the role of the irish medicines board pat o’mahony chief executive
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The Role of the Irish Medicines Board Pat O’Mahony Chief Executive. The IMB Mission. To protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products. IMB Functions. - PowerPoint PPT PresentationTRANSCRIPT
The Role of the Irish Medicines Board
Pat O’MahonyChief Executive
04/19/23 Slide 2
To protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products.
The IMB Mission
04/19/23 Slide 3
IMB Functions
1. Authorisation of medicinal products for Human (H) and Veterinary (V) use
2. Inspection and licensing of manufacturers (H & V) and wholesalers (H)
3. Competent Authority for Medical Devices4. Competent Authority for Blood Directive and
for Tissues and Cells Directives5. Approval of Clinical Trials (H) and clinical
investigations (MD)6. Pharmacovigilance/Vigilance 7. Sampling and Analysis
04/19/23 Slide 4
8. Enforcement (H)
9. Overseeing Recalls
10. Issue of Export Certificates (H & V)
11. Issue of GMP Certificates (H & V)
12. International representative function
13. Advice to Government
14. New areas planned including cosmetics
IMB Functions
04/19/23 Slide 5
• Effective Risk Management and Improving Consumer Safety
• Effective Regulation through the on going Development of our Workforce and non-staff Resources
• Effective Communication with all Stakeholders
Irish Medicines Board Objectives
Board
CommuncationsCommittee
Chief ExecutivePat O’Mahony
AdvisoryCommittee for
HumanMedicines
Clinical ExpertSub-committee
Panel I
Pre-clinicalExpert Sub-committeePanel III
Blood andBiologicalsExpert Sub-committee
Panel II
Herbal MedicinesSub Committee
AdvisoryCommittee for
Medical Devices
Finance andCorporate Affairs
DepartmentRita Purcell
HumanMedicines
DepartmentJoan Gilvarry
IT and ChangeManagementDepartment
SuzanneMcDonald
ComplianceDepartmentJohn Lynch
Medical DevicesDepartment
Ann O’Connor
VeterinaryMedicines
DepartmentJ Gabriel
Beechinor
Senior ScientificAdvisor
J Michael Morris
Audit Committee
AdvisoryCommittee for
VeterinaryMedicines
Clinical TrialsSub-Committee
IMB Organisational Structure
Quality ManagerCaitriona Fisher
04/19/23 Slide 7
Herbal Medicinal Products
There are two routes available to license herbal
medicinal products in Ireland:
1. A Marketing Authorisation [MA] (as per article 8(3) for a full authorisation or article 10a for well-established use authorisation, of Directive 2001/83/EC as amended)
For more detail on products in this category please see the Human Medicines Licensing section of the IMB website
04/19/23 Slide 8
Herbal Medicinal Products
2. A Certificate of Traditional-use Registration (as per article 16a of Directive 2001/83/EC as amended)
Products in this category are registered under the Traditional Herbal Medicinal Products Registration Scheme and are known as traditional herbal medicines
04/19/23 Slide 9
Traditional Herbal Medicinal Products
• Specific provisions were introduced for traditional herbal medicinal products in accordance with the Traditional Herbal Medicinal Products Directive (2004/24/EC)
• This directive has now been transposed into Irish law by the Department of Health and Children [DoH&C]
04/19/23 Slide 10
Traditional Herbal Medicinal Products
• The Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007)
were implemented on 23rd July 2007 by the Minister for Health and Children
• The DoH&C designated the IMB as the competent authority for implementation of this legislation and on this basis the IMB in August 2007 established our national registration scheme the:
Traditional Herbal Medicinal Products Registration Scheme
04/19/23 Slide 11
Traditional Herbal Medicinal Products Registration Scheme
• Under this registration scheme an applicant can apply for a certificate of traditional-use registration for their traditional herbal medicinal product
• A registration will be called a traditional-use registration and will be allocated a TR number (TR x/x/x)
04/19/23 Slide 12
Traditional Herbal Medicinal Product
• is a product that fulfills the following criteria (according to Directive 2004/24/EC):
• Is intended and designed for use without the intervention of a medical practitioner for diagnosis, prescription or monitoring of treatment
• taken orally, for external use or inhalation
04/19/23 Slide 13
Traditional Herbal Medicinal Product
• administered exclusively at a specified strength and dose
• on the market for a ‘period of traditional use’
• must not be harmful under normal conditions of use
04/19/23 Slide 14
Timeframe for implementation of the regulations/Transition period
• The regulations state that no medicinal product can be placed on the market without a prior marketing authorisation or certificate of traditional-use registration
• The regulations provide an exemption from this requirement until 30th April 2011 for traditional herbal medicinal products that were on the market in the State on the coming into force of the regulations
04/19/23 Slide 15
Traditional-use registration applications
• The new regulations also include a provision for the IMB to establish a date by which applications for traditional-use registration must be submitted, this date has been set:
• 1st Jan 2010
04/19/23 Slide 16
Licensing of Homeopathic Medicinal Products
Simplified Registration Scheme
National Rules – authorisation
Full Authorisation - PA
04/19/23 Slide 17
Simplified Registration Scheme
Launched by the IMB in 2002 under:EC Directive 92/73/EC and National Legislation S.I. No.142 of 1998.
To qualify for this scheme Homeopathic products must: Be for oral or external use Be sufficiently dilute to guarantee safety Make no therapeutic claims
Currently the IMB has 116 applications under consideration.
04/19/23 Slide 18
How to find information
Thank You
Pat O’MahonyChief Executive
Irish Medicines Board