Forward Regulatory Plan 2021-2023: Regulations amending the Natural Health Product Regulations - Expand 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
On March 13, 2020, Bill C-4 entitled the Canada–United States–Mexico Agreement Implementation Act received Royal Assent. In order to implement the Canada-United States-Mexico Agreement (CUSMA), regulatory amendments to the Natural Health Products Regulations (NHPR) were necessary for Canada to meet its commitments.
As part of the implementation, Health Canada established a guidance document on the distribution of drugs as samples, as well as a list of the specific natural health products that can be distributed as samples directly to consumers: List A: List of Certain Natural Health Products for Distribution as Samples.
Health Canada intends to amend the list for natural health products (NHPs) to include all currently authorized products in the product categories set out in the CUSMA and that meet the identified criteria (i.e., for topical use, localized and non-systemic effect, and meets the definition of a cosmetic). Currently, only a subset of those products are included in the NHPR.
Regulatory cooperation efforts (domestic and international)
This initiative delivers on a CUSMA commitment.
Health Canada considered the regimes of relevant international counterparts when developing the regulatory proposal.
Potential impacts on Canadians, including businesses
These proposed regulatory changes would allow companies to, under certain conditions, distribute samples of a wider range of low-risk NHPs than is currently permitted through the regulations.
Consultations
Since developing the lists for CUSMA, further analysis and stakeholder consultation has been completed on the categorization of low-risk NHPs, as part of the work on the Self-Care Framework, which supports a broadening of the lists.
A 60 day period public consultation was launched on August 11, 2020. This public comment period was intended to gather feedback from:
- Consumers and patients;
- Consumer and patient safety associations;
- Industry and industry associations; and,
- Healthcare professionals and healthcare professional associations.
In addition, Canadians will have an opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in fall 2021.
Further information
Related information can be found on the departmental website:
- Lists Incorporated by Reference
- List A: List of Certain Natural Health Products for Distribution as Samples
- 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: 613-946-6586
Email: hc.lrm-mlr.sc@canada.ca
Date the regulatory initiative was first included in the Forward Regulatory
February 2021
Consult Health Canada's acts and regulations web page for:
- a list of acts and regulations administered by Health Canada
- further information on Health Canada's implementation of government-wide regulatory management initiatives
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:
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