REGULATORY AFFAIRS SERVICES FOR VETERINARY MEDICINES – FROM NEW MARKETING AUTHORISATIONS TO MAINTENANCE
Bringing veterinary medicines to market – and keeping them there – requires strict compliance to regulations. Medfiles offers regulatory affairs services for veterinary medicines, backed by over 10 years of experience in submissions, veterinary legislation and regulatory procedures in the EU and UK. Our Veterinary Medicines Team includes specialists well experienced in the EU Veterinary Medicinal Products Regulation, national UK legislation and VMD guidance, as well as US FDA requirements.
You can outsource individual tasks or the entire regulatory process – with Medfiles, you gain access to dedicated experts, regulatory insight, and flexible solutions tailored to the specific needs of your veterinary products. In addition to regulatory support, we offer veterinary pharmacovigilance services and feed regulatory services.
Over 10 years of experience in veterinary regulatory affairs
200+
Global and local regulatory responsibilities for veterinary products
95+
Marketing authorisations granted in Europe (CP, DCP, MRP, NP)
150+
VNeeS dossiers created and submitted in the last 5 years
Regulatory affairs services for veterinary medicines in the EU and UK
- classification as a veterinary medicinal product (veterinary medicinal product vs. medical device, veterinary medicinal product vs. feed or supplement)
- new marketing authorisations (NP, DCP, SRP and CP procedures)
- maintenance of marketing authorisations (VRA, VNRA, UPD and implementations)
- vet ASMF submissions
- documentation such as Part 1 and Part 2 documents and product information (including QRD updates to version 9)
- compilation and submission of VNeeS
- local tasks based on national requirements
Regulatory affairs services for veterinary medicines in the USA
- classification as an animal drug
- GAP analyses of marketing authorisation dossiers (EU vs USA)
- documentation for new animal drug applications (ANADA, NADA) and supplemental applications, including labelling documents.
Ready for the EU market? GO/NO-GO assessment for veterinary medicinal products
Before committing significant resources to dossier preparation, clinical studies or pharmacovigilance system set-up, it pays to know exactly what lies ahead. Our fixed-fee GO/NO-GO assessment gives pharmaceutical companies, animal health start-ups and non-EU marketing authorisation holders a clear, practical assessment of what is needed for successful EU marketing authorisation – covering regulatory strategy, dossier readiness evaluation and pharmacovigilance obligations.
We identify your regulatory and pharmacovigilance gaps early, recommend the most suitable EU procedure, and set out a realistic roadmap to market – so you commit resources with confidence, not guesswork.
Read about our regulatory affairs services for veterinary medicines:
CMC expert services for veterinary medicines
Efficient product development and smooth regulatory approval depend on well-prepared CMC documentation. With our expert support in CMC, you can ensure that your veterinary product documentation meets both EU and global requirements.
We assist you with writing Part 2 and 1C1 documentation for marketing authorisation applications, variations, and clinical trial documentation (IMPD/IND), as well as active substance documentation such as ASMF, DMF and CEP. Our expertise ensures that your dossier will meet the current regulatory requirements with a reasonable level of detail, aiming for a positive outcome as well as easy maintenance of the marketing authorisation in the future. We help you with your elemental impurities risk assessments.
Our experienced team combines regulatory expertise with a practical understanding of pharmaceutical manufacturing and analytics – helping you progress with confidence at every stage of development.
See also:
- New EU veterinary GMP regulations: is your quality system clearly demonstrable
- Repurposing human medicines for veterinary use: key considerations
- Bimeda & Medfiles: Partnership in veterinary regulatory affairs in the EU
- Vetcare & Medfiles: Centralised marketing authorisation process
- Vetcare & Medfiles: Working together on the maintenance of marketing authorisations of vet medicines
- Six reasons to engage CMC experts in drug development
Marketing authorisation applications for veterinary medicines
Medfiles supports veterinary pharmaceutical companies throughout the entire marketing authorisation process – from strategic planning and product classification to dossier preparation, submission, and coordination with authorities. Our experienced team guides you early in the development phase to determine product classification and the appropriate regulatory pathway, helping to avoid unnecessary delays.
We offer full-service support for national, decentralised (DCP), mutual recognition (MRP), subsequent recognition (SRP), and centralised (CP) procedures within the EU. Our services include compiling and submitting marketing authorisation applications, performing gap analyses of existing dossiers, writing parts 2 and 1C1, coordinating communications with regulatory authorities, handling of responses and national phase.
See also:
- Bimeda & Medfiles: Partnership in veterinary regulatory affairs in the EU
- Vetcare & Medfiles: Centralised marketing authorisation process
- Repurposing human medicines for veterinary use: key considerations
- Free webinar: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the PV system
Marketing authorisation maintenance services for veterinary medicines
Keeping your veterinary medicinal products compliant and market-ready requires timely updates and a clear understanding of regulatory requirements. Medfiles offers reliable support for the ongoing upkeep of your authorisations, whether you need full outsourcing or targeted assistance with specific tasks.
