“Dispensing” Division 63
“Industry” Division 65
Special Investigation Unit 67
Some figures for the DG INSPECTION 68
2009 FAMHP personnel and budget 71
P&O Division 71
B&Mc Division 74
Other Support services 77
ICT Division 77
Translation Services Division 78
Logistics Unit 78
Legal Affairs Division 79
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As planned, in 2009 the Agency was able to complete its restructuring with the introduction of the new organisation chart and the installation of the three Directors-General. The goal of this change was to optimise work processes and to ensure optimum use of available resources. A number of issues such as appointing the members of middle management still need to be settled.
Taking into account the delicate public sector budget situation and the difficult economic environment faced by our partners in 2009, the government agreed to the FAMHP drawing from the financial reserves in exchange for the commitment of the Transparency Committee to making available the necessary financing for the further development of the Agency in 2011.
In the meantime, the FAMHP has continued its mission, recording numerous successes. In the area of, among other procedures, variations (or changes to marketing authorisations) the Agency has doubled its performance since 2009. Not only could the submitted applications now be processed in a timely manner, but the backlog that had built up was also reduced. In November 2009, the FAMHP processed its 3000th application for a clinical trial since the introduction of the law relating to experiments on the human person.
As the Minister already mentioned, 2009 was overshadowed by the A/H1N1 flu crisis, in which we played an important role on the national, but also on the European level through our active participation in the scientific evaluations of marketing authorisation applications for the pandemic vaccines.
In 2009 the Agency developed its own website, www.fagg.be, an essential, dynamic and effective instrument for our work.
In 2009 we also launched our very first campaign aimed at the general public: “Medicines via the internet? Don’t surf with your health!”.
Then there was also the start of the Belgian Paediatric Clinical Research Network, a step forward for the quality of future clinical trials to guarantee new, safe and efficient products for children.
We have every reason to be pleased with the progress once more accomplished in 2009 – all the more so because simultaneously, as a public institution, we also did our best to fulfil our mission of providing information in the service of the population, in full transparency, which necessarily requires a certain amount of resources.
All achievements presented in this annual report could only be accomplished thanks to the commitment of all staff at the Agency, the trust our partners have once more placed in us and the valuable cooperation with our stakeholders, which we were again able to enhance in 2009. I would like to thank each and every one of these people from the bottom of my heart.
I hope that at the dawn of this new decade we will be able to continue developing along the same lines.
And so, now, on to the Belgian Presidency …
Xavier De CuyperChief Executive Officer of the FAMHP
June 2010
Dear Reader,
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Your medicines and health products are our concern!
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Mission, role and values
MissionThe FAMHP plays an essential role in the protection of Public Health, with the following mission:
“Ensuring, from development to use, the quality, safety and efficacy:
of medicines for human and veterinary use, •including homeopathic medicines and herbal medicines, pharmacy made and officinal preparations;of health products including medical •devices and accessories, and raw materials (active pharmaceutical ingredients) for the preparation and production of medicines.
Ensuring, from collection to use, the quality, safety and efficacy:
of all operations involving blood, cells and •tissues, which are also defined as health products”.*
* Based on the law of 20 July 2006 (B.S. - M.B. 08/09/2006) concerning the establishment and functioning of the FAMHP.
RoleTo ensure the quality, safety and efficacy of medicines and health products in clinical development and on the market.
ValuesThe values nurtured within the FAMHP are carefully selected, and form the unifying theme in our day-to-day activities:
professionalism•integrity•sincerity and transparency•comprehensiveness•participation.•
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“New” in 2009
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“New” in 2009
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A new website for the FAMHP
Dominique Leyh and her project team listened to the expectations of the different partners of the FAMHP, so that everyone can easily find the necessary information. “Each partner has different interests, depending on the function they fulfil in the medicinal or health product sector, whether they are researchers or investigators, healthcare professionals, patients or consumers, or members of another national or international institution. Our organisation’s website was primarily developed in order to meet the needs of healthcare professionals, but it is also a great resource for patients and consumers,” says Dominique Leyh. The information concerning the Agency’s activities is
classified into three categories for medicinal products for human and veterinary use: medicines, health products and special products. This includes information about clinical trials, authorisation procedures for medicines in Belgium, pharmacovigilance, inspection and control activities and advertising regulations. The website also focuses on the proper use of medicines, reporting of adverse effects of the use of medicines, generic medicinal products and the sale of medicines over the Internet.
With its website, the FAMHP wanted to create an active tool for communication, and therefore provides the option to register to receive a newsletter to keep up to date with new information about various specialised areas.
Sixty-one news reports were published in 2009, and no fewer than 1,200 Internet users registered to receive our “news”. Our website receives a monthly average of 8,500 unique visitors, and between 70,000 and 80,000 pages were viewed.
TThe Agency’s very own
website went online on
21 January 2009. Until then, all
information could be found on
the website of the FPS Public
Health. The new website was
developed in collaboration with
Fedict (FPS Information and
Communication Technology).
With the new website, the
FAMHP wanted to develop
a dynamic and efficient
instrument to support it in the
performance of its tasks. The
website is kept in the colours
of the Agency’s house style,
and its clear structure ensures
optimum ease of use.
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Annual Report 2009
A new website for the FAMHP
Dominique Leyh, Internet Project Manager
at the FAMHP:
“With the new website the FAMHP has developed
a dynamic and efficient instrument for the
performance of its tasks and, in summary, an active
communication tool.”
“Our website meets the needs of healthcare
professionals, but it is also a great resource for patients
and consumers.”
website visitor statistics 2009
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
80,000
90,000
01 03 04 05 06 07 08 09 10 1202 11
VisitorsPages visited
Month in 2009
Num
ber o
f vis
itors
/ pa
ges
visi
ted
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New regulations for retail pharmacists promulgated with the R.D. of 21 January 2009
“A review of the R.D. of 31 May 1885 concerning
approval of the new instructions for doctors,
pharmacists and drugstore keepers was unavoidable in order to bring the regulatory
framework up to date and to formulate it with
greater clarity. Many of its provisions were, after all,
outdated or included in other regulations.”
Internet. An accompanying
circular to retail pharmacists
clarifies a number of essential
points concerning these issues.
A review of the R.D. of 31 May 1885 concerning approval of the new instructions for doctors, pharmacists and drugstore keepers was unavoidable in order to bring the regulatory framework up to date and to formulate it with greater clarity. Many of its provisions were, after all, outdated or included in other regulations. The revised R.D. contains the basic principles, and governs the tasks of pharmacists carrying out their profession in a public or retail pharmacy, or in another institution in which a pharmacy is authorised to operate (e.g. in a penitentiary institution). This decree does not apply
to pharmacists working in a hospital pharmacy: they continue to be governed by the R.D. of 31 May 1885.
As concerns the dispensing of medicines, the pharmacy continues to be the place of choice. However, there is now a variant that enables retail pharmacies authorised to operate in Belgium to sell approved, prescription free human medicines and also certain medical devices over the Internet, subject to very strict conditions. There are also rules for the dispensing delivery of Internet orders.
Dispensing must take place as follows:
from the pharmacy;•under the full responsibility •of the retail pharmacist;in accordance with good •pharmaceutical practices.
Other provisions ensure that the sale, ordering, packaging and delivery comply with patient privacy rules. The website must also promote the rational use of medicines and medical devices. To accomplish this, the site must necessarily contain a certain amount of information about the proper use of the products.
The accompanying circular to retail pharmacists points out a number of important issues in this respect, such as the following obligations:
for retail pharmacists and •operators of pharmacies selling medicines or medical devices over the Internet, to report the existence of their website to the FAMHP and to the Order of Pharmacists;
TThe R.D. of 21 January 2009
(B.S. - M.B. 30 January 2009)
concerning instructions for
pharmacists, supersedes and
replaces the R.D. of 31 May 1885
and introduces new regulatory
provisions for retail pharmacists.
These provisions aim at better
management of the preparation
of medicines, of the
responsibility of pharmacists,
of the accessibility of
pharmacies and of the
dispensing of medicines, and
stipulate good pharmaceutical
practices for retail pharmacists.
This decree also regulates the
legal sale of medicines over the
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Annual Report 2009
New regulations for retail pharmacists promulgated with the R.D. of 21 January 2009
to comply with the •regulations concerning information and advertising about medicines on the pharmacy’s entire website.
The FAMHP stipulated these strict conditions in order to protect the public from the potential health risks connected with illegal purchases of medicinal products over the Internet. To this end, the Agency has published on its website the list of authorised pharmacies in Belgium that have reported their sales site to the FAMHP. This provides Internet users with an instrument enabling them to determine whether a website selling medicines and health products does indeed belong to a pharmacy authorised in Belgium.
Louis Jacobs,Responsible for the “Dispensing” Division, FAMHP:
“The website must also promote the rational use of
medicines and medical devices.
To accomplish this, the site must necessarily contain
a certain amount of information about the proper
use of the products.”
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Questions to Xavier De Cuyper, Chief Executive Officer of the FAMHP.
The autonomous Agency was created in 2007, so why a new organisation chart now?
“Since the creation of the autonomous Agency, the first phase of its development has led to both the Chief Executive Officer’s services and also the Support services acquiring their final identity. During this transition period and awaiting the formal appointment of the three Directors-General (N-1 appointees), the core activities of the medicinal products authority remained organised as in the Directorate-General for Medicinal Products of the FPS Public Health. On the occasion of its second
anniversary, the Agency completed the design of its new structure, so that the final result of this process could be presented on 1 February 2009 in the form of the new organisation chart.”
What goals were aimed at with the development of this new organisation chart?
“In order to further optimise both the working processes and also the use of the available resources, this new structure provides for logical distribution of the core activities of the FAMHP among three Directorates-General, or pillars:
The DG PRE authorisation: •all activities prior to approval of the first marketing authorisation for a medicine or health product.
The DG POST authorisation: •all activities after approval of the first marketing authorisation for a medicine or health product.the DG INSPECTION or •all inspection and control activities.
“In 2009 the Agency completed the design of its new structure and presented
it as a new organisation chart.”
Agency’s new organisation chart now operational
Executive council of the FAMHP (left to right):Pascal Giloteau - Support services Coordinator, Vanessa Binamé - Director-General DG POST authorisation, Xavier De Cuyper - Chief Executive Officer, Paul Ballegeer - Head of the Legal Affairs Division, Josiane Van der Elst - Director-General DG INSPECTIONGreet Musch - Director-General DG PRE authorisation.
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The pillars were developed to meet the following goals:
a transparent structure •reproducing a medicinal product’s life cycle;an integrated spearhead •policy;the most efficient use of •staff according to their competences, with the added benefit of increased motivation;simple and clear procedures •to prevent bottlenecks;balanced development of the •three pillars; transversal collaboration •across pillars.
With this new organisation chart, the Agency seeks even more closely to meet the expectations of its partners, and to fulfil its role of guaranteeing the quality, safety and efficacy of medicines and health products in the best possible manner.”
“The new organisation chart enables the Agency to meet the expectations of its partners even better, and to fulfil its role in an optimum
manner.”
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EXECUTIVE COUNCIL
Crisis Unit
(non permanent)
SPEARHEAD
COORDINATORS
R&D Division
(human)
Marketing Authorisation
Division(human)
Medicines for Veterinary Use
Division
Assessors Division
Control Policy
Division
“Industry”
Division
“Dispensing”
Division
SOE-USE
Special Investigation Unit
DG PRE authorisation
Marketing Authorisation
Division
Variations & Renewals
Vigilance Division
(pharmaco, materio, haemo,
bio)
Health Products Division
Proper Use Division
DG POST authorisationDG INSPECTION
Support services
B&Mc D
ivision
ICT Division
Legal Affairs D
ivision
P&O D
ivision
Translation Services D
ivision
Transparency CommitteeConsultative Committee
Scientific Committee
CHIEF EXECUTIVE OFFICER
Internal Audit & Quality
Program Management
Office Unit (PMO)
International
Relations Unit
Communication Division
Belgian network for paediatric clinical research
TThe Paediatric Medicines
Regulation came into effect
in December 2006. In this
context, a Paediatric Committee
(PDCO) was set up in the
European Medicines Agency
(EMA), chaired by our Belgian
colleague Daniel Brasseur. The
first Paediatric Investigation
Plan (PIP) opinions were
published in October 2007. In
future, the industry will have to
submit such plans in advance
in order to obtain an indication
equivalent to that approved for
adults and also in order to apply
for a potential extension of their
patent protection rights. This
new regulation has implications
not only for pharmaceutical
companies but also for the
other parties involved: patients,
parents and children, healthcare
professionals, academic
investigators and the competent
medicinal product authorities.
Together with patient association representatives and healthcare professionals, the PDCO evaluates the PIPs filed by the companies. Following approval, a PIP has to be implemented; but this is not the hardest part. After approval by the Ethics Committees, sponsors must then look for investigators who are able to carry out a clinical trial within a reasonable period of time. Of
course, this involves a number of conditions:
a sufficient number of young •patients with a specific condition must be found;parents must be informed •of the importance of participating in a clinical trial;the child’s own consent •is requested if he/she is old enough to understand everything and express his/her thoughts.
The institution carrying out the clinical trial must itself also satisfy a number of requirements. For example, it must have research instrumentation and laboratory facilities that will guarantee the quality of the information gathered during the clinical trials. Children are often recruited in several
centres simultaneously. Good coordination is required to ensure homogeneity of the data obtained and their validation in a structured database.
Everything is done to ensure that the results obtained from clinical trials will be reliable and can be correctly interpreted. In this context, the EMA coordinates the activities of the various existing paediatric research networks within the EU and facilitates their mutual collaboration. The goals of this mission are:
guaranteeing the quality •of clinical trials involving children;accelerating their •implementation by lowering costs and limiting requirements;
providing reliable •information;enabling early access to •the market for innovative paediatric medicines.
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Belgian network for paediatric clinical research
paediatric medicines is not only a Belgian contribution to Europe, but especially a significant advance for the quality of future studies and the guarantee of new, safe and effective products for what has to date been a more or less neglected population group. The plan is still in its infancy, but all stakeholders have agreed to re-evaluate the situation within the coming three years.
that their participation in a proposed clinical trial will meet all applicable safety standards and will grant them immediate access to innovative medicines. In addition, the industry will obtain a better overview of the studies being carried out on children, allowing them to inform the young patients’ direct care providers. The pertinent authorities, too, will obtain a better overview of the progress of ongoing studies through the control they exercise over clinical trials at the national level and through the evaluation of PIPs, in which they participate through their representatives within the EMA. Overall, all parties are expected to derive advantages from this approach.
In summary, the creation of a network for clinical trials for the development of innovative
to an academic or private institution. The inventory is not intended to list only the areas of interest and specialisation of each investigator, but rather also to provide an overview of the recruitment potential of each centre. Technical and methodological capabilities are also to be inventoried.
The BVK-SBP can count on the support of pharma.be as the representative of the pharmaceutical industry to help it correctly complete this preparatory evaluation. Thus, pharma.be has allocated funds that will enable a position to be created for two years for a person to draw up an overview of the paediatric study options in Belgium. This is an important step for all parties involved. Over the longer term, it is intended that children and their families can rest assured
New in 2009A meeting devoted, among other things, to the introduction of controls on the “network of networks” by the EMA took place in London on 16 February 2009. In this meeting, Belgium was represented by Professor José Ramet (University of Antwerp), chairman of the Belgian Association for Paediatric Medicine (BVK-SBP) and coordinator of the Belgian Paediatric Clinical Research Network (BPCRN), created on 2 February 2009.
For Belgium, the BVK-SBP has in fact created a network gathering those investigators capable of setting up clinical trials involving children. Initially, the BVK-SBP will draw up an inventory of investigators interested in this specialty, regardless of whether they are in private practice or affiliated
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19
A/H1N1v influenza: the role of the FAMHP in the management of the crisis
The main task is to develop and maintain a national contingency plan to enable appropriate reaction to a potential influenza pandemic in Belgium. In that context and within the scope of the ICI, the FAMHP actively contributes to the medicines logistics aspect.
On 25 April 2009, when the WHO announced human cases of the swine flu in Mexico and in the United States, the FAMHP, via the ICI, and the other organisations involved in dealing with the crisis (such as the FPS Internal Affairs and the FPS Foreign Affairs) assumed a state of readiness. Their goal was to prevent, insofar as possible, the A/H1N1v virus from spreading among the Belgian population and to confront the influenza pandemic in Belgium.
The FAMHP drew up an inventory of the available therapeutic medicinal products and prevention supplies and evaluated the actions that needed to be undertaken in order to be able to combat the crisis. In collaboration with the FPS Public Health, the Agency built up strategic stocks of face masks and antiviral medicinal products, and investigated the possibilities of increasing the production capacity of pharmaceutical companies. For this purpose, our organisation assumed the task of coordination among all organisations involved, in particular in the areas of purchase, storage, distribution and production of medicines and health products. The Defence Department entrusted us with monitoring the strategic stocks and the production
process of the antivirals.
The FAMHP of course also ensures the quality, safety and efficacy of the antiviral medicines and vaccines used in the combat against the pandemic. On a European level, Belgium followed step-by-step the scientific evaluation inherent in rendering available the pandemic vaccines by means of granting an MA, and coordinated the data stream to the pertinent Belgian bodies in order to develop appropriate strategies.
In addition, communication during the management of the influenza pandemic was considered to be an essential task of the ICI in view of the fact that its call centre processed a great number of questions received by e-mail or telephone.
In that aspect, too, the FAMHP played a significant backup role as a provider of information for questions concerning its competences. In this context, the Agency could rely on the academic vaccine network for answers to highly specific practical questions.
Thanks to its close collaboration with the professional associations and the Order of Pharmacists, the FAMHP was able to constitute a first instance procedural framework for the ongoing supply of wholesalers - distributors, retail pharmacies and hospital pharmacies with antivirals and face masks. In a second phase, the FAMHP ensured the creation and operational readiness of a procedural framework for the distribution of the pandemic influenza vaccine.
SSince 2007, the FAMHP,
and previously the
Directorate-General for
Medicinal Products of the
FPS Public Health, have
been involved in the various
activities of the Interministerial
Commissariat for Influenza
(ICI), created in 2005 following
upon the decision of the
first special interministerial
conference on Avian influenza.
The ICI is a general coordination organisation for actions implemented in consultation with other bodies, both on the federal and regional levels and also at EU level. The Commissariat also manages contacts with the European and other international institutions.
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A/H1N1v influenza: the role of the FAMHP in the management of the crisis
then entered in the European EudraVigilance database. This enables us to remain attentive in the event of unexpected adverse effects following mass administration of these medicines.
A new component since December 2009 is that we regularly publish reports on our website concerning the adverse effects reported in Belgium in connection with the use of these medicinal products.”
form was drawn up for the pandemic. This form was provided in October 2009 to all healthcare professionals via the Folia Pharmacotherapeutica of the Belgian Centre for Pharmacotherapeutic Information, a non profit association, and was also made available on our website.”
What does the FAMHP do with the reports it receives?
“Each report of adverse effects inherent to the use of anti- influenza medicinal products and the pandemic vaccine received by the FAMHP is, like all other reports, assessed by the Belgian Centre for Pharmacovigilance for medicines for human use (BCGH-CBPH) of the FAMHP in accordance with the criteria of the WHO. The report is
able, if necessary, to intervene immediately in the event of potential signs or symptoms of adverse reactions by prescribing changes in the use of these medicines if applicable. The programme was part of, and a further supplement to the European risk management plan.”
What does the specific pharmacovigilance programme involve?
“The specific pharmacovigilance programme involves reinforced national monitoring of medicines, based on healthcare professionals reporting adverse effects after use of antivirals and the pandemic vaccine. Such adverse effects can be reported directly to the FAMHP or to the authorisation holder itself. In addition, a specific reporting
Questions to Xavier De Cuyper, Chief Executive Officer of the FAMHP.
Why did the FAMHP introduce a specific pharmacovigilance programme for the influenza vaccine and the antiviral medicines in use in Belgium?
“Because of the increased use of antivirals and the marketing of a new pandemic vaccine that would in all probability be administered on a greater scale than the vaccine against seasonal influenza, we decided to reinforce our pharmacovigilance system. It was therefore also entirely reasonable to gather additional information about potential adverse effects of these medicines outside of the standard conditions of clinical trials. The goal was to be
“Within the ICI, the FAMHP actively contributed to the medicines logistics aspect.
In collaboration with the FPS Public Health, the FAMHP
built up strategic stocks and provided coordination
services for the different organisations involved.
The FAMHP of course also assured the quality, safety
and efficacy of the antiviral medicines and vaccines.
”
“In view of the situation, we gathered additional information about the
medicines’ potential adverse effects.
”
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21
Quota system
among the different Belgian
wholesalers - distributors on a
prorata basis in respect to their
previous annual orders. This
practice is not unlawful.
It is however the case that the sale of certain medicinal products outside the Belgian territory through intracommunity distributors or exporters can lead to the products not being available in Belgium. The export of medicines to third countries and the intracommunity distribution of medicines to other European countries by pharmaceutical companies authorised to do so is entirely legal.
In April and September 2009, consultations took place upon the initiative of the FAMHP on the subject
of problems relating to the quota system for medicinal products. The FAMHP invited the representatives of professional associations of (pharmaceutical) companies, wholesalers - distributors, pharmacists working in retail and hospital pharmacies as well as representatives of the RIZIV-INAMI and the Office of the Minister for Public Health to participate in these consultations.
During the round table discussions, a number of professional organisations presented their vision of the quota system as well as their own analysis of its causes. A number of possible solutions were proposed. The FAMHP, for its part, assessed the state of affairs of the distribution of medicinal products in Belgium, explaining its own analysis of
the potential causes for the unavailability of medicinal products as a result of the quota scheme and presented the changes to the pharmaceutical regulations that our Agency will propose to resolve the issue of medicinal products unavailability.
At the consultation of September 2009 it was agreed that the FAMHP would develop a list of the most important medicinal products subjected to quotas that are regularly unavailable. This list was compiled on the basis of, on the one hand, the list of medicinal products subjected to quotas, and, on the other hand, the list of medicinal products most frequently reported as unavailable. Unavailability can be due to the quota system or to other factors such as
temporary unavailability due to production issues. It is proposed that we request wholesalers - distributors’ commitment to refrain from intra-community export or distribution and sales to exporters of medicines from this list for a certain test period, and that pharmaceutical companies commit to no longer applying quota to these medicines.
A list of 22 medicines was developed. The FAMHP will draw up a document with the commitments each sector (i.e. the pharmaceutical companies, wholesalers - distributors, pharmacists, FAMHP) must meet during the test period in order to limit the problems that can be assigned to the quota system as much as possible without changing the Belgian regulatory framework.
RRationing of medicines by
the application of quotas is a
practice that has already existed
for a long time, and which is
implemented by a number of
pharmaceutical companies
in Belgium and other EU
countries. The principle consists
in using the consumption
figures of previous years
to calculate the quantity
of medicines that must be
produced on an annual basis to
satisfy the needs of the Belgian
market. Both a provisional
margin and a safety margin are
also added to this quantity. This
quantity is then distributed
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Quota system
The FAMHP has also conducted investigations at pharmacies suspected of illegally distributing or exporting medicines. The FAMHP carried out a number of different targeted inspections leading to sanctions whenever the suspicions were confirmed. These controls will be continued.
After the test period, the situation will be assessed to decide whether or not the law amendments proposed by the FAMHP are appropriate.
Communication in relation to experiments
S The Ethics Committees involved in processing the application can also use the website to state whether they have received the complete application file. From the start of the processing timeline for the application, information is exchanged at legally defined moments among the local Ethics Committees, the Committee issuing the single opinion, the FAMHP and the sponsor.
This project was a big challenge, as it called for all stakeholders (including the Ethics Committees, the FAMHP and the sponsors) to carry out a standardisation and harmonisation of their work processes. The challenge on the technical side consisted in providing a sufficiently high level of security to ensure the exchange of confidential information.
Since 2006, a number of
stakeholders in the clinical trials
arena have been collaborating
to develop a website seeking
to improve communication
concerning clinical trials. This
interactive website allows a
sponsor to enter data online for
the experiment being carried
out.
On 1 August 2009 the application was deemed ready for testing with “real” applications. The experiences from this pilot phase will be used to eliminate the last few imperfections from the system, so that it can in future be used for all types of clinical trial applications.
