SPC harmonisation

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.

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.

To compile an annual list of RVMPs that will be subject to SPC harmonisation, the CMDv has published a form on the website: https://ec.europa.eu/eusurvey/runner/SPCHarm2022MAH, which may be submitted by the 31st of May 2022.

For any question regarding the form, please contact the CMDv secretariat (CMDv@ema.europa.eu).

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