Interim policy on the packaging, labelling and sale of naloxone kits

December 9, 2024

On this page

Background

Naloxone kits play a critical role in the response to opioid overdoses. It is important that there be an uninterrupted supply of these products in Canada.

In Canada, naloxone kits are regulated under the Food and Drugs Act and its regulations (the Food and Drug Regulations and the Medical Devices Regulations). This means that the packaging, labelling and sale of naloxone kits must meet certain requirements to help ensure the quality, safety and efficacy of these kits.

Health Canada is aware that:

Helping to ensure the supply of naloxone kits

Naloxone is a critical life saving tool for healthcare providers, community organizations and individuals across the country. It is essential that we maintain the continued supply of naloxone kits while also ensuring that appropriate health and safety requirements are met.   Health Canada will exercise discretion with enforcing certain packaging, labelling and sale requirements under the Food and Drug Regulations and the Medical Devices Regulations for naloxone kits, so long as certain conditions are met.

Health Canada will revisit this interim policy in the fall of 2025, or earlier as needed. Health Canada is also developing new draft guidance on co-packaged drug products to replace the existing kits policy. We intend to launch a public consultation on the draft guidance by early 2025. Health Canada will continue to engage and communicate regularly with all interested parties involved in the packaging, labelling and sale of naloxone kits.

Conditions for the packaging, labelling and sale of naloxone kits

You must meet the following conditions if you package, label or sell naloxone kits.

If you sell, package or label naloxone kits in Canada, you must:

In addition, if you only package or label naloxone kits in Canada, you must also:

All naloxone kits available in Canada must:

If you are currently packaging and labelling naloxone kits, you must provide a written attestation to Health Canada confirming that the above-mentioned conditions are fulfilled by January 30, 2025. If you commence activities after this date, please provide your letter of attestation no later than 30 calendar days after the date on which you commence activities. Please send your signed letter of attestation to del.questions-leppp@hc-sc.gc.ca with the subject line "Naloxone Kit Attestation."

If you are concerned that these conditions may impact the availability of supply in Canada, let us know as soon as possible. Email us at del.questions-leppp@hc-sc.gc.ca with the subject line "Naloxone Kit Concerns."

Related links

Page details

Date modified: