EC-Canada MRA, SECTORAL ANNEX ON GOOD MANUFACTURING PRACTICES (GMP)

EC-Canada MRA, SECTORAL ANNEX ON GOOD MANUFACTURING PRACTICES (GMP)

This Mutual Recognition Agreement (MRA) Sectoral Annex on Good Manufacturing Practices (GMP) Compliance Certification pertaining to medicinal products/drugs has been developed by the European Community (EC) and Canada to: (a) enhance bilateral regulatory cooperation; (b) establish mutual recognition for GMP compliance certification and acceptance of Manufacturing Authorizations/Licences directly issued by the authorities designated equivalent after the successful completion of a confidence building exercise; (c) develop an infrastructure for on-going communications/consultations between Canada, the European Commission, and the Regulatory Authorities of the EC Member States to enable regulators to determine and maintain the equivalency of their GMP compliance programmes.