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The Irish Medicines Board and the regulation of herbal and other medicinesCrowne Plaza Hotel, Dublin Airport - 28th April 2010

Dr. J.M. MorrisSenior Scientific Advisor, IMB

IHTA Annual Conference

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Overview

• Introduction to medicines regulation

• Classification of products as medicines

• Herbal medicines regulatory framework

• Homeopathic medicines

• Other medicines

• Herbal medicines post 2011

• Conclusions and questions

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

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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.

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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

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IMB Guideline “Definition of a Human Medicine”

• Non-legally binding advice – definition is in 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

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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

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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)

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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

Directive on Traditional Herbal Medicinal Products [THMPs]

• Must meet pre-defined standards:

- Quality

- Safety

- Traditional Use

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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

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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

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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

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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

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IMB Herbal Medicines Project 2000 - 2002

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

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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)

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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

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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

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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

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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

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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

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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

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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

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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

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Herbal Medicines post 2011 (2)

• Few registrations

• Herbal medicines masquerading as foods

• “Health claims” vs. medicinal claims

• Illegal products

• Marketplace availability of herbal products?

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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

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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

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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

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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

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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

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Questions

Thank you for your

attention

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