Kristof Bonnarens, Responsible for the R&D Division (human), FAMHP
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implementation of the new Scientific-technical Advice (StA) within the FAMHP
Questions to Christophe Lahorte, STA project manager at the FAMHP.
Scientific-Technical Advice within the FAMHP, what does this involve?
“In the course of 2009 and based on the pertinent law and its implementation decree, the option was created within the DG PRE authorisation for – among other organisations – pharmaceutical companies and research centres to request national scientific and/or technical advice for research and development relating to medicines for human and veterinary use. This advice is requested with a view
to potential Clinical Trial Applications - CTAs, for MAs and for variations to existing medicinal product MAs.”
Why Scientific-Technical Advice within the FAMHP?
“The most important goal of the FAMHP in providing such national STA is to promote the development of new medicines inasmuch as possible and to act as a facilitator from a regulatory perspective, all of which is intended to improve the availability of innovative medicines for patients. In practice we consider this service to apply in the broadest sense; thus the FAMHP has also provided STA for (traditional) herbal medicines.”
How was this new service organised?
“The FAMHP implemented a new, centralised and transparent service within the DG PRE authorisation that will ensure timely processing of national STA applications. Absolute confidentiality must be ensured and potential conflicts of interest among the experts involved must be avoided.
The FAMHP wishes to ensure close follow-up of national and European opinions issued at an earlier date, e.g. via the interface with the SAWP of the EMA. This is important in order to guarantee the quality and consistency of national opinions issued by the FAMHP.
In the context of the current project for national STA the FAMHP, in collaboration with the partners involved, has developed a number of instruments with a view to providing an efficient service to the applicants. This involves, among other things:
formal procedures and •timelines;a central mailbox/helpdesk;•a database for national and •European opinions;an electronic application •form;guidelines for applicants;•a feedback questionnaire;•the regulatory framework for •national STA (such as the R.D. of 31 March 2009, B.S. - M.B. 14 April 2009) concerning the conditions, timelines,
procedures and contributions for national STA applications submitted to the FAMHP.
The progress of the project and this new service are regularly followed up by the national STA working group, with representatives of the pharmaceutical industry and the FAMHP.”
How does one apply for STA?
“Official applications for national STA falling within the legal definition of complex advice (FULL STA) or ad hoc advice (AD HOC STA) must be submitted to the FAMHP’s DG PRE authorisation. Applications must be sent electronically to the central mailbox
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implementation of the new Scientific-technical Advice (StA) within the FAMHP
[email protected]. In addition, applicants are requested to send at least two hard copies of the national STA application by post. STA applications must comprise sufficient supporting documentation and a completed electronic application form in order to ensure targeted and efficient processing of the advice application forms during the procedure and to enable the FAMHP to formulate correct and qualitative advice. Applicants can download the electronic application form from the FAMHP’s website.”
How much does an application cost?
“At present, the fees for national STA applications submitted to the FAMHP are as follows, regardless of whether they
concern initial or follow-up STA applications:
for complex opinions (FULL •STA): € 1976.15;for ad hoc opinions (AD HOC •STA): € 197.61.
The applicant is requested to enclose evidence of payment with the STA application, as this is verified at the time of validation of the application. The same rates apply to all national STA applications, regardless of:
the status of the applicant: •for example, sponsors of clinical trials, pharmaceutical/biotechnology companies (such as small biotech spin-offs, SMEs, multinationals), research centres;
the area to which the advice •pertains (e.g. paediatrics, oncology);the timing of the application •for the national advice (e.g. initial as opposed to follow-up advice).”
So how does the FAMHP handle this?
“All FULL and AD HOC STA applications submitted are subjected to a validation phase in order to verify whether the application meets all requirements.
FULL STA applications are processed by the FAMHP in a face-to-face meeting or a teleconference with the applicant within 70 days following validation. The applicant is expected to draw up
minutes of the meeting and to send them to the FAMHP within the fourteen days following the meeting. Then, within fourteen days following receipt of the draft minutes, the FAMHP returns the approved version to the applicant.
AD HOC STA applications are processed by the FAMHP by means of the issuance of a written opinion within thirty days following validation.
Once the final advice has been issued, the applicant receives a feedback questionnaire that can be completed on a voluntary basis and sent back to the FAMHP. The purpose of the questionnaire is to find out the applicant’s opinion of the quality aspects of the national STA service they received.”
“In 2009 it became possible to ask for national scientific and/or technical advice for research and development relating to medicines for
human and veterinary use. And we are doing all this in order to improve the
availability of innovative medicines for patients.
”
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Annual Report 2009
25
On 19 October, the FAMHP
presented its first information
campaign to the general public:
“Medicines via the internet?
Don’t surf with your health!”.
This campaign originates from
the excellent collaboration
between the Proper Use and
Communication Divisions and
the DG INSPECTION, and was
launched with the support of
the Minister for Public Health,
Ms Laurette Onkelinx.
The campaign was conceived in order to make the population aware of the potential dangers it may expose itself to when buying medicines over the
Internet illegally, and in order to hand people the key to buying medicines online in complete safety. Attention was also paid to the crucial role played by doctors and pharmacists within the scope of the proper use of medicines.
In addition to its role as a repressive control organisation and its combat against illegal practices as the authority responsible for the quality, safety and efficacy of medicinal products, the FAMHP also has an educational and informational function in regard to the general public to ensure that people can safely manage their health, which includes the proper use of medicinal products.
It was a nationwide campaign set up with the help of the Prime Minister’s FPS Chancellery. It was originally intended to run for just one month. By means
of banners on different websites and on MSN, posters in sports halls, wellness centres and university campuses and in press articles in various publications such as Metro, readers were invited to visit the minisite of the campaign, www.geneesmiddelen-via-internet.be,www.médicaments-par-internet.be
There was a second wave to the campaign at the end of December 2009 and in early January 2010 when it also appeared in magazines with a broad readership: Sport/Foot Magazine, Sport/Voetbal Magazine, Ma Santé, Goed Gevoel, Vitaya Magazine, LE VIF week-end and Knack weekend.
The minisite of the campaign, www.geneesmiddelen-via-internet.be,www.médicaments-par-internet.be, will remain accessible via a banner on the FAMHP website.
First campaign:“Medicines via the internet?Don’t surf with your health!”
O
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Annual Report 2009
By means of a 15 question quiz, users can test their knowledge concerning the purchase of medicinal products over the Internet, find a number of recommendations about how to procure safe medicinal products and download an information flyer.
“The campaign hands the population the key to
buying medicines online in complete safety.
”
Questions to Marie-Louise Bouffioux, Responsible for the Proper Use Division, FAMHP.
Why was a campaign of this type necessary?
“With the lightning speed of development of the World Wide Web, the number of illegal websites offering medicines for sale has strongly increased. In view of the health risks involved in buying illegal medicines over the Internet, and because there is only a limited effect of government controls and measures concerning the black market, in particular as concerns an international approach to the problem, it is necessary to warn the general public and make them aware of the potential risks. According to the WHO,
half of the medicines sold over the Internet are counterfeit *.”
What concept was chosen for this campaign?
“In view of the target public, i.e. people who buy things over the Internet and who are receptive to offers involving medicinal products, the campaign was primarily carried out online. The message is clear: “Medicines via the internet? Don’t surf with your health!”. The visual takes advantage of the double meaning of the snake together with the bowl of Hygieia. The bowl is usually the symbol for the science of healthcare, well-being and trust; the snake, on the other hand, which can behave in an insidious and dangerous manner when challenged, in this
case represents the unknown medicinal products supplier, whose identity and intentions are a mystery to us.”
How was the campaign received?
“It is difficult to place an exact figure on the results unless the target group is surveyed afterwards. We can however say that the campaign was a great success, both with the media and our partners but also, and above all, with our target group: the general public.
In October 2009 alone, the campaign minisitewww.geneesmiddelen-via-internet.be,www.médicaments-par-internet.be, received 491,179 visits**. Our clear message, the quality of our texts and the self-explanatory
“On the dynamic minisite of the campaign,
www.geneesmiddelen-via-internet.be,www.médicaments-par-internet.be,users can test their knowledge and
find recommendations.”
symbolism of our snake, which gives off a hissing sound at every wrong answer, were appreciated by our partners. The Agency is even being contacted by foreign institutions that now use our campaign as a reference.”
* Source: http://www.who.int/impact/FinalBrochureWHA2008a.pdf. **Source: Prime Minister’s FPS Chancellery.
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27
operation Pangea ii or the Belgian participation in an international operation to fight online sale of counterfeit and other illegal medicinal products
Questions to Roy Vancauwenberghe, Inspector of the Special Investigation Unit (SOE-USE) of the FAMHP.
What does Operation Pangea II represent?
“The fight against counterfeit and other illegal medicinal products requires not only a coordinated approach among the various bodies involved at a national level, but also a determined international cooperation in view of the fact that such illegal practices do not respect national borders.
Pangea II is one such internationally coordinated action that took place from 16 to 20 November 2009, focusing on the online sale of counterfeit and other illegal medicinal
“Operation Pangea II draws attention to the
illegal purchase of medicinal products over the Internet.
The fight against illegal medicinal products is a priority of the Belgian
government.”
products. This type of action seeks to attract attention to the purchase of medicines over the Internet, more particularly in the illegal segment. This operation was the fifth in a row and was set up by the British medicines authority, the MHRA.
Operation Pangea II was coordinated by Interpol under the aegis of the IMPACT initiative of the WHO. This initiative was further supported by the World Customs Organisation, which investigated the postal distribution linked to Internet ordering, and by the PFIPC. Twenty-six countries, including Belgium, collaborated in this operation.”
How was it done?
“A number of websites offering medicinal products were screened. Once again, an increase in the number of such sites has been noticed. The operation focused on the essential characteristics of illegal websites, the companies offering these products, the payment systems and the delivery of the orders via postal packages. The Belgian Customs and Federal Police as well as the FAMHP intensively collaborated in this action.”
How is Belgium looking to such operations?
“The fight against counterfeit and other illegal medicinal products is a priority of the Belgian government, and is included in the 2009-2010
action plan of the Secretary of State who ordinates the fight against fraud (in the economical sector), Carl Devlies. The intention is to develop a more intense collaboration and coordinated exchange of information among Customs, the FAMHP, the Federal Police, the FPS Economy and the FPS Justice.”
What results were obtained from Pangea II in Belgium?
“We would summarise the most noteworthy results as follows:
Five sale and auction sites •offering illegal medicinal products have been shut down. For a number of other sites, there are international investigations ongoing.Fifty postal packages intended •for Belgian purchasers were
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develop standard procedures which may improve the fight against pharmaceutical crime.There is an urgent need •for specific regulations concerning transit.The results demonstrate that •most of the illegal traffic sent by using the postal system involves slimming products, erectile dysfunction products, hormonal substances and sedatives. This is important information which may shape the future policy.”
originate primarily from India, Hong Kong, the USA, Egypt, China, Thailand and Brazil.”
What’s next?
“Well, joint actions of this type usually result in a number of conclusions and decisions:
Collaboration among the •Postal Service, Customs, the FAMHP and the Federal Police makes it possible to have a much more accurate picture of illegal Internet commerce and the illegal international trafficing of medicines. This is essential in order to develop an appropriate national policy.This coordinated approach •also makes it possible to
At Bierset airport, only •transit traffic was noticed. Some twenty consignments with approximately 20,000 doses were, in collaboration with other European countries, blocked for further examination:
approximately 5 % were -counterfeit drugs;another 30 % consisted of -prohibited psychotropics and significant quantities of illegal and counterfeit slimming herbs of Chinese origin;approximately 50 % were -hormonal products.
Qualitative testing was carried out on a number of products, and investigations were started up by the FPS Justice in collaboration with the Federal Police.The seizures appeared to •
seized at the Belgian national airport. These packages contained approximately 9,500 tablets or capsules representing:
erectile dysfunction -products being counterfeit, 5 %;illegal slimming products -containing prohibited and/or dangerous substances, more than 35 %;illegal hormonal or -prohormonal products of dubious quality, 30 %;herbal potency drugs -containing yohimbine, 7 %;ephedrine, an appetite -suppressant, 3 %;illegally imported -antibiotics, cholesterol lowering drugs, antidepressants, blood pressure medicines and painkillers.
“The results demonstrate that most of the illegal traffic
sent by using the postal system involves slimming
products, erectile dysfunction products, hormonal
substances and sedatives.”
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29
Project Backlog2009 trends
FFor several years now, we
have focused our attention on
working through our backlog.
The realisation came in 2009
with the approval of a new
action plan. This action plan was
communicated to authorisation
holders in a circular and in
two information sessions
organised in collaboration with
the pharmaceutical industry.
Another communication was
routed via the @ctua of July,
2009.
As shown in the graphs below, the different actions have led to an impressive increase in the number of applications completed in 2009 and in the backlog being reduced.
Another special feature in 2009 in relation to the processing of MA applications was the effective split of the old Registration division into two new divisions: the Marketing Authorisation Division (human) of the DG PRE authorisation and the Marketing Authorisation Division – Variations & Renewals of the DG POST authorisation. In view of the results achieved it can be said that our staff have very satisfactorily dealt with these changes.
Actions undertaken in 2009
Spontaneous filing of •“withdrawal letters” by the authorisation holders; According to the industry concerned, our backlog can also be related to the presence of old applications no longer
Applications 2007 2008 2009 trends, 2008-2009
iN 7,968 8,715 8,704 - 0,1 %
out 2,527 6,363 11,771 85 %
trends
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
2007 2008 2009
IN OUT
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Annual Report 2009
Worksharing; •The assessors developed an “MRP-like” procedure. This procedure enables an evaluation carried out by another European Member State to be used for the approval of an application in Belgium.
if the necessary documents are not filed within six months. Further to an opinion of the Council of State and because this rule does not enable the legally stipulated deadlines for the processing of MA applications to be met, it is necessary to adapt the maximum period for obtaining the necessary documents for the administrative closing.Risk analysis of backlog •applications in the evaluation phase; The Assessors Division organised various actions to help catch up on the backlog. One of the actions is a risk analysis of the applications to be assessed, which clearly helps to define the evaluation priorities. This type of analysis is also carried out for PSUR and national five-yearly renewals.
of the scientific procedure; In order to shorten the period of time that is necessary for the administrative completion of MA applications, the file managers are requested to assess these documents during the procedure. Within the scope of this evaluation, monthly indicators should enable the most frequent administrative mistakes to be highlighted.Regulations for the •withdrawal of inactivated applications; In view of the sometimes long waiting times for obtaining the necessary administrative documents for the closing of a MA application, a proposal was formulated to adapt the R.D. of 14 December 2006. This change follows a circular concerning inactivation, and comprises an automatic withdrawal of the applications
and the date of closing of the implementation file.Readability test – Risk Based •Approach for medicinal products approved before 1 May 2005; The FAMHP developed a risk analysis based evaluation. This should reduce the workload caused for the assessors by adapting the MAs filed before the coming into effect of the new regulations.Completion of applications •without impact on the “MA Light” (and the SPC, the package leaflet and the labelling) by the FAMHP; A simplified procedure was developed for the processing of variation applications, without impact on the administrative documents concerning an MA.Complete evaluation of the •SPC, the package leaflet and the labelling within the scope
requiring evaluation in view of scientific progress and applications filed at a later date. The FAMHP therefore encouraged the pertinent authorisation holders to withdraw such applications, and a procedure has been developed to facilitate the withdrawal of old applications.Implementation of “referrals”, •“class labelling” and other European decisions and recommendations; A simplified procedure has been developed for this type of application in order to enable rapid processing of applications concerning the implementation of European decisions or recommendations. In 2009 the average processing time for applications using the simplified procedure was 25 days between the date of filing
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FAMPH communication optimisation project
FFollowing the creation of
the Agency’s autonomous
Communication Division and
a number of communication
tools, optimisation of the
existing tools began in 2009.
The Communication Division tells us more about this project:
Was an optimisation of the existing tools actually necessary?
“Also, and perhaps even most of all, in the area of communication it is very important to follow new trends. In 2007 we were looking at developing an autonomous division. With limited resources we succeeded in designing
a logo and a house style, creating a temporary intranet, and launching an internal and an external newsletter. We have evolved from paper newsletters to “heavy” mails with attachments in PDF format, so now we felt it was time to switch over to the new trend of dynamic HTML newsletters.
The evaluation of the internal communication optimisation project was completed towards the end of 2009. The results will be implemented in early 2010. Our “optimised” tasks are also the cornerstone of our organisation’s strategic communication plan.”
Is the purpose of the exercise only to optimise the existing tools?
“Of course not. In view of the fact that the Agency is a federal public service and that in addition the nature of our work involves difficult and often confidential data, we can safely say that in this context communication is not the simplest of issues. In addition, to date we have used a rather reactive approach, but we’re learning. The first results of networking with journalists became apparent in the substantial increase of attention devoted to the FAMHP in both the written and the audiovisual media. In 2009 we had our first successful information campaign, which was launched under a lot of media attention and in the presence of the Minister of Public Health.”
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FAMPH communication optimisation project
Two press conferences have been planned for early 2010 for our media contacts:
the launch of the website with •the PILs and SPCs;the coordinated approach to •counterfeit and other illegal medicinal products.”
And what’s next?
“For the internal communication project, the way of thinking towards a more high performance intranet has now started. We want a sound search function, and in view of the implementation of the new organisation chart and the complete definition of the management structure, the pertinent business information must also be fitted in here. For the optimisation of external communication we will start by drawing up a clear overview of our Agency’s various target groups.
“The evaluation of the internal communication optimisation project was
completed towards the end of 2009.
”
“For the optimisation of external communication,
the Agency drew up a clear overview of the various
target groups.”
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2009 “Results”
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35
Pillar 1, the DG PRe authorisation, or all activities prior to approval of the first marketing authorisation for a medicine or health product
establishing an inventory of the tasks, rationalising the processes and defining priorities in consultation with the stakeholders involved. we carried out a highly positive catch-up operation in the processing of backlogged applications in the Marketing Authorisation (human), Medicines for Veterinary use and Assessors Divisions. i am really grateful to all staff for their commitment, both in the implementation of this new organisation – which for some was after all a substantial adjustment on a personal level – and for their strong will and consistent perseverance in reducing the backlog of applications.
Monitoring the activities of the staff allowed me to assess the need for additional staff. this is necessary in order to be able to take the next step towards
In the words of the Director-General, Greet Musch.
“the newly designed organisation chart of the DG PRe authorisation was successfully implemented in the course of 2009. in addition to two new staff divisions, Management Support and Scientific Advice & Knowledge Management, the four operational divisions: R&D (human), Marketing Authorisation (human), Medicines for Veterinary use and Assessors, were also instituted. in view of the specific nature of the activities, we also added two operational units: the Homeopathic & Herbal Medicinal Products unit and the unit that supports the Pharmacopoeia commission and the delivery of authorisations for raw materials used by retail pharmacists.
the focus in 2009 was on
a reorientation of resources after the current situation has stabilised, staying in line with the developments announced in the Road Maps of the eMA and the HMA on the one hand and with the development of the spearheads and related areas of expertise within the FAMHP. it is our intention to get a substantial number of these new staff members on board in the course of 2010. in addition, 2010 will see the appointment of the middle management, which will enable the management team of the DG PRe authorisation to be completed.
it is clear for me now that 2010 will be a challenging year for the DG PRe authorisation. the correct balance must be found in order to continue the actual service performance in a successful manner while simultaneously performing the
role of the Belgian Presidency of the eu as competently as possible. the DG PRe authorisation will hold numerous formal and informal meetings. in 2010 we will also very actively work on the development of the regulatory and scientific areas of knowledge by means of the implementation of a knowledge management system and by growing the StA service.
i will also ensure that together with all the staff of my DG, all my colleagues at the FAMHP and all stakeholders on the field we will be able to take a further step forward in the ultimate interest of the patient.”
36
FAMHP ~
Annual Report 2009
R&D Division(human)
Marketing Authorisation
Division(human)
Medicines for Veterinary Use
Division
Assessors Division
DG PRE authorisation
Greet Musch is an industrial
pharmacist and earned her
doctorate in Pharmaceutical and
Biomedical Science at the Free
University of Brussels in 1990.
Greet followed a management
training at Vlerick in 1994 and a
PUMP training organised by the
FPS P&O in 2003.
Following eight years’
experience in the
pharmaceutical industry in
the field of scientific research
as manager of the chemical
and pharmaceutical analytical
activities in the development
of innovative medicines, Greet
went to work in the public
sector. She progressed from
senior assessor “Quality” to
head of the R&D Division
within the Directorate-General
for Medicinal Products of
the FPS Public Health, later
the FAMHP. Greet is also a
member of the Clinical Trial
Facilitation Group (CTFG)
and of the Working Group for
Clinical Trials of the European
Commission.
On 21 January 2009 the Chief
Executive Officer announced
that Greet Musch would be
appointed at the FAMHP as
Director-General of the DG
PRE authorisation.
FAMHP ~
Annual Report 2009
37
R&D Division (human)
Within the new organisation chart, the R&D Division (human) is the logical successor of the former R&D Division. This division is responsible for the processing and follow-up of applications to perform clinical trials in Belgium. This involves both the applications for the first administration of a new medicine to human patients (first in human) and those pertaining to the very extensive testing of medicinal products in the later stages of development.
The core task of the R&D Division (human) is the protection of the subjects participating in clinical trials. This is done by means of an in-depth evaluation of the quality and safety of the medicines to be used for research purposes in such clinical trials. Together with the Ethics Committees, the risks and benefits of each trial are examined, and, if necessary, further information is requested from the trial sponsor. If the safety of the subjects cannot be guaranteed, the trial cannot go ahead.
In addition to this basic task, the R&D Division (human) promotes the development of innovative medicines, primarily by means of ensuring that the approval process for clinical trials can take place as expediently as possible.
The R&D Division (human) is responsible for:
receiving, verifying, •processing and approving applications for clinical trials;risk evaluation for each trial •and arriving at an adequate evaluation of the applications;follow-up on approved •applications by processing changes (amendments) and follow-up on e.g. adverse effects reports, annual safety reports and reports of (early) trial termination;processing of applications •for Compassionate use programmes and Medical need programmes.
The R&D Division (human) in 2009
On a European level, Belgium remained clearly present in the European discussion
platforms around clinical trials, such as the CTFG. A two-day workshop was organised in this facilitation group focusing on two spearheads of the FAMHP: EARLY PHASE DEVELOPMENT and ONCOLOGY. The division also actively cooperated in the pilot phase of the Voluntary Harmonised Procedure, a project that is developing a European application procedure for multinational clinical trials.
At the Belgian level, the regular consultation with the partners continues. Various consultation meetings were organised with clinical trial sponsors in order to clarify the procedures and explain the FAMHP’s requirements. A pilot project was started with a number of manufacturers of experimental medicinal products to simplify the notification system.
R&D Division(human)
Marketing Authorisation
Division(human)
Medicines for Veterinary Use
Division
Assessors Division
DG PRE authorisation
38
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Annual Report 2009
R&D Division (human)
medicinal products. This will be put into practice in the course of 2010 in a number of circulars to the pertinent target groups.
Frequent consultations also took place with the Ethics Committees, both in general and for individual applications, and a number of information sessions were organised for fully recognised Ethics Committees. This consultation involved a discussion of the components for harmonisation and improvement of the current situation. In parallel, consultations were also started about the role and responsibilities of both the FAMHP and the Ethics Committees within the clinical trial approval procedure.
Internally, cooperation was further developed, e.g. in connection with the processing of reports on adverse effects, the inspections concerning the execution of clinical trials and the expectations regarding production of experimental
2007 2008 2009 trends, 2008-2009
original applications/complete applications for clinical trials 560 633 527 - 17 %
Amendments/changes to original applications 1,214 1,504 1,547 + 3 %
Proportion of phase i trials out of the total number of applications 24 % 26 % 25 % - 1 %
Non-commercial (academic) trials 7 % 7 % 7 % Stable
Applications processed within the legally provided timeframe (15-28 calendar days) 95 % 97 % 95 % - 2 %
Compassionate use programmes - 4 10 + 150 %
Medical need programmes - 37 36 - 3 %
A few figures
The number of applications for clinical trials decreased in 2009. The number of amendments nonetheless remained on the increase. The percentage of phase I trials and non-commercial (academic) trials remained stable.
