Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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 (1), and in particular Article 146(2) thereof,

Whereas:

(1) It is appropriate to substantially update the requirements set out in Annex II to Regulation (EU) 2019/6, which took over the dossier requirements set out in Annex I to Directive 2001/82/EC of the European Parliament and of the Council (2), as that Regulation did not update those dossier requirements at the time of repealing that Directive. The dossier requirements set out in Annex I to Directive 2001/82/EC had last been updated in 2009. Therefore, Annex II should be amended to take account of scientific progress and developments since 2009, including international guidance from the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), World Health Organisation (WHO) and the organisation of Economic cooperation and development (OECD) standards.

(2) It is also appropriate to set out requirements for biological veterinary medicinal products and novel therapy veterinary medicinal products introduced as new categories of veterinary medicinal products by Regulation (EU) 2019/6. For those products, specific technical requirements to be presented when applying for a marketing authorisation should be defined.

(3) Recognising that antimicrobial resistance to medicinal products is a growing health problem in the Union and worldwide, Regulation (EU) 2019/6 introduced specific legal provisions aimed at limiting the risk of development of antimicrobial resistance to medicinal products. It is therefore appropriate to introduce specific technical requirements for antimicrobial veterinary medicinal products.

(4) This Regulation should apply from 28 January 2022 in accordance with Article 153(3) of Regulation (EU) 2019/6.

(5) Regulation (EU) 2019/6 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Regulation (EU) 2019/6 is replaced by the text in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 28 January 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 8 March 2021.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 4, 7.1.2019, p. 43.

(2) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).