Glavni sadržaj
Food Safety

Statement of DG SANTE on Article 152(2) of Regulation 2019/6 on veterinary medicinal products

Member States and stakeholders have raised concerns in relation to the practical application of Article 152(2) of Regulation (EU) 2019/6 on veterinary medicinal products and the need to ensure continued supply of veterinary medicines on the EU market.

The Commission services recognise the need for legal certainty for competent authorities and stakeholders in order to protect animal health.

The Commission services are therefore taking urgent, necessary steps in order to address the interpretation problems, which have been raised and to remove any legal uncertainty, which could risk disruption in the supply of veterinary medicines as this new Regulation enters into application.

The Commission services are preparing a proposal for a legal act that would set out a transitional regime for existing marketing authorisations, in order to address the issues raised in relation to the application of certain requirements of Regulation 2019/6 to veterinary medicinal products as of 28 January 2022.

The proposed legal act would allow marketing authorisation holders to continue to place veterinary medicinal products complying with the packaging and labelling requirements of Directive 2001/82 or Regulation 726/2004 on the market until 29 January 2027.

The proposal would not affect the obligation to comply with the other relevant provisions of Regulation (EU) 2019/6 as of 28 January 2022. Once adopted, the legal act would apply retroactively, starting on 28 January 2022.

UPDATE: On 2 March 2022, the Commission adopted the legislative proposal for a legal act, referred to in the statement above