Draft guidance on co-packaged drug products: Closed consultation

From: Health Canada

Current status: Closed

This consultation ran from March 18 to May 18, 2025.

Health Canada has drafted a guidance document on co-packaged drug products. This document explains the regulatory requirements for co-packaged drug products and their components.

Who was the focus of this consultation

Health Canada engaged with 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Key points about the draft guidance

This draft guidance explains the regulatory requirements for co-packaged drug products and their components.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• Draft guidance on co-packaged drug products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