MRA on GMP Inspections between Switzerland and Canada extended
Recommendation
9/10 April 2025
Berlin, Germany
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The Mutual Recognition Agreement (MRA on Medicinal Products: Drug GMP Compliance Certification, Sectoral Annex on GMP) between Switzerland and Canada on the GMP certification of medicinal products has been in force since 2000. The text has not been revised since then.
However, Health Canada and Swissmedic have now agreed to extend the existing approach of recognising GMP inspection results to include inspections carried out in countries outside the territories of the respective contracting parties. In addition, "stable" medicinal products derived from human blood or human plasma will be included. In addition, it was agreed to introduce processes for the exchange of information and compliance for product-specific on-site evaluations (OSE) by Health Canada and pre-approval inspections by Swissmedic.
Source: Swissmedic
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