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dossier	COM(2022)76 - Transitional rules for the packaging and labelling of veterinary medicinal products authorised in accordance with Directive ...
document	COM(2022)76
date	May 30, 2022

Article 1

Definitions

For the purposes of this Regulation, the following definitions apply:

(1)	‘veterinary medicinal product’ means a veterinary medicinal product as defined in Article 4, point (1), of Regulation (EU) 2019/6;

(2)	‘labelling’ means labelling as defined in Article 4, point (24), of Regulation (EU) 2019/6;

(3)	‘package leaflet’ means a package leaflet as defined in Article 4, point (27), of Regulation (EU) 2019/6;

(4)	‘placing on the market’ means placing on the market as defined in Article 4, point (35), of Regulation (EU) 2019/6.

Article 2

Transitional rules

Veterinary medicinal products which were authorised or registered in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 and which comply with Articles 58 to 64 of Directive 2001/82/EC, in the version applicable on 27 January 2022, may be placed on the market until 29 January 2027, even if their labelling and, where applicable, package leaflet are not in compliance with Articles 10 to 16 of Regulation (EU) 2019/6.

Article 3

Entry into force and application

This Regulation shall enter into force on the day 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.