EU Procedures with Traditional Herbal Medicinal Products · Herbal Medicinal Products ... Different...

Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbHwww.basg.gv.at

EU Procedures with Traditional Herbal Medicinal Products

R. LängerDept. for Herbal Medicinal Products & Homeopathics

AT in the role of the RMS

Vienna, 3.10.2013

www.basg.gv.at

Overview

•Background

- Legislation

- Discussions at HMPC, CMDh

•Mandatory EU procedures

•EU procedures on a voluntary basis

- Examples

•Advice to applicants

•Conclusions

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Legislation

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Community Monograph/List entry

Yes

No

EU proceduresmandatory

Take due account of a registration granted inanother member state

THMPapplication

Dir. 2001/83/EC as amended

Art. 16d, 2

Art. 16d, 1

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Legislation

4R. Länger, 3.10.2013

Community Monograph/List entry

Yes

No

EU proceduresmandatory

Take due account of a registration granted inanother member state

THMPapplication

Dir. 2001/83/EC as amended

Art. 16d, 2

Art. 16d, 1

EU procedures ona voluntary basis

???

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Mandatory EU procedures

•… shall apply by analogy to registrations granted in accordance with Article 16a, provided that a Community herbal monograph/List entry has been established

•So far 2 DCP for THMPs, both with RMS BE:

- Passiflorae herba, dry extract

o HMPC monograph on traditional use

- Combination Valerianae radix + Lupuli flos dry extract

o HMPC monograph on well-established use (!)

•More than 800 registrations of THMPs -only 2 EU procedures?

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•?? Many THMPs are registered by the same applicant in several member states on a national basis

- Reasons?o Applicants:

� Insufficient harmonization in the assessment between National Competent Authorities?

� Divergent opinions on the HMPC monograph?� Fees?

o National Competent Authorities:� Different interpretation of the legislation

» 100% congruence between HMPC monograph and THMP necessary?

» Mandatory in case of deviations regarding posology, wording of indication, age limits, ….?

» Or even mandatory when the herbal preparation is contained in the HMPC monograph?

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•?? Many THMPs are registered by the same applicant in several member states on a national basis

- Consequences

o Applicant

� Several and different requests to modify the dossier

� Necessity to keep different dossiers up-to-date

o National Competent Authorities

� Multiple assessment with divergent outcomes

» E.g., granting of the registration vs. refusal

o Patient

� Different presentation of the same medicinal product to the patient

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„.. shall take due account of registrations granted …“

• Interpretation:

- Only a potential serious risk to public health may be a reason not to accept the registration of a THMP by another member state

o = Informal mutual recognition

•Reality:

- Assessment of identical applications with different outcomes

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EU procedures on a voluntary basis

•CMDh Q&A- http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/

Questions_Answers/CMDh_287_2013_Rev1_2013_02_clean_.pdf

- Is the use of MRP/DCP possible even if neither a Community list entry nor a Community monograph exists for the active substance(s) (herbal substance, herbal preparation, combination)?

The CMDh agreed that MRP/DCP is possible for registration of THMPs on a voluntary basis even if neither a Community list entry nor a Community monograph exists provided that adequate and sufficient documentation for traditional use and safety is enclosed in the dossier submitted. However, it should be clarified that the use of MRP/DCP is the decision of the Member State. Discussion with Member States intended to be included in any procedure, is recommended before submission of an application.

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Examples

• Combination Valerianae radix + Lupuli flos

�Mandatory EU procedure

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Examples

• Combination Valerianae radix + Lupuli flos + Melissae folium

- No HMPC monograph for the combination

�EU procedure on a voluntary basis

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EU procedures for THMPs on a voluntary basis

•Practical advice

- Early contact to RMS and intended CMS

- Dossier:

o Data on genotoxicity

� At least AMES-test (according to OECD standards) with the herbal preparation / combinaton of herbal preparations

o Evidence on traditional use, combination products

� Reference to HMPC monographs of the individual active substances not sufficient

� Evidence of traditional use of the combination necessary

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EU procedures for THMPs on a voluntary basis

•Practical advice

- In case RMS = AT:

o Offer to support the applicant and speed up the process using the contacts during HMPC meetings

o Offer for formal National Scientific Advice

� In case of detailed questions related to the content of dossier

o Offer for informal meetings

� For general discussions, procedural advice, …

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EU procedures on a voluntary basis: variations

•CMDh Q&A

- Registrations are not within the scope of the EC Regulation 1234/2008 (“Variation Regulation”) and have to follow national procedures. How can the dossier and the SmPC be kept harmonized?

In order to keep the documents (dossier and SmPC post approval ) harmonized between member states, the CMDh agreed to apply the Variation Regulation by analogy, in case MRP/DCP had been used for registration of a THMP.

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Conclusions

•EU procedures for THMPs mandatory when herbal substance / herbal preparation is contained in a community monograph or the community list

• If not: EU procedures on a voluntary basis possible

- All involved member states have to agree

- Early contact with agencies advisable

•When registration is granted using a EU procedure the Variation Regulation should apply by analogy

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Towards harmonizationin Europe!

With AT as RMS

EU Procedures with Traditional Herbal Medicinal Products · Herbal Medicinal Products ... Different...

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