Swissmedic: Refined Interpretation of the MRA with Canada
Health Canada and Swissmedic agreed to expand the existing approach to include both the recognition of GMP extra-jurisdictional inspection outcomes (inspections outside Switzerland and Canada) as well as active pharmaceutical ingredient and stable medicinal products derived from human blood or human plasma in the operational scope.
Furthermore, they agreed on the information sharing and reliance processes related to Health Canada’s on-site evaluation and Swissmedic’s pre-approval inspection.
Source:
Swissmedic: General communications
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