Europe – CMDh : Homeopathic Medicinal Products – Questions & Answers

Homeopathic medicinal products – Disagreement in procedures – Referral to CMDh

1. 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?
According to Article 13 (1) of Directive 2001/83/EC, 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 CMDh.

2. 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 CMDh-Referral?
If no agreement could be reached at the end of the CMDh-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 CMDh – of each MS concerned by the procedure to issue a registration for this homeopathic medicinal product or not…