European Commission publishes statement on interpretation of Article 152, paragraph 2
The European Commission has listened to concerns regarding a difference in interpretation of the transitional provision in Article 152, paragraph 2 of the Veterinary Medicinal Products Regulation that came into force today.
A strict interpretation of the transitional provision in Article 152, paragraph 2 could lead to a disruption to the supply of veterinary medicinal products as of today. This had recently caused a great deal of concern among marketing authorisation holders, but also among the national authorities.
The European Commission has decided to resolve the differences in interpretation identified. A legal act is to be published to this end. The proposed legal act would allow marketing authorisation holders to continue to place veterinary medicinal products complying with the packaging and labelling requirements of Directive 2001/82 or Regulation 726/2004 on the market until 29 January 2027. The proposal would not affect the obligation to comply with the other relevant provisions of Regulation (EU) 2019/6 as of 28 January 2022.
Once adopted, the legal act would apply retroactively with effect from 28 January 2022.
The European Commission has published the above information in a statement.