Forward Regulatory Plan 2022-2024: Regulations Amending the Food and Drug Regulations - Export and Transhipments of Drugs

Title of Regulatory Initiative

Regulations Amending the Food and Drug Regulations - Export and Transhipments of Drugs

Enabling Act

Food and Drugs Act


Health Canada is proposing amendments to the Food and Drug Regulations to extend drug establishment licensing and good manufacturing practices requirements to persons conducting licensable activities with drugs solely for export that are otherwise exempt from the application of the Food and Drugs Act and Food and Drug Regulations under section 37 of the FDA.

The amendments would clarify that drugs in transhipment through Canada must be in bond.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap as 'Establishment licensing scheme for drugs and medical devices'.

This regulatory initiative is associated with Health Canada's stock review plan.

Regulatory cooperation efforts (domestic and international)

The amendments contribute to meeting Canada commitments made during negotiations of the Canada-European Union Comprehensive Economic Trade Agreement.

Potential impacts on Canadians, including businesses

It is anticipated that the amendments would support maintaining Canada's international reputation as a country that manufactures and exports good quality drugs.


Drug establishment licence holders were consulted on the exports and transhipments proposal as part of a larger consultation initiative undertaken for proposed amendments related to drug establishment licence modernization between April and June 2019. A targeted stakeholder outreach was also conducted in August 2020.

The proposed regulations were pre-published in the Canada Gazette, Part I, on June 12, 2021, for 75-day comment period. No major concerns were raised by stakeholders.

Final publication of the Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs) in the Canada Gazette, Part II, is expected to take place in spring 2022.

Further information

Related information on the import and export of health products can be found on Health Canada’s website.

Additional information can be requested from the departmental contact.

Departmental contact information

Catherine Hudon
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada

Telephone: 343-540-8524

Date the regulatory initiative was first included in the Forward Regulatory

January 2021

Consult Health Canada's acts and regulations web page for:

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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