Theme page about the new veterinary medicinal products regulation

Updated 15 May 2024

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

Registration of QPPV and PSMF number for veterinary medicinal products

Under Commission Implementing Regulation EU 202116 of 8 January 2021, all Marketing Authorisation Holders of Veterinary Medicinal products in the EU, must register information on Qualified Persons for Pharmacovigilance QPPV and Pharmacovigilance System Master File PSMF in the Union Product Database UPD

Initial registration of information about QPPV and PSMF

The initial registration of information about QPPV and PSMF number, must be done by submitting the relevant variation, that does not require assessment (VNRA). The Danish Medicines Agency can inform that, no fee will be charged, for initial registration of this information, if the registration is made no later than 31. December 2023. At the initial registration of the information in UPD, “one-off registration of QPPV” or “one-off registration of PSMF number”, must be entered in the Submission comment field.

Subsequent changes to the information about QPPV and PSMF

Subsequent changes to the information about QPPV or PSMF must be submitted via the relevant VNRA. The Danish Medicines Agency can inform that, in accordance with the Executive Order on fees for Medicinal Products and Pharmaceutical Companies etc., these changes will be charged.

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

Variations requiring assessment 

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

Application form for variation requiring assessment

Variations not requiring assessment

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

Request form for Re-examination of RMS assessment report

Variations not requiring assessment

Commission Implementing Regulation (EU) 2024/916 of 26 March 2024 amending Implementing Regulation (EU) 2021/17 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council

Commission Implementing Regulation (EU) 2023/997 of 23 May 2023 amending Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council

Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council

CMDv Best Practice Guide for Variations not requiring assessment

CMDv Template for Letter of intent (LoI) for the submission of a VNRA supergrouping

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 of Regulation (EU) 2019/6

Application form for recommendation on a variation

Request form - Request for a recommendation on the classification of a not already listed variation

Questions and answers regarding variations

CMDv Q&A – List for the submission of variations according to regulation (EU) 2019/6

CMDh and CMDv Q&A – QP declaration

Worksharing

CMDv Best Practice Guide for Worksharing (hma.eu)

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

National guideline

Guideline on variations to marketing authorisations for medicinal products for animal use

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

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.