SPC Harmonisation

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

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 2025

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.

Please find here the link to the survey to be completed should you wish to propose candidates for the SPC harmonisation procedure.

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

Name of VMP	Name of the active substance	Name of MAH	RMS	Status	Action for generic/hybrids MAH to apply for the VRA*	Product Information
Catosal	Butafosfan, Cyanocobalamin	Elanco	DE-BVL	Concluded on 06 April 2024 Harmonisation of part II closed on 26 May 2024	60 days after the decision of the national competent authority has been issued	eu-pi-combined
Finadyne	Flunixine meglumine	Merck	ES	Expected date for the end of the procedure: 20 July 2024
Estrumate	Cloprostenol	Intervet	FR	Expected date for the end of the procedure: 20 July 2024
Domosedan	Detomidine hydrochloride	Orion	IE	Concluded on 10 April 2024 Harmonisation of part II closed on 2 May 2024	60 days after the decision of the national competent authority has been issued	eu-pl-domosedan-10-mg-ml-inject eu-lab-domosedan-10-mg-ml-inject eu-spc-domosedan-10-mg-ml-inject
Planate	Cloprostenol	Merck	NL	Expected date for the end of the procedure: 20 July 2024

* According to article 71 of the Regulation (EU) 2019/6, MAHs of generic/hybrid products shall apply within 60 days a variation requiring assessment in order to align the SPC (concerning target species, clinical information referred to in point (c) of article 35(1) and withdrawal period) of their products. In the case of hybrid marketing authorisations, whereby parts of the SPC have been supported by product-own data (for example additional target species or a withdrawal period based on product-own data), the information in the SPC, based on product-own data will not be harmonised.
MAHs are advised to consult the CMDv best practice guide.

Products for SPC harmonisation 2024

Name of VMP

Name of the active substance

Name of MAH

RMS

RECEPTAL

Buserelin acetate

Intervet

SYNULOX TABLETS*

SYNULOX DROPS

Amoxicillin trihydrate andPotassium clavulanate

Zoetis

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