Veterinary medicine - ANMV

Implementation of EU rules: impact on marketing authorisations (MAs) for medicinal products marketed outside the European Union

The French agency for veterinary medicinal products (Anses-ANMV) has prepared several notes for the competent authorities of countries importing veterinary medicinal products in order to explain the impact of Regulation 2019/6 on marketing authorisations (MAs) for veterinary medicinal products authorised in France, in particular as regards the change of frame of the summaries of product characteristics (SPCs) to QRD version 9 format, the new procedure for harmonising SPCs and the amendments to MAs not requiring assessment which are recorded in the European Union Product Database (UPD).

SPC format (QRD Version 9)

Article 152 of Regulation (EU) 2019/6 requires MA holders to update the Summaries of Product Characteristics (SPCs) of authorised medicinal products by 29 January 2027. The update shall be carried out by means of an amendment requiring assessment. This implies a one-off alignment of the SPC with version 9 of the QRD (Quality Review of Documents) models, in accordance with Regulation (EU) 2019/6, for veterinary medicinal products placed on the market in France in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004. 

All marketing authorisations granted in accordance with Regulation (EU) 2019/6 will be granted in QRD V.9 format.

Read the note on SPCs format (QRD V9)

SPC harmonisation

With the entry into application of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC, a new procedure, the procedure for the harmonisation of SPCs, was created in accordance with Section 4 of that Regulation.

During this procedure, the SPC of veterinary medicinal products authorised by a national procedure in several EU Member States is harmonised. The national competent authorities in which veterinary medicinal products are authorised have 180 days to examine the differences between the national SPCs and reach an agreement on a harmonised SPC.

Read the note on SPCs harmonisation

Variations not requiring assessment (VNRAs)

Following the granting of a marketing authorisation (MA) for a veterinary medicinal product, the MA holder has an obligation to keep the competent authority informed of changes to its product.

In accordance with Regulation (EU) 2019/6, variation applications are classified either as non-assessment variations (VNRAs) or as assessment variations (VRAs).

VNRAs shall be registered by the MA holder within 30 days of their implementation in the Union Product Database (UPD). Detailed information on the UPD and the registration of these notifications is available on the EMA website.

The notification of approval/rejection of VNRAs shall be made by the competent authority by recording the decision in the UPD. 

Read the note on variations not requiring assessment (VNRAs)