HALMED successfully fulfills all evaluation conditions of Health Canada for implementation of the Mutual Recognition Agreement
25.03.2016
Agency for Medicinal Products and Medical Devices of Croatia (HALMED) had succesfully 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, available on the Health Canada website:
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).
On the occasion of acceptance of HALMED, management and assessors of Health Canada congratulated the Agency, and particularly its inspection team on a great effort put into the fulfillment of all necessary requirements.
Based on the agreement between the European Commission and Canada, regulatory bodies encompassed by the agreement can exchange information on marketing authorisations and safety of medicinal products, accept manufacturing licences as well as accept and exchange GMP certificates. According to the agreement, regulatory bodies also retain the right to conduct inspections on the territory of another party. In that respect, the Canadian regulatory body can conduct inspections in Croatia, whereas HALMED can conduct inspections in Canada.
More about the content and terms of the Mutual Recognition Agreement between the European Commission and Canada can be read on the following Internet pages:
http://ec.europa.eu/health/international-activities/index_en.htm
http://ec.europa.eu/health/international-activities/bilateral-relations/index_en.htm#fragment1
Details on the conditions in the area of good manufacturing practice are available on the following link:
http://ec.europa.eu/health/files/international/doc/mraeccan_en.pdf
