What we heard: Draft guidance on co-packaged drug products

On this page

• Introduction
• Stakeholder engagement
• Key themes
• Summary of feedback
• Next steps
• Contact us

Introduction

Health Canada published the Draft guidance on co-packaged drug products for public consultation on March 18, 2025 until May 18, 2025. This report provides an overview of the comments we received on the draft guidance.

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. Co-packaged components could include other drugs, medical devices, natural health products, and cosmetics. The draft guidance aims to provide clear definitions and detailed descriptions of regulatory requirements that apply to co-packaged drug products. Its goal is to help sponsors ensure they meet all applicable safety, efficacy and quality standards.

Co-packaged drug products and their components may be subject to separate regulations made under the Food and Drugs Act. These regulations govern the manufacture and sale of various types of health products that can be packaged and sold together, including:

• the Food and Drug Regulations (FDR) for drugs
• the Natural Health Products Regulations (NHPR) for natural health products
• the Medical Devices Regulations (MDR) for medical devices

When drugs are co-packaged with other components, each applicable regulation applies both to the individual components and to the co-packaged product as a whole. Through this consultation, Health Canada heard that applying several regulations to one co-packaged product may result in sponsors facing overlapping regulatory requirements in a few specific areas. This overlap may lead to duplication and increase the regulatory burden for sponsors.

Stakeholder engagement

Health Canada invited feedback from a wide range of stakeholders, including pharmaceutical manufacturers, industry associations, and other third-parties engaged in manufacturing or importing drugs in Canada. We received 15 responses:

• 9 from individual companies
• 6 from industry associations across various sectors

Key themes

Stakeholders expressed support for Health Canada’s efforts to update the guidance and provide additional clarity on regulatory considerations for co-packaged products. Several stakeholders found the policy direction to be aligned with previous pre-market authorization experiences and valued the modernized examples and definitions provided in the draft guidance.

There were no significant discrepancies among the responses to the consultation, and the feedback highlighted similar concerns in specific areas, such as:

• the need for further clarity and criteria in classifying drug kits and convenience packs
• potentially duplicative requirements arising from being subject to concurrent application of multiple regulations
• logistical challenges related to labelling requirements on inner and outer component labels, outer kit labels, product monographs, and product inserts when several products are enclosed in a single package
• the need to harmonize terminology and improve integration between relevant policies and guidance documents

Summary of feedback

1. Clarity in co-packaged products classification

Stakeholders requested that the final guidance outline clearer criteria for distinguishing between drug kits, convenience packs, and drug-device combination products (DDCPs). They reported that some co-packaged drugs and devices have historically been classified as DDCPs, despite their definition as being “integrated in a singular product”. This could create confusion about how definitions of product classes are being applied. For example, it was noted that drugs co-packaged with a medical device delivery system (such as a syringe) are sometimes classified as DDCPs and, in other cases, as drug kits with a convenience component as outlined in this draft guidance. Stakeholders have requested additional clarity in final guidance and expressed concern that ambiguity in classification could lead to product development challenges.

In summary:

• Stakeholders requested clearer distinctions between drug kits, convenience packs, and DDCPs, along with more examples. They also asked for guidance on how these classifications affect regulatory requirements, including product authorization.
• Stakeholders recommended updating Health Canada’s DDCP policy at the same time as finalizing the co-packaged drug products guidance. They emphasized the need for clearer classification criteria to distinguish co-packaged drug-delivery kits from DDCPs. They also asked for clarification on whether the term 'integrated' applies to certain co-packaged products assembled at the point of use.

2. Reducing duplication from multiple regulatory frameworks

Stakeholders expressed that overlapping requirements from multiple regulations can lead to duplication and increased regulatory burden. They also noted that obtaining separate drug and medical device establishment or site licences for each component adds to this burden. Many sponsors report facing similar challenges related to overlapping frameworks for product authorization, labelling and post-market reporting for co-packaged drug products. They noted that these challenges could lead to increased costs and delays in product launches. Stakeholders suggested that harmonization would enable more predictable pathways for multi-component products and could streamline regulatory processes within Health Canada.

Examples of potentially duplicative requirements:

• Stakeholders urged Health Canada to allow consolidated reporting for adverse events involving co-packaged products. They noted that current requirements vary depending on the type of component, often requiring separate reports. Stakeholders encouraged Health Canada to reduce duplication and administrative burden by improving internal processes. They suggested allowing a single report to be filed that includes information on several co-packaged components, regardless of the types of components.
• Stakeholders suggested that Health Canada review and potentially adjust perceived duplicative establishment licensing requirements based on the risk profile of the co-packaged components. For example, some noted that licensing requirements for the co-packaging of a drug with low-risk device or natural health product convenience components (such as antiseptic swabs or bandages) often entail several establishment licenses with similar controls. They suggested that these risks may potentially be managed under a single establishment license.

3. Practical and risk-based labelling requirements

Several stakeholders advocated for labelling rules that are practical to implement, particularly for co-packaged drug products containing drug or other components that have already been authorized individually. Many stakeholders expressed that the regulatory requirements for labelling of co-packaged drug products, which have only now been clearly outlined in the draft guidance, could increase costs for manufacturers, and introduce potential confusion for end users. Several stakeholders suggested that labelling rules for co-packaged drug products should consider practicality of implementation to help ensure clarity, safety, and supply chain resilience.

Examples of logistical challenges with labelling:

• Stakeholders strongly expressed that the regulatory requirement to display the DIN assigned to the drug kit on the inner labels of components could disrupt packaging workflows and increase costs. Strong feedback was received against mandatory inclusion of kit DINs on inner labels and on individually authorized drugs and diluents. Suggestions included limiting the “kit DIN” to outer drug kit packaging and retaining previously authorized inner labels, when possible.
• Stakeholders expressed concern about the mandatory inclusion of the “kit DIN” on inner labels of individually authorized components that would be considered a natural health product when sold separately. In these cases, stakeholders have suggested allowing the issued natural product number (NPN) on the inner labels when applicable.
• Some stakeholders noted that the recommendation to indicate the regulatory authorization status of medical devices on the kit outer label is not one they have encountered before. They also noted that this information would occupy limited space available on a drug kit label, and questioned whether this information improves clarity or product safety.
• Another stakeholder highlighted challenges in ensuring that outer labels of components in a convenience pack are visible under normal conditions of sale, when they are enclosed in an outer carton or case. They recommended limiting labelling requirements on the outer surface of the convenience pack to indicate the authorization status of drug and natural health product components. This approach would align with the recommendation for medical devices.

4. Harmonization and integration with other existing policies and guidance

Several stakeholders recommended that Health Canada consolidate or cross-reference relevant documents to improve overall clarity. They noted that navigating multiple documents could be confusing and suggested moving information to related guidance to make it easier to locate and interpret connected information.

Proposed examples of integration with other policies and guidance:

• Stakeholders suggested integrating some sections of the co-packaged guidance with the Labelling of Pharmaceuticals for Human Use guidance and the Post-DIN Changes guidance.
• Others stakeholders highlighted the need to align terminology and expectations with the DDCP policy and the guidance on adverse event reporting for medical devices and natural health products.

Next steps

Health Canada thanks everyone who participated in the online consultation.  We will carefully consider all feedback and comments in the future development of this guidance document. The draft guidance will remain on our website as a reference document outlining current regulatory expectations for co-packaged drug products.

Contact us

For questions about the contents of this report or next steps, contact:

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
1600 Scott St, Holland Cross - Tower B
Address Locator: 3106B
Ottawa ON K1A 0K9
Email: policy_bureau_enquiries@hc-sc.gc.ca