HALMED applied for PIC/S membership
15.09.2014
The Agency for Medicinal Products and Medical Devices (HALMED) received on 5 September 2014 from the PIC/S Secretariat a confirmation that HALMED’s application for membership in the Pharmaceutical Inspection and Co-operation Scheme (PIC/S) is valid.
The following application assessment for the PIC/S membership will involve an inspection of the national competent authority for granting manufacturing licenses, quality system, legislation, extent of inspector’s education and visit of PIC/S delegates. During their visit, PIC/S delegates participate as observers in a GMP inspection carried out by HALMED on a manufacturing site in Croatia.
Pharmaceutical Inspection Co-operation Scheme (PIC/S) ensures an active co-operation in the field of good manufacturing practice, facilitates experience and information exchange, promotes improvement and harmonisation of standards and inspection procedures of pharmaceutical manufacturers and maintains mutual trust among competent authorities. The competent authority’s PIC/S membership is also beneficial to manufacturers as it reduces double inspections and opens access to some international markets.
Here you may find more about the PIC/S and its role and the membership procedure.
