Guide to the Supplementary Rules Respecting Nicotine Replacement Therapies Order: Implementation

On this page

• Overview
• New requirements for new and pending NRT applications
• Sell through period for licensed NRTs
• Transition period for marketed NRTs
• Compliance and enforcement measures
• Surveillance
• Updating the List of Nicotine Replacement Therapy Dosage Forms that may be Accessible for Self-selection by Purchasers or Consumers

Overview

The Order came into force on the day on which it was published (August 28, 2024). Health Canada has provided a transition period of six months (February 28, 2025) for your NRT to comply with certain requirements, as well as a 'sell-through' transitional rule in certain circumstances.

The impact of this Order on a given product depends on the status of the product licence and whether the product is in a dosage form on the List.

New requirements for new and pending NRT applications

If you wish to submit a product licence application for an NRT or have an NRT product licence application in queue with us, you must submit mock-ups of your packages and labels before a licence may be issued. You must also ensure that your NRT is compliant with all other requirements in the Order that come into force immediately, including new requirements relating to the brand name and flavour(s).

Refer to the Mock-ups subsection under the Prohibitions and Application Requirements section for more information.

Sell through period for licensed NRTs

To remove unintended barriers to the supply of licensed NRTs for adults who are accessing them to quit smoking, amendments to the transitional provisions related to certain packaging and labelling requirements were published on February 12, 2025.

These amendments extend the date of the permitted sale provisions in subsections 30(2) and 30(3) of the Order until November 28, 2025.

They do not change the permitted sale provision in subsection 30(1), which allows a person to sell an NRT that is not in accordance with section 10 if it was labelled before August 28, 2024, or in the case that it was imported, it was imported and labelled before that day.

Refer to the Regulatory Impact Analysis Statement for more information.

NRT dosage forms on the List

If the dosage form of your NRT is on the List and it was labelled in accordance with the Regulations, or if it was labelled and imported into Canada before August 28, 2024, it can continue to be sold until its expiry, even if it does not comply with the packaging and labelling requirements under section 10.

If the dosage form of your NRT is on the List and it was labelled in accordance with the Regulations on or before November 28, 2025, it can continue to be sold until its expiry even if it does not comply with the packaging and labelling requirements under sections 14 to 16 and 20 to 23 of the Order.

For clarity, if your NRT was labelled before August 28, 2024, but was imported into Canada after this date, it can now be sold until its expiry without labels and packages that are compliant with sections 14 to `16 and 20 to 23, as long as the NRT was otherwise labelled in accordance with the Regulations.

NRT dosage forms not on the List

If the dosage form of your NRT is not on the List, it was labelled in accordance with the Regulations, or if labelled and imported into Canada before August 28, 2024, and is flavoured with mint, menthol, or a combination of mint and menthol, it can continue to be sold until its expiry by a pharmacist or individual working under the supervision of a pharmacist, even if it does not comply with the packaging and labelling requirements under section 10.

If the dosage form of your NRT is not on the List, it was labelled in accordance with the Regulations on or before November 28, 2025, and is flavoured with mint, menthol, or a combination of mint and menthol, then it can continue to be sold by a pharmacist or individual working under the supervision of a pharmacist until its expiry, even if it does not comply with the packaging and labelling requirements under sections 14 to 16 and 20 to 23 of the Order.

For clarity, if your NRT that is in a dosage form not on the List is flavoured with mint, menthol, or a combination of mint and menthol and was labelled before August 28, 2024, but was imported into Canada after this date, it can now be sold until its expiry by a pharmacist or individual working under their supervision without labels and packages that are compliant with sections 14 to 16 and 20 to 23 of the Order, as long as the NRT was otherwise labelled in accordance with the Regulations.

Transition period for marketed NRTs

There is a transition period to February 28, 2025 for marketed NRTs to comply with the requirements under sections 10 and 18 to 28 of the Order. Your NRT must be in compliance with all requirements in the Order thereafter, unless the sell-through provisions outlined above apply.

Compliance and enforcement measures

Health Canada will conduct compliance and enforcement activities through a risk-based approach, in alignment with existing departmental policies such as the Compliance and enforcement policy for health products (POL-0001) in order to protect the health and safety of individuals in Canada.

Surveillance

As per section 24 of the Regulations, all market authorization holders are required to report to Health Canada any serious adverse reactions associated with their product, within 15 days after the day on which they become aware of the reaction. In addition, all market authorization holders are required to annually prepare and maintain a summary report that contains a concise and critical analysis of all adverse reactions associated with their product. Furthermore, the Minister may request licence holders to submit to Health Canada the Annual summary reports as per subsection 24 (3) of the Regulations.

A risk-based approach will be taken for surveillance of NRTs. For each authorized NRT product with a dosage form that is not on the List, it is expected that the licence holder will submit to Health Canada an Annual Summary Report after the first 12 months of marketing as per subsection 24 (2) of the Regulations. After review, Health Canada will determine if there is a need to submit reports on an annual basis. For authorized NRT products with a dosage form that is on the List, it is expected that the licence holder will only submit an Annual Summary Report to Health Canada upon request of the Minister.

Further guidance on preparing an Annual Summary Report is available in the Health Canada document, Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products - Guidance Document for Industry.

Updating the List of Nicotine Replacement Therapy Dosage Forms that may be Accessible for Self-selection by Purchasers or Consumers

The Guidance on Additions to the List of Nicotine Replacement Therapy Dosage Forms describes the type of evidence and information that may be considered when adding an NRT dosage form to the List.

Health Canada may also remove a dosage form from the List, which could be prompted by new safety information, or by other new or emerging public health information.

The process of amending the List will follow Health Canada's Incorporation by Reference Policy.