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IHTA Annual Conference. The Irish Medicines Board and the regulation of herbal and other medicines. Crowne Plaza Hotel, Dublin Airport - 28 th April 2010. Dr. J.M. Morris Senior Scientific Advisor, IMB. Overview. Introduction to medicines regulation Classification of products as medicines

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ihta annual conference
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

  • 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
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
what is a medicine ii
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:

  • Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
  • 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.
requirements of medicinal products
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
imb guideline definition of a human medicine
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
classification process 1
Classification Process 1
  • Application form on IMB website


  • Complete application form in full
  • Enclose all labels, leaflets, promotional


  • Pay attention to websites used to promote products
  • Application fee €250 (€200 for supplements)
  • Submit to Classification Committee
  • Response usually within 28 days
imb classification committee
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)
classification process 2
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
Directive on Traditional Herbal Medicinal Products [THMPs]
  • Must meet pre-defined standards:
          • - Quality
          • - Safety
          • - Traditional Use
  • 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
  • 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
manufacturing considerations
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

eu irish initiatives
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
homeopathic medicines
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
simplified registration
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)
documents to be submitted
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
srp products
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
homeopathic medicines national rules scheme 2010
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
homeopathic national rules 2 safety evaluation
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
homeopathic medicines national rules labelling
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
other medicines
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
other medicines 2
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
herbal medicines post 2011
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
herbal medicines post 2011 2
Herbal Medicines post 2011 (2)
  • Few registrations
  • Herbal medicines masquerading as foods
  • “Health claims” vs. medicinal claims
  • Illegal products
  • Marketplace availability of herbal products?
herbal medicines post 2011 3
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
herbal medicines registration
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
herbal medicines registration 2
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


herbal medicine registration 3
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



- Industry

  • Draft list has approximately 150 entries
  • Looking forward to further discussion
  • 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

Thank you for your