GO/NO-GO assessment for veterinary medicinal products: a clear path to EU marketing authorisation
Planning to bring a veterinary medicinal product to the EU market? The Medfiles GO/NO-GO assessment for veterinary medicinal products is a fixed-fee regulatory and pharmacovigilance assessment that helps you determine your product’s readiness for EU marketing authorisation. It identifies regulatory and pharmacovigilance gaps and explains what steps are still required before you commit significant resources to the marketing authorisation process.
Whether you are a pharmaceutical company, an animal health start-up or a non-EU marketing authorisation holder looking to obtain an EU marketing authorisation, the assessment helps you identify regulatory gaps early, minimise approval risks and establish a realistic path towards marketing authorisation.
When should a GO/NO-GO assessment be carried out?
Ideally, the assessment should be carried out before significant resources are committed to dossier preparation, clinical trials or pharmacovigilance system set-up. It can help clarify the applicable regulatory route, what is already in place, what is still missing and what should be prioritised before proceeding with the marketing authorisation application. This helps reduce the risk of costly surprises and provides a concrete, prioritised plan for the next steps.
What’s included in the assessment?
- Classification and regulatory positioning:
A preliminary assessment of your product’s classification and regulatory position, with support for Authority classification advice if needed.
- MAH and operating model readiness:
An assessment of marketing authorisation holder (MAH), pharmacovigilance and other operational requirements for the planned EU set-up.
- Recommended EU procedure:
The most suitable EU marketing authorisation procedure for your product.
- Pharmacovigilance readiness:
An assessment of PV requirements, including QPPV and PSMF readiness, and identification of areas that still need to be established or addressed.
- Dossier readiness review:
A review of the available dossier documentation to assess its readiness for an EU marketing authorisation application.
- Roadmap and recommended next steps:
A practical roadmap towards EU marketing authorisation, including recommended actions and priorities for moving forward.
- Prioritised gap analysis:
Identification of key regulatory and dossier gaps, with priorities for what should be addressed before proceeding with the application.
- Budgetary estimate:
A realistic estimate of the expected costs for the full marketing authorisation application (MAA) project based on the identified regulatory path and needs.
Benefits of the GO/NO-GO assessment
1
Identify regulatory and dossier gaps before committing significant resources
2
Understand which requirements should be addressed first
3
Reduce the risk of regulatory issues and delays later in the process
4
Get a clear plan for the next steps towards EU marketing authorisation
5
Identify pharmacovigilance requirements and potential gaps early
6
Understand the expected resources and budget for the full MAA project
BOOK A FREE 30-MINUTE MEETING
Ready to assess your veterinary product’s path to EU marketing authorisation?
Let’s discuss your product, regulatory situation and how the GO/NO-GO assessment could support your next steps.
Medfiles’ veterinary medicine experience
10+
Year’s of experience in veterinary RA & PV
90+
Clients in 20 countries
(EU, USA, Asia)
95+
Marketing authorisations granted in Europe (CP, DCP, MRP, NP)
200+
Global and local regulatory responsibilities for vet products
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 into veterinary medicines
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:
- Free webinar: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the pharmacovigilance system
- Meet Medfiles’ dedicated animal health team
- Meet our people: Veterinarian brings valuable expertise to veterinary pharmacovigilance
- Bimeda & Medfiles: Partnership in veterinary regulatory affairs in the EU
- Vetcare & Medfiles: Working together on the maintenance of marketing authorisations and pharmacovigilance of veterinary medicines