Summary

Marketing authorisation holders of veterinary medicinal products authorised under Directive 2001/82/EC or Regulation (EC) No 726/2004 are required to comply with the requirements set out in Articles 10 to 16 of Regulation (EU) 2019/6. Transitional rules regarding the implementation of this obligation were laid down in Regulation (EU) 2022/839. Specifically, this Regulation provides in Article 2 that: “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.” 

At the Standing Committee meeting of 22 February 2024, the following clarification was made: “Pursuant to Regulation (EU) 2022/839, batches compliant with the packaging and labelling requirements set forth in the Regulation (EC) No 726/2004 and Directive 2001/82/EC can continue to be released until 29 January 2027. Batches released thereafter would have to be compliant with the labelling and packaging requirements under Regulation (EU) 2019/6.”

Therefore, from 30/01/2027 only batches that comply with the packaging and labelling requirements laid down in Regulation (EU) 2019/6 can be released.

As long as a veterinary medicinal product is not marketed in the EU, the marketing authorisation holder is not obliged to submit a variation G.I.18. However, if the marketing authorisation holder wishes to market its veterinary medicinal product in the EU after 30/01/2027, the labelling and, where applicable, package leaflet must be in QRD-V9 format. Consequently, a corresponding variation (VRA G.I.18) must be submitted and approved in due time before the veterinary medicinal product is marketed (EMA/CMDv/181154/2021). Only after a positive outcome of this VRA G.I.18 may batches of the veterinary medicinal product be released and the veterinary medicinal product marketed.

Year of issue 2025
Date 14.02.2025

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