Forward Regulatory Plan 2022-2024: Amendment to the Fees in Respect of Drugs and Medical Devices Order (Natural Health Products Fee Proposal)
Title of Regulatory Initiative
Amendment to the Fees in Respect of Drugs and Medical Devices Order (Natural Health Products Fee Proposal)
Enabling Act
Description
Health Canada is proposing amendments to the Fees in Respect of Drugs and Medical Devices Order to expand the existing Fees Order to include the evaluation of applications of natural health products, the issuance of site licences, and the right to sell natural health products in Canada.
The proposed amendments would respond to the recommendations and findings from the Commissioner of the Environmental and Sustainable Development (CESD) in its audit report on Natural Health Products. Health Canada acknowledged cost recovery is needed to support program improvements in its response to the audit. The proposed amendments would also level the playing field for product lines of similar risk (e.g., non-prescription drugs).
Regulatory cooperation efforts (domestic and international)
This initiative is not part of a regulatory cooperation plan.
Potential impacts on Canadians, including businesses
It is anticipated that the implementation of fees for natural health products would ensure businesses pay a fair share for the private benefit of access to the Canadian market, while maintaining small business mitigation. Fees would support Canadians' access to natural health products that are safe and effective.
Consultations
An initial information session for stakeholders was held in winter 2022.
At this time, additional engagement is planned for fall 2022, once the fee proposal is published.
Further information
Related information can be found on:
CESD NHP audit report, including department response
Additional information can 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 2022
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