MRA with Canada

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EC - Canada MRA

The Sectoral Annex on Good Manufacturing Practice (OJ L280 on 16/10/1998) started its operational phase on 1 February 2003. The Joint Sectoral Group met on 17 January 2003 and agreed that the transitional activities should end. The Joint Committee was informed. The list of products covered under the Annex includes human and veterinary medicinal products. Veterinary immunological products are not included. The Annex is not in operation for pre-approval inspections and stable medicinal products derived from human blood or human plasma. The agreement is based on exchange of certificates of GMP compliance for manufacturers and batch certificates. The contents of these certificates are agreed and available on this website. The two-way alert system is in operation.

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