Ensuring quality in medicinal product distribution: Medfiles as LEO Pharma’s responsible pharmacist in Finland

LEO Pharma is a pharmaceutical company founded in 1908 and headquartered in Denmark. Throughout its history, LEO Pharma has advanced the standard of care for people with skin conditions. The company develops innovative treatments for skin conditions such as psoriasis, eczema, acne and skin infections.

– Our mission is to improve the lives of people with skin diseases, their families and society by breaking new ground in pharmaceuticals and demonstrating a lasting commitment to patient care,” says Kristien Vanelderen, Head of Quality International at LEO Pharma.

Based in Belgium, Kristien leads a team of Quality Managers responsible for ensuring Good Distribution Practice (GDP) compliance for LEO Pharma’s commercial affiliates across Europe and Asia Pacific.

LEO Pharma’s collaboration with Medfiles began about four years ago, with Medfiles acting as the Responsible Pharmacist (RP) for Finland. In Finland, the wholesale trade in medicinal products is subject to a licence issued by the national competent authority, Fimea. Each company that holds a medicinal product wholesale dealer’s licence needs to have a responsible pharmacist.

To qualify for this role, the RP must be M.Sc. Pharmacy registered in Finland. The RP is responsible for the quality of the distribution of medicinal products. This role is essential for compliance with both EU and Finnish pharmaceutical regulations, and for foreign clients poses two challenges: the language barrier and the specific qualification for the role.

– The role of the responsible pharmacist is a critical position, especially due to the language barrier. Not many of LEO Pharma’s Nordic colleagues understand and speak Finnish, which makes Medfiles’ support invaluable.

In addition to the RP role, Medfiles also assists LEO Pharma with the intake and handling of customer complaints throughout the Nordic region.

Kristien is happy with the collaboration over the years and emphasises Medfiles’ high level of expertise and professionalism.

– I am very happy with the support and knowledge that Medfiles provides. The quality of their work always meets our expectations.

One of the outstanding benefits of the partnership has been continuity. LEO Pharma has developed a stable and reliable working relationship with Medfiles as the key roles at Medfiles have remained unchanged over the years.

– Continuity is one of the most valued aspects of our collaboration. Working with familiar experts over an extended period of time has provided stable support and minimised the need for frequent onboarding of new personnel.

LEO Pharma’s partnership with Medfiles highlights the value of a trusted and knowledgeable partner in the role of responsible pharmacist. With Medfiles’ local expertise and regulatory support, LEO Pharma ensures compliance and quality when distributing medicines in Finland.

See also: Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics

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