Regulatory Overview: Non-prescription drugs in Canada: Submission information and requirements

Submission information and requirements

You must file a submission or application to Health Canada to request a Drug Identification Number (DIN) for your non-prescription drug (NPD) before selling your product in Canada. The Natural and Non-prescription Health Products Directorate of Health Canada is responsible for authorizing NPDs for sale in Canada. Your NPD may be authorized as either a Division 1 or a Division 8 drug. Division 1 drugs are authorized pursuant to the requirements of Part C, Division 1 of the Food and Drug Regulations (FDR) and Division 8 drugs are authorized pursuant to the requirements of Division 8 of the FDR. The division will determine what submission or application types are available to use to seek a DIN. For more information on how to prepare a submission or application, consult the following resources. You may also contact the Natural and Non-prescription Health Product Directorate for further clarification if needed: nnhpd-dpsnso@hc-sc.gc.ca

Note: The resources on this page are a collection of many guidance documents and links. Not all links may be relevant for your product nor need to be consulted.

New Applications:

This section provides resources for sponsors on how to obtain a DIN for a drug before selling it in Canada.

Post-authorization changes:

After obtaining market authorization for a drug, a sponsor may wish to make a change to the drug or information related to the drug. This section provides resources on how to notify Health Canada about a change and filing information related to it.

Application or submission management:

This section provides resources on how to manage your drug application or submission. You also can find information on what to expect regarding performance standards and your obligations to Health Canada once you have obtained a DIN.

Small business mitigation for drugs and medical devices

Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs)

Evidence requirements

When you submit an application or submission for market authorization of an NPD, you will be required to provide information to demonstrate that your product meets the requirements as set out in the Food and Drugs Act and Food and Drug Regulations. Depending on your drug product, this may include information such as:

Quality data
Safety and efficacy data
Your proposed labelling

Health Canada, as an official member to the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use, is committed to the implementation of ICH guidelines and standards related to safety, efficacy, and quality. These guidelines and standards outline the information and evidence that may be provided to support your NPD application / submission. For more information consult the following resources below.

Note: The resources on this page are a collection of many guidance documents and links. Not all links may be relevant for your product nor need to be consulted.

Quality (Chemistry and Manufacturing):

Clinical data and non-clinical:

Packaging and labelling:

Generic drugs:

Drug establishment licences

Any person who fabricates, packages/labels, imports, distributes, wholesales or tests drugs must apply for and maintain a Drug Establishment Licence (DEL). A DEL allows establishments to conduct licensable activities in Canada and demonstrates their ability to meet good manufacturing practices (GMP). This requirement applies to drugs in a finished dosage form and active pharmaceutical ingredients. The Regulatory Operations and Enforcement Branch (ROEB) at Health Canada is responsible for overseeing compliance, monitoring, and enforcement activities including managing DELs and GMP compliance oversight.

To learn more about the DEL and how to obtain one, consult the following:

Good manufacturing practices

Good manufacturing practices (GMP) are a set of internationally recognized standards to ensure drug quality and safety before they are sold. To ensure compliance with GMP regulations, Health Canada inspects establishments that fabricate, package/label, import, distribute, wholesale or test NPDs.

To help you comply with these requirements, consult:

Advertising

Only health products authorized for sale in Canada may be advertised. Advertisements must comply with legislative and regulatory requirements, and the information therein must not be false, misleading, or deceptive.

For more information on advertising:

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2026-07-31