Within the framework of Regulation (EU) 2019/6, a new procedure has been created with SPC harmonisation across the member states, which aims to harmonise the information in the Summary of Product Characteristics of veterinary medicinal products containing the same active substance in relevant sections.

Basically, the new procedure is divided into 3 consecutive phases:

1. Selection process of veterinary medicinal products to be submitted for SPC harmonisation and designation of a reference member state (duration > 6 months). Both, marketing authorisation holders and National Competent Authorities (NCAs) submit proposals for reference veterinary medicinal products to be harmonised. The priorisation list, included in the Best Practice Guide for the selection of the products for the SPC harmonisation shall be used for the proposal submission and the decision on selection. The final list of reference veterinary medicinal products will be published by the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv).
   
   

   • Proposals for reference VMPs for SPC harmonization by the Marketing Authorization Holders must be submitted by May 31 of each year.

     
     For this purpose, please use the online form provided: LINK TO FORM
     
     

   • Products for SPC harmonisation
     The lists of veterinary medicinal products subject to SPC harmonisation endorsed by the CMDv and the HMA are listed on the CMDv website.
     
     

2. SPC harmonisation of the reference veterinary medicinal products (intended for a procedure of 180 days). Detailed information on the procedure can be found in the Best Practice Guide for the harmonisation procedure of the SPC of the reference products.
   A Part II variation is carried out in parallel or prior to SPC harmonisation, if necessary. At the end of the procedure, national marketing authorisations are transferred into MRP authorisations.
   
   

   • The results of the SPC harmonisation procedures are published on the CMDv website in due time once the procedures ended (including harmonised product information texts (English version)).
     
     

3. SPC harmonisation of generic and hybrid veterinary medicinal products in adaptation with the harmonised reference veterinary medicinal product (aligned in form of a variation with standard time table of 60 days).

   
   Detailed information on the procedure can be found in the Best Practice Guide for the harmonisation procedure of the SPC of generic/hybrid veterinary medicinal products. 
   
   

   • In line with information on CMDV website, regarding action for generic/ hybrids MAH to apply for the VRA, the following deadline applies:
     Within 60 days after the decision of the national competent authority has been issued.
     As the national competent authority decision and the respective product information text in the relevant language of the member state are the basis for the generic and hybrid veterinary medicinal products adaptation with the harmonised reference veterinary medicinal product, information on the status of the DE-BVL national competent authority decision including German product information texts can be found in the following table:

Decision DE-BVL (national competent authority) for products for SPC harmonisation 2023:

All procedures, in analogy to other cross-member state procedures, are designed within a fixed formal and scheduled flow chart, with the CMDv providing the overall management and the respective reference member State (RMS) providing guidance throughout the procedure as well as preparing the assessment reports.

More information:
SPC HARMONISATION

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