Packaging and labelling of veterinary medicinal products:  transitional rules

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.

The regulation will apply from 28 January 2022.