SPC harmonisation procedure

Chapter 4 of the Veterinary Medicinal Products Regulation outlines the procedure to be followed with regard to the harmonisation of the Summary of Product Characteristics (SPC) for veterinary medicinal products which have been granted marketing authorisation on the national level. Pursuant to this procedure, both national competent authorities (NCAs) and marketing authorisation holders (MAHs) may propose harmonisation of SPCs of reference veterinary medicinal products (RVMPs).

Veterinary medicinal products eligible for an SPC harmonisation procedure

Harmonised SPCs can be drawn up for reference veterinary medicinal products with active ingredients that have the same qualitative and quantitative composition as well as the same pharmaceutical form. Whose marketing authorisation holder has been granted marketing authorisation on the national level in different EU member states. 

Generic or hybrid veterinary medicinal products that have a reference product that is a reference veterinary medicinal product mentioned above must be subjected to the follow-up procedure.

Each year, the CMDv draws up a list of reference veterinary medicinal products that are subject to SPC harmonisation. The CMDv will then appoint a reference member state (RMS) for each procedure. 

SPC harmonisation procedure application

Do you, in your capacity as a marketing authorisation holder, wish your product to be submitted to the SPC harmonisation procedure? 

Every year, all NCAs and MAHs may submit proposals for reference veterinary medicinal products to be subjected to harmonisation. Proposals must be submitted by the end of May in any given year. 

• When you submit your application, you must explain why you have chosen this particular reference veterinary medicinal product for SPC harmonisation.
• Submit your application to the CMDv secretariat. 
• To do so, please use the SPC Harmonisation Application Form for MAHs as shown in Annex 4 to the Best Practice Guide for the Selection of Products for SPC Harmonisation. Please use a separate form for each reference veterinary medicine product you propose for SPC Harmonisation.
• Please append to your application form a comparative table as referred to in Annex 5 and the proposed harmonised SPC.

You may only propose SPC harmonisation for a reference veterinary medicinal product for which you yourself are the marketing authorisation holder.

Phases

The SPC harmonisation procedure for veterinary medicinal products has three phases: 

• 1. Selection phase.

You can read more about this in the Best Practice Guide for the Selection of Products for SPC Harmonisation. 

• 2a Reference veterinary medicinal product investigation phase 

• 2b Updating the SPC of the reference veterinary medicinal product on a national level 

Read more about Steps 2a and 2b in the Best Practice Guide for the Harmonisation Procedure of the SPCs of the Reference Products. 

• 3a Harmonisation of SPCs of generic and hybrid veterinary medicinal products 
• 3b Updating the SPCs of generic and hybrid veterinary medicinal products on a national level 

Read more about the harmonisation of generic and hybrid veterinary medicinal products in the Best Practice Guide for the Harmonisation Procedure of the SPCs of Generic/Hybrid Veterinary Medicinal Products. 

SPC harmonisation for generic and hybrid veterinary medicinal products

Are you the marketing authorisation holder of a generic or hybrid veterinary medicinal product that is subject to an SPC harmonisation procedure as a reference product? 

If so, you are required to amend your SPC in accordance with the SPC that was adopted following a harmonisation procedure. To this end, you must submit a variation requiring assessment (VRA) within 60 days of the completion of the SPC harmonisation procedure.  

Legal basis

Chapter 4 of the Veterinary Medicinal Products Regulation outlines the procedure to be followed with regard to the harmonisation of SPCs for veterinary medicinal products which have been granted marketing authorisation on the national level.

More information

All the aforementioned BPGs can be found here on the CMDv's website. If you have any further questions about the SPC harmonisation procedure, please contact the Veterinary Medicinal Products Unit.