Proposal for SPC harmonisation of a veterinary medicinal product

According to Article 69-72 of Regulation (EU) 2019/6, National Competent Authorities (NCAs) as well as Marketing Authorisation Holders (MAHs) 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 of the regulation. The CMDv shall, annually, draw up a list of RVMPs which shall be subject to SPC harmonisation and the CMDv shall also appoint a reference Member State (RMS) for each RVMP concerned.

Marketing authorisation holders may propose RVMPs for SPC harmonisation by filling in and submitting the request form before 31 May 2022.

More information on the SPC harmonisation procedure can be found on the CMDv website.

Questions related to the request form or the SPC harmonisation procedure can be raised to the CMDv secretariat.