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
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Slide 1
Overview
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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
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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.
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Slide 4
Requirements of Medicinal Products
• Marketing is controlled by valid authorisation
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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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Slide 5
IMB Guideline “Definition of a Human Medicine”
• Non-legally binding advice – definition is in
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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
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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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Slide 7
IMB Classification Committee
• Multidisciplinary scientific in-house committee
• Consists of representatives from Human
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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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Slide 8
Classification Process 2
• Open to dialogue – removing a claim or
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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
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Slide 9
Directive on Traditional Herbal Medicinal Products
[THMPs]
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Must meet pre-defined standards:
- Quality
- Safety
- Traditional Use
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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
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Slide 11
Efficacy
• Full product authorisation application
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clinical trial data
• Well-established use’
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bibliographic applications
• 2004/24/EC -30 years on market, at least
15 in EU for THMP registration
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Slide 12
Manufacturing considerations
• Good Agricultural Practice [GAP]
• Good Manufacturing Practice [GMP]
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Manufacturer’s Authorisation
• Good Distribution Practice [GDP]
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Manufacturer’s/Wholesaler’s Authorisation
Third country importation = manufacture
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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
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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
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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)
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Slide 16
Documents to be submitted
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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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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
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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
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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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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
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Slide 20
Homeopathic medicines national rules labelling
• General labelling requirements of Directive
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(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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Slide 21
Other medicines
• Anthroposophic medicines
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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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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
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Slide 23
Herbal Medicines post 2011
• Since July 27th 2007 no new THMP can come
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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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Slide 24
Herbal Medicines post 2011 (2)
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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
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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
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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
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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
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Slide 29
Conclusion
• Need to be aware of the distinction between medicines
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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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Slide 30
Questions
Thank you for your
attention
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Slide 31