3.2.1: About CMDh (ALT-O)
3.2.2: Statistics (ALT-S)
3.2.3: Press Releases (ALT-P)
3.2.4: Procedural Guidance (ALT-L)
3.2.5: CMDh-Referrals
3.2.6: Product Information (ALT-T)
3.2.7: Advice from CMDh
3.2.8: Templates
3.2.9: CMD subgroups / working groups (ALT-G)
3.2.10: Paediatric Regulation (ALT-N)
3.2.11: Questions & Answers (ALT-Q)
- 3.2.11.1: Applications for MA
- 3.2.11.2: CMDh Referrals
- 3.2.11.3: Variations
- 3.2.11.4: Post referral phase
- 3.2.11.5: PSURs & Renewals (ALT-W)
- 3.2.11.6: Product Information / Information on medicinal products
- 3.2.11.7: Generics & Usage Patents
- 3.2.11.8: Biologicals
- 3.2.11.9: Homeopathics
- 3.2.11.10: Advice from CMDh
- 3.2.11.11: EU-Enlargement
3.2.12: Contact Form
3.2.13: Contact Points
3.2.14: What's new history (ALT-Y)

Homeopathic medicinal products disagreement in procedures referral to CMD(h)

June 2007

Question 1 (June 2007)
What will be the situation for homeopathic medicinal product (as defined in Article 14 of Directive 2001/83/EC) if no agreement could be reached at the end of a MRP or DCP?

Answer:
According to Article 13 (1) of Directive 2001/83/EC, as amended, for the registration of homeopathic medicinal products only Article 29 (1) to (3) shall apply. Therefore if a Member State cannot approve within the timeframe given in Article 28 (4), the assessment report and the labelling on the grounds of potential serious risk to public health, the RMS will refer the points of disagreement to the CMD(h).

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Question 2 (June 2007)
What will be the situation for homeopathic medicinal product (as defined in Article 14 of Directive 2001/83/EC) if no agreement could be reached at the end of the CMD(h)-Referral?

Answer:
If no agreement could be reached at the end of the CMD(h)-Referral between the Member States concerned by the procedure, the issue will not be forwarded to the European Medicines Agency for arbitration. As no further information is given in the legislation how to conclude the national phase of the registration, MS and the EU-Commission have agreed in the spirit of the legislation on the following interpretation: It is a national decision - taking into account the assessment report of the RMS and the discussion at the CMD(h) - of each MS concerned by the procedure to issue a registration for this homeopathic medicinal product or not.

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Number of application forms for registration of homeopathic medicinal products

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Question 3 (January 2009)
We plan to submit an application for a MRP or DCP for a registered homeopathic medicinal product. The application will involve several dilutions of a homeopathic stock. Please can you advise how many application forms are necessary?

Member States have agreed that in the case of several dilutions of a homeopathic stock only one application form per homeopathic stock for the same pharmaceutical form is needed. The single dilutions have to be listed in the application form.
The application for a registered homeopathic medicinal product in MRP or DCP is characterised by the normal MRP/DCP-numbering system (CC/D/nnnn/sss/X/vvv; The Notice to Applicants Volume 2A Procedures for marketing authorisation, Chapter 2 Mutual Recognition, Section 7. Numbering System for the Procedures for Mutual Recognition and Decentralised Procedure; Revision 5, February 2007) in which ‘n’ is the specific number (4 digits) for the actual medicinal product which equals to the homeopathic stock and is further characterised by ‘s’ (sequential speciality number) for the individual dilutions. No sub-numbering system is in place if the same final dilution is the result of a series of C-, D- or M-dilutions.
Further characterisation of the dilutions of a homeopathic stock by a different numbering system may exist in Member States

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