AESGP Conference

1. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
European Legislation for Herbal Medicinal Products – Harmonisation of Traditional Medicines Since 10 Years
Prof. Dr. Werner Knöss
Chairperson, Committee on Herbal Medicinal Products, EMA
Head of Department Licensing 4, BfArM, Germany

2. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
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With reference to the publication policy of the European Medicines Agency (EMA) I do not speak on behalf of the Committee on Herbal Medicinal Products (HMPC) or the EMA.
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The views expressed here may not be understood or quoted as being made on behalf of the HMPC/EMA or reflecting the position of the HMPC/EMA.
Disclaimer 2

3. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
The European Network for Medicinal Products
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European Commission
European Parliament
Regulatory framework, law
Directives, Regulations
NCA and HMA
Assessment
Marketing authorisation
DCP, MRP, national
EMA
Coordination
Guidance
Centralised procedure
EDQM
Quality standards
General
Herbal drugs/preparations

4. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
Legislation – Traditional Medicines
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5. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
HMPC – successful harmonisation since 2004 5
Community Monographs on
safety and efficacy
Guidance documents

6. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
HMPC – Monographs, List Entries,
Public Statements, Revisions
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051015202530RevPSLEM

7. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
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Monographs 127
(25% incl. WEU)
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List Entries 12
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Revisions 8
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Public Statements 13
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Guidance about 30
www.ema.europa.eu
HMPC – Scientific and Regulatory Standards 7

8. Monographs – Just 3 mouse clicks
assessment report, references, public comments

9. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
Transparency – Agendas, Minutes www.ema.europa.eu 9

10. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
Uptake of the Simplified Registration by
Applicants
(reference: www.ema.europa.eu)
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More than 1300 registrations!

11. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
Therapeutic Areas
Reference www.ema.europa.eu
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12. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
Experience in Harmonisation of non-Prescription Medicines 12
Committee on Herbal Medicinal Products 95% (or even more) of Community monographs are on herbal substances/ preparations for self-medication Community Monograph = virtual European procedure
COMPOSITION:
1 member per Member State
1 member each from Norway and Iceland (EEA- EFTA states)
optional co-opted Members
Each member nominated by a Member State also has an alternate

13. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
Selected Key elements
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Prioritisation and continuation of work on monographs and list entries
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Regular revision of monographs
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Reporting on uptake and impact analysis
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Harmonisation of assessment related to non- European traditional herbal substances
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Communication (patients, public, science)
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Coordination with EU bodies (e.g. EDQM, EFSA)
HMPC Work Programme 2012 - 2015 13

14. 14
applies to registered and to authorised HMP
may be replaced by a monograph or the list from the HMPC in registrations
identical for
marketing authorisations and registrations
Marketing Authorisation
Registration
Pharmacovigilance
Consumer information; labeling; advertising
Efficacy
new trials
bibliographic
traditional use
Safety
expert report bibliographic new tests
new tests
bibliographic
Quality Control
Good Manufacturing Practices
Good Agricultural and Collection Practices
new
well-established
traditional

15. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
Particulars of THMP/HMP 15
Food
Medical
Devices
Medicinal
Products
Cosmetics
Specific set of scientific data
Dosage and administration
following therapeutic purpose
Patients
Quality requirements defined
Adequate labelling
Pharmakovigilance
Different sets of particulars

16. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
… in cases of doubt … Please remember!!!
Article 2
1. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.
2. In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a ‘medicinal product’ and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply.
Directive 2001/83 EC 16

17. Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)
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Clear legal framework – implemented, accepted and applied
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Harmonisation by the HMPC (guidance documents and Community monographs, coordination EDQM)
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Transfer of data from medicines to food is inappropriate
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Definitions should improve differentiation of products and not increase confusion
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Classification should ensure transparency about products for patients and public health – looking forward to better legal definitions
Conclusions 17

18. Thank you for your attention!
Federal Institute for Drugs and Medical Devices | The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health (Germany)