FAMHP ~
Annual Report 2009
39
Marketing Authorisation Division (human)
The new Marketing Authorisation Division (human) became operational on 1 July 2009 after a short period of transition. The structure of the division is fully in development and is at present divided among three units depending on the task descriptions:
MRP/DCP/NP Unit; •This unit is responsible for granting the first national MA for a medicinal product according to the mutual recognition procedure (MRP), the decentralised procedure (DCP) and the national procedure (NP). These three different procedures are described in the R.D. of 14 December 2006. The tasks of this unit consist of the validation, follow-up and closing of various procedures, and the processing of the Active
Substance Master Files (ASMF).
CP Unit; •This unit is responsible for following up on the central procedure (CP), for both new applications and for variations and renewals for which no national MA is delivered. The tasks of this unit primarily concern the follow-up of applications during the evaluation phase.
ASMF Unit; •This unit is responsible for ASMF follow-up.
Looking back on a successful transition
At the end of February 2009 the former Registration Division was split into the Marketing Authorisation Division
(human) within the DG PRE authorisation and the Marketing Authorisation Division – Variations & Renewals within the DG POST authorisation.
The former Registration Division had three sub-units:
Dispatching, which received •and validated applications;Management, which managed •the applications;Closing, for the administrative •closing of applications and delivery of the MA.
Before splitting into the two abovementioned divisions, it was necessary not only to review the staff ’s job descriptions but also to establish new functional teams.
During the first six months of 2009 the transition team, consisting of the staff members
of the former Registration Division, worked closely together to develop a phased action plan. This action plan was discussed in depth and finally validated by the Directors-General involved. During this validation, the focus was on guaranteeing the application output and keeping the backlog project action plan on track.
Marketing Authorisation
Division(human)
R&D Division(human)
Marketing Authorisation
Division(human)
Medicines for Veterinary Use
Division
Assessors Division
DG PRE authorisation
40
FAMHP ~
Annual Report 2009
30-day deadline. This is not always possible, but every day our highly motivated team aims to meet this deadline.
DCP or NP. The team was thoroughly trained during the second half of 2009. A great deal of attention was paid to the closing of 23 of the 27 backlogged clusters. The great challenge facing the team is at all times to accomplish closing of the applications within the legal
the number of query rounds during the closing process, resulting in shorter throughput times.Closing; -The closing team is responsible for the administrative closing of MA applications filed within the scope of an MRP,
What do we do?
MRP/DCP/NP Unit; •In this unit we distinguish two teams:
Validation – Management; -This team consists of five file managers and five administrative staff who ensure proper validation and follow-up of new MA applications submitted through the MRP, DCP and NP procedures. Staff members are given the necessary training. In September 2009, one of the Backlog action plan projects, i.e. the evaluation of SPCs/PILs and labelling, was successfully introduced. This project was introduced in order to have the administrative checks carried out simultaneously with the evaluation phase, with the goal of limiting
overview of the Marketing Authorisation Division (human)
0
10
20
30
40
50
60
70
07 08 09 10 11 12
IN OUT
Month in 2009
Num
ber o
f app
licat
ions
FAMHP ~
Annual Report 2009
41
Homeopathic & Herbal Medicinal Products unit
Remark: the general points described in this annual report in connection with MAs are to a great extent also applicable to registrations that are specific to some homeopathic medicines and traditional herbal medicines.
The role of the Homeopathic & Herbal Medicinal Products Unit is the granting and follow-up of registrations and MAs of homeopathic and herbal medicines. This unit is entrusted with the evaluation and management in the broadest sense of the word of registration and MA applications for homeopathic and herbal medicines, and with processing applications
CP Unit; •Two file managers work within this unit not only to ensure the follow-up on CP applications, but also to make an active contribution to the two spearheads ONCOLOGY and VACCINES. In order to enable these file managers to function efficiently, they are provided with the necessary training and take part in close formal consultation meetings with the Belgian branch of the CHMP. This unit also includes three staff members who work on the backlog regarding the Follow Up Measures (FUM). In the second half of 2009, 46 of the 61 backlogged FUM were completed.
ASMF Unit; •This unit is responsible for ASMF follow-up. The evaluation of these ASMF takes place in parallel with the MA application for the finished product. In the second half of 2009, this unit was able to eliminate its entire backlog.
overview of ASMF applications
0
5
10
15
20
25
07 08 09 10 11 12
New applications Updates
Month in 2009
Num
ber o
f app
licat
ions
42
FAMHP ~
Annual Report 2009
Herbal medicines
A herbal medicine is any medicinal product for human use that contains, as its active substances, exclusively one or more herbal substances, one or more herbal preparations or a combination of one or more herbal substances and one or more herbal preparations **.
In accordance with the R.D. of 14 December 2006 there are three procedures for issuing an MA or registration for herbal medicinal products:
the full procedure;•the Well Established Use •procedure;a specific procedure for •traditional (TU) herbal medicines as stipulated in Article 43 of this Decree.
18,000 homeopathic medicines were notified, and the phased registration procedure is ongoing.
The Homeopathic & Herbal Medicinal Products Unit ensures follow-up of applications for amendment of the content of the notification of notified homeopathic medicines not yet registered/authorised. Each new homeopathic medicine that has not yet been notified needs to be registered/authorised before it can be placed on the market. Two procedures are described in this connection in the R.D. of 14 December 2006. Currently there are various ongoing registration procedures and procedures for obtaining an MA. The HCG - HCM plays a crucial role in the processing of these applications.
Homeopathic medicines
A homeopathic medicine is any medicinal product obtained as a result of a homeopathic manufacturing process described in the European Pharmacopoeia or, in the absence thereof, in one of the pharmacopoeias officially in use in the European Member States, from substances referred to as homeopathic raw materials*.
There have been homeopathic medicines on the market for a long time. The regulators have implemented measures to apply controls to this market taking into account the developments at European level. In Belgium, in a first phase all homeopathic medicines that were on the market had to be notified in preparation of their registration/authorisation. Approximately
for amendment of such registrations and existing MAs. Various file managers and experts are responsible for managing the applications and for the evaluation of quality, safety and efficacy of the medicines. The unit also collaborates in the supply of STAs.
The Homeopathic & Herbal Medicinal Products Unit coordinates the tasks and provides the secretariat function for two independent commissions:
Evaluation commission for •homeopathic medicines for human and veterinary use (HCG - HCM);Evaluation commission for •traditional herbal medicines for human use (CKG - CMP).
* and ** Source: law of 25 March 1964.
The Homeopathic & Herbal Medicinal Products Unit is reponsible for the evaluation and management of these applications, as well as for processing applications for changes to registrations and MAs for herbal medicines. For this purpose, a file manager and various experts work closely together with the CKG - CMP.
FAMHP ~
Annual Report 2009
43
including preparation of the monographs by the experts;collaboration with the DG •Animals-Plants-Foodstuffs of the FPS Public Health.
Only 125 notifications were filed within the scope of the notification project by twelve different companies, including only two non-pharmaceutical companies.
means of a number of written procedures, as well as dealing with:
the granting of the first six •registrations for traditional herbal medicines in Belgium;follow-up on applications •concerning new and current applications, both for new registrations/authorisations and for variations;further follow-up of the •TU notification project with the publication of the R.D. of 28 June 2009;interaction with the Mixed •commission of the FAMHP for which the CKG - CMP issues expert opinions;preparation of scientific •opinions;the link with the HMPC also •
the general monograph concerning preparation methods for homeopathic raw materials and deconcentration;the processing of requests -for modification of notifications.
In the year 2009 two important meetings with stakeholders were held concerning the timelines for CTD format filing and cross-referencing for homeopathic medicines.
At the start of 2008, an autonomous commission, the CKG - CMP, was established, which continued its activities in 2009. The Commission met four times and assured the continuity of the current applications by
finalisation of a clarification -note concerning module 5 data for both the simplified and the full procedure.
Preparation for and •interaction with:
the HMPWG, by means -of participation in two meetings at European level. Belgium is acting as rapporteur for the First Safe Dilution (FSD) and Justification of homeopathic use projects. There is also consultation on quality aspects, including stability. The unit coordinated two working groups for the two projects, and four draft documents* were published on the HMA website for public consultation;the EDQM-HMM, for -
A few figures
The HCG - HCM met eleven times in 2009.The commission dealt with:
Monitoring of the test phase:•128 assessment reports -(including advertising applications) of module 3 as well as responses to questions;twenty assessment reports -(including advertising applications) of module 5;sixteen company requests -for response deadline extensions;twelve applications for -changes to notifications;drafting of standard -comments regarding the various aspects of module 3;
* Source: http://www.hma.eu/79.html.
44
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Annual Report 2009
obtaining an MA remained approximately stable: - 550 applications, NP;
33 applications, MRP; -16 applications, DCP; -
evaluation of eight •applications for TGV - ATU.
(Co-)rapporteurships:
During 2009 Belgium was •active as (co-)rapporteur in:
seven CPs for new -medicines;seventeen CPs for variations; -five referrals. -
Medicines for Veterinary use Division
For the sixth year in a row the number of closed MA applications within the Medicines for Veterinary Use Division has exceeded the number of new applications submitted. We nevertheless note a steep increase in the number of incoming applications for veterinary medicines. In 2009 there was primarily a strong increase in the number of type IA variations.
In order to further reduce the backlog of current applications, the following measures were taken in 2009:
on 1 September 2009, the •Medicines for Veterinary Use Division was enhanced with the assignment of one file manager and one administrative assistant;on 1 September 2009, a •contract was signed with an external expert for the evaluation of the NP for renewals;the collaboration with •the CODA-CERVA for the evaluation of the quality applications for vaccines was extended.
R&D Division(human)
Marketing Authorisation
Division(human)
Medicines for Veterinary Use
Division
Assessors Division
DG PRE authorisation
A few figuresApplications
Meetings:
eleven plenary meetings of the •Evaluation commission for medicines for veterinary use;eleven meetings of the Bureau •of the commission.
Number of applications managed by the Evaluation commission for medicines for veterinary use:
increase of 8 % in NP •evaluation reports for obtaining an MA as compared to 2008. The number of applications discussed for MRP and DCP for
2007 2008 2009 trends, 2008-2009
total number of applications submitted 829 1,138 1,746 + 53 %
total number of closed applications 915 1,654 1,810 + 9 %
FAMHP ~
Annual Report 2009
45
Assessors Division
Since similar skills and expertise are required for the evaluation of the different types of applications managed by the various divisions of the FAMHP, a decision has been made to centralise this expertise in an Assessors Division. Assessors specialise in the relevant scientific domains to serve the FAMHP’s various other divisions.
The following groups work within this division:
chemical, biological and •pharmaceutical assessors;non-clinical assessors;•clinical assessors;•veterinary medicine assessors.•
Evaluation tasks and priorities
It is not possible to assess all incoming applications within the FAMHP itself. Based on a risk analysis, a differentiation is made between applications:
that must be fully assessed;•for which an abbreviated •evaluation suffices;for which no specific •evaluation is necessary.
This analysis takes into account the risks involved for Public Health, the responsibility of the FAMHP, the evaluation by the EMA or the competent medicinal product authorities of other European Member States, and the areas in which the FAMHP is seeking to establish expertise.
Overview of the most important evaluation tasks
CTAs for medicines for •human use:
initial study and -amendments;quality and non-clinical -aspects.
MA:•human and veterinary; -first application, Type II -variations & renewals;DCP, MRP, CP and NP. -
STA:•human and veterinary; -national and European. -
Risk Management Plans:•human and veterinary -medicine.
PIP.•
Backlog action plan
By the end of 2010, the purpose of the backlog action plan concerning the backlog of the NP evaluation is:
complete elimination of the •backlog concerning medicines for human usea significant reduction of the •backlog for medicines for veterinary use.
As part of the action plan, among other things, the number of Belgian evaluations of applications previously assessed by another European Member State is being reduced. In 2009 the number of applications pending evaluation has significantly decreased. The results confirm that accomplishing this goal before the end of 2010 is realistic.
R&D Division(human)
Marketing Authorisation
Division(human)
Medicines for Veterinary Use
Division
Assessors Division
DG PRE authorisation
46
FAMHP ~
Annual Report 2009
e.g. by collaborating in the development of new guidelines;general support of the •FAMHP by coordinating and/or participating in projects such as the spearheads, and answering scientific enquiries;harmonisation of the •evaluation reports, e.g. by implementing a peer review system and consultation in internal, scientific meetings;training, in order to keep the •relevant expertise up to date.
Other assessor tasks
Beside the evaluation of scientific data, the most important tasks of the assessors are the contributions to national and international scientific committees and active participation in projects in support of the FAMHP. The Assessors Division represents the FAMHP in four of the five scientific committees within the EMA and their essential working groups. Three of the four spearhead coordinators of the FAMHP also work within this division. The goals are:
participation in scientific •committees, e.g. by means of the presentation and discussion of evaluation reports, and in the activities of the pertinent scientific working groups,
Distribution of tasks of the assessors (average)
Evaluation Scientific committees FAMHP support Harmonisation Training Other
FAMHP ~
Annual Report 2009
47
Pillar 2, the DG PoSt authorisation, or all activities following approval of the first marketing authorisation for a medicine or health product
In the words of the Director-General, Vanessa Binamé.
“My new function as Director-General is a real challenge for me. the public sector is under ever more pressure from the users’ growing expectations, and must work ever more efficiently and at the same time take strict budgetary obligations into account. this requires great adjustments, such as:
rationalisation of the •organisations and simplification of the procedures;accountability and performance •measurement of the people involved;very strict follow-up and •control;
improvement of the quality •of the service and the relationships with the users.
in fact, there has been no lack of challenges since i took up my post. i keep on learning thanks to my colleagues, all of whom are specialists in their own technical fields, and – with a lot of patience – have given me an insight into their specialisations and initiated me into their world. in fact, this is of course not at all obvious when you are constantly balancing your obligations and limitations. Meeting these goals sometimes needs tonnes of energy and more time than expected, but i don’t allow this to stand in my way.
like many other people, i am of the opinion that we must be an efficient Agency in the service of the entire population and of patients in particular. A lot of things still need to be accomplished within the DG
PoSt authorisation. this ranges from the simplification of the administrative procedures to the development of the area of medical devices, via the improvement of the information we provide to patients to increased pharmacovigilance for new medicinal products and health products. Finally, there are also the new competences of the Agency in connection with human tissue material.
the end of 2009 put a lot of pressure on my staff. thanks to their enthusiasm and persistence and the high quality of their work, numerous projects have been brought to a successful end. this was the case in connection with the coming into effect of the new regulations concerning variations, the introduction of risk analysis for the evaluation of five-yearly renewals, preparations for the publication of SPCs and Pils
on our website, and the coming into effect of the law concerning human tissue material. And i can only tell you that 2010 will bring no less pressure!
i would also like to take advantage of this opportunity to express my thanks to the various representatives of the sector who have collaborated with us in our improvement and development projects. we have developed a partnership and seek to find solutions together that are realistic for both parties alike. it is very important that our decisions be based on the realities in the field. it would not be appropriate to stipulate measures that cannot be implemented in practice. in that regard, consultation is very important and the feedback we receive helps us to continuously develop and improve, day in and day out.
Marketing Authorisation
Division
Variations & Renewals
Vigilance Division
(pharmaco, materio, haemo,
bio)
Health Products Division
Proper Use Division
DG POST authorisation
48
FAMHP ~
Annual Report 2009
Later she coordinated the
processing of CP applications.
Thereafter, she combined
the roles of flow coordinator
for a pharmacotherapeutic
group with the tasks of
staff member of the former
Registration Division of
the Directorate-General for
Medicinal Products of the FPS
Public Health, now the FAMHP.
Between June 2007 and October
2009 Vanessa represented
Belgium within the CMD(h) and
NTA. In September 2009 she was
appointed Director-General of the
POST authorisation pillar of the
FAMHP by the Chief Executive
Officer.
Vanessa Binamé completed
her Pharmacy studies in 1998
at the University of Liège.
Then, in 2003, she earned a
supplementary diploma in
management at the FUSL
University School in Brussels.
From 2005 to 2007 she
participated in the Pharmed
programme organised by the
Free University of Brussels,
and between 2008 and 2009 she
attended the Vitruvius training,
a leadership development
programme of the FPS P&O.
In 2001 Vanessa started working
at the then General Pharmaceutical
Inspectorate as a file manager
for TSE applications.
Now, i must thank my colleague wim Penninckx. He held the post of interim Director-General of the DG PoSt authorisation until i was appointed in September 2009. thanks to his efforts and on the basis of his action plan, 2009 became an overwhelming success for my DG!”
FAMHP ~
Annual Report 2009
49
Marketing Authorisation Division – Variations & Renewals
The new Marketing Authorisation Division – Variations & Renewals became operational on 1 July 2009 after a short period of transition. The structure of the former Registration Division, with its three subunits Dispatching, Management, and Closing, was maintained during the first half of 2009.
A few figures
Activity Figures trends
ClusterFive-yearly renewals and variations with impact on the closing documentsApplications
uploading•validating•managing•closing•
Administration of the MeSeA database
IN: 1,869OUT: 2,268
2009 is the first year in which more applications were closed than received.
Project BacklogLetter of withdrawal; •Companies are advised to spontaneously withdraw applications which are still pending at the FAMHP and in which they themselves no longer have an interest.
Implementation of referral, class labelling and European •recommendations; Because these applications often deal with safety aspects, a simplified procedure was designed enabling companies to implement the mandatory changes in the SPCs and PILs for the concerned product.
Variations without impact on light AMM; •In the course of the analysis of the backlog it became apparent that a great number of the applications still pending were simple variations that had no influence on the closed documents. These applications were filtered out and closed by a special team. For the newly submitted applications, too, a separate working method was set up, whereby one single file manager handles the application from beginning to end.
IN: 26OUT: 26
IN: 8OUT: 8
IN: 2,062OUT: 2,518 including 492 backlog applications
Start: 30 June 2009this project later ➞became standard procedure.
Start: 30 June 2009this project later ➞became standard procedure.
Start: 30 June 2009this project later ➞became standard procedure.
Marketing Authorisation
Division
Variations & Renewals
Vigilance Division
(pharmaco, materio, haemo,
bio)
Health Products Division
Proper Use Division
DG POST authorisation
50
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Annual Report 2009
Activity Figures trends
Project Backlog (continued)Full evaluation of the SPCs, PILs and labelling during the procedure; •In order to prevent too many queries in connection with the SPCs, PILs, labelling and packaging at the closing phase of an application, the evaluation of a number of administrative data is shifted from the closing phase to the evaluation phase of the application.
Change MAH; •The scope of this project was expanded to include change of distributor’s name and medicinal product name if connected to a change of MAH and batch releaser.
IN 236OUT 233
Start: Applications filed since 1 September 2009
this project later became ➞standard procedure.
Start: 30 June 2009this project later became ➞standard procedure.
Conclusionin the last six months of 2009, 4,167 applications were introduced, and 5,019 were closed. when counting the first six months of the year, the difference becomes even more significant. 2009 is the first year in which the FAMHP succeeded in closing more applications than the number of applications submitted.
Better Regulationon 1 January 2010, a new regulation for the management of variations for medicinal products came into effect. this new regulation contains a number of important changes:
a new classification for the variations;•type iB variations by default;•do-and-tell principle;•grouping of variations;•worksharing;•new rules for implementation;•implementation of concrete deadlines for the adaptation of the authorisations.•
Adaptation of the regulatory framework, in collaboration with the Legal Affairs Division.
First amendment to the R.D. of 14 December 2006, in September 2009.
Adaptation of MeSeA, in collaboration with the Marketing Authorisation Division (human) and Cegeka.
Implemented with the “December release”.
Adaptation of the procedures and SOP. Implemented in December 2009.
Organising information sessions for internal staff and external partners (industry).
Implemented in October, November and December 2009.
Staff training. Implemented in December 2009.
Crossover Projects Division
General classification for supply;The division collaborated in the development of a foundation document for assignation of the general classification for supply.
Management of national type II variations analytical;Transfer of management of the variations from the assessors to the file managers.
Implementedall these variations are managed by the file managers of the Marketing ➞Authorisation Division – Variations & Renewals.
Evaluation of national type IB variations;Transfer of the evaluation of these applications from the assessors to the file managers.
Implementedall these variations are evaluated and managed by the file managers of the ➞Marketing Authorisation Division – Variations & Renewals.
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Annual Report 2009
51
Vigilance Division (pharmaco, materio, haemo, bio)
The mission of the Vigilance Division (pharmaco, materio, haemo, bio) is to watch over the safety in use of medicinal products for human or veterinary use (pharmacovigilance), of medical devices (materiovigilance), of blood and unstable blood derivatives of human origin (haemovigilance), and of human tissue material (biovigilance). This mission comprises the collection of information, the evaluation of this information and taking appropriate measures where applicable.
The most important tasks of the division are:
The collection and evaluation •of:
individual reports of adverse -reactions originating from MA holders and healthcare
professionals (medicines for human and veterinary use);periodic reports in the area -of pharmacovigilance (PSUR) (medicines for human and veterinary use).annual safety reports -regarding clinical trials (ASR) for trials carried out with medicines authorised in Belgium (human medicines);incidents following the -use of medical devices; this enables dangerous devices to be taken off the market and to remedy shortcomings of medical devices with a view to a gradual improvement of their quality and better safety for patients and users;information concerning -serious adverse events and reactions with blood and blood components;
information concerning -serious adverse events and reactions with human tissue material; since 1 December 2009 it is mandatory to report such events in accordance with the publication of the R.D. of 28 September 2009. Since 2008 reporting has taken place on a voluntary basis while awaiting publication of the abovementioned decree.
The management and •evaluation of applications for five-yearly renewals approved via NP (medicines for human use).Participation in activities •within the scope of European pharmacovigilance (medicines for human and veterinary use).Dissemination of •information in the area of pharmacovigilance for
the attention of healthcare professionals and the public.Implementation of the •measures proposed after evaluation of pharma- covigilance data. This is done in collaboration with the Marketing Authorisation Division – Variations & Renewals and the DG PRE authorisation (medicinal products for human and veterinary use).Implementation of the •measures proposed after the evaluation of materio-, haemo- and biovigilance data;
Vigilance Division
(pharmaco, materio, haemo,
bio)
Health Products Division
Proper Use Division
DG POST authorisation
Marketing Authorisation
Division
Variations & Renewals
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Activity 2008 2009 trends,2008-2009
Pharmacovigilance of medicines for human use
PSUR 1,015 1,891 + 86 %
Five-yearly renewals 77 79 + 3 %
Individual reports of adverse reactions 4,125 4,244 + 3 %
Materiovigilance
Number of adverse reactions 805 1,038 + 29 %
Haemovigilance
Number of serious adverse events and reactions 782 852 + 9 %
Five-yearly renewals and PSuR: Backlog trends (applications pending)
Five-yearly renewals 812 645 - 21 %
PSUR 2,566 2,487 - 3 %
eudraVigilance backlog( January 2005-April 2008: trend in % of reports still to be handled)
Electronic forms 79 % 31 % -
Yellow paper forms 100 % 70 % -
A few figures
As can be seen from the table below, the action plans have enabled the reduction of part of the backlog of the PSUR, five-yearly renewals and reports to be introduced into EudraVigilance. These actions will be continued and expanded in 2010.
The actions undertaken within the scope of the PROACTIVE VIGILANCE spearhead are described in the present annual report in the spearheads section.
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53
Health Products Division
Blood, cells and tissues
The law of 19 December 2008 concerning the acquisition and use of human tissue material for medicinal purposes in humans or scientific research came into effect on 1 December 2009. It is supplemented by a law of 23 December 2009 containing special provisions. As a result of these laws, all institutions approved under the previous regulatory framework must renew their authorisation in compliance with the new regulations. This also applies to facilities operating a care programme in reproductive medicine, to clinical biology laboratories performing work in the area of the capacitation of male gametes, to intermediary structures, and to facilities dealing in the production of human tissue material (autologous transplants).
A few figuresA total of 120 to 160 •applications are expected in 2010.Five authorisations of •blood facilities and one authorisation of a facility for human tissue material were extended in 2009.The interdepartmental •committee of blood experts has not met since 2008 and is therefore de facto dissolved.The FAMHP was represented •in the meetings of the Blood Working Group of the Belgian Federal Supreme Health Council (six meetings) and of the Cell, Tissue and Organ Working Group of the Belgian Federal Supreme Health Council (ten meetings). The consultation between these working groups related primarily to proper use, quality standards and technical standards for
products of human and animal origin.
