Health Canada has released a draft guidance document on co-packaged drug products, now open for public consultation. The guidance explains how these products and their individual components are regulated under the Food and Drugs Act and its regulations.
If your business is involved in developing, packaging, distributing, importing or wholesaling co-packaged drug products, this is your opportunity to review and respond to proposed compliance requirements. The draft outlines key factors Health Canada considers when evaluating co-packaged drugs and is designed to provide greater clarity on classification, labelling, and authorization.
What are co-packaged drug products?
Co-packaged drug products are made up of 2 or more components sold together in a single package, at least 1 of which is a prescription or non-prescription pharmaceutical or biologic drug subject to the Food and Drug Regulations (FDR). These products are available in many formats, including those made up of a drug component together with:
- Other health products (other drugs, medical devices or natural health products);
- Cosmetics or other consumer products.
What the draft guidance covers
The draft guidance highlights five key areas to help businesses understand their regulatory obligations. First, it defines the types of co-packaged products, especially those that include at least one pharmaceutical or biologic drug. Second, it clarifies when a drug identification number (DIN) is required before a co-packaged product can be sold.
The guidance also explains packaging, labelling, importation, and distribution requirements, and outlines when additional authorizations may be needed. Finally, it provides guidance for third-party packagers and labellers, such as those preparing convenience packs. Together, these points offer a clearer path to compliance.
Why this update is important
The new draft guidance from Health Canada focuses on five main areas to clarify regulatory expectations:
It defines different types of co-packaged drug products, especially those that include at least one pharmaceutical or biologic drug.
It explains when a drug identification number (DIN) must be assigned before the product can be marketed.
It outlines packaging, labelling, importation, and distribution requirements.
It highlights situations where other authorizations may be needed.
It provides guidance for third-party packagers and labellers, including those involved in convenience packs.
Together, these points give companies a clearer understanding of what’s needed to stay compliant when bringing co-packaged drug products to the Canadian market.
Get involved before May 18, 2025
Health Canada is inviting feedback from all stakeholders until May 18, 2025. If your company works with co-packaged drugs, this is your chance to help shape the final version of the rules.
You can visit the official consultation page to read the full draft and share your comments.
Need help figuring out what this means for you?
Our regulatory experts at Quality Smart Solutions are here to help. If you’re unsure whether your product fits this category or how to prepare for the new rules, we can walk you through the next steps.
We can help you assess your product, interpret the draft guidance, and get ready for a smooth submission. Contact us or fill out our form below for a free consultation with one of our experts.
