Transitional provisions

Upon the entry into force of the Veterinary Medicinal Products Regulation, the previously applicable Regulation 2001/82/EG ceased to apply. The Veterinary Medicinal Products Regulation is binding for all Member States. Only limited freedom has been granted regarding the incorporation of the EU regulations into national legislation governing veterinary medicines. 

Article 152

A variety of transitional provisions have been established within the Veterinary Medicinal Products Regulation in order to facilitate a smooth transition from the old legislation to the new legislation. Article 152 is an important part of these transitional provisions. It has since transpired that Article 152(2) has resulted in ambiguity. For this reason, the European Commission has decided to further clarify this article via a legislative act.

Following publication, this has been made retrospectively applicable as of 28 January 2022.
This legislative act enables holders of marketing authorisations for veterinary medicines to continue bringing these medicines to market up to and including 29 January 2027. This applies to veterinary medicines that still comply with the packaging and labelling requirements specified in Directive 2001/82 or Regulation 726/2004. More information on this matter can be found here.

Veterinary medicines withdrawn as of 28 January 2022

Upon the entry into force of the Veterinary Medicinal Products Regulation, only limited freedom has been granted regarding incorporation of the EU regulations into national legislation. As a result, some veterinary medicines have lost their previously applicable national grounds for admission. The following provisions apply to the veterinary medicines specified in this list:

• A six-month transitional arrangement applies, ending on 28 July 2022. During this period, these veterinary medicines can still be manufactured and brought to market;
• These veterinary medicines can be purchased, supplied for distribution and used until the end of the expiry date displayed on the medicines. This is permitted until 29 January 2027 at the latest;
• This transitional period can be used to apply for a new marketing authorisation for a veterinary medicine in line with the Veterinary Medicinal Products Regulation.

These veterinary medicines can no longer be manufactured after 28 July 2022.

Transitional period antimycotics and antiprotozoal agents

A transitional period has been set for antimycotics (antifungals) and antiprotozoal agents intended exclusively for specific companion animals due to a possible lack of availability. You can read more about this in this news item.

In this list you can read which antimycotics and antiprotozoal agents may still be marketed until 31 December 2024.

More information

Do you have any questions regarding the transitional provisions? If so, please contact the Veterinary Medicinal Products Unit.