Health Canada has released a draft guidance document on co-packaged drug products, now open for public consultation.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, or distributing 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 two or more drugs sold in one package but in separate dosage forms. For example, a tablet and a cream that are meant to be used together. These are common in treatments that require multiple forms of delivery.
This draft guidance helps companies figure out whether Health Canada will consider a co-packaged item a single drug product or separate products. That matters when it comes to getting approval, labelling correctly, and meeting the right rules.
Why this update is important
The draft guidance outlines what Health Canada looks at when reviewing co-packaged products:
- What the product is used for and how it’s meant to work
- Whether combining items changes how they work or how safe they are
- What’s written on the label and how the product is marketed
- Whether the directions make sense for a product sold together
Knowing these points helps you prepare stronger applications and avoid delays in getting your product to market.
Get involved before April 23, 2025
Health Canada is inviting feedback from all stakeholders until April 23, 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We can help you assess your product, interpret the draft guidance, and get ready for a smooth submission.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.
