Drug Products - Pharmaceutics; Pharmaceutics (ICS 11.120)
Proposed Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs); (25 pages, available in French and English).
The proposed amendments to the Food and Drug Regulations would apply regulatory requirements to drugs manufactured in Canada solely for export that are otherwise exempt from the application of the Food and Drugs Act and the Food and Drug Regulations under section 37 of the Food and Drugs Act. Manufacturers, packagers/labellers, testers, distributors and wholesalers of drugs solely for export would be required to hold a drug establishment licence and comply with good manufacturing practices. The proposed amendments would also clarify that drugs transhipped through Canada must be in bond.