When the Finnish animal health company Vetcare wanted to launch a combination sedative for dogs, Medfiles helped them to obtain marketing authorisation for the medicine in all European countries at once, through centralised procedure in 2021. Ever since, Medfiles has had the pleasure of assisting Vetcare in maintaining the marketing authorisation and managing the pharmacovigilance duties related to the veterinary medicine.
MAINTAINING A MARKETING AUTHORISATION REQUIRES CAREFUL PLANNING, KNOWLEDGE OF LEGISLATION AND DIVERSE EXPERTISE
Regulatory requirements for marketing authorisations and pharmacovigilance of veterinary medicines are constantly changing. Medfiles monitors these changes with a careful eye and helps marketing authorisation holders keep their marketing authorisations up to date at all times. The Medfiles VET experts provide competent support and ensure in a reliable and efficient manner that clients’ products are compliant, with dedicated specialists for demanding variation applications, CMC tasks, pharmacovigilance system maintenance and product information updates.
“The current EU VET regulation and its new variation classifications, VRA and VNRA, make careful planning all the more important. Medfiles has helped Vetcare in planning, classifying and implementing variation applications related to MA maintenance work, in preparing Part 2 documentation, writing critical expert reports and in updating product information texts. In addition, Medfiles has compiled and submitted applications on behalf of the MAH,” says Elina Krannila, Senior Regulatory Affairs Expert at Medfiles.
“We also cover maintenance tasks for markets outside the EU, such as the UK and the United States,” Krannila continues.
“With special expertise in the manufacturing of injection products, Medfiles has helped us in preparing documentation for maintaining a marketing authorisation in the United States,” says Kirsi Tapaila, Vetcare’s Director of Regulatory Affairs and Commercial Product Support.
EXPERT HELP FOR PROCESS VALIDATION, PORTAL USE AND COMMUNICATION WITH AUTHORITIES
Medfiles offers a vast range of services which help provide comprehensive support to clients during the maintenance phase of a marketing authorisation. For example, Medfiles has advised Vetcare on QC analytics in production and helped Vetcare with process validation documentation, ensuring that the validation is compliant with the marketing authorisation.
The Medfiles experts are well-versed in using EMA’s UPD and IRIS portals for managing variations and communicating with the authorities. Of EMA’s pharmacovigilance portals, Medfiles uses Data Warehouse (DWH) and EVWeb. The experts also review packaging materials, taking into account official guidelines and country-specific national requirements, a crucial aspect for the launch phase.
OUTSOURCING PHARMACOVIGILANCE TASKS FREES UP RESOURCES FOR PRODUCT DEVELOPMENT
Already during the marketing authorisation process, Medfiles helped Vetcare prepare a pharmacovigilance system master file, the PSMF, and other necessary standard operating procedures related to pharmacovigilance. As Medfiles has years of experience in maintaining pharmacovigilance systems, Medfiles’ experts were well equipped to ensure that Vetcare’s processes and quality systems were at the required level for monitoring the safety and efficacy of the centrally authorised veterinary medicinal product.
“Our pharmacovigilance team works closely with the Vetcare’s QPPV. We process adverse event reports, monitor safety signals and maintain the PSMF. We also help with the recording of the annual benefit-risk balance conclusions and with many kinds of quality tasks related to pharmacovigilance,” Krannila lists as examples.
“A significant part of the pharmacovigilance work for the combination sedative is handled by Medfiles. Everything is based on competent experts and a well-working infrastructure, such as the pharmacovigilance database and the electronic document management system. Outsourcing has freed up Vetcare’s resources for other tasks, such as developing new products. Working together has gone very well, and Medfiles’ work is of high quality and reliable, says Vesa Myllys, Vetcare’s QPPV and R&D Director.
“We are committed to keeping our promise to our clients, and we make sure that each and every task is carried out accurately and always on time,” Krannila says.
“Medfiles’ independent way of working is an advantage for us. And such a large pool of professionals can provide the right expertise for every need,” Tapaila adds.
“We at Medfiles are very proud and excited about what we can do together,” Krannila concludes.
Medfiles’ services for veterinary medicines
EXPERTISE IN LEGISLATION AND MONITORING REGULATORY CHANGES
Our VET Team closely monitors regulatory changes and provides expert support to ensure smooth transition to compliance with the new requirements.
UPDATE AND TRANSLATION OF PRODUCT INFORMATION TEXTS
Our competent PI Team and QRD 9 experts translate and update your product information texts, making sure that they are always clear, accurate and up to date.
VNEES/ECTD
Our skilled experts compile electronic applications (VNeeS/eCTD) and manage submissions.
PHARMACOVIGILANCE SERVICES
Our PV system includes a PV quality system, a pharmacovigilance database and a QPPV service to ensure safety monitoring, adverse reaction reporting, signal management and cooperation with authorities on an international level.
CMC EXPERTISE AND DOCUMENTATION
Variation classification, consultation, writing Parts 2 and 1C1 ASMF updates and submissions. Our CMC experts are ready to help you with your manufacturing processes and analytics.
MA APPLICATIONS AND MAINTENANCE
We plan and prepare applications carefully and efficiently in accordance with the implementation schedule, minimising questions from the authorities.
Vetcare Oy was established to provide animals and the veterinarians who care for them with medications that best suit the animals. This same approach still guides the company’s innovation initiatives. Vetcare sells, markets, exports and develops medicines and other products that promote the well-being of animals. Every year, the company invests a significant part of its operating profits in the development of pharmaceutical products that suit animals better, along with medicines and complementary feeds to promote the well-being of animals.
