11 - 12 december 2013 shakaryan mkrtich authority position concerning implemen-tation of efficient...
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11 - 12 DECEMBER 2013 SHAKARYAN MKRTICH11 - 12 DECEMBER 2013 SHAKARYAN MKRTICH
AUTHORITY POSITION CONCERNING IMPLEMEN-TATION OF EFFICIENT
APPROACHS IN FIGHTING AGAINST COUNTERFEITING OF MEDICAL
PRODUCTS
AUTHORITY POSITION CONCERNING IMPLEMEN-TATION OF EFFICIENT
APPROACHS IN FIGHTING AGAINST COUNTERFEITING OF MEDICAL
PRODUCTS
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What is the true picture?
$75 billion black market10,000 deaths every year
10 tons of counterfeit medicine seized
Customs seizeMillions of medicines
at border
400 counterfeit Medicines factories
shut down
Hospitals flooded with counterfeits
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ALL THE TYPES OF MEDICAL PRODUCTS ARE ALL THE TYPES OF MEDICAL PRODUCTS ARE COUNTERFEITEDCOUNTERFEITEDALL THE TYPES OF MEDICAL PRODUCTS ARE ALL THE TYPES OF MEDICAL PRODUCTS ARE COUNTERFEITEDCOUNTERFEITED
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Health is a social human right – counterfeiting of
medicines is a criminal act with a dramatic impact on the
health of the most vulnerable persons - patients
CONTRADICTION WITH HUMAN RIGHTS CONTRADICTION WITH HUMAN RIGHTS CONVENTIONCONVENTIONCONTRADICTION WITH HUMAN RIGHTS CONTRADICTION WITH HUMAN RIGHTS CONVENTIONCONVENTION
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Territory: Territory: 29,74 thous. km.sq. Population: Population: 3,21 million
REPUBLIC OF ARMENIAREPUBLIC OF ARMENIA
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LEGAL INSTRUMENTS AND PROCEDURES TO COMBAT AGAINST COUNTERFEITING
- ARMENIAN CRIMINAL CODE, 2006
- WHO RECOMMENDATIONS, DEFINITIONS, IMPACT
- CIS AGREEMENT “ON COMBATING AGAINST COUNTERFEITINGS” 2008
- SIGNATURE OF MEDICRIME, 20 SEPTEMBER 2012
-ESTABLISHING SPOCs, SPOC NETWORKS
-TRAINING ON EDQM PLATFORM IN YEREVAN NOVEMBER 8-9 2012
LEGAL INSTRUMENTS
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Scientific Centre of Drug and Medical Technology Expertise of MoH of RA
REGULATION OF MEDICINAL PRODUCTS
LAW ON MEDICINES/1998GOVERNMENT DECREE 581/2000
IMPORT IMPORT CONTROLCONTROL
IMPORT AUTHORIZATIONIMPORT AUTHORIZATION
Customs code Products3001, 02, 03,04, 05, 06, 06, 06, 08 PHARMACEUTICAL PRODUCTS
2941 Antibiotics
1211 plants etc for pharmacy, perfume, insecticides etc
0510 ambergris, castoreum etc, glands etc for pharmacy
2904-2909, 2912-2940, 2942 ORGANIC CHEMICALS1301, 1302 lac, natural gums, resins, gum-resins and balsams
1504,1520 fats & oils, their fractions, fish & marine mammal1108 starches, inulin1702 sugars nesoi, incl. chem pure lactose etc, caramel1804, 1805 cocoa butter, fat and oil, cocoa powder, not sweetened2207, 2209 ethyl alcohol, undenat, n/un 80% alc, alcohol, 2712 petroleum jelly, mineral waxes & similar products2801, 2802, 2804, 2810, 2847, 2851 fluorine, chlorine, bromine & iodine
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Permission
Documentation expertise and
identification with registration samples
Scientific Centre of Drug and Medical Technology Expertise of MoH of RA
8
Application
Preliminary expertise
Sampling
Final Expert Conclusion
Rejection
Quality Control of selected
medicines
Positive Inconsystency
Applications for import authorization: 2,000 – 2,300Applications for import authorization: 2,000 – 2,300Applications for import authorization: 2,000 – 2,300Applications for import authorization: 2,000 – 2,300
IMPORT AUTHORIZATIONIMPORT AUTHORIZATION
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SAMPLINGIMPORT AUTHORIZATIONIMPORT AUTHORIZATION
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COMPARISON WITH AUTHORIZED SAMPLES FROM THE DATA BASE OF DRACOMPARISON WITH AUTHORIZED SAMPLES FROM THE DATA BASE OF DRA
originaloriginalcounterfeitcounterfeit
microscopymicroscopy
