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
Public consultation on the revision of the Best Practice Guides for SPC harmonisation
After the first experiences with the SPC harmonisation procedure and comments received from industry a reflection took place at the SPC harmonisation WG and on CMDv level. A complete overhaul was carried out, incorporating numerous suggestions and lessons learned. The updated Best Practice Guides can be found on the corresponding subpage. Please send your comments to CMDv@ema.europa.eu until 15 September 2026, using the following template.
Request form for proposing a veterinary medicinal product for SPC harmonisation exercise 2027(4th round)
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. Candidates proposed after the annual deadline of 31 May will be considered directly as proposals for the next round the subsequent year. Therefore, continuous submission of proposals throughout the year are encouraged and appreciated.
For the 2027 selection phase, there is a once-only extension of the deadline for submitting proposals of candidate reference VMPs to 31 July 2026.
Any question can be raised to the CMDv secretariat (CMDv@ema.europa.eu).
Products for SPC harmonisation
The current list of veterinary medicinal products subject to SPC harmonisation endorsed by the CMDv and the HMA is listed in the table below. The procedures follow the timetables agreed between the MAH and the RMS.
The results of the SPC harmonisation procedures will be published on the CMDv website in due time once the procedures ended.
The lists of veterinary medicinal products subject to SPC harmonisation in previous rounds can be found in the dedicated subpage.
Products for SPC harmonisation 2026 (3rd round)
Name of VMP | Name of the active substance | Name of MAH | RMS | Status | Action for related VMP MAH to apply for the VRA* | Product Information |
Rimadyl palatable tablets (10 mg, 20 mg, 50 mg) | Carprofen | Zoetis | IE | pending | 60 days after the decision of the national competent authority has been issued | |
Galastop | Carbergoline | Ceva | DE | pending | 60 days after the decision of the national competent authority has been issued |
List of generic/hybrid and informed consent VMPs of the VMPs subject to SPC harmonisation 2026
The generic, hybrid and informed consent VMPs of the VMPs that were subject to the SPC harmonisation is now published. The list of VMPs mentioned in the table may not be exhaustive. So, all MAHs of generic and hybrid VMPs of the reference VMP that were subject to SPC harmonisation are invited to apply for the appropriate VRA to align the SPC of their products to the SPC of the reference product according to the article 71 of the Regulation 2019/6. Similarly to the action required for generic and hybrid MAs, the MAH of an informed consent should submit a VRA to amend the SPC of its informed consent product, within 60 days after the decision of the national competent authority has been issued.
Click here for the 2026 list of generic, hybrid and informed consent VMPs of the VMPs subject to SPC harmonisation.