On March 18, 2025, Health Canada released a Notice that it is seeking feedback on a draft guidance on co-packaged drug products. As used in the draft guidance, “co-packaged drug products” are products having two or more components sold together in a single package, at least one of which is a prescription or non-prescription pharmaceutical or biologic drug subject to the Food and Drug Regulations. The draft guidance outlines current regulatory requirements for co-packaged drug products and their components, based on whether they are drug kits or convenience packs.
Health Canada last addressed co-packaged drug products in a 1997 policy on assigning drug identification numbers for drug products in kits. Since then, the number and diversity of co-packaged drug products has increased. Co-packaged drug products pose unique challenges, particularly regarding DIN assignment and for packaging and labelling. Regulatory inconsistencies could introduce risks to the health and safety of Canadians. The draft guidance intends to provide clearer definitions and more detailed descriptions of regulatory requirements to ensure all co-packaged drug products meet applicable safety, efficacy and quality standards. Once finalized and implemented, the guidance will replace the 1997 policy.
The draft guidance is targeted at:
- holders of authorizations for co-packaged drug products or drug components;
- third parties involved in packaging, labelling, or selling co-packaged drug products;
- importers of drugs intended for Canada that may apply for a DIN; and
- manufacturers, importers and distributors of all classes of medical devices included in a co-packaged drug product.
The guidance clarifies:
- when a DIN must be assigned to a co-packaged drug product before it may be marketed;
- packaging, labelling, importation and distribution requirements;
- additional authorizations needed before marketing;
- requirements for third-party packagers and labellers; and
- submission requirements for post-market changes and other authorizations.
The deadline for providing submissions on the draft guidance is May 18, 2025. Feedback can be emailed to bpsip-bpspiconsultation@hc-sc.gc.ca.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.