Human tissue material: new powers, new rules
Human tissue material comprises any biological body material, including human cells and tissues, gametes, embryos, gonads and fragments of gonads, foetuses, as well as the substances extracted therefrom, regardless of their degree of processing*.
The new regulations concerning human tissue material came into effect at the end of 2009, as a result of the coordinated publication of a whole set of laws, in order to meet all prerequisites for an optimum start for these new powers. On 23 October 2009 the first implementation decrees of the law of 19 December 2008 concerning the acquisition and
use of human tissue material were published in the B.S. – M.B. All the above enabled the law and its implementation decrees to come into effect on 1 December 2009. The law of 19 December 2008 applies to the donation, removal, acquisition, testing, processing, preservation, storage, distribution and use of human tissue material intended for medicinal applications in humans or for scientific research. The Agency was assigned new competences in this context in the areas of ethics, quality and vigilance concerning human tissue material.
In order to simplify the exchange of information with the new partners, the Agency set up an informal consultation platform with hospital representatives affected by this topic.
* Source: law of 19 December 2008 on the acquisition and use of human tissue material for medicinal purposes with a view to medicinal application in humans or for scientific research.
Vigilance Division
(pharmaco, materio, haemo,
bio)
Health Products Division
Proper Use Division
DG POST authorisation
Marketing Authorisation
Division
Variations & Renewals
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a M.D. published in August of 2009.
international cooperation and Belgium’s participation in the meetings with the competent authorities and the European working groups are essential.
The FAMHP is also responsible for the notification and supervision of the notified bodies established on Belgian territory. There are two of these organisations in Belgium: Apragaz and SGS Belgium. Finally, the FAMHP also provides authorisations for clinical evaluations of critical products.
Progress recorded in 2009
Within the scope of the regulations concerning the care plan for diabetics, associations wishing to supply lancets, needles or swabs must obtain an authorisation from the FAMHP. This approval is regulated by
products may be marketed without the intervention of the competent authority. The conformity inspection at the manufacturer’s is undertaken by a third party (a notified body), which issues a CE certificate. This certificate allows the manufacturer to include the European CE conformity mark on all relevant products. Medical devices with CE marks are approved for free circulation within the EU.
Therefore, on the basis of these European directives the FAMHP is principally charged with supervising the market by monitoring incidents (materiovigilance) and by inspecting manufacturers, distributors and retailers established on the Belgian territory. In view of the free circulation of goods,
medicinal applicability to humans, but also within the scope of innovative therapies based on tissue manipulation. These highly innovative medicines hold hope for numerous, often rare, diseases for which no or only few therapeutic options existto date.
The Agency is also responsible for supervision in matters concerning human tissue material, referred to as biovigilance. All facilities are under the obligation to report adverse reactions and serious adverse events to the Agency.
Medical devices
The European directives applicable to medical devices are referred to as the New Approach Directives. This means that
The Agency is thus now also responsible for inspections in facilities performing actions such as obtaining, testing, processing, preservation, storage or distribution – including imports and exports – of human tissue material. When the inspection is completed with a favourable opinion, the facilities obtain an authorisation for their activities. The first preliminary authorisations were in fact already granted before the end of 2009.
This regulation comprises very broad topics, as it applies, among other things, to bone tissue, stem cells, gametes, the preservation of skin and keratinocyte cultures. This domain will undoubtedly undergo significant development in the coming years within the scope of
Activity iN out
Tax declarations 724 724
Notifications for distribution 157 149
Export certificates 643 643
Clinical trials 36 36
Custom manufacturer notifications 12 12
Class I manufacturer notifications 127 33
Approval within the scope of the care plan - diabetes 41 41
A few figures
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55
Proper use Division
The safety and efficacy of medicines and health products are closely associated with their correct use. In order to promote proper use of medicines, it is first of all important for both healthcare professionals and patients/consumers, as well as for those organisations involved in healthcare to have easy access to objective, appropriate and up-to-date information concerning medicines and health products.
The Proper Use Division (BUM) ensures that all stakeholders have access to the necessary information allowing them to take the most appropriate decisions for a rational and safe use of medicines and health products.
The most important tasks of the division are:
providing information •about medicines and health products;introduction of standards •in the area of advertising, and, especially in regard to the general public, prior review of all advertising and information campaigns on radio and TV that make reference to medicinal products.
Actual accomplishments in 2009
In collaboration with the other divisions of the Agency and with the technical cooperation of Fedict, the BUM Division ensures the maintenance and further development of the FAMHP’s website. This division collects and distributes relevant information about
medicines and health products and also manages the database of medicines authorised in Belgium. This database can be consulted on the Agency’s website and is an important instrument also used by all other divisions and departments of the FAMHP as part of their work. For the BUM Division itself, this database is the source of answers to the numerous queries concerning information about medicines and originating from healthcare professionals, patients/consumers, the industry or other national or foreign organisations.
Healthcare professionals need to be encouraged to promote the rational use of medicines. In this respect it is important that they have access to objective and constantly up-to-date information in order to adapt their practices to the
principles of Evidence Based Medicine. In this context, the Agency supports provision of pharmacotherapeutic information to care providers and has concluded partnerships with independent organisations providing objective information about medicines i.e. with the non-profit associations BCFI-CBIP and Project Farmaka. In doing so, both the content expectations of healthcare professionals and also the user friendly accessibility and consultability of the data are taken into account.
In 2009 the BUM Division experienced three highlights within the information function:
The launch of the new website •of the FAMHP; On 21 January 2009, in collaboration with the Communication Division
Vigilance Division
(pharmaco, materio, haemo,
bio)
Health Products Division
Proper Use Division
DG POST authorisation
Marketing Authorisation
Division
Variations & Renewals
56
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Annual Report 2009
representative associations, to help with the compilation of SPCs and PILs and their publication on the website. The publication project, which is planned to start in early January of 2010, will in a first phase involve medicines authorised in Belgium and available on its market.
Advertising
It is also important for the rational and safe use of medicines that the information provided about them in advertising messages is in agreement with the elements approved when the MA for the medicine was granted. At the same time, the rational use of medicines must also be promoted. Thus, any advertising for medicines for human use intended for the general public is checked
that complete and updated versions of these documents are available to all those who need them. For this reason, these documents will be made publicly available on the Agency’s website. The FAMHP is in fact under the statutory obligation to do so in application of the R.D. of 14 December 2006. The FAMHP will start a project enabling publication and updating of the documents based on internal data processing. The implementation of this project is planned to start in early 2012. While awaiting the results of this project, and in order to be able to publish the information as quickly as possible, the FAMHP can count on the cooperation of the pharmaceutical companies, and more particularly their
pharmacists. The information concerning the role of the Internet in the commerce of counterfeit and other illegal medicines demonstrates that, in addition to all conventions and controls organised on a national and international basis to fight this scourge, it is also absolutely necessary to educate the population about the risks it exposes itself to by illegally buying medicinal products over the Internet.The preparation of the •publication of the SPCs and PILs; The SPCs and the PILs that are approved with the registration or MA of a medicinal product constitute the basic information and reference for safe and adequate prescription, dispensing and use of such medicines. It is consequently of the utmost importance
[email protected], but also an address for questions about medicines authorised in Belgium: [email protected] campaign “Medicines via •the Internet? Don’t surf with your health!”; Under the umbrella of the BUM Division and in collaboration with the Communication Division and the DG INSPECTION, the FAMHP introduced this year its first campaign: “Medicines via the internet? Don’t surf with your health!”. The campaign was conceived to render the population aware of the potential dangers it may expose itself to when illegally buying medicines over the Internet, and in order to hand people the key to buying medicines in complete safety with the advice of doctors and
and with the cooperation of all other departments, the BUM Division launched the new website of the FAMHP. The website was given a clear structure and offers simple navigation, thus becoming a dynamic and efficient instrument to help our Agency to carry out its mission. One of the novelties on the website is the possibility to register to receive the “news” of the FAMHP. Thus, registered users are quickly informed whenever any reports are published that contain news about regulatory affairs or new administrative procedures, and more particularly when it’s related to problems with the safety, quality or unavailability of essential medicines. Also, the website introduces not just a new general contact address:
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Annual Report 2009
57
A few figures
Prior review of advertisements aimed at the general public
Radio and television advertisements
Number of meetings of the Commission for the supervision of advertising
17
Number of visa requests for advertisements 65
Number of visa requests for information campaigns 13
Other media Number of notifications 347
information
Requests for information
Received1,594
representing 4,276 questions
Processed1,599
representing 4,307 questions
Reports published on the new website of the FAMHP
61
Risk Management Plans – supplementary risk limitation measures
Approval applications filed 28
Opinions delivered (first opinion favourable or preliminarily negative)
20
prior to publication. Radio and television advertisements are provided with a visa granted further to an opinion from the Commission for the supervision of advertising of medicines for human use or after notification to the FAMHP if involving other media.
In order to regulate the quality and relevance of messages to the public, a prior visa is required for radio and TV information campaigns about human health and diseases which refer directly or indirectly to medicines. This visa is also issued by the Minister for Public Health following an opinion from the Commission for the supervision of advertising for medicines for human use.
58
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59
Pillar 3, the DG iNSPeCtioN or all inspection and control activities
risk-based inspections •in consultation with the stakeholders;self-auditing controls;•team inspections;•inspections of veterinary •medicines up-to-date with the new regulations;control activities in countries •outside the eu;more attention for control •activities in regard to medical devices;control activities in the new •domain of cells and tissue.
Development of a “corporate database inspection” will be crucial. inspection and control do, of course, comprise managing and enforcement in order to ensure that intentional violations are detected and hunted down. SPoC networks at national and international level must facilitate and improve these processes.
i found a team that was a treasure trove of knowledge, experience and human potential. And, yes, there is a saying about “new boss, new rules” which mostly creates anxiety … but if this is translated into “new coach, new opportunities”, then one can freely plan on building on what’s already there. the DG iNSPeCtioN approach plan was also characterised by the fact that it evolved from a stable foundation.
A logical course of action starts out from a properly framed control policy. in practice there are guidelines for planning inspections and controls, but there is plenty of room for research and development. in connection with this, a concept of “art nouveau” inspections came up:
this lead to my membership of the Federal Supreme Health Council and my chairmanship of the european Assisted Conception Consortium, which, in the context of this directive and in collaboration with the european Commission, gathered the healthcare professionals and regulators working in the field of reproduction. this brought about my first contacts with the FAMHP, which is the authority responsible for cells and tissue in Belgium, and created the interest that led me to enter my name for the selection of the Director-General of the DG iNSPeCtioN at the FAMHP.
it was well into 2009 before i took up my new role. i will therefore also take this opportunity to thank my predecessor, Paule Jacqmain, for her commitment in exercising the role of interim Director-General. when i arrived,
In the words of the Director-General, Josiane Van der Elst.
“Although i am not “Agency grown”, for me, choosing to apply for this job as a manager in a federal public service seemed like a very natural move in my career path, which began in the academic world. Because of my supervisory functions, the “management” aspect came up much earlier, but the seed for the switch from clinical/scientific management within university hospitals to regulatory management within the public healthcare sector was planted in around 2000. At that time, the field of medically assisted reproduction was first included in the scope of applicability of the european “cells and tissue” directive. it felt natural to begin to move in the national and international regulatory corridors of power.
Control Policy
Division
“Industry”
Division
“Dispensing”
Division
SOE-USE
Special Investigation Unit
60
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Annual Report 2009
DG INSPECTION
cycle can then be repeated ad infinitum.
And, finally, – there is no coach without a team.”
On 1 November 2009, Josiane
Van der Elst took office as
Director-General of the DG
INSPECTION. Josiane started
her biology career as a scientific
researcher, and enhanced
this phase of her professional
life by earning a doctorate
in reproductive biology. The
next step was her job as head
of the laboratories for in-vitro
fertilisation, combined with her
part-time employment as an
associate professor, first at the
University of Ghent and later at
the Free University of Brussels.
this is in line with the policy memorandum from the Minister of Public Health and with that of the Medicrime Convention of the Council of europe.
More specifically, i would like to develop the transversal relationships within the DG iNSPeCtioN and with the other two DGs, the Support services, the Communication Division, the PMo unit and the international Relations unit. this must fit within a context of total Quality Management (tQM) which in itself must also be in line with the strategy of the Government Commissioner for internal Control & internal Audit. Although tQM sometimes strikes fear in people’s hearts, the concept is really quite simple: first a self-evaluation, then an improvement plan, followed by verification that the goal has actually been accomplished. this
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61
Control Policy Division
Although the Control Policy Division was not yet operational in 2009, the planning of the different types of inspections was nonetheless determined in accordance with a policy based on risk analysis. In the future, this division will be empowered to develop a control plan for all inspections, for the evaluation of the key performance indicators, and for the development and later monitoring of standardisation based on the regulatory framework. The division will not only work closely together with the two other inspection divisions and the Special Investigation Unit, but also with the other two DGs.
The DG INSPECTION is also responsible for other administrative tasks such as dealing with quality issues, the retail pharmacies registry, recognition of Qualified Persons
(QP), of the persons responsible for pharmacovigilance and of the persons responsible for information.
Control Policy
Division
“Industry”
Division
“Dispensing”
Division
SOE-USE
DG INSPECTION
Special Investigation Unit
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Annual Report 2009
Control Policy Division
“Dispensing” Division
involved in criminal activities in both countries.Increased supervision •of precursors in the pharmaceutical sector; Notifications of suspicious orders and transactions and the alarm reports transmitted to us in 2009 via the usual channels, the INCB and the European Anti-Fraud Office (OLAF), allowed us to arrive at the conclusion that the trend of prior years continues to persist. The fact that criminals try to procure category 1 precursors from the pharmaceutical sector, and not only via the big pharmaceutical companies but also downstream and all the way down to pharmacies, made further implementation of the current regulations in regard to precursors necessary.
Precursors Unit
In addition to the normal tasks, these are some special accomplishments in the area of the Precursors Unit in 2009:
Inclusion of the Precursors •Unit in the FEDLAND protocol; This is a cooperative effort between the Belgian Federal Office of the Public Prosecutor (Federaal Parket van België) and the National Office of the Public Prosecutor of the Netherlands (Landelijk Parket van Nederland). This protocol aims at accomplishing a synchronised legal approach to international organised drug crime. Special attention is devoted to fighting synthetic drugs and precursors and the organised crime related thereto,
In consultation with the stakeholders, the inspectors of this division regularly carry out themed actions.
The division also comprises three units that are competent for specially regulated substances as concerns market supervision and the delivery of authorisations:
the Narcotics and •Psychotropic Substances Unit;the Precursors Unit;•the Unit in charge of •supervision of processes involving anabolic, antibiotic and hormonal substances.
The principal tasks of the “Dispensing” Division are:
inspections of retail and •hospital pharmacies and stocks of medicines at veterinarians. Since the second quarter of 2009, five veterinarian inspectors have been effectively active in the field;the retail pharmacies •registry and the secretariat of the Commission for the establishment of retail pharmacies;the granting of licences for •retail pharmacies;the secretariat of •the Commission for the recognition of pharmacists-clinical biologists.monitoring and control •of the stocks of medicines potentially present in retail and hospital pharmacies.
“Dispensing”
Division
SOE-USE
Special Investigation Unit
DG INSPECTION
Control Policy
Division
“Industry”
Division
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Annual Report 2009
63
Visit of the Chinese •delegation on 3 September 2009; On 3 September 2009, the Precursors Unit received a visit from Chinese authorities aimed at learning how the regulations concerning precursors are implemented in Belgium. Not just the theoretic aspect, but also the practical organisation of control, inspection and collaboration were examined. The Chinese delegation was joined by representatives of the European Commission.
Manual import and export licences1,800
1,700
1,600
1,5002008 20092007
1,553
1,719
1,609
Automatic import and export licences6,200
6,000
5,800
5,6002008 20092007
5,961
5,683
6,092
Global import and export licences7,850
7,600
7,3502008 20092007
7,517
7,402
7,701
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Annual Report 2009
“industry” Division
of compliance with the quality standards applicable to the organisation of clinical trials. Recruiting and training of one inspector have been completed. The procedures and the reminders necessary to carry out inspections have been completed and introduced. In collaboration with the R&D Division (human) of the DG PRE authorisation, and based on a risk analysis, a theoretical plan was developed and submitted to the sector.Pharmacovigilance; •This division is in charge of verifying in the field whether the quality standards for the collection of pharmacovigilance data are indeed being complied with. These inspections and controls took place for the second year in a row. Some
the market or banned from distribution.
Medical devices; •The mission of the “Industry” Division is to ensure that medical devices are distributed via an authorised and high quality circuit. The year 2009 was devoted to the introduction of procedures, reminders and various other related documents, as well as to the training of two inspectors. In collaboration with the DG POST authorisation, the administrative unit of the division was responsible for the development and control of 657 CMDs, which corresponds to a decline of approximately 10 %.GCP; •The “Industry” Division is responsible for carrying out inspections within the scope
existing authorisations to be effected. In related domains, we report the following figures:GMP certificates: 1,490, or -status quo;Certificates of -pharmaceutical product: 3,283, representing an increase of 20 %. These certificates were, just as in 2008, issued within an average period of fourteen days. Both domains are of importance in the area of export and recognition, and for our industry abroad.RAS: a total of 188 alerts -were processed in 2009, representing an increase of 30 %. Of these 188 alerts, 45, or 20 %, referred to potentially serious problems. These medicines had to be withdrawn from
The tasks of the “Industry” Division include:
The area of manufacturing •and wholesale distribution of medicines; Three new inspectors were hired in 2009, which represents 2.5 FTEs. This reinforcement to the team resulted in:
the performance of 248 -inspections, representing an increase of 10 % as compared to 2008;the participation of the -inspectors in training on the fundamental legal principles of relevance for their function;the performance of -inspections as a team on complex sites. These inspections enabled 26 new authorisations to be granted and 160 changes to
Control Policy
Division
“Industry ”
Division
“Dispensing”
Division
SOE-USE
DG INSPECTION
Special Investigation Unit
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Annual Report 2009
65
improved the quality of activities involving blood and human tissue. The facilities have undertaken these highly demanding actions and in doing so recognise the relevance of the remarks for jointly improving quality levels. The facilities were informed of the new standards by means of a series of questions and answers in the run-up to December 2009, the time of the coming into effect of the new law 19 December 2008 concerning •human tissue material.
controls of websites of retail pharmacies;in the course of 2009 the -DG INSPECTION also devoted itself to processing applications for recognition as qualified person for information.
Blood banks and human •tissue material banks; In 2009, 75 inspections took place in blood facilities and facilities working with human tissue material. These inspections gave rise to three critical, 27 severe and 271 miscellaneous remarks. Two commercial facilities voluntarily stopped their activities involving human tissue material following the inspector’s visit. No enforcement measures were necessary. Publication of these remarks led to the implementation of corrective measures that significantly
ten inspections are carried out each year.Control on advertising and •other promotional activities in relation to medicines and medical devices; In 2009, the DG INSPECTION primarily devoted itself to the following tasks:
follow-up on complaints -filed with the FAMHP via the specific contact point;implementation of planned -controls on advertising messages appearing in the medical and pharmaceutical trade press;implementation of planned -controls of bonuses and extras offered by companies selling medicines or medical devices to healthcare professionals within the scope of scientific events involving at least one overnight stay;implementation of planned -
66
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Special investigation unit
Unit and the Interdepartmental Commission for Fraud Prevention Coordination. Internationally, consultation takes place among the 27 European Member States via HMA-WGEO, at European Commission level, the platform of the Council of Europe, the PFIPC and the IMPACT upon the initiative of the WHO.
EU were processed in 2009. This concerns in particular painkillers, erectile dysfunction medicines, antidepressants, sleeping pills, anabolics or performance enhancing products, flu medicines, slimming and smoke cessation products.
In view of the complex nature of pharmaceutical crime, in addition to the repressive approach, the FAMHP’s mission also includes making patients and the general public aware of the safe and appropriate purchase and use of medicines.
In view of the cross-border aspect of pharmaceutical crime, the FAMHP also actively participates in consultations at national and international level. In Belgium, related organisations are the Multidisciplinary Hormone
The Special Investigation Unit (SOE-USE) is a transversal unit within the DG INSPECTION. The SOE-USE carries out its work within an extensive internal and external network, and is, among other things, in charge of all cases involved in the fight against pharmaceutical crime, such as imitation, counterfeiting, illegal trade, fraud, doping and Internet fraud.
With Internet orders, medicines seized by Customs are forwarded to the FAMHP, and our Agency initiates an administrative investigation procedure. The consequences of this investigation range from a notification to the customer having placed the order to the institution of legal proceedings.
More than 3,000 postal packages from outside the
Control Policy
Division
“Industry”
Division
“Dispensing”
Division
SOE-USE
Special Investigation Unit
DG INSPECTION
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67
Activity 2007 2008 2009 trends, 2008-2009
Number of inspections in:retail pharmacies•hospital pharmacies•medicinal stocks at veterinarians •(as from April 2009, there were five veterinary inspectors in function)Pharmaceutical companies•
GMP -GDP -
7338954
6968
95184
134
84145
93277
425
100148
- 2 %- 8 %217 %
19 %2 %
Number of official reports issued by:retail pharmacy inspectors•hospital pharmacy inspectors•pharmaceutical industry inspectors•
863
12
1349
12
153129
14 %33 %
- 25 %
Narcotics and psychotropic substances, number of:inspections of stock and accounts at manufacturers, •wholesalers-distributors, importers and exporters (Fr)licence reviews:•
import (Fr) -export (Fr) -
inspections of stock and accounts at manufacturers, •wholesalers-distributors, importers and exporters (Nl)licence reviews:•
import (Nl) -export (Nl) -
316
31849
212
513118
297
38338
249
53787
167
23226
241
53990
- 44 %
- 39 %- 32 %
- 3 %
1 %3 %
Applications for import/export licencesAverage period for obtaining a licence of this type
Narcotics forms, numberAverage period for sending a narcotics form
7,5145 days
600,0008 days
7,7015 days
600,0008 days
7,4027 days
570,0005 days
- 4 %
- 5 %
Precursors, number:activities licences to market participants•import/export licences:•
export -import -number of pre-export notifications -intra-community trade -suspicious orders and transactions -
88
20011
2801,224
53
81
18917
1891,517
52
69
32521
3083,192
63
- 15 %
72 %6 %
63 %110 %21 %
Some figures for the DG iNSPeCtioN
68
FAMHP ~
Annual Report 2009
Activity 2007 2008 2009 trends, 2008-2009
Hormones and antibiotics, number of:new licences (Nl)•renewals (Nl)•extensions of certificates (Nl)•new licences (Fr)•renewals (Fr)•extensions of certificates (Fr)•
11699
119566039
9869
124524560
5939
106493657
- 40 %- 43 %- 15 %- 6 %
- 20 %- 5 %
export, number of:GMP certificates•certificates of pharmaceutical products•CMD•other certificates (e.g. certified copies, analysis reports)•export declarations•declarations of toll manufacturing activity•
1,6533,181
73427614963
1,4812,730
725353196114
1,4903,283
657357196104
1 %20 %- 9 %
1 %0 %
- 9 %
RAS of Qualityof which:
of Belgian origin•from Europe•
of class 1•of class 2•of class 3•unclassified•fraud/counterfeit•
for medicines for human use•for medicines for veterinary use•for raw materials•IMP•
150 141
5685
46691286
129921
188
81107
451162007
1632140
33 %
“14/12/06” and “30/06/2004” licences, number of:new applications•applications for amended licences•
41274
28154
- 32 %- 44 %
Number of applications for variations submitted to the Advisory commission:urgent applications•applications processed according to normal procedure•
2472
16114
28125
75 %7 %
FAMHP ~
Annual Report 2009
69
Activity 2007 2008 2009 trends, 2008-2009
Commission for the establishment of retail pharmacies, French language chamber, number of:
applications•decisions•
5255
4842
6859
42 %41 %
Registry of pharmacies, French language chamber, number of:applications for amendments•current applications (monthly average)•attestations/authorisations delivered•
437117442
29593
325
- 33 %- 21 %- 26 %
Commission for the establishment of retail pharmacies, Dutch language chamber, number of:
new applications•ministerial decisions•
6697
5992
72154
22 %67 %
Registry of pharmacies, Dutch language chamber, number of:applications for amendments•current applications (monthly average)•attestations/authorisations delivered•
- 189--
479140445
153 %
Soe-uSe:number of applications: infringements of the R.D. of 12 April 1974•number of applications: other infringements of medicinal product •regulationsassistance to public prosecutors and number of opened files•number of postal packages inspected•
--
--
1218
101736
1639
702,392
33 %117 %
- 31 %225 %
Recognition of pharmacists – clinical biologists:French language chamber• , number of:
new training plans -approvals issued -
Dutch language chamber• , number of:new training plans -approvals issued -
108
75
107
146
97
168
- 10 %0 %
14 %33 %
70
FAMHP ~
Annual Report 2009
2009 FAMHP personnel and budgetP&o Division
had had the opportunity to develop this new leadership style, which focuses on the human being as its central concern.