We support the maintenance of your marketing authorisations, including variations (VRA, VNRA), writing parts 2 and 1C1, updating ASMF, handling of responses, MAH transfers, and implementation of regulatory or technical changes as required by authorities. Our competent PI Team and QRD 9 experts translate and update your product information texts. We compile electronic applications (VNeeS/eCTD) and manage submissions. We are especially familiar with procedures in the EU and UK, and can also support your US market activities, including supplemental applications and documentation.
See also:
- Free webinar: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the PV system
- Best practices for Vet QRD template 9.1 updates
- Best practices for managing veterinary variations under Regulation (EU) 2019/6: VNRA, VRA and worksharing explained
- Bimeda & Medfiles: Partnership in veterinary regulatory affairs in the EU
- Vetcare & Medfiles: Working together on the maintenance of marketing authorisations of vet medicines
- Best practices for Vet QRD template updates
Local regulatory affairs services for veterinary medicines
In the Nordic and Baltic countries we support you with national requirements, database updates, product information and marketing material compliance. We have in-depth local knowledge which ensures alignment with national requirements.
Product Information and Translation Services
Medfiles’ Product Information Team consists of experienced translators and regulatory experts who produce clear, compliant product information texts such as SmPCs, package leaflets and labelling in multiple languages. We offer both preparation and translation services, covering Finnish, Swedish, English, Estonian, Latvian and Lithuanian – and other languages via our partner network. Using translation memory tools and the four-eyes principle, we ensure consistency, accuracy and regulatory compliance. Our services also include proofreading of mock-ups and updates to local authority databases (Pharmaca Fennica, VNR database, LiiV, FASS, DKMAnet, Farmalogg and Felleskatalogen).
Review of marketing materials for veterinary medicinal products
Medfiles offers expert review of marketing materials for both prescription and over-the-counter medicinal products, ensuring compliance with local legislation and ethical codes without compromising marketing impact. Our service includes medical, editorial and ethical evaluation, covering various formats such as brochures, websites, social media content, videos and presentations. With strong experience across the Nordics and Baltics, we provide clear feedback, identify potential risks and offer practical solutions.
See also:
In addition to the above services, our regulatory affairs experts can work for you as a part-time or full-time outsourced resource. Our Veterinary Medicines Team works in close collaboration with the other Medfiles units. This means that you can, for instance, seamlessly outsource your veterinary pharmacovigilance to us, or benefit from our feed and feed additives services, from product development to regulatory reviews, registrations and marketing, provided by our dedicated Feed Team.
By choosing Medfiles, you gain the flexibility to outsource all or part of your project to us. You benefit from dedicated experts, regulatory insight, and tailored solutions to support the successful development and approval of your veterinary products.
Free WEBINAR: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the pharmacovigilance system
In our webinar you will learn about the main changes and requirements brought about by the Veterinary Medicinal Products Regulation. In the webinar we will discuss variation management and the relationship between pharmacovigilance systems and the related quality measures.
“Medfiles’ personnel have always been very approachable, respectful, with full availability independently of the season of the year and always happy to help and assist. Thanks to good cooperation and experiences, we have been a satisfied client for many years. Our partnership with Medfiles remains a cornerstone of our success, enabling us to deliver innovative and effective solutions to the animal health market.”
– Bimeda
“Medfiles’ independent way of working work is an advantage for us. And such a large pool of professionals can provide the right expertise for every need. – – We always felt secure in knowing the process was moving forward, as Medfiles’ experts kept us well informed. Any questions we had were answered promptly. Our cooperation was reliable and professional at all times.”
– Vetcare
insights on veterinary regulatory affairs
Our expert team regularly writes blogs on veterinary medicines, covering topics such as trends in animal health, the repurposing of human medicines for veterinary use and the Veterinary Medicines Regulation (EU) 2019/6.
Contact us
You may also be interested in:
- Flexible regulatory outsourcing: choosing the level of support that fits your needs
- Best practices for managing veterinary variations under Regulation (EU) 2019/6: VNRA, VRA and worksharing explained
- New EU veterinary GMP regulations: is your quality system clearly demonstrable
- 3 trends affecting the animal health industry in 2026
- How companies developing human and veterinary medicines can benefit from SME status in the EU
- Free webinar: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the PV system
- Best practices for Vet QRD template 9.1 updates
- Bimeda & Medfiles: Partnership in veterinary regulatory affairs in the EU
- Vetcare & Medfiles: Centralised marketing authorisation process
- Vetcare & Medfiles: Working together on the maintenance of marketing authorisations and pharmacovigilance of veterinary medicines
- Meet Medfiles’ dedicated animal health team
- Repurposing human medicines for veterinary use: key considerations
- Current trends shaping animal health