IHTA Annual Conference The Irish Medicines Board and the regulation of herbal and other medicines Crowne Plaza Hotel, Dublin Airport - 28th April 2010 Dr. J.M. Morris Senior Scientific Advisor, IMB 13/04/2015 Slide 1 Overview • • • • • • • 13/04/2015 Introduction to medicines regulation Classification of products as medicines Herbal medicines regulatory framework Homeopathic medicines Other medicines Herbal medicines post 2011 Conclusions and questions Slide 2 What is a Medicine I • Definition given in Article 1.2 of Directive 2001/83/EC • Revision in Directive 2004/27/EC • IMB guide to definition of a medicinal product for human use based on • Composition • Claim • Presentation • Function 13/04/2015 Slide 3 What is a Medicine II Article I of Directive 2001/83/EC, as amended by Directive 2004/27/EC makes changes to the definition of a Medicinal Product. The new definition states that a medicinal product is: (i) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (ii) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. 13/04/2015 Slide 4 Requirements of Medicinal Products • Marketing is controlled by valid authorisation • • • • or registration Protection of consumers Medicines should be of good quality Risk of using the product should be reasonable and acceptable in the light of the expected benefit Demonstrable therapeutic benefit should be anticipated 13/04/2015 Slide 5 IMB Guideline “Definition of a Human Medicine” • Non-legally binding advice – definition is in • • • • 13/04/2015 the Directive Borderline between MP’s and foods, cosmetics, Medical Devices etc. Adjudication by IMB Classification Committee Application form and fee Guideline revised February 2008 Slide 6 Classification Process 1 • Application form on IMB website • • • • • • www.imb.ie Complete application form in full Enclose all labels, leaflets, promotional material Pay attention to websites used to promote products Application fee €250 (€200 for supplements) Submit to Classification Committee Response usually within 28 days 13/04/2015 Slide 7 IMB Classification Committee • Multidisciplinary scientific in-house committee • Consists of representatives from Human • • • • • Medicines, Medical Devices, Compliance Departments Expertise in medicine, pharmacy, herbal medicine, toxicology, market surveillance and pharmacovigilance , medical devices, cosmetics. Meets once monthly Typically 100 applications p.a Provides a formal response in writing Decisions can be appealed to ACHM (final) 13/04/2015 Slide 8 Classification Process 2 • Open to dialogue – removing a claim or • • • • even changing language may alter status Consultation with other interested parties – e.g. FSAI for food supplements Two way process – FSAI makes referrals to IMB also Same active may be present in medicines and foods – e.g, garlic, ginger Some herbs may be present exclusively in foods i.e. not medicines provided no claims made 13/04/2015 Slide 9 Directive on Traditional Herbal Medicinal Products [THMPs] • Must meet pre-defined standards: - Quality - Safety - Traditional Use 13/04/2015 Slide 10 Quality • All traditional medicinal products must conform to agreed quality standards as for any other medicinal product • Herbal Medicinal Product Guidelines – HMPWP 2001/83/EC - where appropriate New legislation 2004/24/EC EMA guidelines • European Pharmacopoeia monographs 13/04/2015 Slide 11 Efficacy • Full product authorisation application => clinical trial data • Well-established use’ => bibliographic applications • 2004/24/EC -30 years on market, at least 15 in EU for THMP registration 13/04/2015 Slide 12 Manufacturing considerations • Good Agricultural Practice [GAP] • Good Manufacturing Practice [GMP] Manufacturer’s Authorisation • Good Distribution Practice [GDP] Manufacturer’s/Wholesaler’s Authorisation Third country importation = manufacture 13/04/2015 Slide 13 EU/Irish initiatives • European Scientific Co-Operative on Phytotherapy [ESCOP] • Pharmaceutical Committee of the European Union • Herbal Medicinal Products Working Committee [HMPC]/Other Working Parties of the European Medicines Agency IMB Herbal Medicines Project 2000 - 2002 13/04/2015 Slide 14 Homeopathic medicines • Simplified Registration Procedure provided for in 2001/83/EC Chapter 2 • No Hom MP on the market unless it has a MA or SRP • National Rules Scheme adopted in Ireland to allow limited claims on basis of supporting data 13/04/2015 Slide 15 Simplified registration • Products administered orally or topically • No specific medicinal claims on labels and literature • Sufficient degree of dilution I in 10,000 or 1/100th of smallest allopathic dose of POM • That is 4x(4d)-2C – or greater dilution (potency) 13/04/2015 