Theme page about the new veterinary medicinal products regulation

20 April 2022

On 28 January 2022, the new veterinary medicinal products regulation enters into force. The regulation is directly applicable in the member states. It is important to know the rules of the regulation, but also to be aware of national rules that still regulate the area.

It is your responsibility to keep abreast of any new legislation in the area.

This theme page will help you along the way. It will be updated regularly with links and material whenever information of relevance becomes available.

Link to the veterinary medicinal products regulation

See, e.g. articles 5-41 of the regulation

See, e.g. articles 55-59 of the regulation

See, e.g. articles 60-68 of the regulation

  • Variations requiring assessment: 

EMA-CMDv Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations: EMA-CMDv VRA guidance (hma.eu)

Application form for variation requiring assessment: Application form for variation requiring assessment

CMDv Best Practice Guide for Variations requiring assessment: BPG VRA (hma.eu)

Re-examination of variations requiring assessment: Best Practice Guide for Re-examination of RMS assessment report procedure

Application form for re-examination: Request form for Re-examination of RMS assessment report

CMDv Best Practice Guide for Variations not requiring assessment: BPG VNRA (hma.eu)

  • Variations that are not listed in the regulation:

Procedural advice for requests for the classification of variations not already listed in Commission Implementing Regulation (EU) 2021/17 or EMA/CMDv guidance on the details of the classification of variations requiring assessment according to Article 62

  • Questions and answers regarding variations:

CMDv Q&A – List for the submission of variations according to regulation (EU) 2019/6: CMDv Variation QA (hma.eu)

CMDh and CMDv Q&A – QP declaration: 2. CMDh-CMDv QA QP declaration (hma.eu)

  • Worksharing:

CMDv Best Practice Guide for Worksharing: BPG worksharing (hma.eu)

CMDv Template for letter of intent (LoI) for the submission of a worksharing procedure: TEM_LoI_worksharing.docx (live.com)

  • National practice for changing the name of a veterinary medicine

Assessment and authorisation of a change in the name of a veterinary medicine in Denmark prior to the submission of a variation

See article 72 of the regulation

See, e.g. articles 73-81 of the regulation

Rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products:

Link to regulation on good pharmacovigilance practice and pharmacovigilance system master file

EMA’s website on pharmacovigilance guidance applicable from 28 January 2022

  • There are six modules in the guideline on veterinary good pharmacovigilance practices (VGVP guideline):

See, e.g. articles 85-87 of the regulation

  • Pending. To be updated.

See, e.g. articles 88-94 and 96-98 of the regulation

See, e.g. articles 99-101 and 103 of the regulation

See article 95 of the regulation

Link to regulation on good distribution practice for active pharmaceutical ingredients: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R1280&qid=1627976059608

See article 102 of the regulation

See, e.g. article 104 of the regulation

See article 105 of the regulation

  • Pending: Link to executive order on prescriptions and dose dispensing of medicines
  • Requirements for veterinary prescriptions
  • Pending negotiations and adoption: Model for veterinary prescription requirements

See, e.g. articles 106-118 of the regulation

  • Pending: Link to the Danish Veterinary and Food Administration’s planned theme on the veterinary regulation

See, e.g. articles 119-122 of the regulation

  • See complementary rules in executive order no. 130 of 25 January 2022 on advertising, etc. of veterinary medicines (in Danish only). The executive order regulates, for example, the storage of advertising material, financial advantages for healthcare professionals and certain other professionals, cost-reasoned discounts for pharmacies and other retail distributors of veterinary medicines, notification of funding for healthcare professionals and certain other professionals engaged in the sale of medicines outside pharmacies. It also contains provisions on the pharmaceutical companies’ information and notification obligations regarding funding.
  • Draft notes of guidance on advertising, etc. of veterinary medicines were submitted for public consultation on 31 January 2022. Any comments to the draft must be submitted to the Danish Medicines Agency by 1 March 2022.

Article in Danish on how the veterinary medicinal products regulation will affect veterinarians (source: the Danish veterinary medical journal “Dansk Veterinærtidsskrift”)

Wholesale distribution of certain substances now requires a wholesale distribution authorisation. Contact the Danish Medicines Agency if you are a wholesale distributor or wish to wholesale distribute certain substances.

Pending: Executive order on fees