Theme page about the new veterinary medicinal products regulation
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.
1. Marketing authorisations and application requirements
See, e.g. articles 5-41 of the regulation
- CMDv information on marketing authorisations
- Application form for marketing authorisation
- Application (dossier) requirements, including link to regulation amending Annex II to the regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.180.01.0003.01.ENG&toc=OJ%3AL%3A2021%3A180%3ATOC
- Labelling and package leaflet See articles 10-17 and link to QRD template: https://www.ema.europa.eu/en/veterinary-regulatory/marketing-authorisation/product-information/veterinary-product-information-templates#future-template-(v.9)-section
- National guidelines on labelling, etc. of veterinary medicines (in Danish only).
- Miscellaneous: Regulation establishing the criteria for the designation of antimicrobials, human use only: EUR-Lex - 32021R1760 - EN - EUR-Lex (europa.eu).
- Link to regulation 2022/1255 designating antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans: L_2022191DA.01005801.xml (europa.eu)
- Link to regulation on transitional rules for labelling of veterinary medicinal products authorised under previous rules.
2. Authorisation procedures for marketing authorisations
See, e.g. articles 42-54 of the regulation
- Central procedure: European Medicines Agency | (europa.eu)
- Authorisation procedures: CMDv information on MRP, SRP and DCP
- Re-examination procedure:
3. The Union Product Database and collection of data on antimicrobial veterinary medicines
See, e.g. articles 55-59 of the regulation
- Union Product Database (UPD)
- Data held in the Union Product Database
- Application of SPOR
- Link to the regulation on specifications for the Union Product Database: https://eur-lex.europa.eu/eli/reg_impl/2021/16/oj
- Link to the regulation on specification for collection of data on antimicrobials: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32021R0578.
- Pending negotiations and adoption: Regulation on the format and method for collection and quality assurance of antimicrobials.
- Link to regulation on the format of the data to be collected on the sales and the use of antimicrobials.
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.
4. Changes to the terms of a marketing authorisation, including variations
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
- Variationer der ikke kræver en vurdering:
CMDv Best Practice Guide for Variations not requiring assessment: BPG VNRA (hma.eu)
- Variations that are not listed in the regulation:
- 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: 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 guideline
Guideline on variations to marketing authorisations for medicinal products for animal use
5. Harmonisation of summaries of product characteristics
See, e.g. articles 69-71 of the regulation
- CMDv.s Best Practice Guides on harmonisation:
Best Practice Guide for the selection of the products for the SPC harmonisation
Best Practice Guide for the harmonisation procedure of the SPC of the reference products
- Pending negotiations and adoption: Rules on worksharing procedures.
6. Environmental risk assessment
See article 72 of the regulation
- With the intention of harmonising certain summaries of product characteristics, the EMA has issued guidelines for identifying products potentially harmful to the environment and for their risk assessment if marketed before 2005: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-interpretation-article-72-regulation-eu-2019/6-environmental-safety-documentation-environmental-risk-assessment-certain-veterinary-medicinal_en.pdf
7. Pharmacovigilance in the EU
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):
- Collection and recording of suspected adverse events for veterinary medicinal products https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-veterinary-good-pharmacovigilance-practices-vgvp-module-collection-recording-suspected_en.pdf
EMA hosts online training on 13 January 2022 https://www.ema.europa.eu/en/events/union-pharmacovigilance-database-follow-webinar-collection-recording-suspected-adverse-events
Information from previously held online training on 23 and 24 November 2021 is available at the EMA website https://www.ema.europa.eu/en/events/union-pharmacovigilance-database-webinar-adverse-event-collection-recording - Signal Management https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-veterinary-good-pharmacovigilance-practices-vgvp-module-signal-management_en.pdf
Information from previously held online training on 8 December 2021 is available at the EMA website https://www.ema.europa.eu/en/events/union-pharmacovigilance-database-webinar-signal-detection-analysis - Veterinary pharmacovigilance communication https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-veterinary-good-pharmacovigilance-practices-vgvp-module-veterinary-pharmacovigilance_en.pdf
- Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-veterinary-good-pharmacovigilance-practices-vgvp-module-pharmacovigilance-systems-their_en.pdf
Information from previously held online training on 8 December is available at the EMA website https://www.ema.europa.eu/en/events/webinar-veterinary-pharmacovigilance-phv-inspections-systems-their-quality-management-systems-phv - Controls and pharmacovigilance Inspections https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-veterinary-good-pharmacovigilance-practices-vgvp-module-controls-pharmacovigilance_en.pdf
- Link to the regulation on good pharmacovigilance practice: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R1281&qid=1627975964936
- Link to the regulation on the content of the pharmacovigilance system master file: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R1281&qid=1627975964936
8. Homeopathic veterinary medicinal products
See, e.g. articles 85-87 of the regulation
- Pending. To be updated.
9. Manufacturing of medicines
See, e.g. articles 88-94 and 96-98 of the regulation
- Application for authorisation to manufacture and import medicines and intermediate products: Application for authorisation to manufacture and import medicines and intermediates
10. Wholesale and retail distribution
See, e.g. articles 99-101 and 103 of the regulation
- Application for authorisation of wholesale distribution of medicinal products within the EU/EEA: Application for authorisation of wholesale distribution of medicinal products within the EU/EEA.
- Link to good distribution practice for veterinary medicines: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R1248
11. Importers, manufacturers and distributors of active pharmaceutical ingredients (APIs).
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
12. Parallel trade
See article 102 of the regulation
- National procedure rules for parallel trade in veterinary medicines are laid down in the executive order on parallel trade in veterinary medicines (in Danish only).
- National guidelines on parallel trade in veterinary medicines (in Danish only).
- Pending: Best Practice Guide from CMDv on parallel trade in veterinary medicines
- Pending: Danish application form to be used to apply for authorisation to parallel trade a veterinary medicine, and Danish application form for notification of changes to medicines that are parallel traded and to the parallel trade authorisation.
13. Retail of veterinary medicines at a distance
See, e.g. article 104 of the regulation
- Link to the executive order on pharmacies’ and retail distributors’ online sale of medicines.
- Link to logo on online sale of veterinary medicines.
- Link to the regulation on a common logo for retail of veterinary medicinal products at a distance: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R1904
14. Veterinary prescriptions
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
15. Use of medicines
See, e.g. articles 106-118 of the regulation
- Link to the Danish Veterinary and Food Administration’s page about the areas of the Veterinary Medicinal Products Regulation it administers: https://foedevarestyrelsen.dk/Dyr/Laegemidler-til-dyr/
16. Advertising for veterinary medicines
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.
17. Inspections and control
See, e.g. articles 123-128 of the regulation
18. For veterinarians in particular
- See “Veterinary prescriptions” above
- Pending: List of antimicrobials reserved for treatment of humans. See “Marketing authorisations and application requirements” above.
- Veterinarians are still required to report side effects
19. Certain substances
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.
Various new regulations