2004 - Main contents

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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

table>(1)Regulation (EU) 2019/6 of the European Parliament and of the Council (3) began to apply on 28 January 2022.

(2)

Marketing authorisation holders and registration holders of veterinary medicinal products authorised or registered under Directive 2001/82/EC of the European Parliament and of the Council (4) or under Regulation (EC) No 726/2004 of the European Parliament and of the Council (5) are not able to comply, by 28 January 2022, with the requirements set out in Articles 10 to 16 of Regulation (EU) 2019/6. Furthermore, competent authorities are not in a position to process all the necessary variations, as defined in Article 4, point (39), of Regulation (EU) 2019/6, of marketing authorisations granted in accordance with either Directive 2001/82/EC or Regulation (EC) No 726/2004, and thereby to ensure compliance with Articles 10 to 16 of Regulation (EU) 2019/6 in a timely manner.

(3)

Therefore, it is necessary to provide for transitional rules for the packaging and labelling of veterinary medicinal products authorised or registered in accordance with either Directive 2001/82/EC or Regulation (EC) No 726/2004 to ensure the continued availability of those veterinary medicinal products in the Union and to establish legal certainty. The transitional rules should be limited to veterinary medicinal products that do not comply with the packaging and labelling requirements of Regulation (EU) 2019/6 but comply with all other provisions of Regulation (EU) 2019/6.

(4)

Regulation (EC) No 726/2004 does not lay down specific requirements for labelling and packaging. However, it follows from Article 31(1), Article 34(1), point (c), Article 34(4), point (e), and Article 37(1), second subparagraph, of Regulation (EC) No 726/2004, in the version applicable on 27 January 2022, that products authorised under that Regulation are to comply with Articles 58 to 64 of Directive 2001/82/EC.

(5)	This Regulation lays down transitional rules, which should apply from the date of application of Regulation (EU) 2019/6, that is from 28 January 2022. Therefore, this Regulation should apply from that date.

(6)

Since the objectives of this Regulation cannot be sufficiently achieved by the Member States, but can rather, by reason of its effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(7)	This Regulation should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union,