Forward Regulatory Plan 2022-2024: Regulations amending the Natural Health Product Regulations (Expanding List A: List of Certain Natural Health Products for Distribution as Samples)

Title of Regulatory Initiative

Regulations amending the Natural Health Product Regulations (Expand List A: List of Certain Natural Health Products for Distribution as Samples)

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing amendments to the Natural Health Products Regulations to incorporate all currently authorized products in the product categories set out in the Canada-United States-Mexico Agreement (CUSMA) and that meet the identified criteria (i.e., for topical use, localized and non-systemic effect, and meets the definition of a cosmetic) into the NHPR.

The proposed amendments would expand the list of natural health products that are permitted to be distributed as samples in Canada.

Regulatory cooperation efforts (domestic and international)

This initiative delivers on a CUSMA commitment.

Potential impacts on Canadians, including businesses

The proposed amendments would apply to businesses that distribute samples of natural health products.

Health Canada expects that allowing businesses to distribute samples of a wider range of natural health products than is currently permitted to be of benefit to Canadians, giving them greater access to a wider range of natural health products samples.

Consultations

Stakeholder engagement and consultation took place over a 60-day period starting in August 2020.

Health Canada plans to seek an exemption from pre-publication in the Canada Gazette, Part I, and if approved, plans to publish the changes in Canada Gazette Part II in spring 2023.

Further information

Related information can be found on:

List A: List of Certain Natural Health Products for Distribution as Samples

Comment Period: Proposal to expand lists of certain products for distribution as samples and a list of certain non-prescription drugs for which testing requirements do not apply

Guidance Document on the Distribution of Drugs as Samples – Summary

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

February 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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