Forward Regulatory Plan 2023-2025: 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

Food and Drugs Act


Health Canada is proposing amendments to the Fees in Respect of Drugs and Medical Devices Order (Fees Order) to expand the existing Fees Order to include the evaluation of applications of natural health products, the review of site licences, and the right to sell natural health products in Canada.

Cost recovery would help offset the cost of some natural health product (NHP) program services to industry that are currently fully funded by Canadian taxpayers. The proposed amendments would also support program improvements as per the Health Canada response to the recommendations and findings from the Commissioner of the Environment and Sustainable Development (CESD) in its audit report on NHPs. Health Canada acknowledged cost recovery is needed to support the existing program and planned improvements in its response to the audit. The revenue generated by the proposed fees would allow Health Canada to create an even safer marketplace for consumers, to support industry in complying with regulations through education and guidance, and to conduct inspections to ensure that NHPs are manufactured, imported, labelled and packaged in accordance with regulations.

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

The Government of Canada recognizes the importance of the natural health product industry, which employs more than 50,000 people and generates billions in domestic sales and exports. Health Canada is considering a number of measures to help alleviate the impact of the proposed fees on businesses, such as fee reductions for small businesses and exemption from the pre-market evaluation fee for small businesses marketing their first product. The revenue generated by the proposed fees would allow Health Canada to establish a new, permanent NHP Good Manufacturing Practices inspection program to educate industry on its obligations and to verify industry compliance with regulatory requirements. This would help ensure that Canadians have continued access to a safer marketplace for NHPs.


An initial information session for stakeholders was held in February 2022.

Health Canada  published a fee proposal on its website on May 12, 2023 for a 90-day consultation period which closed on August 10, 2023. Health Canada also held two technical briefings with stakeholders in May 2023 and July 2023 to discuss the fee proposal. The department is completing the review of the comments received, and will determine adjustments to the proposal to mitigate impacts on small businesses, and consult further as necessary.

Further information

Related information can be found on:

Proposed fees for natural health products: Overview -

The CESD’s Report 2 on Natural Health Products audit report, including the department’s response

Report of the standing committee on public accounts on natural health products

Government response to the Eighteenth report of the Standing Committee on Public Accounts entitled: Natural Health Products.

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

Date the regulatory initiative was first included in the Forward Regulatory

April 2022

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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