The Veterinary Medicinal Products Regulation (EU) 2019/6 is now in force. Are you ready for the new requirements?
Do you know how the new regulation affects your veterinary medicinal products?
The Medfiles Pharmacovigilance (PV) and Regulatory Affairs (RA) teams have been closely following the new regulation and participating in the training provided by regulatory authorities. We at Medfiles have extensive experience in veterinary PV and RA maintenance services as well as in new MA applications of veterinary medicinal products through national, MRP/DCP and centralised procedures. Our experts are ready to help you fulfil the obligations of the new requirements by
- providing consultation on the requirements of the new regulation
- planning, grouping and classifying variations
- coordinating new Marketing Authorisation Applications (MAA)
- preparing documents for variations and MAAs, including writing part 2 and 1C1 documents, PSMF summaries and risk management plans
- compiling the VNeeS and taking care of the submission
- updating product information
- reviewing packaging materials
- submitting data to the Union Product Database
- providing full pharmacovigilance services for veterinary products, including compiling the Pharmacovigilance System Master File, writing and updating SOPs and providing validated veterinary safety databases, ICSR and signal management, literature monitoring and set-up and maintenance of your PV systems.
Medfiles is your reliable partner for your product’s entire life cycle management.
For more information, please contact Regulatory Affairs Manager Anna Alonen (firstname.lastname@example.org).