Share your views: Consultation on draft guidance on co-packaged drug products

From: Health Canada

Join in: how to participate

Send us an email

Send an email to bpsip-bpspiconsultation@hc-sc.gc.ca with your ideas or comments to make yourself heard.

Participate by mail

Send a letter with your ideas and input to the address in contact information below.

Who is the focus of this consultation

The Government of Canada would like to hear from all interested parties, including:

• manufacturers of co-packaged drug products and their components
• manufacturers, importers and distributors of all classes of medical devices included in a co-packaged drug product
• others involved in packaging, labelling, importing or selling co-packaged drug products
• health care professionals and associations

Key points about the draft guidance

This draft guidance explains the regulatory requirements for co-packaged drug products and their components. It:

• defines types of co-packaged products
• clarifies when a drug identification number (DIN) must be assigned before it can be marketed in Canada
• clarifies the requirements for authorizing, packaging, labelling and distributing a product
• clarifies the submission requirements for post-market changes and other authorizations that may be required

We will develop and implement a final guidance and implement it based on public feedback.

Learn more:

• Draft guidance on co-packaged drug products
• Health Canada drafts guidance on co-packaged drug products: Notice

Contact us

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