Regulatory & Pharmacovigilance Department

Regulatory & Pharmacovigilance Department

The Regulatory & Pharmacovigilance Department is responsible for obtaining marketing authorisations, ensuring that the approved registration dossiers for all product categories (medicinal products, cosmetics, food supplements, medical devices) are always valid and up-to-date, as well as the functioning of the system for the detection, assessment, understanding, and prevention of adverse reactions or other issues that may be relevant to medicinal products.

The team of regulatory and pharmacovigilance specialists has vast experience in conducting regulatory approval processes and pharmacovigilance activities in the Polish, European, and non-EU markets (more than 60 different markets).

The Regulatory & Pharmacovigilance Department conducts regulatory approval processes for Rx and OTC products under national and European procedures, updates marketing authorisations by way of amendments, and maintains their validity in the regulatory procedures on behalf of both Adamed Pharma S.A and its clients.