Health Canada drafts guidance on co-packaged drug products: Notice
On this page
Background
Health Canada is consulting with stakeholders on a new draft guidance on co-packaged drug products, to reflect the range of products that are entering the Canadian market each year.
Co-packaged drug products are made up of 2 or more components sold together in a single package. At least 1 of the components is a drug subject to the Food and Drug Regulations (prescription or non-prescription pharmaceuticals and biologic drugs).
Co-packaged drug products come in many formats, including those made up of a drug component together with other health products, such as medical devices or natural health products.
Health Canada is also working on a exemption order for naloxone kits. Under this proposed exemption order, naloxone kits would be subject to specific requirements in certain cases.
About the draft guidance
The draft guidance explains the current regulatory requirements for co-packaged drug products and their components. As well as defining types of co-packaged products, it clarifies:
- when a drug information number (DIN) must be assigned before it can be marketed in Canada
- the requirements for authorizing, packaging, labelling, importing and distributing a product
- the submission requirements for post-market changes and other authorizations that may be required
This draft guidance is being published for consultation. We will develop the final version of this guidance and implement it based on public feedback.
The final guidance on co-packaged drug products will help ensure that these products are regulated in a way that:
- is practical
- aligns with industry realities
- addresses consumer and public health needs
How you can get involved
We’re looking for your feedback on the draft guidance. You may also provide your comments on Health Canada’s current frameworks for co-packaged drug products.
We will review all written submissions after the consultation period ends on May 18, 2025. We will consider your feedback in developing the final version of the guidance.
Learn more:
- Draft guidance on co-packaged drug products
- Share your views: Consultation on draft guidance on co-packaged drug products
Contact us
Send your comments to:
Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
1600 Scott St
Address Locator: 3106B
Ottawa ON K1A 0K9
Email: bpsip-bpspiconsultation@hc-sc.gc.ca
Page details
- Date modified: