SPC harmonisation of veterinary medicinal products
With the entry into force of the Regulation (EU) 2019/6, a new procedure, the SPC harmonisation procedure, was created as per Section 4 of this Regulation. This procedure can be divided into three phases:
- Elaboration of a list with proposed reference veterinary medicinal products (RVMP) for SPC-harmonisation and nomination of a reference member state (RMS),
- procedure for harmonisation of the SPC of the RVMP and subsequently
- the harmonisation of the generic and hybrid veterinary medicinal products concerned.
The implementation of the product information according to the new QRDv9-template will be considered within the SPC-harmonisation procedure, therefore the submission of a separate application for a Variation Requiring Assessment (VRA) with code G.I.18 is not required. In case that this variation application has already been submitted, it is recommended to discuss this with the RMS that will be appointed.
For the selection of the RVMPs and handling of this new procedure for SPC harmonisation, the Co-oordination Group for Mutual Recognition and Decentralised Procedures veterinary (CMDv) has prepared three Best Practice Guides.
According to Articles 69-72 of Regulation (EU) 2019/6
- marketing authorisation holders (MAH) and
- national competent authorities (NCA)
may submit proposals of reference veterinary medicinal products to be harmonised.
Request form for proposing a RVMP for SPC harmonisation exercise 2024:
To compile an annual list of RVMPs that shall be subject to SPC harmonisation, the CMDv has published a form on the website. MAHs interested in participating in the upcoming SPC harmonisation exercise are invited to fill in this form: https://ec.europa.eu/eusurvey/runner/2023_MAHSurvey_SPCH, which may be submitted by before 31st of May 2023.
For any question regarding the form, please contact the CMDv secretariat (CMDv@ema.europa.eu).