SPC Harmonisation

Guidance on SPC Harmonisation - according to Articles 70 to 72 of Regulation (EU) 2019/6

Best Practice Guide for the selection of the products for the SPC harmonisation  

Best Practice Guide for the harmonisation procedure of the SPC of the reference products

Best Practice Guide for the harmonisation procedure of the SPC of generic/hybrid veterinary medicinal products

 

Request form for proposing a veterinary medicinal product for SPC harmonisation

According to Article 69-72 of Regulation (EU) 2019/6, National Competent Authorities (NCA) as well as Marketing Authorisation Holders (MAH) may propose harmonisation of the SPCs of Reference Veterinary Medicinal Products (RVMPs) for which a marketing authorisation has been granted in accordance with Article 47.

The CMDv shall, annually, draw up a list of reference VMPs which shall be subject to SPC harmonisation and the CMDv shall also appoint a reference Member State (RMS) for each VMP concerned.

The below form should be filled in by MAHs willing to participate to the SPC harmonisation procedure.

It should be filled in before the 31st of May 2022.

Any question can be raised to the CMDv secretariat (CMDvnoSpam@noSpamema.europanoSpam.eu).

https://ec.europa.eu/eusurvey/runner/SPCHarm2022MAH