Regulation (EU) 2022/839 laying down transitional rules for the packaging and labelling of veterinary medicinal products authorised or registered in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004

What it is

to avoid the risk of shortages of veterinary medicine products which would have led to a serious impact on animal health and welfare, both in farm and companion animals. PROPOSED ACT: Regulation of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: Regulation (EU) 2019/6 on veterinary medicinal products entered into force on 28 January 2022. Holders of marketing authorisations for veterinary medicinal products authorised under Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products or Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use, are not in a position to comply with the requirements set out in Articles 10 to 16 of Regulation (EU) 2019/6 with effect from 28 January 2022. The European Parliament adopted by 589 votes to 5, with 2 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council laying down transitional rules for the packaging and labelling of veterinary medicinal products authorised in accordance with Directive 2001/82/EC and Regulation (EC) No 726/200. Parliament adopted its position at first reading under the ordinary legislative procedure. The proposed regulation responds to the need to provide for transitional rules for the packaging and labelling of veterinary medicinal products authorised or registered in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 in order to ensure the continued availability of these veterinary medicinal products in the Union and to create legal certainty. The transitional rules are 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. The Regulation provides that veterinary medicinal products which have been 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 appropriate, package leaflets do not comply with Articles 10 to 16 of Regulation (EU) 2019/6.

Frequently asked

In scope for these industries