Implementation of Regulation 2019/6 and associated legislation – update December 2024

19/12/2024 Regulatory news

European Commission update

As part of its implementation, Regulation 2019/6 requires the European Commission to adopt delegated and implementing acts. No new legal acts have been published since July 2024.

Work has advance on the elaboration of the implementing measures on GMP for veterinary medicinal products under Article 93(2) of Regulation (EU) 2019/6 in the form of separate implementing acts covering:

  1. GMP requirements for active substances
  2. GMP requirements for veterinary medicinal products
  3. GMP requirements for inactivated immunological veterinary medicinal products (autogenous vaccines)

Maintaining alignment with the GMP requirements for medicinal products for human use and with international standards remains a priority of the EU medicines network.

Further documents will be published by the European Commission as they become available.

EMA update

The EMA published the 18th edition of its Veterinary Medicines Newsletter in September 2024 and the 19th edition in December 2024.  The EMA published version 9.1 of the veterinary QRD product information on 10 December 2024.

CMDv update

The CMDv has advised that:

  • The G.I.2.b Variation Requiring Assessment (VRA) for the harmonisation of the generic/hybrid product according to article 71(1) after SPC harmonisation of the reference product may be grouped with a VRA G.I.18 (one-off alignment of the product information with version 9.0* of the QRD templates i.e. major update of the QRD templates in accordance with Regulation (EU) 2019/6, for veterinary medicinal products authorised in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004).
  • It has been confirmed by the European Commission, to CMDv, that where a veterinary medicinal product (VMP) is not marketed, the submission of a VRA G.I.18 before 29 January 2027 is not mandatory. However, where the VMP is intended to be released to the market within the European Union, the product information must be compliant with the Regulation, prior to release.
  • The CMDv has adopted the updated English QRD template v.9.1. The main purpose of updating the QRD template to version 9.1 is to align with the requirements of the Commission Delegated Regulation for products for oral administration (Regulation (EU) 2024/1159), Commission Implementing Regulation adopting a list of abbreviations and pictograms (Regulation (EU) 2024/875) and Commission Implementing Regulation adopting uniform rules on the size of small immediate packaging (Regulation (EU) 2024/878). 
  • The CMDv has agreed that Marketing Authorisation Holders (MAHs) of generic Marketing Authorisations (MAs) must apply for a separate variation to include additional target species following its inclusion in the harmonised reference VMP, if inclusion of those same target species is desired. 

National update

The Department of Agriculture, Food and the Marine published the Veterinary Medicinal Product Regulations 2024 [SI No 462 of 2024] on 12 September 2024.

The Regulations supplement Regulation 2019/6 in national law and provide for the new electronic prescribing of veterinary medicines, as well as on matters related to the wholesaling, retailing, storage and advertising of veterinary medicines.