Notice of intent to publish a Ministerial Order to exempt certain low-risk non-prescription drugs from Division 8 provisions in the Food and Drugs Regulations

On this page

• Introduction
• Background
• Proposed approach
• Next steps

Introduction

Health Canada regulates non-prescription drugs (NPDs) under the Food and Drug Regulations (FDR), which establish requirements related to product authorization, establishment licensing, labelling, and Good Manufacturing Practices to help ensure safety, efficacy, and quality. Under the FDR, both prescription drugs and NPDs are subject to the same rules. Currently, drugs containing medicinal ingredients that have not been previously authorized in Canada are regulated as “new drugs” under Division 8 of the FDR and must be authorized through an onerous process that applies equally to lower-risk cosmetic-like NPDs (e.g., sunscreens, anti-dandruff and oral care products) and prescription drugs. This results in a disproportionately high regulatory burden and cost (i.e., significant data requirements, up to 300 days for drug review and over $600K for drug authorization) for these lower-risk products, which are available to Canadians for self-selection at various retail outlets and used to treat and prevent common skin conditions such as dandruff, diaper rash, and sunburn.

Health Canada recognizes the challenges that companies face when introducing new lower-risk health products to the Canadian market. Engagement with international partners, including the European Union (EU) through the Canada-EU Regulatory Cooperation Forum, and with domestic industry has highlighted significant barriers for certain lower-risk NPDs that are new to Canada but have been demonstrated to be safe and effective in other jurisdictions. These barriers may limit the availability and range of options for Canadians to treat common conditions. Simplifying and expediting market access for these products, where appropriate, may support the health and safety of people in Canada by increasing product availability and choice.

In addition, Canadian consumers rely heavily on products manufactured and imported from the United States (U.S.) with estimates of over 70% of imports in these product categories from the U.S.^{Footnote 1}. The proposed Order would support a more resilient and diversified supply by supporting Canadians with timely access to new lower-risk NPDs from different markets. This could help mitigate supply pressure and support opportunities for Canadian-based manufacturers in domestic and export markets.

Background

In Canada, lower-risk NPDs are commonly used as part of routine self-care to treat or prevent worsening of minor conditions and to support overall health without the need for intervention by a healthcare practitioner. Some examples of lower-risk NPDs are sunscreens, oral care products, acne treatments and other product categories found on List D: List of Certain Non-prescription Drugs for Distribution as Samples. Access to a selection of these health products is important for meeting the diverse needs of people in Canada and supporting positive health outcomes.

For example:

• A Canadian study examining sun-protective behaviours found  inadequate or inconsistent sunscreen use^{Footnote 2}. Expanded access to new sunscreens can enhance protection against skin cancers and photoaging.
• Recent data from the Canadian Health Measures Survey indicates that the prevalence and severity of tooth decay had not changed since 2007-2009 data, and signs of gum inflammation remained common among Canadians aged 20-79 years^{Footnote 3}. According to the Canadian Dental Association, most oral health conditions are preventable and can be treated early, and oral health can be maintained by establishing a good oral hygiene routine.
• The Canadian Dermatology Association (CDA) reports that 20% of Canadians live with acne, and it is the most common skincare problem seen by doctors^{Footnote 4}. The CDA recommends that people try over-the-counter treatments before seeing their doctor.

To expedite pre-market review of NPDs, Health Canada has developed monographs for drugs that have a well characterized safety and efficacy profile under specific conditions of use. Monograph parameters include the permitted medicinal ingredients, concentrations, indications, directions, and conditions of use (such as warnings). If a drug meets all parameters outlined in the monograph, it may be eligible for an expedited authorization under Division 1 of the FDR without the need for additional evidence. While the majority of lower-risk cosmetic-like NPD submissions meet the parameters of the existing Health Canada monographs and have been authorized under Division 1, this pathway to market is not available to products containing medicinal ingredients not previously authorized in Canada even if they have been deemed safe and effective in other jurisdictions.  

Proposed approach

Health Canada is proposing to publish a Ministerial Class Exemption Order (Order) that would exempt low-risk NPDs included on List D (List of Certain Non-prescription Drugs for Distribution as Samples) from the application of Division 8 prohibitions and requirements of Part C of the Food and Drugs Regulations (FDR) that apply to new drugs, provided the drug complies with one of Health Canada’s published monographs. The effect of such exemption would be to enable the sponsors for these drugs to make an application for market authorization under Division 1 for a Drug Identification Number (DIN) without a Notice of Compliance. These products would then be subject to requirements under Division 1 of the FDR.

The NPDs in List D are low-risk health products in Canada and include acne therapy products, anti-dandruff products, antiperspirants, antiseptic skin cleansers, athlete’s foot treatment, diaper rash products, medicated skin care products, oral health products (toothpastes, mouthwashes), throat lozenges, and sunscreens.

Health Canada intends to update monographs over time and add new drug ingredients to support low-risk NPDs being authorized in an expedited manner under Division 1 of the FDR.

The Order would:

• Support and improve public health objectives by improving Canadians’ access to NPDs that are important for treating and preventing common health conditions and support more consistent use of these products;
• Support quicker Canadian market access, increased consumer choice, and market competition for new low-risk NPDs to enable Canadians to more readily obtain products intended to treat and prevent common health conditions;
• Reduce barriers and cost for industry of bringing certain NPDs to the Canadian market; and
• Continue to ensure the safety and efficacy of NPDs and support proportionate regulatory oversight.

The Order would also contribute to Health Canada’s Red Tape Reduction (RTR) initiative by reducing trade barriers (Theme 1) and enhancing flexibility (Theme 4). The Order would address challenges faced by regulated parties and complement the ongoing RTR activities related to the modernization of oversight for NPDs.

Length of exemption

The exemption would apply until the Simplifying Part C of the Food and Drug Regulations come into force, after which the Order would be repealed.

Next steps

Health Canada will hold targeted consultation sessions with stakeholders following publication of the notice.

Through the publication of this Notice of Intent, Health Canada invites interested stakeholders to provide comments on the proposed approach. Below are some guiding questions.

Questions

1. Would being exempt from requirements under Division 8 of the FDR encourage you to seek market authorization and/or manufacture your “List D” low-risk non-prescription drug in Canada?
2. Does your company have any new medicinal ingredients used in “List D” products in foreign jurisdictions with supporting evidence of safety, effectiveness, and quality to update a Health Canada monograph? If so, what are the medicinal ingredients?

Health Canada welcomes your feedback including supporting evidence to add ingredients to Health Canada monographs via e-mail by July 14, 2026 at: nnhpd.consultation-dpsnso@hc-sc.gc.ca.