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

Guidance for Mutual Recognition Procedure after finalisation of an article 82 referral procedure with a positive decision by the EC and after a SPC harmonisation

Request form for proposing a veterinary medicinal product for SPC harmonisation Exercise 2024

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 product information template v.9 will be introduced during the SPC harmonisation procedure i.e. there is no need to submit a separate variation application (G.I.18). In case you already submitted such a variation application, you will be able to discuss it with the RMS that will be appointed.

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

Products for SPC harmonisation 

The lists of veterinary medicinal products subject to SPC harmonisation endorsed by the CMDv and the HMA are listed in the tables below. The procedures follow the timetables agreed between the MAH and the RMS.

The results of the SPC harmonisation procedured will be published on the CMDv website in due time once the procedures ended.

Products for SPC harmonisation 2023

Products for SPC harmonisation 2024

*The VMP ‘SYNULOX TABLETS’ is constituted of 3 strengths.