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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| EC-Canada MRA, SECTORAL ANNEX ON GOOD MANUFACTURING PRACTICES
(GMP) |
| Internet: | http://ec.europa.eu/health/files/international/doc/mraeccan_en.pdf |
| Origin/Publisher: | EG Kommission |
| Content: | 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. |
| Document Type: | Annex |
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