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
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 (CMDv@ema.europa.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 |
|
| Finadyne | Flunixine meglumine | Merck | ES | Concluded on 20 July 2024 | 60 days after the decision of the national competent authority has been issued | eu-pi-combined-finadyne |
| Estrumate | Cloprostenol | Intervet | FR | Concluded on 23 July 2024 | 60 days after the decision of the national competent authority has been issued | eu-pi-combined-estrumate |
| 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 |
| Planate | Cloprostenol | Merck | NL | Concluded on 22 July 2024 | 60 days after the decision of the national competent authority has been issued | eu-pi-combined-planate |
| * 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. |
List of generic/hybrid products of the VMPs subject to SPC harmonisation
The generic and hybrid products of the VMPs that were subject to the SPC harmonisation is now published. The generic VMPs are highlighted in green and hybrids in orange. The list of VMP mentioned in the table may be not exhaustive. So, all MAHs of generic/hybrid products of the reference products 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.
Click here for the 2023 list of generic/hybrid products of the VMPs subject to SPC harmonisation.
Products for SPC harmonisation 2024
| Name of VMP | Name of the active substance | Name of MAH | RMS |
| RECEPTAL | Buserelin acetate | Intervet | IE |
SYNULOX TABLETS* SYNULOX DROPS | Amoxicillin trihydrate andPotassium clavulanate | Zoetis | DE |
*The VMP ‘SYNULOX TABLETS’ is constituted of 3 strengths.