Changes to policy on drug good manufacturing practices and DEL enforcement (POL-0004)

Drug Establishment Licensing Bulletin 132, April 1, 2022

Health Canada has made changes to the policy on drug good manufacturing practices (GMP) and drug establishment licence (DEL) enforcement (POL-0004). This policy supports the consistent and transparent application of compliance and enforcement actions under Canada’s GMP and DEL regulatory schemes.

The changes:

• incorporate plain language principles to make the document easier to read and understand
• describe specific enforcement measures Health Canada will take to ensure regulated parties are complying with the Food and Drugs Act and Part C, Division 1A (DEL) and Divisions 2 to 4 (GMP) of the Food and Drug Regulations (the Regulations)

The policy changes apply to persons and activities subject to drug GMP and DEL requirements under Part C, Divisions 1A and 2 to 4 of the Regulations. They also apply to importers of drugs under exceptional circumstances under Division 10.

The updated version of POL-0004 will come into effect on April 1, 2022.

If you have questions before your next drug GMP inspection, please send your inquiry to drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca.