Implementing the EU Regulation on veterinary medicines

Transitional rules for packaging and labelling of veterinary medicines

Transitional rules (Regulation (EU) 2022/839) apply until 29 January 2027 to the packaging and labelling of veterinary medicines authorised or registered under the previous regulatory framework, Directive 2001/82/EC or Regulation (EC) No 726/2004.

Clarification of Article 152(2) of Regulation 2019/6

Guidance to Applicants – Veterinary Medicinal Products

The European Commission developed guidance on the rules for veterinary medicines to help stakeholders better understand and comply with their obligations under the EU regulation on veterinary medicines, and to ensure a level playing field, i.e. that the rules are implemented in the same way across the EU.

Marketing authorisations expiring after 28 January 2022

Some marketing authorisations granted under the previous regulatory framework expire only after the EU regulation on veterinary medicines became applicable.

What to do if your marketing authorisation expires after January 2022

Delegated and implementing regulations

The EU regulation on veterinary medicines requires the European Commission to adopt delegated and implementing regulations on some well-defined topics to further specify technical requirements on the topics concerned.

List of the abbreviations and pictograms common throughout the Union to be used in the packaging of veterinary medicinal products (Article 17(2))

Rules on the size of small immediate packaging units (Article 17(3))

Criteria for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of those antimicrobials (Article 37(4))

List of antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans (Article 37(5))

Necessary measures and practical arrangements for the Union database on veterinary medicinal products (Article 55(3))

Requirements for the collection of data on antimicrobial medicinal products used in animals (Article 57(3))

Format for the collection of data on antimicrobial medicinal products used in animals (Article 57(4))

List of variations not requiring assessment (Article 60(1))

Format and content of the pharmacovigilance system master file and its summary (Article 77(6))

Good pharmacovigilance practice (Article 77(6))

Good manufacturing practice for veterinary medicinal products (Article 93 (2))

Good manufacturing practice for active substances used as starting materials in veterinary medicinal products (Article 93(2))

Good distribution practice (GDP) for active substances used as starting material in veterinary medicinal products (Article 95(8))

Good distribution practice (GDP) for veterinary medicinal products (Article 99(6))

Design of the common logo to be displayed on websites offering veterinary medicinal products for sale at a distance (Article 104(7))

Rules on appropriate measures to ensure the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed (Article 106(6))

List of antimicrobials, which shall not be used in accordance with Articles 112–114 or which may be used in accordance with these articles subject to certain conditions (Article 107(6))

Content and format of the information contained in the single lifetime identification document for equine animals (Article 109(1))

Model forms for entering the information contained in the single lifetime identification document for equine animals (Article 109(2))

List of substances used in veterinary medicinal products authorised in the Union for use in food-producing terrestrial animal species or substances contained in a medicinal product for human use authorised in the Union which may be used in food-producing aquatic species (Article 114(3))

List of substances which are essential for the treatment of equine species, or which bring added clinical benefit compared to other treatment options available for equine species and for which the withdrawal period for equine species shall be six months (Article 115(5))

Detailed rules regarding animals or products of animal origin imported into the Union (Article 118(2))

The EU rules on use of certain antimicrobials in animals also apply to animals and products of animal origin imported into the EU.

Legal Acts

Commission Delegated Regulation (EU) 2023/905 on the application of the prohibition of use of certain antimicrobial medicinal products to animals or products of animal origin exported from third countries into the Union
- Public consultation and feedback on the draft regulation
Commission Implementing Regulation (EU) 2024/399 amending Implementing Regulation (EU) 2020/2235 and Implementing Regulation (EU) 2021/403 as regards model certificates for the entry into the Union of consignments of certain products of animal origin and certain categories of animals
Commission Implementing Regulation (EU) 2024/2020 amending and correcting Implementing Regulation (EU) 2020/2235 as regards model certificates for the entry into the Union of consignments of certain products of animal origin and certain categories of animals and correcting Implementing Regulation (EU) 2024/399
Commission Implementing Regulation (EU) 2024/2598 on a list of countries authorised for entry into the EU of certain animals and products of animal origin intended for human consumption as regards the application of the prohibition on the use of certain antimicrobial medicinal products

Information sessions with Third Countries

12 January 2023 – Informative session on Regulation (EU) 2019/6 on Veterinary Medicinal Products
- Agenda
- Presentation
8 June 2023 – Informative session on next steps concerning the implementation of Commission Delegated Regulation (EU) 2023/905 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries into the Union – Meeting with Third Countries.
6 March 2024 – Meeting between the European Commission and Third Countries on the state of play concerning the implementation of Commission Delegated Regulation (EU) 2023/905 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries into the Union.
- Agenda
- Presentation

Amendments to Annex II (Article 146(2))