Personnel
This year, the P&O Division also made significant investments in staff training. Thus, two staff members of the division took part in the Certification test project organised by Selor. After their successful participation, the P&O Division now enjoys greater independence in relation to certain selection procedures, which should enable more flexible assignments within the organisation to meet its needs. Thanks also to this investment, it should be possible to staff the 2010 personnel plan to a good 90 %.
In 2009 two staff members who meet the requirements for holding management positions started the Vitruvius training cycle, a leadership development programme of the FPS P&O. Already in 2008 four colleagues
method on the organisation was assessed, and the reference framework intended to serve as a basis for the introduction of telework on a larger scale in 2010 was defined.
In order to evolve from an administrative partner into a business partner in the implementation of the FAMHP’s strategic goals, the P&O Division was involved in regular consultation with the Executive council to define the specific pertinent expectations. In addition to an advisory role in the regulatory arena, the focus is also on competency management. This approach is designed to help our Agency meet its goals. Now some internal brainstorming imposes itself in relation to the development of action plans destined to record progress over the short term.
The P&O Division is responsible for HR management and organisational development within the FAMHP. The division’s most important mission is to strive for optimal efficiency and performance for each individual staff member as well as for the organisation as a whole.
Organisation
The most significant change in 2009 in the area of HR organisation was the introduction of the Agency’s new organisation chart. The three pillars, or DGs, and the internal responsibilities have been defined, and three Directors-General have been appointed to manage each of these three pillars, or DGs.The Telework test project started in 2008 was continued in 2009. The impact of this work
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71
Distribution Nl-Fr
Distribution male-female
Male Female
Distribution fulltime-equivalent
Distribution contractual - statutory
Statutory Contractual Fr Nl
250
200
150
100
50
0
139
235274
100 % 80 % 66 % 50 % 0 %
69
2 17 12
250
200
150
100
50
0
226
148
0
50
100
150
200
300
250
200
150
100
50
0
190184
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Age
80
70
60
50
40
30
20
10
0<20 35-4020-25 40-4525-30 45-50 55-6030-35 50-55 60-65
Distribution across levels
250
200
150
100
50
0 A A1B A2C A3D A4
200
45
99
30
120
100
60
80
40
20
0
Distribution across level A
46
104
26 24
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B&Mc Division
The main tasks of the B&Mc Division are:
compiling and monitoring •the annual budget;recording income and •expenditure and compiling the annual financial accounts;paying invoices.•
Some information on the budget
Our Agency’s 2009 budget, approved by Parliament, amounted to EUR 55,726,159 in income and EUR 55,509,739 in expenditure. Income includes the government grant of EUR 19,048,000, paid via the FPS Public Health, and the organisation’s own income from the application of various laws and regulations. This includes income from the
Agency’s reserves estimated at EUR 760,000. In addition, the FAMHP has received authorisation to take EUR 1,700,000 out of its financial reserves.
Distribution of income for 2009
After the preliminary closure of the accounts for the year, the income for 2009 came to a total of EUR 53,576,971. This amounts to a shortfall of 3.86 % in our income as compared to the budget forecast. This can be explained with the fact that the financial reserves allocated in the amount of EUR 1,700,000 were not utilised. Without taking this amount into account, revenues were 0.83 % lower than forecast in 2009. The difference relates entirely to the Agency’s own income.
The generated income consisted of EUR 34,528,971 of our own income and EUR 19,048,000 of granted funds. Our own income represents 63 % of the total income. The granted funds therefore represent 37 %.
An analysis of the FAMHP’s own income shows that 31 % of it comes from retributions and 69 % from fees for service. These taxes are, depending on the applicable legislation and regulations, collected on the basis of the number of packages of medicines and raw materials sold or on the basis of the turnover generated from medical devices. In terms of the FAMHP’s own income there is also the special fee from the EMA to pay for the FAMHP’s activities at European level amounting to EUR 3,164,257. There is one other fee that is
noteworthy for its intended purpose, since the “clinical trial” contribution of EUR 1,944,898 is not just intended to cover the Agency’s costs for these trials, but also plays a large role in the financing of Ethics Committees.
As far as taxes are concerned it should be pointed out that the tax on packaging, the so-called “30 centimes and 15 centimes”, represented an amount of EUR 4,625,635 or 43 % of the taxes. These taxes were unusually high in 2009 because of the extraordinary collection of amounts due from prior years. Another important tax is the packaging or “50 centimes” tax. This represents EUR 4,592,280 or 43 %. This last tax is not used in financing the Agency, but is allocated in its entirety to the permanent monitoring of medicines.
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B&Mc Division
this involved booking 18,302 virtual sales invoices in the “computerised day books”. The data are encoded manually. Information about the entries, such as the reconciliation of fees and the corresponding service applications, is mainly obtained from the MeSeA system, more specifically by means of verification of the “public inbox payment tracking”. Account allocation data that are not included in MeSeA are communicated by conventional means using the administrative forms and financial folders of the Agency’s different divisions and departments.
are checked and entered into the accounting system after approval. Payments are made automatically (after a dual digital signature) within the month via the Isabel payment system.
The FAMHP’s own income for 2009 is the result of exactly 21,149 payments into seven different bank accounts, each designed to receive specific types of payments. The accounts are, for example, for payments received from the EMA, “clinical trials”, medicated animal feed, taxes on the number of packages and an account for miscellaneous fees.
Cash received is booked as income under the correct turnover entry. This turnover is then debited against the fee for each submitted service application. In 2009
Registration of transactions and accounting principles
Since the creation of the Agency, the B&Mc Division has performed double accounting. The purpose of this measure is not only to meet the legal requirements, but also to bring greater transparency to the different incoming and outgoing financial flows. It also results in a clearer understanding of the financial functioning of the FAMHP for the various stakeholders. All items of income and expenditure are collected within the same IT system so that accounting statements can easily be generated for immediate review.
For its expenditure in 2009, the FAMHP had a total of 3,988 invoices. These invoices
Distribution of expenditure for 2009
The “preliminary” expenditure for 2009 amounted to EUR 50,190,200, of which EUR 20,541,597 was committed to personnel costs (statutory and contractual staff ), corresponding to 41 % of expenditure. Another significant item of expenditure is the payment of the subsidy for financing NAT blood tests; this represented EUR 10,087,649 or 20 % of all expenditures. Two other important expenditure items were the costs incurred in control and analysis assignments for medicines, and IT expenditure. These costs amounted to EUR 4,570,258 and EUR 2,346,428, respectively, or 9 % and 5 % of all expenditures.
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2009 FAMHP income (excluding grant)
NAT blood test subsidy Control and analysis of medicines IT expenditure Personnel costs Other expenses
25 %
20 %
9 %
5 %
41 %
the Agency’s budget for 2009, in euros Activity Budget Actual
income
Grant 19,048,000 19,048,000
Own income 36,678,159 34,528,971
Total 55,726,159 53,576,971
expenditure
Salaries and social security contributions 24,745,079 20,541,597
Other personnel costs 867,000 886,534
Non-ICT operating costs 16,247,199 16,288,046
ICT operating costs 3,078,312 2,289,493
Non-ICT capital expenditure 76,500 39,946
ICT capital expenditure 408,000 56,935
NAT blood test subsidy 10,087,649 10,087,649
total 55,509,739 50,190,200
FAMHP expenditure 2009
54 %
31 %
9 %6 %
13 %
13 %
5 %
EMA fees “Clinical trial” fees Other contributions “30 ct & 15 ct” tax “50 ct” tax Other fees
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other Support servicesiCt Division
The ICT Division is responsible, among other things, for meeting the Agency’s hardware and software needs. As an example we may cite MeSeA, an application developed by the FAMHP that has become essential for, among other things, the follow-up and processing of applications for MA for medicines for human use. In addition, the ICT Division is the service provider for a number of communication needs of the Agency, such as teleconferencing.
Primarily, the division uses internal ICT experts, although external IT experts are called upon for individual projects.
In view of the fact that the Agency is still relatively young, and thus evolving, there remain a number of projects fully under development in addition
to the many that have already been completed. The existing applications and services, too, are regularly reviewed and further enhanced if necessary. This is always done in close consultation with the concerned division, unit, department or other party involved.
Accomplishments in 2009
Within the scope of the •Agency’s autonomy in regard to the FPS Public Health, an autonomous helpdesk was created and further efforts were made to develop an autonomous ICT Division. The necessary preparations were made to enable the physical migration of the ICT infrastructure from the FPS Public Health to the FAMHP’s infrastructure.A teleconferencing system, •which is essential in the
framework pertaining to variations.The PSUR database was •launched. This database is primarily intended for follow-up of the safety of approved medicines. Both the online and offline checker have been equipped with a number of new checks. Our checker, which is used for electronic input of applications concerning medicinal products for human use, is also employed by a number of European Member States, i.e. France, Spain, Ireland, Bulgaria, Lithuania and Poland.A survey was carried out •in collaboration with our partners in the pertinent industry about the expected changes in electronic medicinal product applications as a result of the European formats: eCTD
Agency’s European context, was put in place.The CTA data were migrated •to a new database in order both to improve the performance and to accelerate reporting as well as to enable the teleworking option. In general, the necessary technical preparations are being made to ensure that the teleworking option can be further expanded.The application for the •follow-up of new specialty names for medicines, intended to prevent mistakes in dispensing and administration due to names that are too similar, was comprehensively modernised, expanded, and implemented.A number of bugs were •resolved in MeSeA and a number of new functionalities were added within the scope of the new regulatory
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The Logistics Unit takes care of all ordering and installation as concerns office equipment and other furniture for the entire Agency, including multifunction copiers. This unit is responsible for the management of the paper archives, the processing of incoming and outgoing correspondence, and catering services for the FAMHP’s various meetings.
For 2009 we record the successful move of 60 people from the different divisions of the Support services.
(PowerPoint) presentations •and speeches.
As is the case for all Belgian federal public services documents primarily need to be translated from French to Dutch and vice versa. To a lesser extent, there is also a need for translations into English and German.
The translators in the Translation Services Division of the FAMHP are responsible for translating and reviewing texts and providing linguistic advice.
These are some of the documents translated in 2009:
internal and external •reporting, such as the internal newsletters Vit@, Vit@ Express and Vit@ MeSeA, the external newsletters @ctua, @ctua EXPRESS, press releases, service memoranda, circulars, correspondence, job vacancies and job descriptions;draft regulations;•answers to parliamentary •questions;contracts and agreements;•minutes and reports;•MeSeA work description cards;•
and external clients like the pharmaceutical industry, and in order to ensure that the European collaboration becomes ever more expedient.
and NeeS. The results of this survey enable us better to react to the needs and expectations concerning the electronic filing of applications for MA for medicines for human use.The first data transfer for •the Genuine Medicines Source within e-Health has been completed. This is a relatively new system for better electronic exchange of administrative data within the Belgian public services concerned and other partners.A number of projects are •still under development, and of course there are always new projects and requests for changes to existing applications. They are intended even better to meet the needs of both internal clients (FAMHP staff )
translation
Services Division
logistics
unit
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disputes:•court proceedings and -coordination of the elements for the defence;administrative fines. -
In 2009, the Legal Affairs Division of the FAMHP was responsible, among other matters, for the following:
regulatory issues:•implementation of the -responsible minister’s policy goals;drafting and follow-up of -regulations;developing proposals for the -improvement of the existing regulatory framework;following up on the -development of the European regulatory framework;transposition of the -European regulatory framework into national law;
legal advice and information;•amnesty applications;•
legal Affairs
Division
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Chief executive officer’s servicesCommunication Division
The Communication Division is responsible for both the internal and the external communication policy, and assumes the role of the spokesmanship of our organisation. This division aims to guarantee an ongoing service by means of shared knowledge of the tasks within its small team, with the goal of providing support to the entire organisation.
The Communication Division represents the FAMHP in COMMnet, the communication network for the Belgian public services of the FPS P&O, and internationally in the WGCP of the HMA.
Following the establishment of this new division within the Agency and the creation of a number of different communication tools, optimisation of the existing
accomplishments began in 2009.
* Only the three Chief Executive Officer’s services represented here were operational in 2009.
*
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CHIEF EXECUTIVE OFFICER
Program Management
Office Unit (PMO)
International
Relations Unit
Communication Division
Chief executive officer’s servicesCommunication Division
The “FAGG-AFMPS 2008 – 2012” project currently consists of some seventy projects and continues to receive special attention, so as to ensure that the FAMHP can also meet its specific objectives for 2010. Within that framework, the PMO Unit will carry on and further optimise the coordination, planning and follow-up of the numerous projects of the Agency, as well as the pertinent communication.
significant progress primarily include:
implementation of a new •system for rapid information of healthcare professionals;implementation of the new •procedure for variations;preparation of the publication •of the SPCs and PILs on our website;institution of a consultation •committee consisting of the three Directors-General and the spearhead coordinators;organisation of external •communication and development of an interactive website, for the exchange of scientific advice.
The PMO Unit continued the implementation of its mission in 2009 and focused on the further development of the various activities initiated in 2008. A number of projects started within the scope of the “FAGG-AFMPS 2008 – 2012” project were also successfully completed.
To recapitulate: the “FAGG-AFMPS 2008 – 2012” project comprises a number of key factors and strategic goals to convert our Agency, over the medium term, into an efficient, smoothly running organisation. For 2009 we note the launch of the Agency’s new website; other projects having experienced
PMo unit
Program Management office
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CHIEF EXECUTIVE OFFICER
Program Management
Office Unit (PMO)
International
Relations Unit
Communication Division
European Parliament, for the management of the agenda and thus the planning, from the point of view of both the content and the organisation;participation in the task •force for drawing up the strategy paper II of the HMA. This document is to be finalised during the Belgian presidency;publication of the results of •the BEMA initiative 2008, with identification of the following significant focal points:
completion of the review -of the R.D. of 31 May 1885 and replacement by the R.D. of 21 January 2009 comprising instructions for pharmacists, or in other words the update of the R.D. of 31 May 1885 and the regulation of new aspects such as Internet sales of non-prescription medicines.
There are currently three directive proposals: counterfeiting, pharmacovigilance and patient information;Preparation for the Belgian •presidency with the agenda of the meetings to be organised by the FAMHP, the RIZIV-INAMI - FAMHP conference, and the agenda of the Council group to be chaired by the FAMHP. In this context, Conrad Consulting has been asked to take care of the logistics aspects of the meetings to be organised by the FAMHP. For the coming presidency we also note the organisation of regular contacts with the FPS Public Health, the RIZIV-INAMI, the office of the Minister of Public Health, our partners, the “Tri-Chairmanship”, the European Commission and the Members of the
international Relations unit
The International Relations Unit is responsible for the coordination of the internal and external flow of information in national and international contexts, with a view to the harmonisation of Belgium’s positions on the international arena.
For 2009 we will primarily recall the following agenda items:
increasing the FAMHP’s name •recognition in the national circuit, including via the Eurocoordinators Group;following up on the “Pharm •pack” in collaboration with our stakeholders: industry, patient groups, European and international professional associations, the other European Member States, and also Belgian and other European Members of Parliament;
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CHIEF EXECUTIVE OFFICER
Program Management
Office (PMO) Unit
International
Relations Unit
Communication Division
and the members of the FAMHP commissions. In this context, a code of conduct relating to conflicts of interest was developed for FAMHP staff members, commission members and external experts;drawing up a protocol -with the FPS Economy for the introduction of a coordination platform in order to structure and organise bilateral consultation about the interaction of the different activities in connection with medicines and health products of these two institutions;follow-up of the -interministerial economic commission and completion of the rules and regulations governing the three committees of the FAMHP.
The result was published in the Belgian journal of acts, orders and decrees (B.S.-M.B.) and a circular with practical guidelines was sent out;completion of the -implementation of the directive concerning medical devices by means of the R.D. of 17 March 2009, amending the R.D. of 18 March 1999 concerning medical devices. The purpose of the exercise is the implementation and simplification of specified obligations such as the strengthening of the FAMHP as a unique point of contact. We also note the merger of the two commissions empowered to deal with medical devices;signing of the conflict of -interest statements by all FAMHP staff members
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the three committees of the FAMHP Scientific Committee
The Scientific Committee met four times in the course of 2009. It completed the evaluation of the current procedures in the various commissions acting within the FAMHP. It became apparent from this analysis that for a great number of commissions there already was a community platform of experts ensuring the uniformity and continuity of the scientific work carried out in these commissions. From the review of the working methods of the various commissions it also became apparent that the Scientific Committee consists of highly heterogeneous groups: some commissions have primarily scientific goals, while others are rather of an administrative nature.
In the course of 2010 thought will be devoted to the possibility of creating subgroups within the Scientific Committee to take into account the specific characteristics of the different commissions.
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Transparency CommitteeConsultative Committee
Scientific Committee
CHIEF EXECUTIVE OFFICER
Scientific Committee
The members of the Transparency Committee also attended a presentation about the manner in which the FAMHP will measure and visualise its strategic goals via KPIs. These KPIs will regularly be presented at the plenary meetings starting in 2010.
At a working group meeting, the ONCOLOGY and VACCINES spearheads were also presented to the members of the Transparency Committee as well as to a number of experts.
In 2009, the Transparency Committee held five plenary meetings in which the 2009 budget was monitored, the 2009 personnel plan was discussed, and an opinion was issued about the 2010 budget. In 2009, the Council of Ministers imposed a supplementary savings requirement in the personnel budget of 1.5 % on all federal bodies, but simultaneously granted the FAMHP credits in order to enable it to carry out an additional mission. This new competency refers to the Law of 19 December 2008 on the acquisition and use of human tissue material for medicinal purposes with a view to medical application in humans or for scientific research.
Other questions concerning the role of the FAMHP were also discussed, such as our role in the influenza pandemic and the related blood supply problem.
The Consultative Committee met four times in 2009. The members became acquainted with the Agency’s new organisation chart and with the Directors-General of the three Pillars, or DGs. On this occasion they presented the main features of their action plan.
In 2009, the Consultative Committee answered a number of general questions from our stakeholders. The role of the FAMHP in connection with homeopathic medicines was explained in a meeting and a presentation illustrated the strategy in relation to pharmacovigilance by means of an overview of our Agency’s various projects and activities.
Consultative Committee transparency Committee
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the four spearheads of the FAMHPoNColoGY spearhead
The following three specialties were selected during the start-up phase of the ONCOLOGY spearhead:
specialty 1: Neuro-oncology;•specialty 2: Advanced •Therapies for oncological indications;specialty 3: Paediatric oncology.•
The following specialties are planned to be added to this spearhead at a later stage:
specialty 4: Oncological •orphan indications;specialty 5: Antiemesis in •chemotherapy.
For 2009 we note the following status and future prospects for the various strategic goals of the ONCOLOGY spearhead.
Various academic experts who have in the meantime
confirmed their collaboration with the FAMHP by filing an Expert Nomination Form and a Declaration of Interest have been identified within selected specialties.
On 8 June 2009 the EMA Management Board selected the candidacy of Professor Jean-François Baurain as an Alternate Member within the CHMP. Professor Baurain heads the Medical Oncology Laboratory at the Catholic University of Louvain, and is assistant Clinical Director of the Medical Oncology Ward of the Saint-Luc University Clinic. He specialised in the treatment of gynaecological cancer, breast cancer and brain tumours. He is also experienced in the area of innovative therapies such as vaccination for the treatment of melanoma. His appointment signified an important step for
the ONCOLOGY spearhead in view of the fact that our Agency can now assume an active profile in the issuance of MAs for oncology medicines via the CP. On the one hand we can now assume the role of (co-)rapporteur for medicines within the ONCOLOGY spearhead’s selected specialties, and on the other hand we can participate directly in the discussions concerning oncology medicines for which we have no responsibility as a (co-)rapporteur within the CHMP.
The minimum required internal expertise must urgently be further developed in agreement with the GAP analysis for the DG PRE authorisation. This should enable us to increase our involvement in the regulatory procedures for medicines with oncological indications.
With regard to contacts with the pharmaceutical industry, the consultations resulted in:
portfolio/scientific meetings •in the area of oncology;an “Early Phase Development •– Oncology” workshop, organised on 19 and 20 October 2009, in collaboration with various sponsors of clinical oncology trials within the scope of the CTFG.
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the four spearheads of the FAMHPoNColoGY spearhead
database within the general expert database of the FAMHP is planned for 2010. Further sensitisation of the relevant national and international stakeholders is required in function of STA, CTA, MA and pharmacovigilance. A number of national and international activities are also planned.
Another item on the agenda is the further consolidation of current activities in connection with CTA, PIP and STA. In order to guarantee maximum involvement in the follow-up of MA applications, greater involvement is also planned in the CP of oncology medicines. In parallel, a proactive composition of the evaluation teams is under consideration.
for use in chemotherapy and for a generic oncology medicine.Belgium coordinated the -scientific review of seven PIPs, and evaluated the preclinical sections of 14 other PIPs.
Monthly project group meetings are planned starting in January 2010. This consultation will enable transversal exchanges of relevant information about CTA, PIP, STA, MA, pharmacovigilance and inspections. This platform facilitates the feedback from CHMP, SAWP, CAT, PDCO, CMDh and PhVWP, and provides input for the future organisation of the ONCOLOGY spearhead.
The integration of the ONCOLOGY spearhead expert
Some figures for 2009
23 % of all CTAs were for •oncology medicines, in particular for phase I and II clinical trials;An application for a Medical •need programme for a haematology indication;At national level: start-up •phase with two scientific opinions;At European level:•
Belgium provided the -coordinator for some 13 oncology opinions, including three paediatric opinions;Belgium accepted four -applications concerning generic oncology medicinal products, for which our country assumed the role of the reference Member State via a DCP;Belgium was the rapporteur -in a CP for an antiemetic
Within the scope of the activities of the ONCOLOGY spearhead, contacts were also made with various national committees and organisations, such as the Belgian Society for Pediatric Hematology and Oncology, the Federal Cancer Centre, the College of Oncology, the Belgian Society for Medical Oncology, and with international committees and organisations, such as the Paediatric Oncology Task Force, the EMA and the National Institutes of Health in the USA. Our collaboration with the EORTC was reaffirmed.
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VACCiNeS spearhead
Before the A/H1N1v California virus broke out, three pandemic vaccines had been authorised based on the avian H5N1 or avian influenza strain. Three companies had an authorisation that could be activated as soon as the WHO announced the crisis phase of a pandemic. The EU regulators were ready to face this phase.
As soon as the new influenza strain became known, three companies started with the production of their vaccine and with the submission of data for the final variation that would enable distribution of the pandemic vaccine.
The FAMHP staff involved also contributed to the negotiations of the office of the Minister of Public Health in terms of the purchase of vaccine for the Belgian population.
become much more severe, as it would have made it possible to vaccinate very large groups of the European population.
In the second half of 2009 we were fully faced with the influenza pandemic, and with a race against time in the step by step evaluation of the pandemic vaccines. This was preceded by six years of preparatory work: from 2003, the year when the European Commission requested the VWP to prepare for a pandemic, until 2009. Directive upon directive was written and published during that time in order to enable a rapid procedure for the preparation and authorisation of a pandemic vaccine. All this was based on the principle of annual approval of vaccines for seasonal influenza.
