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Canada specifies timelines for inspections in new guidance

This article was originally published in The Gold Sheet

Executive Summary

Health Canada has issued a final guidance outlining its policy on the scheduling of inspections. The guidance is called "GMP Inspection Policy for Canadian Drug Establishments" and requires that new establishments should be ready for an inspection when submitting their application for an establishment license (EL). The agency will perform an initial inspection within three months of receiving a request for an EL. The agency warns that if establishments are not prepared for an initial inspection when contacted by the inspectorate, their application will be withdrawn. The new policy went into effect for all inspections scheduled after Jan. 31. The guidance notes that fabricators, packagers, labelers and testing laboratories will be inspected every 24 months, while importers, distributors and wholesalers will be inspected every 36 months



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