IMPORT AUTHORIZATIONIMPORT AUTHORIZATION
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QUALITY CONTROL FACILITIES
IMPORT AUTHORIZATIONIMPORT AUTHORIZATION
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DATA BASE OF IMPORTED MEDICINESDATA BASE OF IMPORTED MEDICINES
- Name and address of the Importer
- Name and address of the Supplier
- Medicines name, dosage form, strength,
- Manufacturer and holder of marketing
authorization
- Unit price
- Quantity
- Batch number
- Expiry date
IMPORT AUTHORIZATIONIMPORT AUTHORIZATION
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Scientific Centre of Drug and Medical Technology Expertise of MoH of RA
13
Import rejection from 1998-2012Import rejection from 1998-2012
IMPORT AUTHORIZATIONIMPORT AUTHORIZATION
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COUNTERFEIT CASES DETECTED FROM 2001-2012
DETECTION OF COUNTERFEITDETECTION OF COUNTERFEITN
um
ber
of
Cas
es
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Counterfeit Dietary Supplements
REGULATION OF MEDICINAL PRODUCTS
Contains undeclared ingredient
tadalafil 34.73mg Contains undeclared ingredient tadalafil
16.12mg
No marketing authorization for DS
DETECTION OF ILLEGAL MEDICINESDETECTION OF ILLEGAL MEDICINES
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IMPORT AUTHORIZATIONIMPORT AUTHORIZATION
SAMPLING CUSTOMS PROCEDURE
CUSTOMS RELEASE
EXPERTISE OF DRA
C U S T O M S C O N T R O L
IMPORT
PART OF CUSTOMS CONTROLPART OF CUSTOMS CONTROL
50%50%
1%1%
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CounterfeitCounterfeit
Counterfeit AUGMENTIN powder for injection
Contains ampicillin 1.396mg instead of the active ingredients- amoxicillin, clavulanic acid/ 1g+200mg
REGULATION OF MEDICINAL PRODUCTS
RegisteredRegistered
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Counterfeit RocephinRocephin powder for solution for injection-2013
RegisteredRegistered CounterfeitCounterfeit
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МОДЕРНИЗАЦИЯ ИНФОРМАЦИОННЫХ
ПРОЦЕССОВ В ЗДРАВОХРАНЕНИИ
МОДЕРНИЗАЦИЯ ИНФОРМАЦИОННЫХ
ПРОЦЕССОВ В ЗДРАВОХРАНЕНИИ
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DEFINITION OF COUNTERFEITINGDEFINITION OF COUNTERFEITING- legislative - counterfeit, medical and medicinal product, victim, similar - legislative - counterfeit, medical and medicinal product, victim, similar crimecrimeb. in guidlines – pharmaceutical criminal activity, SPOC, signalb. in guidlines – pharmaceutical criminal activity, SPOC, signal
-PROVIDING FOR THE CRIMINALISATION OF CERTAIN ACT PROVIDING FOR THE CRIMINALISATION OF CERTAIN ACT - - Article 5 – Manufacturing of counterfeitsArticle 5 – Manufacturing of counterfeits
- Article 6 – Supplying, offering to supply, and trafficking in counterfeits –Article 6 – Supplying, offering to supply, and trafficking in counterfeits –- Article 7 – Falsification of documents Article 7 – Falsification of documents - Article 8 Similar crimes involving threats to public health Article 8 Similar crimes involving threats to public health
LEGAL PROVISION REGARDING TO COLLABORATION AND CO-LEGAL PROVISION REGARDING TO COLLABORATION AND CO-OPERATION BETWEEN AUTHORITIESOPERATION BETWEEN AUTHORITIES
- National measures of co-operation and information exchange- National measures of co-operation and information exchange- International co-operation- International co-operation
RATIFICATION OF MEDICRIMERATIFICATION OF MEDICRIME CONVENTION
COMPREHENSIVE TOOL IN COMBATING AGAINST COUNTERFEITINGS
MEDICRIME CONVENTION
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MEDICRIME CONVENTIONChapter V –Measures for prevention Article 18 - Preventive measures 1. Each Party shall take the necessary legislative and other measures to establish the quality and safety requirements of medical products.
2. Each Party shall take the necessary legislative and other measures to ensure the safe distribution of medical products.
