How to apply for a non-prescription drug authorization in Canada: Overview
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Overview
Non-prescription drugs (NPDs) are pharmaceutical drugs that are available to consumers without a prescription from a healthcare professional. In Canada, they are generally available to consumers at retail stores or pharmacies by self-selection, while some other NPDs are behind the counter requiring the assistance of a pharmacist. On the other hand, prescription drugs require a prescription from a healthcare professional. The Prescription Drug List sets out a list of drugs and classes of drugs that require a prescription. Both prescription and non-prescription drugs are regulated under the Food and Drug Regulations.
According to the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDR), before NPD sponsors (applicants) import, sell or advertise an NPD, a market authorization must be obtained. NPDs 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 FDR and Division 8 drugs are authorized pursuant to the requirements of Division 8 of the FDR. For Division 1 drugs, a drug identification number (DIN) is required, and for Division 8 drugs, a Notice of Compliance (NOC) is required in addition to a DIN. To request market authorization for an NPD, an application that complies with the requirements outlined in the FDR must be filed with Health Canada. The Natural and Non-prescription Health Products Directorate (NNHPD) at Health Canada is the federal authority for regulating NPDs in Canada.
Purpose
The purpose of this guidance document is to help NPD sponsors determine which type of application/submission should be filed when seeking market authorization for an NPD and the information to support establishing the safety, quality and efficacy of drug products. It provides an overview of our existing processes including the intake method (Regulatory Enrolment Process) and applicable resources. This guidance document will cover the most common submission types for an initial NPD authorization and certain post-authorization changes:
- Application for a Drug Identification Number (DINA)
- Application for a Drug Identification Number – Category IV product (DINF)
- New Drug Submission (NDS)
- Abbreviated New Drug Submission (ANDS)
Scope
This guidance document applies to most NPDs that have not yet received market authorization. For information on how to determine if your product is a NPD, and on the related NPD requirements, consult the Regulatory Overview: Non-prescription drugs in Canada webpage.
The following products are out of scope of this guidance:
- Ethical drugs, as listed in the Drug Product Database, which may be available without a prescription, such as:
- Nitroglycerin
- Epinephrine
- Some professional use drugs (for example, nitrous oxide and hemodialysis solutions)
This guidance should be read in conjunction with other relevant guidance documents:
- Guidelines on the Preparation of DIN Submissions
- Regulatory Requirements for Drug Identification Numbers (DINs)
- Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality Document
- Guidance document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs