Centralised marketing authorisation process requires diverse expertise – Medfiles’ expertise employed as the driving force for a new veterinary MA


With its expertise, Medfiles helped the Finnish veterinary pharmaceutical company Vetcare successfully receive a marketing authorisation (MA) throughout Europe for a combination sedative drug product developed for dogs.

Even centralised marketing authorisation processes can be outsourced. This is, at least, the case when a contract research organisation (CRO) has sufficient expertise, extensive professional knowledge and excellent organisational skills. Medfiles showed that this is exactly what they can offer when helping Vetcare, a Finnish veterinary pharmaceutical company, successfully receive a marketing authorisation for a new proprietary medicine they developed. The company’s two-molecule combined drug, developed for short-term sedation of dogs and pain relief caused by medical procedures, was authorised in the EU in December 2021.

“We have been involved in more than 90 new marketing authorisation processes, and more than 400 pharmaceutical products have been successfully authorised with our help. We have in-depth expertise from each stage of the regulatory affairs process, from the pre-submission stage and registration of the active substance to answering additional questions”, says Anna Alonen, Regulatory Affairs Manager at Medfiles.

Aiming toward long-term partnerships

Medfiles has a long history of collaboration with Vetcare which started outsourcing its analytical services and product development partnership to Medfiles nearly twenty years ago. The first joint regulatory affairs projects took place almost fifteen years ago. Alonen says that mutual trust was established right from the first meetings. An open conversation culture created a tight bond.

“When a customer entrusts their product into our hands, it becomes like our own – we take 100 percent responsibility for it”, says Alonen.

The preparation of Vetcare’s new combined sedative drug application began in 2016. Medfiles took the lead with the marketing authorisation process for the duration of the entire project and also served as the main contact point for the European Medicines Agency EMA.

“During the process, project management skills, proactivity and fluent communication are essential. Experts in both companies must constantly be kept up to date and aware of what is happening next”, Alonen emphasises.

Knowhow for all stages of regulatory affairs process

Medfiles’ role in the marketing authorisation process often entails educating the customer. Usually, collaboration begins with a training session in which Medfiles’ experts talk about what will happen in each stage, what is to be expected, what data needs to be ready and how it should be presented.

“Our strength lies in our experts’ diverse areas of knowledge and the close cooperation between teams. Marketing authorisation applications (MAA) involve a demanding documentation process that requires chemical, pharmaceutical, preclinical and clinical expertise, as well as knowhow on how to present product quality, efficacy and safety. The authorities need to get a clear understanding of all these various aspects”, she continues.

A centralised MA process is an extensive undertaking, and Vetcare truly appreciated Medfiles’ professional contribution.

“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”, says Henna Mäkinen, Vetcare’s Director of Production and Regulatory Affairs.

Involved in significant work

Vetcare’s new combination sedative contains two active ingredients – one is Vetcare’s own proprietary molecule and the other is a commonly used anesthetic. The combination sedative is used to sedate dogs and relieve pain during short procedures and examinations. Vetcare’s new original molecule accelerates the dog’s awakening time from sedation and reduces anesthetic side effects.

“We’re especially grateful for the opportunity to take part in bringing a Finnish company’s proprietary drug to the veterinary medicine market”, Alonen says with pride.

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.

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