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WTO notification · TBT

CanadaProposed measure, not in force yet

Pharmaceutical products – Canada

Official title

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, (Available in English and French)

Canada notified this proposed TBT measure to the WTO on 20 May 2026. The comment period closed on 14 July 2026.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

Published here:

At a glance

Products

Drugs

Notifying member
Canada
Status
Proposed measure, not in force yet
Objectives
  • Other
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/CAN/777
ICS classification
  • 11.120 Pharmaceutics
Keywords
Human health

Key dates

Distributed by the WTO
Comment deadline
Closed on 14 July 2026
Proposed adoption
To be determined
Proposed entry into force
These proposed Regulations would come into force on the day of their publication in the Canada Gazette, Part II.

How to comment

The comment period closed on 14 July 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/CAN/777; it can take them up with Canada.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

Health Canada is intending to make a Ministerial Class Exemption Order (Order) that would exempt low-risk non-prescription drugs (NPDs) that meet the applicable requirements of a Category IV monograph from Part C, Division 8 requirements of the Food and Drug Regulations (FDR). These products would be subject to Division 1 requirements of the FDR. Currently, drugs containing medicinal ingredients that have not been previously authorized in Canada are regulated as 'new drugs' under Division 8 of the FDR. This means that low-risk NPDs that contain a new medicinal ingredient are authorized through the same authorization process as prescription drugs that contain new medicinal ingredients. This results in a disproportionately high regulatory burden and cost for these lower-risk products.

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

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