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HALMED successfully fulfilled all requirements and gained membership in PIC/S


Agency for Medicinal Products and Medical Devices of Croatia HALMED) has been officially confirmed as a member of international organisation Pharmaceutical Inspection and Co-operation Scheme (PIC/S).

HALMED's membership had been approved by the PIC/S Secretariat in October 2015 and will formally begin on 1 January 2016. This important achievement confirmed once again the exceptional competence of HALMED's employees who enabled HALMED's positioning in the very top of European and global medicines agencies.

The decision to accept HALMED as the 48th member of PIC/S was based on the detailed assessment of HALMED's quality system, inspection practice as well as competence of its Official Medicines Control Laboratory (OMCL). Along with inspectors of PIC/S, inspectors of the EU's Joint Audits Programme (JAP) as well as inspectors of Health Canada under the EU-Canada Mutual Recognition Agreement (MRA) participated in the assessment.

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 enables additional access to international markets.

More about HALMED's accession to PIC/S membership can be found here.

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