Referred to using codes such as MF59 and AS03, they are in fact known squalenes or W3 fatty acid precursors. W3 fatty acids are not only endogenous substances, they also have a good reputation. They are life essential fatty acids, which, if consumed in large amounts in food, are additionally supposed to have a favourable effect on health. A large number of data were discussed during the consultation, which were very reassuring concerning the use of these adjuvants. This material was transmitted to the VWP of the EMA.
An interesting detail: it turned out that by using adjuvants, only one quarter of the influenza antigen would be necessary, and four times as much vaccine could be produced. This would have been very important if the influenza pandemic had
VACCINES for human use
2009 was a busy year for the VACCINES spearhead – vaccines for human use. Three scientific meetings had been planned for the first six months:
viral vaccines;•bacterial vaccines;•adjuvants.•
The last meeting had a perfect timing. At the time of the influenza pandemic we were able to conduct discussions with a great number of vaccinologists about the sense or lack thereof and the risk or precisely the lack thereof in relation to adjuvants. It was already clear at the time that two out of the three pandemic vaccines would contain an adjuvant. This meeting taught us that the proposed adjuvants held little secrets.
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VACCiNeS spearhead
A few figuresBelgian contributions within the scope of STA and MA applications:
STA:•national: three out of a total -of nineteen;European: seven out of a -total of 65.
CPs:•three co-rapporteurships; -one rapporteurship. -
has helped influenza research take a giant step forward. Now it is important to record all this knowledge in articles and up-to-date procedures.
scientific committees of the ICI in order to enable the correct recommendations to be made.
Fortunately, the A/H1N1v California virus was a mild variant and we were spared a severe epidemic. Now we need to draw conclusions from this experience: What could be done better? Belgium was one of the first countries to start the vaccination campaign. Nonetheless, had we started a few weeks earlier, things would have been even better – certainly if a more aggressive variant had been involved.
Thus, 2010 will be another busy year with the evaluation of the strategies, the vaccines, the adverse reactions and the births of the children of women who were vaccinated during their pregnancy. One thing is for sure: this pandemic
Working with legal affairs and office staff, who were not so familiar with the European procedures for medicinal product authorisation, was quite a challenge.
From July 2009 onwards, things got really busy, and this pressure would remain until after the pandemic had peaked in October–November 2009. An intense collaboration was developed between the FPS Public Health, the ICI and the FAMHP. Each organisation had its own task, but the exchange of information was crucial: many queries from concerned citizens, healthcare professionals and patients that could not be answered by the first line workers found their way to the FAMHP. The data generated by the relevant companies and forwarded to us via the EMA were discussed in the
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Maurice Pensaert, assumed the role of rapporteur. The publication referred to research concerning the potential impact of maternal antibodies on the efficacy of vaccines, which is a significant issue in veterinary medicine;granting of two new •rapporteurships for vaccine CP;rapporteurship or •co-rapporteurship for currently pending procedures for four other vaccines;processing of a clinical •variation for a centrally authorised vaccine for which Belgium was the co-rapporteur;closing of eight analytical •variations;co-rapporteurship for two •of the four ongoing referrals procedures concerning veterinary use.
VACCINES for veterinary use
On European level, the FAMHP confirmed its involvement in the life cycle of vaccines for veterinary use, in particular within the scope of the aspects preceding the granting of the authorisation in 2009.
In this context we note the following:
appointment of Frédéric •Descamps as a member of the SAWP-V in March 2009;coordination of two scientific •opinions for vaccines, submitted to the SAWP-V following the appointment of the Belgian SAWP-V member;publication of a reflection •paper for consultation by the CVMP, in March 2009; For this purpose, the Belgian member of the IWP, Professor Emeritus
On a national basis, in 2009 Belgium acted as RMS for the evaluation for a new vaccine for cattle. In addition, the FAMHP delivered four new TGV-ATU for four vaccines for use against blue tongue, as well as renewals for three others. Another two TGV-ATU were granted for vaccines against botulism, for use in cattle. In 2009, 188 variations for vaccines approved via NP were concluded, and 168 new variations were filed at the FAMHP in the same period.
In the context of reinforced pharmacovigilance, the FAMHP continued the evaluation of the adverse reactions of the different serotype 8 vaccines against blue tongue administered to sheep and cattle during the Belgian mandatory vaccination campaign of 2008-2009. The results were published
in December 2009 in the Folia Veterinaria of the non profit association BCFI-CBIP.
In the area of inspections, the Agency developed a risk analysis based sampling plan for veterinary vaccines. Our inspectors took the first samples and had them analysed at the CODA-CERVA. In collaboration with the CODA-CERVA, the FAMHP also organised two GMP inspections of pharmaceutical companies producing vaccines for veterinary use. The coordination commission that regulates and evaluates the collaboration between the FAMHP and the CODA-CERVA met twice in 2009.
Furthermore, our Agency has also started developing a regulatory framework for autovaccines for veterinary use.
The FAMHP wants to gain greater name recognition in the field of vaccines for veterinary use, and therefore had a number of staff members participate in specific training sessions.
All the above once more demonstrates that the FAMHP is an organisation that is recognised in Europe in the area of vaccines for veterinary use, and that the development of the spearhead is on track.
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PRoACtiVe ViGilANCe spearhead
organisation of •sensitisation sessions on pharmacovigilance;quarterly dissemination, •via Vig-News, an electronic newsletter providing a selection of recent pharmacovigilance information;publication of articles in •specialised journals.
By the end of 2009, 331 healthcare professionals were participating in this project.
Since the launch of this project, an increase has been recorded in the number of adverse reactions reports sent by healthcare professionals directly to the BCGH-CBPH. In 2009, we received some 700 reports as compared to around 600 in 2008, and approximately 300 in 2007. Slightly less than half of
spearhead. The project was launched in 2008 and continued in 2009. To recapitulate: the goal of the project is to broaden our knowledge concerning the safety profile of medicines as a result of an increase in the number of reports sent directly to the BCGH-CBPH and improvements in the quality of these reports.
The following actions were undertaken in 2009 within the scope of the project:
launch of a new, better •structured and more complete hard copy “yellow form” for reporting adverse reactions;start of the development of •an online reporting form in collaboration with an external partner;
these reports originated from project participants. The actions within the scope of this project also had a positive influence on the quality of the reports. Overall, reports were better documented than in the past, and allowed for a higher quality evaluation.
The specific monitoring programme for medicines with a new active ingredient, the “Black Triangle” project, started at the end of 2007 and was continued in 2009.
In addition, in October of 2009 a specific form intended for reporting adverse reactions of antiviral medicines and of the pandemic vaccine against the A/H1N1v influenza virus, Pandemrix, was made available to healthcare professionals.
The goal of the PROACTIVE VIGILANCE spearhead is to establish a series of actions to prevent adverse events and adverse reactions associated with the use of medicines and health products.
PROACTIVE VIGILANCE comprises:
pharmacovigilance, for •medicines for human and veterinary use;materiovigilance, for medical •devices for human and veterinary use;haemovigilance, for blood and •blood components of human origin;biovigilance, for human tissue •material.
The Active pharmacovigilance project relates to medicines for human use and is part of this
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eARlY PHASe DeVeloPMeNt spearhead
Since 2009 it has been possible to obtain STA from our Agency. A few scientific opinions have been requested in connection with the requirements for a first administration of the pertinent product to humans, or concerning the ability to start an early phase clinical trial.
Medicinal products must be produced and prepared in accordance with GMP standards in order to be authorised for administration to patients and trial subjects. This also applies to the early phases of clinical research. It is not always obvious how the GMP standards can be complied with at the early stages of development. The application of GMP standards in early phase trials was discussed with various stakeholders, and a document was finalised that can serve as a foundation for the performance of inspections.
treatment is also likely to be effective in humans, and investigation into which candidate medicinal product stands the greatest chance of ultimately being developed as a medicinal product.
The revised ICH M3 directive, which came into effect in December 2009, contains clear instructions concerning pre-clinical requirements for the performance of exploratory trials. This directive is of course also applied by the FAMHP, and will shortly replace the temporary recommendations for pre-clinical requirements used by the FAMHP for some years now.
The pre-clinical requirements for exploratory studies under the two directives are very similar.
As concerns EARLY PHASE DEVELOPMENT, rapid and expert processing of the applications for the performance of clinical trials remains a priority within the FAMHP.
In 2009 we recorded filing of:
44 applications for the •performance of clinical trials with a product being administered to humans for the first time;eighteen applications and •three presubmissions within the framework of exploratory clinical trials; The majority of these applications referred to trials involving a first administration in humans. The rest concerns trials that must allow, at a very early stage, determination of whether the proposed
This was primarily intended to enable close follow-up of the safety in use of the pandemic vaccine.
In the area of veterinary pharmacovigilance, in 2009 awareness campaigns for veterinarians continued, as well as the adverse reactions follow-up programme within the scope of the blue tongue vaccination campaign.
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In October of 2009 the FAMHP organised a workshop within the scope of the CTFG. A number of issues concerning early phase trials, such as oncology studies, GMP aspects, NIMP within clinical trials, and exploratory studies were discussed with the competent authorities of other European Member States.
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FAMHP representatives at national and international levelinternational representation
with our European colleagues, and consultation ensures better harmonisation.
DG INSPECTION
Regarding harmonisation of inspection and control activities, and the fight against pharmaceutical crime, the staff of the DG INSPECTION are represented at the international fora bringing together various international medicinal products authorities.
in a number of European committees and working groups. European evaluation tasks, e.g. as rapporteur for the CP or as a coordinator in the European STA procedure, can only be acquired and efficiently performed if we are present in the relevant committees and working groups.
DG POST authorisation
The DG POST authorisation is in turn represented in various European committees and working groups engaged in the area of vigilance and proper use of medicines and health products. By means of this participation we remain informed at all times of the developments taking place in relation to medicines, medical devices, blood, cells and tissues. Belgium’s know-how is shared
DG PRE authorisation
The DG PRE authorisation plays an important role in the encouragement of innovation, the evaluation of clinical trials, and the processing of applications for MAs and amendments to existing MAs for medicines for human and veterinary use. The evaluation of MAs issued by the FAMHP usually takes place via a European procedure. European directives and guidelines are used even in purely national procedures. It is extremely important for the DG PRE authorisation to closely follow up on the changes and evolution in the regulation and to ensure a pertinent active contribution to the relevant discussions that take place at European level. The DG PRE authorisation is therefore also permanently represented
In order to optimally carry out
the tasks of the FAMHP, the
Agency counts on the FAMHP
commissions, the national
consultation platforms with
public services, institutions
and stakeholders, and on the
FAMHP’s representatives on
national and international
commissions, committees and
working groups.
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CEOs: Chief Executive Officer’s services Ss: Support services
On the following pages you will find an overview of the internal staff members who represent the Agency in the most frequently meeting international committees, working groups and other platforms:
eMA Management Board Xavier De Cuyper, Chief Executive Officer
eMA Committees
Committee for Advanced Therapies - CAT Claire Beuneu (DG PRE)
Committee for Medicinal Products for Human Use - CHMP Pieter Neels (DG PRE)
Committee for Medicinal Products for Veterinary Use - CVMP Bruno Urbain (DG PRE)
Committee for Orphan Medicinal Products - COMP André Lhoir (CEOs)
Committee on Herbal Medicinal Products - HMPC Heidi Neef (DG PRE)
Paediatric Committee - PDCO Daniel Brasseur (DG PRE)Jacqueline Carleer (DG PRE)
CHMP/CVMP working party
Joint CHMP/CVMP Quality Working Party - QWP Katrien Van Landuyt (DG PRE)
CHMP working parties
Biologics Working Party - BWP Alan Fauconnier (DG PRE)
Efficacy Working Party - EWP Anne Rogiers (DG PRE)
Pharmacovigilance Working Party - PWP Jean-Michel Dogné (DG POST)
Safety Working Party - SWP Sonja Beken (DG PRE)
Scientific Advice Working Party - SAWP Walter Janssens (DG PRE)
Similar Biological (Biosimilar) Medicinal Products Working Party - BMWP Karen de Smet (DG PRE)
Vaccine Working Party - VWP Daniel Brasseur (DG PRE)Pieter Neels (DG PRE)
CVMP working parties
Efficacy Working Party - EWP-V Sandy Vermout (DG PRE)
Pharmacovigilance Working Party - PWP-V Lionel Laurier (DG POST)
Scientific Advice Working Party - SAWP-V Frédéric Descamps (DG PRE)
Working Group on Quality Review and documents - QRD Christophe Debruyne (DG PRE)
eMA and its working groups
CTS vet Christophe Debruyne (DG PRE)
EudraCT Kristof Bonnarens (DG PRE)
EudraGMP Pieter Vankeerberghen (Ss)
Eudranet Pieter Vankeerberghen (Ss)
EUDRAPHARM Marie-Louise Bouffioux (DG POST)
EudraVigilance Expert Working Group - EWG Margriet Gabriels (DG POST)
EudraVigilance Joint Implementation Group Lionel Laurier (DG POST)
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EudraVigilance Telematic Implementation Group - TIG Margriet Gabriels (DG POST)
EudraVigilance Member State User Group - MSUG Margriet Gabriels (DG POST)
EudraVigilance Veterinary Medicinal Products Lionel Laurier (DG POST)
Eurs IABG Pieter Vankeerberghen (Ss)
GCP Inspectors Working Group Dominique Delforge (DG INSPECTION)
GDP Inspectors Working Group Ethel Mertens (DG INSPECTION)
GMP/GDP Inspectors Working Group Josiane Van der Elst (DG INSPECTION)
Joint Audit Programme Wim Van Linden (DG INSPECTION)
Pharmacovigilance Inspectors Working Group Nele Matthys (DG INSPECTION)
Telematics Pieter Vankeerberghen (Ss)
HMPC working party
Quality Drafting Group Heidi Neef (DG PRE)
HMA and its working groups
Clinical Trials Facilitation Group - CTFG Greet Musch (DG PRE)
Coordination Group for Mutual Recognition and Decentralised Procedures - Human - CMDh
Sophie Colyn (DG PRE)
Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary - CMDv
Christophe Debruyne (DG PRE)
EMACOLEX Els Geeraerts (CEOs)Paul Ballegeer (Ss)
Heads of Medicines Agencies, human medicinal products Xavier De Cuyper, Chief Executive Officer
Heads of Medicines Agencies, veterinary medicinal products Françoise Falize (DG PRE)
Homeopathic Medicinal Products Working Group - HMPWG Marie-Anne Mouyart (DG PRE)
Working Group of Communication Professionals Ann Eeckhout (CEOs)
Working Group of Enforcement Officers - WGEO Roy Vancauwenberghe (DG INSPECTION)
Council of europe
EDQM, European Committee (Partial agreement) on blood transfusion (CD-P-TS) Ludo Muylle (DG POST)
EDQM, European Committee (Partial agreement) on organ transplantation (CD-P-TO)
Ludo Muylle (back up) (DG POST)
EDQM, European Committee on Pharmaceuticals and Pharmaceutical Care Marie-Louise Bouffioux (DG POST)
EDQM, European Committee of Experts on Minimising the Public Health Risks posed by Counterfeiting of Medical Products and Related Crimes (CD-P-PH/CMED)
Roy Vancauwenberghe (DG INSPECTION)
EDQM, European Committee of Experts on quality and safety standards in pharmaceutical practices and Pharmaceutical Care (CD-P-PH/PC)
Tom Brusselmans (DG INSPECTION)
EDQM, European Committee of Experts on the Classification of Medicines as Regards their Supply
Marie-Louise Bouffioux (DG POST)
EDQM, European Pharmacopoeia Commission René Hanselaer (DG PRE) Katrien Van Landuyt (DG PRE)
CEOs: Chief Executive Officer’s services Ss: Support services
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Homeopathic Manufacturing Methods - HMM Marie-Anne Mouyart (DG PRE)
Pompidou Group Dirk Mergan (DG INSPECTION)Bernard Vandenbosch (DG INSPECTION)
Technical Advisory Board - TAB, certification procedure Marie-Joëlle De Vos (DG PRE)
Council of european Ministers
EU Customs Working Party Dirk Mergan (DG INSPECTION)
Horizontal Working Party on Drugs Dirk Mergan (DG INSPECTION)Bernard Vandenbosch (DG INSPECTION)
Working Group on Medicinal Products and Medical Devices Els Geeraerts (CEOs)
european Commission
Drug Precursor Committee (Brussels) Dirk Mergan (DG INSPECTION)
European Monitoring Centre for Drug and Drug Addiction - EMCDDA Bernard Vandenbosch (DG INSPECTION)
Expert Working Group, (EU) Guidelines for operators (Brussels) Dirk Mergan (DG INSPECTION)
Meeting of the Competent Authorities on Blood Ludo Muylle (DG POST)
Meeting of the Competent Authorities on Tissues and Cells Ludo Muylle (DG POST)Josiane Van der Elst (DG INSPECTION)
Medical Devices working groups Frédérique Meulders (DG POST)
Operation Crystal flow (Den Haag) Dirk Mergan (DG INSPECTION)
Pharmaceutical Committee - Human Medicinal Products Els Geeraerts (CEOs)Wim Penninckx (DG PRE)
Pharmaceutical Committee - Veterinary Medicinal Products Lionel Laurier (DG POST)
Standing Committee - Human Medicinal Products Els Geeraerts (CEOs)Wim Penninckx (DG PRE)
Standing Committee Precursors Dirk Mergan (DG INSPECTION)
Standing Committee - Veterinary Medicinal Products Els Geeraerts (CEOs)Lionel Laurier (DG POST)
PFiPC
Permanent Forum on International Pharmaceutical Crime Roy Vancauwenberghe (DG INSPECTION)
PiC/s
PIC/s Committee Josiane Van der Elst (DG INSPECTION)
uNo
Committee on drugs - Vienna Bernard Vandenbosch (DG INSPECTION)
International Expert Conference - Vienna Dirk Mergan (DG INSPECTION)Bernard Vandenbosch (DG INSPECTION)
others
Benelux Chief Veterinary Officers Working Group on Veterinary Medicinal Products Louis Jacobs (DG INSPECTION)Lionel Laurier (DG POST)
CEOs: Chief Executive Officer’s services
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National representation The overview set forth below lists the commissions and consultation platforms with other public services, institutions and stakeholders, distributed over the Agency’s three pillars or DGs. This breakdown is based on task distribution; for a number of commissions and platforms, all activities are coordinated from a single pillar.
DG PRe authorisation DG PoSt authorisation DG iNSPeCtioN
FAMHP Commissions
Evaluation commission for homeopathic medicines •for human and veterinary useEvaluation commission for medical devices•Evaluation commission for medicines for human •useEvaluation commission for medicines for veterinary •useEvaluation commission for traditional herbal •medicines for human usePharmacopoeia Commission•
Evaluation commission for homeopathic medicines •for human and veterinary use Evaluation commission for medical devices•Evaluation commission for medicines for human •use Evaluation commission for medicines for veterinary •useEvaluation commission for traditional herbal •medicines for human use
Advisory Commission•Commission for the approval of institutions •assigning preliminary approvals for scientific eventsCommission for the establishment of retail •pharmacies and chambers of appeal (for applications in French and for applications in Dutch)Commission for the recognition of •hospital pharmacistsCommission for the recognition of •pharmacists-clinical biologistsCommission for the supervision of advertising for •medicines for human use
Consultation platforms with FAMHP stakeholders
Backlog Working Group•Clinical Trial Task Force (CTTF)•Consultation platform FAMHP - Industry•Consultation platform for electronic prescription of •medical feed TOR•VET-TOR (veterinary medicine, formerly •V-Amazone)Working Group IT with Industry•
Backlog Working Group •Consultation platform Blood•Consultation platform FAMHP - Industry•Consultation platform Human tissue material•Consultation platform Medical devices•Patient Platform•TOR•VET-TOR (veterinary medicine, formerly •V-Amazone)Working Group IT with Industry•
Consultation platform Blood•Consultation platform FAMHP - Industry•Consultation platform for electronic prescription of •medical feedConsultation platform Hospital pharmacists•Consultation platform Human tissue material•Consultation platform Medical devices•Consultation platform with APB and OPHACO•TOR •VET-TOR (veterinary medicine, formerly •V-Amazone)
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National consultation platforms with public services and institutions
BAPCOC (with FPS Public Health)•Biosafety Advisory Council (with WIV-ISP and the •Division of Biosafety and Biotechnology)Consultation platform with FANC-AFCN•Mixed Commission, Chamber for products for •human use and Chamber for products for veterinary use (with FPS Economy, FPS Public Health and FAVV-AFSCA)Professional Ethics Committee (with FPS Public •Health - DG Animals-Plants-Foodstuffs) Strategic unit/RIZIV-INAMI•
BAPCOC (with FPS Public Health)•Consultation platform with e-Health•Consultation platform with FANC-AFCN•Interdepartmental committee of experts on blood, •organs, cells, tissues and embryos (with FPS Public Health, KCE, RIZIV-INAMI and WIV-ISP)Interdepartmental network on “information society •services” (with FPS Economy)Mixed Commission, Chamber for products for •human use and Chamber for products for veterinary use (with FPS Economy, FPS Public Health and FAVV-AFSCA)Non-availability of medicines (with RIZIV-INAMI)•RECIP-E Guidance Committee (electronic •prescription in the outpatient sector)Strategic unit/RIZIV-INAMI•Working group on blood of the Belgian Federal •Superior Health CouncilWorking group on cells, tissues and organs of the •Belgian Federal Superior Health Council
Coordination commission with CODA-CERVA•Consultation platform Internal Control - Internal •AuditConsultation platform of the Precursors Unit with •Customs, Federal Police and Justice (FEDLAND)Consultation platform with e-Health•Consultation platform with FAMHP (SOE-USE) - •FAVV-AFSCA (NOE)Consultation platform with FANC-AFCN•Consultation platform with FAVV-AFSCA•Consultation platform with FAVV-AFSCA, FPS •Public Health and Public Health Minister’s office (Veterinary Medicine)Consultation platform with WIV-ISP•DGO-SCM Guidance Committee (with APB and •OPHACO)Guidance Unit for the FAMHP - FAVV-AFSCA Protocol•Influenza (in cooperation with external partners)•Interdepartmental Commission for Fraud •Prevention Coordination in the economic sectors - ICCF-CICFInterdepartmental committee of experts on blood, •organs, cells, tissues and embryos (with FPS Public Health, KCE, RIZIV-INAMI and WIV-ISP)Interdepartmental coordination unit for food safety •control ICVV-CICSAInter DG drugs (with FPS Public Health and •RIZIV-INAMI)Mdeon Board of Management•Multidisciplinary Hormone Unit•Mixed Commission, Chamber for products for •human use and Chamber for products for veterinary use (with FPS Economy, FPS Public Health and FAVV-AFSCA)Non-availability of medicines (with RIZIV-INAMI)•Potassium iodide tablets campaign (with FPS •Interior Affairs)Provincial medical commissions (with FPS Public •Health)RECIP-E Guidance Committee (electronic •prescription in the outpatient sector)Strategic unit/RIZIV-INAMI•Therapeutic Magistral Formularium•
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Below we present some interesting information for 2009 on the various commissions and consultation platforms as well as the names of some of the staff members who ensure their permanent representation, in alphabetical order in each case.
Commissions and consultation platforms Representatives
Advisory CommissionThis scientific commission provides advice to the Minister of Public Health in matters such as:
Exception requests from pharmaceutical companies, for example in the following cases:• o authorisation to produce products other than medicines in their authorised facilities; o temporary authorisation to import and distribute medicines not authorised in Belgium in cases of unavailability on the Belgian market;
Proposals for refusal or suspension of a manufacturing licence, a wholesale distribution licence or a recognition as a QP.•
In 2009 there were six meetings, in which 125 exception requests were approved via the standard procedure, and 25 via the emergency procedure.
Séverine BrasseurRobert DelattinKarin FroidbiseIsabelle StrepenneJosiane Van der ElstWim Van Linden
Backlog working GroupThis working group offers an informal platform for the representatives of the pharmaceutical industry via their professional associations and for the FAMHP divisions authorised to issue MAs. It also stipulates new rules to enable better performance in the processing of registration and MA applications. Furthermore, the working group is also responsible for the follow-up of the measures instituted and for potentially required corrective actions.
The working group met nine times in 2009.
