Regulating Medicines in a Globalized World The Need for Increased Reliance Among Regulators (2020) / Chapter Skim
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Appendix B: Table of Mutual Recognition Agreements
Appendix B: Table of Mutual Recognition Agreements
Pages 109-118
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Appendix B Table of Mutual Recognition Agreements 109
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European January 1, GMP inspections and Human chemical pharmaceuticals; medicinal gases; human Union (EU) 1999; June 2001 batch certification biologicals, including vaccines, immunologicals, and for veterinary biotherapeutics; human radiopharmaceuticals; stable medicinal medicines products derived from human blood or human plasma; homeopathic medicines, if classified as medicinal products; vitamins, minerals, and herbal medicines if classified as medicinal products; products intended for use in clinical trials, investigational medicinal products, except those used in phase I clinical trials; intermediate products and bulk pharmaceuticals; active pharmaceutical ingredients, only for human medicinal products; veterinary chemical pharmaceuticals; premixes for the preparation of veterinary medicated feedstuffs; veterinary immunologicals, including vaccines, immunologicals, and biotherapeutics.
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Temporary exclusions: Stable medicinal products derived from human blood or human plasma; active pharmaceutical ingredients or bulk pharmaceuticals. Definite exclusions: 111 Blood and blood components; veterinary biologics.
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; NHPs (Note: Currently, certificates of compliance are provided by MRA partners. In Canada, regulatory amendments are being prepared that will allow Canadian NHP companies to hold an establishment license in addition to the site license required under the NHP regulations)
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Temporary exclusions: Stable medicinal products derived from human blood or human plasma; active pharmaceutical ingredients or bulk pharmaceuticals. Definite exclusions: Blood and blood components; veterinary biologics.
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It does not address the Canadian requirements for lot-to-lot release of these products as set forth under Section C.04.015 of the Food and Drug Regulations.) Temporary exclusions: Stable medicinal products derived from human blood or human plasma; active pharmaceutical ingredients or bulk pharmaceuticals.
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: human medicines with limited and batch certification only, including chemical pharmaceuticals; homeopathic medicinal scope, updated products if classified as medicinal products and subject to GMP scope July 2018 requirements in Japan; vitamins, minerals, and herbal medicines if classified as medicines by both parties; biological pharmaceuticals, including immunologicals and vaccines, that are produced by cell culture utilizing natural or recombinant microorganisms or established cell lines or derived from nontransgenic plants and nontransgenic animals; active pharmaceutical ingredients of any medicine covered in the agreement; sterile medicines that belong to any of the above categories. continued 115
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Switzerland June 2002 GMP inspections, GLP, Human chemical pharmaceuticals; medicinal gases; human and batch certification biologicals, including vaccines, immunologicals, and biotherapeutics; human radiopharmaceuticals; stable medicinal products derived from human blood or human plasma; advanced therapy medicinal products; homeopathic medicines if classified as medicinal products; vitamins, minerals, and herbal medicines if classified as medicinal products; products intended for use in clinical trials (IMPs) ; active pharmaceutical ingredients; intermediate products and bulk pharmaceuticals; veterinary chemical pharmaceuticals; premixes for preparation of veterinary medicated feedstuffs; veterinary immunologicals, including vaccines, immunologicals, and biotherapeutics.
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Food and Drug Administration recognizes all EU Member States. NOTES: EEA = European Economic Area; EU = European Union; GLP = good laboratory practice; GMP = good manufacturing practice; IMP = investigational medicinal product; NHP = natural health product.
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