Forward Regulatory Plan 2023-2025: Updates to Fees in Respect of Drugs and Medical Devices

Title of Regulatory Initiative

Updates to Fees in Respect of Drugs and Medical Devices

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing amendments to the Fees in Respect of Drugs and Medical Devices Order. Proposed amendments would reflect Health Canada's review of its cost recovery regime for human drugs and medical devices, and would better reflect current costs of program delivery.

Regulatory cooperation efforts (domestic and international)

This initiative is not part of a formal regulatory cooperation work plan.

Potential impacts on people in Canada, including businesses

There may be business impacts, as the revised fees would apply to businesses involved in the sale of certain health products in Canada.

Consultations

Health Canada plans to publish the amended Order in the Canada Gazette, Part ll, which is expected to take place in fall 2024.

Consultations, including publication of a fee proposal, are targeted for 2024 and will be done prior to publishing in the Canada Gazette, Part II.

Further information

Additional information on this proposal may be requested from the departmental contact.

Departmental contact information

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Telephone: 613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date the regulatory initiative was first included in the Forward Regulatory

April 2023.

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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