Scope of activities
The Department is responsible for supervising the conditions of manufacturing and importing medicinal products and conducting on-site inspections of manufacturers or importers of medicinal products, investigated medicinal products and advanced therapy medicinal products, as well as entrepreneurs engaged in manufacturing, importing and distributing of active pharmaceutical ingredients used as raw materials in the manufacturing process of medicinal products. Moreover, the Department conducts inspections in third countries at the request of a Marketing Authorisation Holder applying for a marketing authorisation, or in case of a medicinal product imported to Poland for further processing. The scope of the Department’s duties includes quality assurance within the scope of conducted inspections, and cooperation with the GMP Inspection authorities of EU and Mutual Recognition Agreement (MRA) Member States, organisations like Pharmaceutical Inspection Cooperation Scheme (PIC/S), the European Commission, European Directorate for the Quality of Medicines (EDQM), World Health Organization (WHO) and with national competent authorities around the world.
phone: + 48 22 44-107-05
fax: + 48 22 635-99-57
12 Senatorska Str.
Director of GMP Inspection Department
Deputy Director of GMP Inspection Department