HALMED successfully fulfils all evaluation conditions of Health Canada for implementation of the Mutual Recognition Agreement

21 Feb HALMED successfully fulfils all evaluation conditions of Health Canada for implementation of the Mutual Recognition Agreement

Agency for Medicinal Products and Medical Devices of Croatia (HALMED) had successfully fulfilled all conditions within the evaluation conducted by the Canadian regulatory body Health Canada with the purpose of implementation of the Mutual Recognition Agreement with Canada (EC-Canada MRA) in the area of conformity of good manufacturing practice (GMP) programs. The operational phase of the agreement begins on 1 April 2016.

On this date, the Republic of Croatia and HALMED will be added to the list of regulatory bodies encompassed by the Mutual Recognition Agreement between the European Commission and Canada.

The decision of acceptance of HALMED was based on the detailed review of the quality system, inspection practice, competence of HALMED’s Official Medicines Control Laboratory (OMCL) as well as legislation. Documentation review and observation of inspection practice in inspection of manufacturers had been conducted simultaneously with assessment within the Joint Audit Program (JAP) and application for membership in international organisation Pharmaceutical Inspection and Co-operation Scheme (PIC/S). Assessors of PIC/S and JAP as well as Health Canada had participated in the audit of HALMED, along with a representative of the US Food and Drug Administration (FDA).

Originally published on 23 March 2016 by Agency for Medicinal Products and Medical Devices of Croatia HALMED at http://www.almp.hr/en/Novosti-i-edukacije/Novosti/2016/HALMED-uspjesno-ispunio-sve-evaluacijske-uvjete-Health-Canade-u-svrhu-primjene-sporazuma-o-medusobnom-priznavanju/1524