Canada and EU recognize good manufacturing practices extra-jurisdictional inspection outcomes before April 1, 2021

Canada and EU recognize good manufacturing practices extra-jurisdictional inspection outcomes before April 1, 2021 Canada and the European Union (EU) officially recognized good manufacturing practices (GMP) inspections conducted outside of their respective jurisdictions as of April 1, 2021. The extra-jurisdictional inspections are outlined in the Comprehensive Economic and Trade Agreement (CETA)’s protocol on pharmaceuticals. This protocol is known as the Protocol on the Mutual Recognition of the Compliance and Enforcement Programme regarding Good Manufacturing Practices for Pharmaceutical Products. 2023-02-27 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetygood manufacturing practicesCanada and EUrecognize GMPextra-jurisdictional inspectionGMP complianceEU regulatory authority Canada and EU recognize good manufacturing practices extra-jurisdictional inspection outcomes before April 1, 2021HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin/canada-european-union-good-manufacturing-practices-extra-jurisdictional-inspection.html Canada and EU recognize good manufacturing practices extra-jurisdictional inspection outcomes before April 1, 2021HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/conformite-application-loi/licences-etablissement/bulletin-licences-etablissement-pharmaceutiques/canada-union-europeenne-inspections-bonnes-pratiques-fabrication-extraterritoriales.html

Canada and the European Union (EU) officially recognized good manufacturing practices (GMP) inspections conducted outside of their respective jurisdictions as of April 1, 2021. The extra-jurisdictional inspections are outlined in the Comprehensive Economic and Trade Agreement (CETA)’s protocol on pharmaceuticals. This protocol is known as the Protocol on the Mutual Recognition of the Compliance and Enforcement Programme regarding Good Manufacturing Practices for Pharmaceutical Products.

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