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The Role of the Irish Medicines Board Pat O’Mahony Chief Executive

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.

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The Role of the Irish Medicines Board Pat O’Mahony Chief Executive

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  1. The Role of the Irish Medicines BoardPat O’MahonyChief Executive

  2. The IMB Mission To protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products.

  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 Devices 4. Competent Authority for Blood Directive and for Tissues and Cells Directives 5. Approval of Clinical Trials (H) and clinical investigations (MD) 6. Pharmacovigilance/Vigilance 7. Sampling and Analysis

  4. IMB Functions 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

  5. Irish Medicines Board Objectives • 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

  6. IMB Organisational Structure Quality Manager Caitriona Fisher

  7. Herbal Medicinal Products There are two routes available to license herbal medicinal products in Ireland:   • 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

  8. Herbal Medicinal Products • 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

  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]

  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

  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)

  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

  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

  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  

  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

  16. Licensing of Homeopathic Medicinal Products Simplified Registration Scheme National Rules – authorisation Full Authorisation - PA

  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.

  18. How to find information

  19. Thank YouPat O’MahonyChief ExecutiveIrish Medicines Board

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