3. With the aim of preventing counterfeiting of medical products, active substances, excipients, parts, materials and accessories, each Party shall take the necessary measures to provide, inter alia, for:a training of healthcare professionals, providers, police and customs authorities, as well as relevant regulatory authorities;b the promotion of awareness-raising campaigns addressed to the general public providing information about counterfeit medical products;
Chapter V –Measures for prevention Article 18 - Preventive measures 1. Each Party shall take the necessary legislative and other measures to establish the quality and safety requirements of medical products.
2. Each Party shall take the necessary legislative and other measures to ensure the safe distribution of medical products.
3. With the aim of preventing counterfeiting of medical products, active substances, excipients, parts, materials and accessories, each Party shall take the necessary measures to provide, inter alia, for:a training of healthcare professionals, providers, police and customs authorities, as well as relevant regulatory authorities;b the promotion of awareness-raising campaigns addressed to the general public providing information about counterfeit medical products;
MEDICRIME CONVENTION
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FOR COOPERATION WITHIN AN INDIVIDUAL COUNTRY: A NETWORK AMONG SINGLE POINTS OF CONTACT (SPOCS) WITHIN THE DIFFERENT COMPETENT AUTHORITIES
FOR INTERNATIONAL COOPERATION AMONG STATES, THE NATIONAL SPOCS NETWORK IS REPRESENTED BY A “NATIONAL” SPOC”.
COLLABOATION BETWEEN SPOCsCOLLABOATION BETWEEN SPOCsCOLLABOATION BETWEEN SPOCs
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Clarify product’s licensing/distribution status (border,
retail, other level)
Is the medical product legally
marketed?
Does it comply with National
authorisations/ conformity
requirements’?
National SPOCcloses the case in agreement with national SPOCs network
Contain the incident e.g. quarantine, confiscation
Optional: authority assigns operational SPOC for coordination and adoption of
appropriate action
Co-ordination and taking of appropriate enforcement
action
Yes
Yes
NoDRA/Devices
Authority returns
information
NoDRA/
Devices Authority returns
information
Signal suspected case. Reported with all possible information to
Central Reporting Point for evaluation of signal
NationalNetwork among authorities of an individual state
DRA/Devices Authority for public health risk assessment
Penal imprisonmentction
(Fine,)
Other Administrative action (E.g. suspension of
establishment licence, or marketing
authorization)
Immediate action (E.g. seizure of product, recall,
dissemination of information)
NATIONAL AND INTERNATIONAL SPOCNATIONAL AND INTERNATIONAL SPOCHANDLING OF SIGNAL
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National SPOCRole in
international/national co-operation; Central Reporting
Point
International
Co-operation
SPOC for
Customs
SPOC for
Police
SPOC for Other as needed
SPOC for
Judiciary
Industry Investigation SPOC e.g. Qualified/ Responsible Person)
SPOC for Medicines Regulatory Authority (DRA)incl. Official Medicines Control LaboratoriesCompetent Authorities for Medical Devices
SignalsGeneral public;
Health professionals
DRASPOCDRASPOC
NATIONAL AND INTERNATIONAL SPOC
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SPOC DRA/SCDMTE
GMP/GDP INSPECTION
GMP/GDP INSPECTION
PHARMACOVIGILANCE INSPECTION
PHARMACOVIGILANCE INSPECTION
IMPORT/EXPORT AUTHORIZATION
DEPARTMENT
IMPORT/EXPORT AUTHORIZATION
DEPARTMENT
EVALUATION DEPARTMENTEVALUATION DEPARTMENT
DEPUTY HEAD SCDMTE
QUALITY CONTROL