Slide 16 Documents to be submitted • • • • • • • Details of product and stock Details of preparation and control of stock(s) Manufacturing and control file for product Manufacturing authorisation Registrations in other MS Mock-ups of packaging Product stability data 13/04/2015 Slide 17 SRP Products • Exempt from authorisation-no SPC • Exempt from pharmacovigilance • Labelling requirements- Article 69 • Scientific name of stock(s) and dilution level • Name and address of reg holder • “Homeopathic medicinal product without approved therapeutic indication” • No other detail other than as specified 13/04/2015 Slide 18 Homeopathic Medicines National Rules Scheme 2010 • Article 16.2 of Directive 2001/83/EC • Implemented by Regulation 11 of SI 540 of 2007 • Product is a homeopathic medicine i.e. prepared • • • • from homeopathic stocks using a recognised manufacturing procedure (Pharmacopoeia) Indication is appropriate Indication does not need medical diagnosis/intervention Efficacy established in Ireland Safety evaluated 13/04/2015 Slide 19 Homeopathic National Rules (2) Safety evaluation • Reference to published literature • Oral products derived from food substances • Active used in allopathic medicine dilution of 1 in 10,000 minimum (nmt1/100th therapeutic dose) • 1 part per 10,000 MT 13/04/2015 Slide 20 Homeopathic medicines national rules labelling • General labelling requirements of Directive • • • • (TitleV) The product is a homeopathic medicinal product authorised by this procedure Any evidence of efficacy is not based on clinical trials Use for symptomatic relief of the condition specified Consult a Doctor if symptoms persist 13/04/2015 Slide 21 Other medicines • Anthroposophic medicines - regulated as medicines when manufactured by a homeopathic (pharmacopoeial) method • “Spagyrics” – methods unlikely to be approved in the pharmacopoeia • HMM Group of Experts at Ph. Eur making good progress 13/04/2015 Slide 22 Other medicines 2 • Korsakovian dilutions (k potencies) may be included in pharmacopoeia • Bach flower remedies remain outside legislation • Aromatherapy products not regarded as medicines unless specific claims made 13/04/2015 Slide 23 Herbal Medicines post 2011 • Since July 27th 2007 no new THMP can come • • • • • on the market without PRIOR IMB approval Existing herbal medicines can remain on the market up to 30/4/2011 Applications should be received by IMB for by end April 2010 (THMP or WEU) Products with PA’s can of course continue to be marketed Few applications received Problem not restricted to Ireland – same across EU generally 13/04/2015 Slide 24 Herbal Medicines post 2011 (2) • • • • • 13/04/2015 Few registrations Herbal medicines masquerading as foods “Health claims” vs. medicinal claims Illegal products Marketplace availability of herbal products? Slide 25 Herbal Medicines post 2011 (3) • What can IMB do? • All products need to be registered - as herbal medicines - as food supplements • Registration with IMB or FSAI as appropriate • Documented proof of legal status • No documentation - expect products to be seized 13/04/2015 Slide 26 Herbal Medicines Registration • Registration process is feasible and user friendly • IMB is now the primary authority for determining method of sale and supply • No longer bound by the restrictions of prescription legislation • For example Ginkgo biloba could be accepted for THM registration provided suitable indication 13/04/2015 Slide 27 Herbal Medicines Registration (2) • IMB aiming constantly to improve clarity of the registration process • Developing lists of herbal substances which can only be considered as medicines • Examples G. biloba A. belladonna H. perforatum • Some of these might be acceptable OTC once registered as THM’s e.g. Ginkgo Valerian 13/04/2015 Slide 28 Herbal Medicine Registration (3) • IMB also developing a list of herbal substances acceptable for marketing as foods provided no medicinal claims made • Developing policy in conjunction with - IMB expert Herbal sub-Committee - FSAI - DOHC - Industry • Draft list has approximately 150 entries • Looking forward to further discussion 13/04/2015 Slide 29 Conclusion • Need to be aware of the distinction between medicines • • • • • • and foods IMB Classification process is there to assist Herbal and homeopathic medicines require registration or authorisation by April 2011 New national rules scheme introduced for authorisation of homeopathic medicines with limited indications Herbal medicines registration scheme up and running “Positive” and “negative” lists being developed to help improve clarity 30/4/2011 is only 1 year away 13/04/2015 Slide 30 Questions Thank you for your attention 13/04/2015 Slide 31