Christelle BeeckmansVanessa BinaméSophie ColynIris GeussensAnn Verhoye
Belgian Antibiotic Policy Coordination Committee - BAPCoCThis committee was established in 1999 in order to enable consultation and information exchange among experts in the field of antibiotics resistance and use of antibiotics in the different ecosystems (human medicine, veterinary medicine, agriculture). This is a multidisciplinary committee consisting of representatives of the FPS Public Health, various scientific commissions and committees, and experts (such as infectiologists, microbiologists, veterinarians and pharmacists) from various Belgian universities. The commission consists of a secretariat and various working groups: outpatient medicine, veterinary medicine, information, hospital medicine and hospital hygiene. The plenary commission and the different working groups meet at regular intervals to discuss the progress of the various ongoing projects and activities.
Nathalie DeneckerLionel Laurier
Biosafety Advisory Council (BAC)The BAC consists of deputies of the federal ministers of Public Health, Agriculture and Science Policy and representatives of the Walloon and Flemish governments, together with representatives of the government of the Brussels Capital Region. There are also two members of the FAMHP on the board. The BAC also issues opinions within the scope of applications for authorisations that are filed by virtue of EC Regulation 726/2004 on medicinal products or EC Regulation 1394/2007 on advanced therapy medicinal products.
In 2009 the FAMHP acted as the coordinator for a vaccine for veterinary use based on a GMO.
Manu SeverinBruno Urbain
Clinical trial task Force (CttF)The CTTF is an informal consultative platform involving all concerned stakeholders and in which the issues and points for improvement concerning the implementation of the law of 7 May 2004 relating to experiments on the human person are discussed. It has no special attributions: the consultation platform as such does not have a legal basis. Overall, the mission of the CTTF is to optimise the application of the law of 7 May 2004.
In 2009, the CTTF played a role in a number of practical issues, such as the payment of subsidies to Ethics Committees, the follow-up of projects financed with the abovementioned subsidies, and the validation of the recognition of the Ethics Committees on the basis of this law. In addition, a number of European and Belgian initiatives concerning clinical trials and experiments were discussed on a general basis. Further to a number of political and strategic discussions concerning the role and responsibilities of the Ethics Committees, a new consultation model is being sought, to be put into practice in 2010.
Kristof BonnarensGreet Musch
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Commission for the approval of institutions assigning preliminary approvals for scientific eventsThis FAMHP commission is responsible for providing advice to the Minister of Public Health in matters concerning applications from recognised facilities authorised to issue approvals prior to scientific events.
There were two meetings in 2009.
Marie-Louise BouffiouxXavier De CuyperAlain DenisAnne Wespes
Commission for the establishment of retail pharmacies (for applications in French and Dutch)The R.D. of 25 September 1974 lays down rules regarding the opening, transfer and merger of retail pharmacies. This decree also defines the rules for the temporary and definitive closure of pharmacies. It further stipulates, among other things, the role and function of the establishment commissions with a French and a Dutch language chamber, in charge of issuing opinions concerning applications for the opening, transfer or merger of pharmacies. The commission has sixty days following examination of the application to formulate an opinion. As soon as the opinion becomes available to the Minister of Public Health, he or she must make a decision within three months.
In 2009 the French language chamber recorded 68 applications covering transfers, mergers and closures, and issued 53 opinions. This was followed by 59 ministerial decisions; the Dutch language chamber recorded 72 applications covering transfers, mergers and closures, and issued 124 opinions. This was followed by 154 ministerial decisions.
The R.D. of 25 September 1974 also governs registration of retail pharmacies. The following information must be recorded:
the identity of the authorisation holder or its company name and articles of association;•the address of the pharmacy;•the identity of the pharmacy licence holder;•the opening of the pharmacy at the present registered office location;•the transfer of the pharmacy;•the temporary or definitive closure, or temporary transfer of the pharmacy.•
Registration attestations are delivered on the basis of the actual registration. If required by the registration, the exploitation licence will be adapted.
William GallantSteven Hippe Louis JacobsPaul Van der Borght
Commission for the recognition of hospital pharmacistsAmong other things, the plenary sessions of this commission dealt with the latest developments in the area of diplomas and accreditations.
Emmanuelle Gay Marianne Van Malderen
Commission for the recognition of pharmacists-clinical biologists (Fr + Nl)The R.D. of 5 November 1964 establishing the conditions for the licensing of pharmacists entitled to provide services pertaining to clinical biology stipulates that a commission be set up having the mission to issue advice and opinions on applications filed in connection therewith. This commission is also in charge of issuing advice and opinions concerning applications for recognition as a clinical biology training supervisor or training service.
In 2009 the French language chamber of the commission issued seven recognition certificates to pharmacists specialised in clinical biology and approved nine new training plans that had been submitted to it. Three new training supervisors also received recognition.
The Dutch language chamber issued eight recognition certificates to pharmacists specialised in clinical biology and approved sixteen new training plans.
William Gallant
Commission for the supervision of advertising for medicines for human useThis FAMHP commission is responsible for providing advice to the Minister of Public Health in matters concerning applications for licenses for advertising or audiovisual information campaigns for medicinal products.
There were seventeen meetings in 2009 and all opinions were issued within the legal deadline.
Marie-Louise BouffiouxAnn Van Den Broucke
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Consultation platform BloodThis platform for informal consultation with the blood facilities will meet for the first time in early 2010.
Vanessa BinaméXavier De CuyperFrédérique MeuldersThierry RoisinJosiane Van der Elst
Consultation platform FAMHP - APB and oPHACoQuarterly meetings take place with the most representative professional associations of retail pharmacists. Chairmanship of the platform alternates among the APB, OPHACO and the FAMHP. The various issues concerning retail pharmacies are discussed, and projects undertaken by the FAMHP are presented.
Louis JacobsJosiane Van der Elst
Consultation platform FAMHP - Hospital pharmacistsThis consultation platform discusses amendment proposals for the regulations concerning hospital pharmacies as well as proposals concerning standardisation and pharmaceutical services in care facilities.
Paul BallegeerRobert DelattinEmmanuelle GayLouis JacobsMarianne Van Malderen
Consultation platform FAMHP - industryFive meetings of the Consultation platform FAMHP - Industry were organised in 2009.
The following topics were discussed:programme law framework agreement: Backlog, Pharmacovigilance, Package leaflets and STA (national) Helpdesk projects;•MA: statistics, backlog and call centre;•MeSeA: status;•establishment of the FAMHP: status.•
Vanessa BinaméXavier De CuyperPascal GiloteauGreet Musch
Consultation platform FAMHP - Medical devicesThe consultation platform for medical devices met three times in 2009. These meetings discussed, in particular, the taxes and implications caused by the transition of Directive 2007/47/EC into the Belgian regulatory framework.
Carine BakwaVanessa BinaméLida De BoeckKarin FroidbiseAwatif JebariDamien LambotFrédérique MeuldersEls TuylsJosiane Van der Elst
Consultation platform for electronic prescription of medicated feedAt the end of 2009 the FPS Public Health, the FAVV-AFSCA and the FAMHP committed themselves to start working in 2010 on the creation of a legal basis for electronic prescription of medicated animal feed. For some years now, there has been a trial project for the prescription of medicated feed via an electronic application in the mixed fodder sector. The principle is that the veterinarian draws up prescriptions electronically and sends them over a wireless GPRS connection to the feed manufacturer. It appears from the evaluation of this trial project that electronic prescription has significant administrative and practical advantages for all parties involved: veterinarians, manufacturers, breeders and also for the concerned public services. This will, among other things, enable the consumption data of antimicrobial premixed fodders to be monitored.
Louis JacobsLionel Laurier
Consultation platform Human tissue materialThis informal consultation platform was set up in order to facilitate the exchange of information with new partners. The platform consists of the representatives of the hospital sector affected by this new topic.
Vanessa BinaméWalter BontezAndré LhoirDaniel MaricauFrédérique MeuldersJosiane Van der Elst
Consultation platform internal Control - internal AuditGovernment Commissioner De Padt set up the Consultation platform Internal Control - Internal Audit in order to support the services in the correct application of the decrees of August 2007 concerning internal control.
Robert DelattinPascal GiloteauJosiane Van der Elst
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Consultation platform of the Precursors unit with Customs, Federal Police and Justice - FeDlANDFEDLAND is a cooperative effort between the Belgian Federal Office of the Public Prosecutor and the National Office of the Public Prosecutor of the Netherlands. This collaboration aims at a synchronised legal approach to international organised drug crime, in particular by fighting synthetic drugs and precursors and the related organised crime with criminal activities in both countries.
The FEDLAND consultation arose from the idea that national borders no longer exist. It is aimed at carrying out joint criminal investigations with a shared, previously defined goal, with potential legal or other problems being jointly discussed and resolved.
Consultation participants:
representatives of the Dutch Office of the Public Prosecutor;•representatives of the Belgian Office of the Public Prosecutor;•the central services of the Belgian Federal Police (for the supply of information) and the Precursors Unit of the FAMHP;•Dutch national CID, FIOD-ECD (for the supply of information);•ad hoc: representatives of the local public prosecution offices, if necessary, local magistrates, local investigators, local information •managers.
Mark FeliersDirk Mergan
Consultation platform with e-HealthThis is a consultation platform dealing with, among other things, the recognition of Authentic Sources and the optimal use of information technology in pharmaceutical and medical practice.
Margriet GabriëlsLouis Jacobs
Consultation platform with FAMHP (Soe-uSe) - FAVV-AFSCA (Noe)At this level, practical issues in the performance of research are discussed, more particularly the interface between the FAMHP and the FAVV-AFSCA and the definition of their fields of action.
Viviane HenryLouis JacobsRoy VancauwenbergheJosiane Van der Elst
Consultation platform with FANC-AFCNA formal cooperation agreement was made between the FAMHP and the FANC-AFCN in December 2007. Among other things, this agreement seeks to optimise the regulatory framework for the protection of, among others, patients in relation to the medical application of radiopharmaceuticals, and to design a structural framework to stimulate mutual consultation, carry out joint actions, and mutually exchange and transfer the organisations’ respective knowledge and experience. Within the scope of this agreement, the two agencies defined five areas for cooperation in 2009. These areas were recently described in five technical data sheets to be formally approved in 2010:
technical Data Sheet 1: drafting, reviewing, interpreting and enforcing regulations;•technical Data Sheet 2: incidents and vigilance;•technical Data Sheet 3: performance of joint inspections;•technical Data Sheet 4: activities within the scope of the protection of the population against the consequences of nuclear and •radiological contingencies;technical Data Sheet 5: exchange of information and simplification of administrative issues.•
Robert DelattinEmmanuelle GayChristophe LahorteBarbara StubbeJosiane Van der ElstMarianne Van Malderen
Consultation platform with FAVV-AFSCA, FPS Public Health and Public Health Minister’s office, VetConsultation platform for clarification of the distribution of competences and relationships between departments within the FPS Public Health (DG Animal-Plant-Foodstuffs and DG Environment), the FAVV-AFSCA (control policy and control) and the FAMHP (DG PRE authorisation, DG POST authorisation and DG INSPECTION), regarding the regulatory framework in matters of psychotropic agents, the practice of veterinary medicine, MA for veterinary medicines, the distribution circuit for veterinary medicines and the related controls, medicated premixes and animal feed, hormones, biocides, feed supplements, and implantable sterile material.
Françoise FalizeLouis JacobsLionel LaurierJosiane Van der Elst
Consultation platform with wiV-iSPA consultation platform was set up between the FAMHP and the WIV-ISP as a follow-up to the collaboration agreement between the two institutions. Thus, against a fee, the WIV-ISP supports the FAMHP in the exercise of a number of its tasks.
Karin FroidbisePascal GiloteauCaroline NaertAurelie PollJosiane Van der Elst
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Coordination commission with CoDA-CeRVAThe consultation platform acts as a coordination commission that structures and evaluates the collaboration between the FAMHP and the CODA-CERVA.
There were two meetings in 2009.
Frédéric DescampsKarin FroidbiseJosiane Van der Elst
DGo-SCM Guidance CommitteeThe Medicines Control Laboratory (DGO-SCM) Guidance Committee supervises the use of the special contribution paid by retail pharmacists and intended for the “re-control” (reliability and conformity) of medicines.
Pascal GiloteauJosiane Van der Elst
evaluation commission for homeopathic medicines for human and veterinary use - HCG-HCMThe HCG-HCM was set up to provide advice and opinions on MA and registration applications, about the availability of homeopathic medicines to patients, and about scientific questions related to homeopathic medicines. The specificity of homeopathic medicines requires an adapted approach to evaluation and specific expertise while respecting, insofar as possible, the basic requirements for the registration or MA of medicines. For this reason, an autonomous commission was set up with members selected for their knowledge and experience with homeopathic medicines.
The composition of the commission was amended by the R.D. of 10 March 2009.
Marie-Anne Mouyart
evaluation commission for medicines for human useThis commission evaluates MA applications for new medicines for human use via NP, MRP or DCP. It analyses the variations filed at the Agency and pharmacovigilance reports. It also determines whether a medicinal product is subject to medical prescription.
Thus, large packages of narcotics and psychotropic agents should no longer be available in retail pharmacies accessible to the general public in view of the risk of fatal overdosing with this type of product. The commission also focused on the spread of new strains of pneumococci following the vaccination campaign with Prevenar and Synflorix. Currently, the commission is also trying to restrict the prescription of flunitrazepam in view of the potential risks involved in excessive administration of this substance. Depending on the available resources, the commission ultimately also tries to participate in the evaluation of European applications, in particular those applications in which Belgium acts as RMS, and the applications for which the Belgian CHMP member is appointed rapporteur or co-rapporteur.
Specifically, in 2009 the commission followed very closely the vaccination campaign within the scope of the A/H1N1v influenza epidemic.
Christophe FockeValérie Lescrainier
evaluation commission for medicines for veterinary useThe principal mission of this commission is the provision of opinions concerning MA applications, significant variations and five-yearly renewals for medicines for veterinary use filed via NP, MRP or DCP. The commission is also authorised to issue opinions on authorisations for temporary use of vaccines. The commission has set up its own rules and regulations, submitted to the Minister of Public Health. The commission receives the support of a secretariat staffed by FAMHP members appointed by the Minister of Public Health or his/her representatives.
Dries MinneAnicet Ndayabandi
evaluation commission for traditional herbal medicines for human use - CKG-CMPThe CKG-CMP for human use was set up to provide advice and opinions on MA and registration applications, about the availability of herbal medicines to patients, and about scientific questions related to herbal medicines. The specificity of herbal medicines requires an adapted approach to evaluation and specific expertise while respecting, insofar as possible, the basic requirements for the registration or MA of medicines. For this reason, an autonomous commission was set up with members selected for their knowledge and experience with herbal medicines.
Marie-Anne MouyartWim Vervaet
Guidance unit for the FAMHP - FAVV-AFSCA ProtocolThis coordination unit meets several times a year in order to ensure support and/or guidance for the inspection services in implementation of the protocol.
Jean-Pierre HendrickxLouis JacobsJoke LonginJosiane Van der Elst
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influenzaDuring 2009, the FAMHP was regularly appealed to within the scope of the management of the influenza crisis. Our Agency was directly involved in the different bodies that were set up to handle this matter: this includes the ICI-CII, the Evaluation Unit and the Policy Unit of the FPS Interior Affairs. This enabled the FAMHP to actively contribute to the drug logistics aspects and to the measures involved in the fight against the A/H1N1v influenza virus.
Robert DelattinPascal GiloteauPascal GuilminPaule Jacqmain (up to October 2009)
interdepartmental Commission for Fraud Prevention Coordination in the economic sectors - iCCF-CiCFThis commission organises a quarterly meeting within the scope of the fight against economic fraud and with a view to reporting irregularities in the financing of the community agricultural policy and the claims for restitution of amounts wrongly paid in that area.
A few milestones for 2009:
information exchange as a basis for collaboration: continuous process;•information campaign: “Medicines via the internet? Don’t surf with your health!”;•website: operational campaign PANGEA;•collaboration protocol FAMHP - Customs: ongoing;•Medicrime: ongoing.•
Roy VancauwenbergheJosiane Van der Elst
interdepartmental Committee of experts in matters concerning blood, organs, cells, tissues and embryosThe Interdepartmental committee of experts on blood and human tissue material has not met since 2008.
Walter BontezMustafa ChafaiAndré LhoirDaniel MaricauJosiane Van der Elst
interdepartmental coordination unit for food safety control - iCVV-CiCSAThis coordination unit organises quarterly meetings for the improvement of the collaboration among the different services involved in the safety of the food chain and the supervision of compliance with the pharmaceutical regulatory framework. This unit examines problems of a legal, scientific and practical nature.
Accomplishments in 2009:Drafting regulations against the distribution of poppers.•
Viviane HenryLionel LaurierRoy VancauwenbergheJosiane Van der Elst
interdepartmental Network “information Society Services”This working group is coordinated by the Directorate-General Control and Conciliation of the FPS Economy, SMEs, the Self-employed and Energy. This working group has not met since 2007.
Alain Denis
inter DG drugsThe FPS Public Health (DG Basic Healthcare) regularly schedules an Inter DG drugs meeting. These meetings draw up a status of all initiatives undertaken by Public Health globally, i.e. including the FAMHP, in the drugs area. They relate to narcotics and psychotropic agents on the one hand and to the issues surrounding alcohol and tobacco on the other hand.
Louis JacobsBernard Vandenbosch
Mdeon Board of ManagementMdeon is a non-profit organisation that consists of eighteen doctors’, pharmacists’, veterinarians’, dentists’ and nurses’ associations and medicinal products and medical devices industry associations. This organisation is officially recognised by the competent authorities to issue preliminary approvals (visa) for the industry to be allowed to bear the costs related to the participation of healthcare professionals in scientific events with one overnight stay. The FAMHP verifies compliance with this visa requirement.
In 2009 Mdeon, the profession ethics platform, processed 5,959 approval applications. Of these, 84 % were actually granted an approval. The number of applications rose by 5.3 % compared to 2008, in combination with an increase in the number of applicants based abroad.
Marie-Louise BouffiouxXavier De Cuyper
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Mixed CommissionThis commission was set up by the R.D. of 28 October 2008, and consists of a Chamber for products for human use and a Chamber for products destined for veterinary use. The commission only started to operate in March 2009 following publication of its composition on 27 January 2009. The Mixed commission is charged with providing advice about products that, in view of their overall characteristics, fall under the definition of both a medicine and another product subject to a different regulatory framework. The commission can also issue advice or opinions to the Minister of Public Health for the establishment of guidelines for the clarification of the regulatory framework in force.
In its first year, the commission’s Chamber for products for human use issued three opinions for the definition of guidelines, and 197 opinions concerning the status of individual products.
During this first year, the commission’s Chamber for products for veterinary use issued two opinions for the definition of guidelines, and 162 opinions concerning the status of individual products.
Chamber for products for human use:Philippe De BuckPatrick Herné
Chamber for products for veterinary use:Philippe De BuckAlain DenisClaire De VosDominique JanssensDries MinneMarie-Anne MouyartEmmanuelle VanaerschotKatelijne Van Keymeulen
Multidisciplinary Hormone unitThis operational coordination unit meets twice a week to develop actions against illegal fattening or stuffing of animals and the illegal trade in substances with hormonal, anabolic and anti-infectious action. The FAMHP is represented by the liaison officer appointed by the Minister of.Public Health.
Accomplishments in 2009:Three thousand postal packages checked and analysis of the phenomenon.•
Roy Vancauwenberghe
Non-availability of medicinesThis consultation is organised by the RIZIV-INAMI but did not meet in 2009. It discusses the significant problems related to the unavailability of medicines essential for Public Health in order to find solutions.
Séverine BrasseurKarin Froidbise
Patient PlatformThe consultation platform between the FAMHP and patients/consumers will officially start in January 2010 following a first informal meeting in 2009. The platform consists of the LUSS, the Flemish Patient Platform, the Socialist and Christian mutual health insurance funds, Test-Aankoop and OIVO. It is likely that other associations will join the platform in the future.
The topics of pharmacovigilance and patient information will be high on the agenda in 2010.
Marie-Louise Bouffioux
Pharmacopoeia CommissionThe secretariat of the Belgian Pharmacopoeia commission is part of the DG PRE authorisation and is in charge of:
contacts with the secretariat of the European Pharmacopoeia commission;•development of a Therapeutical Magistral Formularium (TMF-FTM);•publication of the Good Officinal Practices guide;•compilation of the list of medicines that need to be stocked at all times and in sufficient quantities at retail and hospital pharmacies;•licensing of raw materials used by retail pharmacists.•
2009 activities:
Belgian Pharmacopoeia Commission: 23 meetings + opinions issued in correspondence;•European Pharmacopoeia Commission: three meetings;•European Pharmacopoeia Commission: 48 meetings with the participation of a Belgian expert;•within the scope of the R.D. of 19 December 1997 concerning raw materials used by retail pharmacists: 39 raw materials approved;•within the scope of the R.D. of 19 December 1997: eight monographs approved.•
Charlotte AmelootMoïse Essoh
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Potassium iodide tablets campaignThe FAMHP participates in the meetings of the FPS Interior Affairs in preparation of the nuclear accidents prevention campaign and of the distribution of potassium iodide tablets to the population in areas around nuclear sites.
Robert DelattinLouis Jacobs
Professional ethics CommitteeThe mission of this committee is to issue advice and opinions in connection with animal trials in all cases covered by the law concerning the protection and welfare of animals (law of 14 August 1986). Upon request from the Minister of Public Health, the Division or an Ethics Committee of a laboratory, the Professional Ethics Committee issues advice or opinions concerning the development and adaptation of methods directed at reducing the number of animal studies, refining them or finding substitutes.
Sonja BekenLionel Laurier
Provincial Medical CommissionsThe retail pharmacy inspectors of the FAMHP’s DG INSPECTION are automatically members of this commission, and report on verified cases of unlawful practice within the scope of the R.D. No. 78 of 10 November 1967.
FAMHP retail pharmacy inspectorsLouis Jacobs
ReCiP-e Guidance CommitteeThis platform, with the professional associations of retail pharmacists, doctors, dentists, the RIZIV-INAMI and the FAMHP, provides guidance in the introduction of electronic prescriptions regulation in the outpatient sector.
Louis Jacobs
Strategic unit with the RiZiV-iNAMiThe membership of this consultation platform includes representatives of the FAMHP, the Public Health Minister’s office, and of the RIZIV-INAMI. This consultation unit is charged with finding a solution for potential ambiguities, contradictions and lacunae in the FAMHP’s and RIZIV-INAMI’s respective regulations concerning medicines, raw materials, medical devices and other reimbursable health products. In some cases the consultation has led to amendments to the existing regulations.
Charlotte AmelootVanessa Binamé
technical Consultation Registration
toRTOR is a consultation platform gathering the FAMHP, the pharmaceutical industry associations and representatives of pharmaceutical companies. During the consultation, technical matters are discussed relating to registration or MA for medicines for human use, including homeopathic and herbal medicines. This forum provides an opportunity to introduce proposals for national guidelines and procedures and to discuss them with stakeholders. The stakeholders can identify bottlenecks in the current or proposed procedures and submit suggestions for improvement. The national application of new European requirements in connection with MA related procedures is also a matter falling within the scope of this platform.
Vet-toRVET-TOR is a consultation platform between the FAMHP (DG PRE authorisation) and the veterinary medicines industry (Pharma.be animal health). This platform discusses the technical aspects of MA procedures for medicines for veterinary use and variations. Since the Medicines for Veterinary Use Division serves as the central contact for the FAMHP’s three pillars/DGs for the veterinary sector, it also deals with specific problems falling under the competence of the DG POST authorisation (pharmacovigilance and proper use) and of the DG INSPECTION (manufacturing, distribution and possession).
Vanessa BinaméSophie ColynIris GeussensMarie-Anne MouyartGreet MuschWim PenninckxJosiane Van der ElstAnn Verhoye
Françoise FalizeLionel LaurierDries MinneJosiane Van der Elst
therapeutic Magistral Formularium – tMF-FtMAfter more than five years of scientific work, the texts of the second edition of the TMF-FTM were finally approved and confirmed in the summer of 2009. These texts refer both to new titles and also updates of the first edition, which was limited to preparations for use in dermatology. In order to keep up with the changes in modern publication methods, it was decided to make this version of the TMF-FTM available on CD-ROM. This operation began in late 2009 and will be completed in 2010.
