Interim policy on the packaging, labelling and sale of naloxone kits
December 9, 2024
On this page
- Background
- Helping to ensure the supply of naloxone kits
- Conditions for the packaging, labelling and sale of naloxone kits
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:
- some establishments in Canada that package, label and sell naloxone kits do not hold the required establishment licences under the Food and Drug Regulations and the Medical Devices Regulations
- some naloxone kits being sold in Canada contain drugs and medical devices that lack product authorizations and labelling required under the Food and Drug Regulations and Medical Devices Regulations
- Naloxone kits typically contain naloxone hydrochloride (prefilled syringe, vial, ampoule or nasal spray device), alcohol swabs, gloves, syringes and instructions for use.
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 Health Canada is also developing new draft guidance on co-packaged drug products to replace the existing kits policy. We intend to launch a public consultation on the draft guidance by early 2025.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:
- report all complaints and problems you become aware of that concern the performance or safety of the product to the original manufacturer or company you purchased the drug or device from
- store and transport packaged and labelled kits in a manner that meets the storage and transport conditions authorized by Health Canada for the naloxone product (vial, ampoule, prefilled syringe or nasal spray) included in the kit
In addition, if you only package or label naloxone kits in Canada, you must also:
- maintain distribution records to enable tracking and tracing of both kit components and assembled kits, such as:
- receipts
- lot numbers
- expiry dates
- dates of distribution
- quantities distributed to each recipient
- store and transport drug and medical device products for use in kits in a manner that meets the storage and transport conditions for these products authorized by Health Canada
All naloxone kits available in Canada must:
- include, in the kit, the instructions for use that align with the original instructions approved by Health Canada for naloxone and medical device products placed in the kit.
- The instructions for use should be in both official languages.
- only include ampoules, vials, prefilled syringes or nasal sprays from naloxone products that are authorized by Health Canada
- These naloxone products must have an "emergency use" indication and be identified as "ethical" (not prescription) on the Drug Product Database.
- only include Class I medical devices sourced from a medical device establishment licence (MDEL) holder and/or Class II medical devices with an active medical device licence
- have the inner labelling of each drug component (ampoule, vial, prefilled syringe or nasal spray) in the kit unaltered and visible
- have the name, address and contact information for the company that packages and labels the kit displayed in a legible and prominent manner in or on the kit
- have the kit's expiration date, lot number and storage conditions clearly visible on the outer kit packaging. This information should be in both official languages.
- The expiration date and storage information for the kit should align with those for the naloxone product, including the storage conditions outlined in the applicable Canadian product monograph.
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."
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