LABORATORY
QUALITY CONTROL
LABORATORY
SCIENTIFIC CENTRE`S SPOCSCIENTIFIC CENTRE`S SPOC
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ADMINISTRATION OFFICER
CUSTOMS POINTSFOR PASSENGERS
CUSTOMS POINTSFOR CARGO
COMBATING AGAINST SMAGLING PRODUCTS
Only 10 Medicines with 5 packs
8 Customs warehouses 8 Customs warehouses
CUSTOMS SPOCCUSTOMS SPOC
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CRIMINAL CRIMINAL INVESTIGATION INVESTIGATION DEPARTMENTDEPARTMENT
GENERAL GENERAL DEPARTMENT ON DEPARTMENT ON
COMBATING COMBATING ORGANIZED ORGANIZED
CRIMECRIME
REGIONAL REGIONAL ADMINISTRAADMINISTRA
TIONTION
11 REGIONS
POLICE SPOCPOLICE SPOC
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- Regular meetings with CustomsRegular meetings with Customs- Ad hoc meetings with Customs and PoliceAd hoc meetings with Customs and Police
COLLABORATION WITHIN SPOC NETWORK COLLABORATION WITHIN SPOC NETWORK
MEETINGS
TRAININGTRAINING
- Training of Customs personnel 3 Dec 2012Training of Customs personnel 3 Dec 2012- Planed training of Customs and Police personnelPlaned training of Customs and Police personnel
JOINT INSPECTIONS
- In Customs warehouses, pharmacies, In Customs warehouses, pharmacies, distributorsdistributors
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POLICE SPOC
POLICE SPOC
JUDICARYSPOC
JUDICARYSPOCCUSTOMS
SPOCCUSTOMS
SPOC
DRASPOCDRA
SPOC
NATIONAL NETWORKNATIONAL NETWORK
NATIONAL NETWORK OF SPOCs
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THE MEDICINES/DEVICE THE MEDICINES/DEVICE REGULATORY AUTHORITY REGULATORY AUTHORITY
SPOC IS RESPONSIBLE SPOC IS RESPONSIBLE FOR THE PUBLIC HEALTH FOR THE PUBLIC HEALTH
RISK ASSESSMENT OF RISK ASSESSMENT OF SUSPECTED/VERIFIED SUSPECTED/VERIFIED
CASES AND FOLLOW-UP CASES AND FOLLOW-UP TO THIS ASSESSMENTTO THIS ASSESSMENT
NATIONAL NETWORK OF SPOCs NATIONAL NETWORK OF SPOCs
CUSTOMS SPOC IS CUSTOMS SPOC IS RESPONSIBLE FOR RESPONSIBLE FOR
REPORTING REPORTING INFORMATION ON INFORMATION ON
DETECTCTED CASES DETECTCTED CASES TO DRA SPOCTO DRA SPOC
POLICE POLICE SPOC IS SPOC IS RESPONSIBLE FOR RESPONSIBLE FOR
REPORTING REPORTING INFORMATION ON INFORMATION ON
DETECTCTED CASES TO DETECTCTED CASES TO DRA SPOCDRA SPOC
POLICE POLICE SPOCSPOC
CUSTOMS CUSTOMS SPOCSPOCDRA SPOCDRA SPOC
PERMANENT INFORMAL SPOC
NETWORK
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RAPIT ALERT NOTIFICATION FORM RAPIT ALERT NOTIFICATION FORM
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NATIONAL SPOCNATIONAL SPOC
PUBLIC HEALTH PROTECTION SHOULD BE A PRIORITY
REACTIVE AND PROACTIVE CO-OPERATIONREACTIVE AND PROACTIVE CO-OPERATION
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COMBATING COUNTERFEITING OF MEDICINES AND SIMILAR CRIMES AND COMBATING COUNTERFEITING OF MEDICINES AND SIMILAR CRIMES AND PROTECTING PUBLIC HEALTH THROUGH LEGAL INSTRUMENTS, AWARENESS-PROTECTING PUBLIC HEALTH THROUGH LEGAL INSTRUMENTS, AWARENESS-RAISING AND CO-OPERATION ON COUNTRY AND MULTINATIONAL LEVELSRAISING AND CO-OPERATION ON COUNTRY AND MULTINATIONAL LEVELS
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Armenia
Georgia
Russia
Moldova
Ukraine
Belarus
Khazakhstan
TRAINING AND QUALIFICATIONTRAINING AND QUALIFICATION
FIRST LEVEL REGIONAL TRAINING FOR THE 6 CIS COUNTRIES
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TRAINING AND QUALIFICATIONTRAINING AND QUALIFICATION
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П О З И Ц И Я Р Е Г У Л Я Т О Р Н О Г О О Р Г А Н АП О З И Ц И Я Р Е Г У Л Я Т О Р Н О Г О О Р Г А Н А
ЗАЩИТА ЗДОРОВЬЯ НАСЕЛЕНИЯ ЯВЛЯЕТСЯ ПРИОРИТЕТОМ
ЗАЩИТА ЗДОРОВЬЯ НАСЕЛЕНИЯ ЯВЛЯЕТСЯ ПРИОРИТЕТОМ
СПАСИБО ЗА ВНИМАНИЕ СПАСИБО ЗА ВНИМАНИЕ