Moïse EssohPascal GiloteauGreet MuschJosiane Van der Elst
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working Group it with industryThe IT working group meets at regular intervals in order to:
discuss European developments in regard to eSubmission;•further develop the national eSubmission Directive;•test the Road Map and the different checks and error messages within the human NeeS checker.•
Sophie ColynLaurence DefaysPieter VankeerberghenAnn Verhoye
working group on blood of the Belgian Federal Superior Health Council + working group on cells, tissues and organs of the Superior Health CouncilThe FAMHP was represented at the meetings of the “blood” (six sessions) and “cells, tissues and organs of human or animal origin” (ten sessions) working groups. These meetings addressed, in particular, the proper use and quality and technical standards for such products.
Walter Bontez
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ContactSome useful informationFederal Agency for Medicines and Health Products - FAMHPVictor Hortaplein - Place Victor Horta 40/40 1060 Brusselswww.fagg.be - www.afmps.be
Reception (general)tel. 00 32 2 524 80 00 (Open between 0800 and 1800)fax 00 32 2 524 80 01e-mail [email protected]
Secretariat of the Chief Executive Officer, Xavier De Cuypertel. 00 32 2 524 80 05fax 00 32 2 524 80 03e-mail [email protected]
Media contacts and external communication actionsCommunication Divisionfax 00 32 2 524 80 03e-mail [email protected] Eeckhout, spokesperson for the FAMHPand Responsible for the Communication Divisiontel. 00 32 2 524 80 12mobile 00 32 495 23 71 69
Webmastere-mail [email protected]
Legal Affairs Divisione-mail [email protected]
Research and developmente-mail [email protected]
Scientific-Technical Advice - STAe-mail [email protected]
Call centre Registration - MAtel. 00 32 2 524 80 04e-mail [email protected]
Medicines for Veterinary Use Divisione-mail [email protected]
Pharmacovigilance of medicines for human usee-mail [email protected]
Medical devicese-mail [email protected]
Human tissue materiale-mail [email protected]
Information about medicines and health productse-mail [email protected]
Inspection and monitoring - Generale-mail [email protected]
Inspection and monitoring - “Industry” Divisione-mail [email protected]
Inspection and monitoring – “Dispensing” Division (pharmacies)e-mail [email protected]
Precursorse-mail [email protected]
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legal context of the FAMHP
Regulations governing organisation, functioning and activities of the FAMHP: visit www.fagg.be - www.afmps.be.•New regulatory issues: laws, Royal Decrees (R.D.), Ministerial Decrees (M.D.) and circulars published in 2009.•
Laws published in 2009
Law of 10 December 2009 regarding various stipulations in healthcare.•Amendments to the law of 25 March 1964 regarding medicines. -
Whenever pharmaceutical companies do not submit the necessary documents required for their application for a MA or registration within a reasonable period of time, the FAMHP experiences administrative problems that stand in the way of efficient management of the MA and the registration of medicines. After the scientific evaluation of the application by the competent commission, certain documents, such as the PIL and the SPC, must be adapted to incorporate the opinion of the concerned commission. Depending on the application, this may be the Evaluation commission for medicines for human use, the Evaluation commission for medicines for veterinary use, the Evaluation commission for homeopathic medicines for human and veterinary use or the Evaluation commission for traditional herbal medicines for human use. The authorisation or registration application for a medicine must comprise the updated version of the PIL and the SPC as well as their official translations and also an example of the packaging before it can be finally closed. When such documents are not submitted, the FAMHP must keep these incomplete applications pending and regularly remind the companies to submit the missing documents, which generates an additional administrative burden. In addition, incomplete applications remain open in the software used for MA and registration, causing a hindrance to good file management. The same applies to applications for amendments (variations) of MAs or registrations. In that case the problem is even more complex, as after a certain period of time, some changes (variations) can be applied directly by the authorisation or registration holder if the Minister or his/her representative has not denied the proposed change or raised an objection against it (silent approval). It then often happens that the FAMHP does not receive the documents of the authorisation or registration application as adapted to the changes (variations) implemented. In order to remediate these problems, it is stipulated that applicants for an MA or registration must submit all documents required for the closing of their application within a period of time stipulated in an R.D. Otherwise the application for changes to the MA or registration will automatically be deemed to have been withdrawn. This would result in the application being closed automatically, and in the company having to submit a new application to obtain or incorporate changes into an MA or registration at its own expense.
- Amendment to the law of 20 July 2006 on the establishment and functioning of the FAMHP. The proposed amendment is intended to make the stipulations that are applicable to the FAMHP by virtue of the law of 16 March 1954 concerning control over certain institutions of public
interest unambiguously applicable to the Agency. This ensures efficient application of these stipulations and those of the law of 20 July 2006 on the establishment and functioning of the FAMHP. Based on the abovementioned law of 16 March 1954, the R.D. of 8 January 1973 for the determination of the status of the personnel of certain institutions of public interest does in fact apply to the FAMHP. The abovementioned R.D. of 8 January 1973 provides that each institution should have an Executive council qualified for the highest level of supervision of the development of the career of permanent civil servants. However, by the installation of other management functions, i.e. three N-1 functions, it is expedient, as concerns the day-to-day management of the FAMHP, to create a body that is qualified not only to handle personnel matters but also other management issues of relevance to the FAMHP’s daily management. In addition it is also appropriate, in order to be able to ensure the multidisciplinary nature of this body and its efficient performance, to provide the option to be able to appoint a limited number of supplementary members. For this reason, this amendment seeks to accomplish the installation of a body, i.e. the Executive board, to assist the Chief Executive Officer in day-to-day management issues, and also to exercise the function of an Executive council as referred to in the abovementioned R.D. of 8 January 1973. To that end it would be necessary to establish that Article 16, § 1 of the abovementioned R.D. of 8 January 1973 does in fact not apply to the FAMHP.
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Law of 23 December 2009 regarding various stipulations in matters of public health.•Law of 25 March 1964 regarding medicines. -
A new concept is inserted into this law, i.e. “closed packaging for individual administration”, which is already technically possible, but does not yet carry legal guarantees as concerns quality and safety.Human tissue material. -
This section seeks to introduce into the law of 19 December 2008 on the acquisition and use of human tissue material for medicinal purposes with a view to medical application in humans or for scientific research, in addition to a more precise definition of the field of application, a number of adaptations concerning, on the one hand, reproductive human tissue material, and on the other hand, the obligations concerning obtention of advice and opinions from an Ethics Committee.
As concerns human reproductive tissue material, the list of Articles of the law of 19 December 2008 applicable thereto and which had originally been established by R.D., is replaced with a legislative regulation having the same legal consequences. It is moreover provided that the capacitation of male gametes can be effected in clinical biology laboratories approved by the Minister of Public Health that are also recognised as intermediary structures in application of the law of 19 December 2008.
As concerns the obligations to obtain advice and/or opinions from an Ethics Committee, a number of clarifications and simplifications are introduced with the purpose of guaranteeing a workable system.
In all other respects, and to guarantee legal certainty and prevent interpretation and adaptation problems of the law of 19 December 2008, a number of clarifying specifications are provided for.Federal Knowledge Centre for Health Care. -
The Chief Executive Officer of the FAMHP is introduced under this title.Law of 16 June 2009 for a postponement of the date of coming into effect of the law of 19 December 2008.•
Royal Decrees published in 2009
R.D. of 14 October 2009• for the appointment of persons in charge of monitoring compliance with the law of 19 December 2008 on the acquisition and use of human tissue material for medicinal purposes with a view to medical application in humans or for scientific research and its implementation decrees.R.D. of 14 October 2009• for the appointment of persons in charge of monitoring compliance with the law of 5 July 1994 concerning blood and blood derivatives of human origin and its implementation decrees.R.D. of 28 September 2009• for the determination of the general conditions to be met by human tissue banks, intermediary structures and production facilities in order to earn recognition.R.D. of 28 September 2009• for the determination of the provisions concerning the reporting of serious adverse reactions and serious adverse events in connection with human tissue material.R.D. of 28 September 2009• concerning monitoring of compliance with the law of 19 December 2008.R.D. of 28 September 2009• for the determination of quality and safety standards in relation to donating, removing, obtaining, testing, processing, storing and distributing human tissue material to be met by human tissue banks, intermediary structures for human tissue material and production facilities.R.D. of 28 September 2009• for the determination of the list of articles of the law of 19 December 2008 on the acquisition and use of human tissue material for medicinal purposes with a view to medical application in humans or for scientific research, applicable to gametes, gonads, fragments of gonads, embryos and human foetal tissue material.R.D. of 28 September 2009• concerning amendments to the R.D. of 23 October 1964 for determination of the standards to be complied with by hospitals and their services.R.D. of 20 September 2009• for the appointment of persons in charge of monitoring compliance with the law of 6 July 2007 concerning medically supported reproduction and destination of excess of embryos and gametes, as well as its implementation decrees.R.D. of 10 September 2009 • concerning amendments to the R.D. of 14 December 2006 concerning medicines for human and veterinary use.R.D. of 28 June 2009 • concerning amendments to the R.D. of 4 April 1996 concerning the sampling, preparation, storage and provision of blood and blood derivatives of human origin.R.D. of 31 March 2009• for the implementation of Article 6 sexies of the law concerning medicines
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R.D. of 17 March 2009• concerning amendments to the R.D. of 18 March 1999 concerning medical devices.R.D. of 21 January 2009• + appendices, containing instructions for pharmacists.R.D. of 21 January 2009• concerning amendments to the R.D. of 15 July 1997 concerning active implantable medical devices.
Ministerial Decrees published in 2009
M.D. of 14 October 2009• concerning appointment of the Minister’s representative, referred to in the R.D. of 28 September 2009, for the determination of the general conditions to be met by human tissue banks, intermediary structures and production facilities in order to earn recognition.M.D. of 14 October 2009• concerning the determination of the price of human tissue material.M.D. of 9 October 2009• concerning the composition and appointment of the members of the Executive council of the FAMHP.M.D. of 10 August 2009• concerning implementation of Article 10 bis §9 of the R.D. of 18 March 1999 concerning medical devices, more particularly in relation to care plans for diabetes patients.M.D. of 28 June 2009• concerning determination of the price of blood and unstable blood derivatives.
Circulars sent in 2009
10.12.2009: Circular 564• - To sponsors of clinical trials. Payment for applications for clinical trials.07.12.2009: Circular 565• - To heads of hospital departments and chief pharmacists. Conservation/storage of human tissue material.16.11.2009: Circular 545 • - To holders of a Belgian MA or registration of medicines for human and veterinary use. Reporting of the person responsible for human or veterinary pharmacovigilance to the FAMHP by the holders of an MA or registration.16.11.2009: Circular 544 • + Appendix - To applicants for registration on the Belgian list of persons responsible for pharmacovigilance for medicines for human and veterinary use. Application for registration as person responsible for pharmacovigilance for medicines for human and veterinary use.16.11.2009: Circular 491• - To the management of blood establishments. Pathogen reduction of platelet concentrates.03.11.2009: Circular 561• - To holders of an MA or registration of medicinal products. Publication on the FAMHP’s website of SPCs and PILs for medicines authorised and marketed in Belgium.26.10.2009: Circular 560• - To heads of hospital departments. Reporting of serious adverse reactions and serious adverse events in connection with human tissue material.26.10.2009: Circular 559• - To managers of human tissue material at facilities working with human tissue material. Reporting of serious adverse reactions and serious adverse events in connection with human tissue material.26.10.2009: Circular 558• - To managers of human tissue material and the persons responsible for human tissue material establishments. Inspection of human tissue material facilities.26.10.2009: Circular 556 • - To the directors-general and the heads of hospital departments. Annual notification concerning human tissue material.26.10.2009: Circular 555 • - To managers of human tissue material and the persons responsible for human tissue material establishments. Procedure to be followed for applications for the determination or review of prices for human tissue material to be set by the Minister.26.10.2009: Circular 554 • + Appendix - To managers of human tissue material and the persons responsible for human tissue material establishments. Description of the human tissue material establishment (Site Master File or SMF).26.10.2009: Circular 553 • + Appendices - To managers of human tissue material and the persons responsible for human tissue material establishments; to the directors-general of hospitals. Annual financial report and inventory report of human tissue material banks.26.10.2009: Circular 552 • + Appendix - To managers of human tissue material and the persons responsible for human tissue material establishments. Content of the
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activities/annual report of human tissue material establishments.26.10.2009: Circular 551• - To managers of human tissue material and the persons responsible for human tissue material establishments. Notifications that must be made within the scope of the maintenance of the recognition of a facility for human tissue material.26.10.2009: Circular 550• - To managers of human tissue material and the persons responsible for human tissue material establishments; to the directors-general of hospitals. Procedure concerning the application for recognition and for the granting of recognition in respect to a human tissue material establishment.04.08.2009: Circular 543• - To the chairs of the Ethics Committees. List of Ethics Committees with full recognition within the scope of the law of 7 May 2004 relating to experiments on the human being.29.07.2009: Circular 547• - human - vet – methods and approach - To MA holders. Communication of data concerning the actual market status of medicines authorised by the European Commission (via CP) in Belgium.27.07.2009: Circular 548• - For the attention of retail pharmacists. Supplementary information concerning Appendix II to the R.D. of 21 January 2009 regarding instructions for pharmacists.30.06.2009: Circular 542 • + Appendices - To holders/applicants of an MA for medicines for human use. Follow-up of applications for MA - Action Plan 2009.04.03.2009: Circular 538 • - For the attention of the management of blood establishments. Selection of blood donors (February 2009).20.02.2009: Circular 537• - For the attention of hospitals: the head of medicine, the chairman of the Transfusion Committee and the manager of the blood bank. Traceability of blood products (revision of the Circular of 28 June 2006) (version of February 2009). Creutzfeldt-Jakob disease, BSE and the risk of contamination of blood products.20.02.2009: Circular 530• - To holders of an MA for medicines for human and veterinary use. R.D. of 21 January 2009 for the determination of filing fees for periodically updated safety reports.03.11.2009: Circular 536• - To pharmacists keeping retail pharmacies. Websites of retail pharmacies.
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Publication information
This report, “The FAMHP moves up a gear. Annual Report 2009.” was created under the coordination of the Communication Division of the FAMHP.
Publication and distributionFederal Agency for Medicines and Health Products - FAMHPCommunication DivisionEurostation IIVictor Hortaplein - Place Victor Horta 40/401060 Brusselstel. 0032 2 524 80 12fax 0032 2 524 80 03e-mail [email protected] - www.afmps.be
Person responsible for the publicationXavier De Cuyper,Chief Executive Officer of the FAMHP
CoordinationCommunication Division of the FAMHPe-mail [email protected]
TranslationTranslation Division of the FAMHP (Dutch, French)CIBE public sector tailored communication (English)
Graphic design and productionCIBE public sector tailored communicationGordunakaai 859000 Ghentwww.cibecommunicatie.be
PhotographyBenjamin [email protected]
This annual report is available in Dutch, French and EnglishThe electronic version of this annual report 2009 is available on the FAMHP website (www.fagg.be - www.afmps.be)
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LIST OF A NUMBER OF DEFINITIONS AND USED ABBREVIATIONS
IA variations
Type IA variations are changes to an MA that have minimal or no effect on the quality, safety or efficacy of the medicinal product.
IB variations
Type IB variations are all changes to an MA that are not defined as a Type IA variation, a Type II variation or a line extension, and that cannot have any significant effect on the quality, safety or efficacy of the medicinal product.
@ctua Electronic newsletter of the FAMHP to its stakeholders
@ctua Express
Electronic newsletter of the FAMHP to the stakeholders, used to communicate specific or urgent reports
A/H1N1v A new human virus of mixed genetic origin, being a reassortment of swine, avian, and human influenza viruses. This virus was identified in Mexico at the end of March 2009.
a.o. Among others
APB The coordinating federation of the Belgian professional associations of independent retail pharmacies
ASMF Active Substance Master File - File concerning the active ingredient only. It consists of an “open part” and a “closed part”. The “open part” can be part of an MA application or a variation to an MA.
ASR Annual Safety Report
B&Mc Budget and Management control
BCFI-CBIP Belgian Centre for Pharmacotherapeutic Information, non-profit association
BCGH-CBPH Belgian Centre for Pharmacovigilance for medicines for human use, within the FAMHP
BEMA Benchmarking European Medicines Agencies
B.S.-M.B. Belgian journal of acts, orders and decrees
BUM Proper use of medicines
BVK-SBP Belgian Association for Paediatric Medicine
CAT Committee for Advanced Therapies
CE Marking that companies are required to display on products falling within the scope of the New Approach Directives - European conformity marking
CHMP Committee for Medicinal Products for Human Use (ex CPMP)
CIBE Public sector tailored communication
CKG-CMP Evaluation commission for traditional herbal medicines for human use
Class labelling
Stipulations(s) in the PIL and the SPC concerning the safety in use of all medicinal products within one class, or of all medicines with the same active substance
CMD Certificate for Medical Device
CMDh Coordination Group for Mutual Recognition and Decentralised Procedures, human
CODA-CERVA
Veterinary Agrochemical Research Centre
COMMnet The network of federal staff members working in communication. It comprises some six hundred people from some sixty federal services for MA.
CP Centralised Procedure for MA
CTA Clinical Trial Application
CTFG Clinical Trial Facilitation Group - A collaborative group established to facilitate and harmonise the organisation of clinical trials in Europe
CVMP Committee for Medicinal Products for Veterinary Use
DCP Decentralised Procedure for MA
DG Directorate-General
(e)CTD (electronic) Common Technical Document - File format for the application for (changes to) MA for medicines for human use
EDQM European Directorate for the Quality of Medicines & HealthCare - European bureau (Council of Europe) for the evaluation of the quality of medicines and healthcare
e-Health Secure platform for electronic data exchange within the Belgian healthcare sector
EMA European Medicines Agency
EORTC European Organisation for Research and Treatment of Cancer - International non-profit organisation promoting and coordinating clinical laboratory cancer research throughout Europe. The mission of the EORTC is to raise cancer treatment standards, and to facilitate the transition between experimental discoveries and brand new treatments.
EU European Union
Eudra-Vigilance
Central EMA database including reports of adverse reactions of human and veterinary medicines approved within the EU, with data provided by European medicines authorities and pharmaceutical companies
FAGG-AFMPS
Federal Agency for Medicines and Health Products, FAMHP
FAMHP Federal Agency for Medicines and Health Products = FAGG-AFMPS
FANC-AFCN Federal Agency for Nuclear Control
Farmaka A non-profit association whose mission is to contribute, by means of research and projects, to the rational use of medicines and medical devices and to place this knowledge at the service of healthcare professionals, consumers and the competent authorities
FAVV-AFSCA Federal food agency
Fedict Federal Public Service for Information and Communication Technology
FEDLAND Consultation platform of the FAMHP’s Precursors Unit together with Customs, the Federal Police and the Justice Department
FIOD-ECD Tax Information and Investigation Department - Economic Control Department - Dutch Tax Investigation Service
FPS Federal Public Service
Fr French
FUSL Schools of Saint-Louis University
GAP analysis
Method for comparison between an actual and a desired situation
GCP Good Clinical Practices
GDP Good Distribution Practices
GMO Genetically Modified Organism
GMP Good Manufacturing Practices
HCG-HCM Evaluation commission for homeopathic medicines for human and veterinary use
HMA Heads of Medicines Agencies - Network of European medicines authorities
HMM Homeopathic Manufacturing Methods
HMPC Committee on Herbal Medicinal Products
HMPWG Homeopathic Medicinal Products Working Group
HR Human Resources
ICH International Conference on Harmonisation
ICI-CII Interministerial Commissariat for Influenza
ICT Information and communication technology
IMP Investigational Medicinal Product
IMPACT International Medical Products Anti-Counterfeiting Taskforce - WHO initiative in the fight against counterfeit medicines
INCB International Narcotics Control Board
IT Information technology
IWP Immunologicals Working Party
R.D. Royal Decree
KCE Belgian Health Care Knowledge Centre
SME Small to medium-sized enterprise
KPI Key Performance Indicator
LUSS A non-profit association of users, patients and citizens interested in health matters
MA Marketing Authorisation
MAH Marketing Authorisation Holder
M.D. Ministerial Decree
Mdeon Mdeon is a non-profit association, the common professional ethics platform set up by doctors’, pharmacists’, veterinarians’ and nurses’ associations and the pharmaceutical and medical devices industry associations.
MeSeA Medicines electronic Submission and electronic Approval
MHRA Medicines and Healthcare Products Regulatory Agency - The British medicines authority
MRP Mutual Recognition Procedure for MA
N-1 Mandate holder - Management position of Director-General
NAT Nucleic Acid Amplification Test - a blood test
NeeS Non eCTD Electronic Submission
Nl Dutch
NIMP Non Investigational Medicinal Product
NOE National Investigation Unit of the FAVV-AFSCA
NP National procedure for MA
NTA Working Group Notice to Applicants - Working group for the development of specific guidelines for the filing of MA applications
OIVO User Associations Research/Investigation Centre
OLAF European Anti-Fraud Office
OPHACO Belgian professional association of cooperative retail pharmacies
P&O Personnel and organisation
PDCO Paediatric Committee
PFIPC Permanent Forum on International Pharmaceutical Crime
pharma.be General association of the Pharmaceutical Industry (AVGI), a non-profit association established to promote the interests of the pharmaceutical industry in Belgium
Pharm-pack
Regulatory proposal submitted at the end of 2008 by the European Commission to the Parliament and the Council, concerning pharmacovigilance, the imitation and counterfeiting of medicines, and patient information
PhVWP PharmacoVigilance Working Party
PIC(/s) Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S)- International cooperation scheme for pharmaceutical inspections
PIL Patient Information Leaflet
PIP Paediatric Investigation Plan
PMO Program Management Office
PSUR Periodic Safety Update Report
PUMP The Public Management Programme is a “training sabbatical”, an intensive government management training programme for Federal civil servants.
R&D Research and Development
RAS Rapid Alert System - System of warnings and urgent information reports concerning medicines and health products;
RECIP-E Pilot project for electronic prescription of medicines in the outpatient sector
Referral Arbitration procedure for MA applications
RIZIV-INAMI National institute for sickness and invalidity insurance
RMS Reference Member State
RQ Five-yearly renewal
SAWP Scientific Advice Working Party
SAWP-V Scientific Advice Working Party, Veterinary
Selor Government recruitment agency
SPC Summary of Product Characteristics
SMF Site Master File - Document drawn up by the manufacturer and containing specific GMP and factual information concerning pharmaceutical industry production and/or controls, the activities carried out at the designated site, and the closely integrated activities in adjacent and neighbouring buildings
SOE-USE Special Investigation Unit of the FAMHP
SOP Standaard Operating Procedure - A series of instructions to be performed in sequential order
SPOC Single Point Of Contact
STA Scientific-Technical Advice
TGV-ATU Authorisation for temporary use
TMF-FTM Therapeutic Magistral Formularium
TOR Technical consultation platform for registration
TQM Total Quality Management
TSE Transmissible Spongiform Encephalopathy
TU Traditional Use - Traditional use of plant based medicines as stipulated in Article 43 of the R.D. of 14 December 2006
UCL Catholic University of Louvain - French-language university
UGent Ghent University
ULB Free University of Brussels - French-language university
ULg Liège University
UNO United Nations Organization
VET Veterinary (animal health)
VET-TOR Technical consultation platform for registration for medicinal products for veterinary use
Vit@ The FAMHP’s monthly internal, electronic newsletter
Vit@ Express
Internal, electronic newsletter for urgent reports
Vit@ MeSeA The FAMHP’s internal, electronic newsletter for all MeSeA reports
Vitruvius A leadership development programme of the FPS P&O
VUB Free University of Brussels - Dutch-language university
VWP Vaccine Working Party
vzw-asbl Non-profit association
WGEO Working Group of Enforcement Officers - Working group for consultation in matters concerning the fight against pharmaceutical crime
WHO World Health Organisation
WIV-ISP Scientific Institute of Public Health
Federal Agency for Medecines and Health Products
Victor Hortaplein - Place Victor Horta 40/401060 Bruxellestel. 0032 2 524 80 00fax 0032 2 524 80 01www.afmps.be
THE FAMHP MOVES UP A GEARAnnual Report 2009
Federal Agency for Medecines and Health Products