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 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 2023

The list of veterinary medicinal products that will be subject to the SPC harmonisation exercise for 2023 was endorsed by the CMDv and the HMA. The products are listed in the following table. The procedures will start according to timetables agreed between the MAH and the RMS.

The result of the SPC harmonisation procedure will be published in the CMDv website in due time once the procedures would have ended.

 

Name of VMP

Name of the active substance

Name of MAH

RMS proposed

Catosal

Butafosfan, Cyanocobalamin

Elanco

DE-BVL

Finadyne

Flunixine meglumine

Merck

ES

Estrumate

Cloprostenol

Intervet

FR

Domosedan

Detomidine hydrochloride

Orion

IE

Planate

Cloprostenol

Merck

NL