Forward Regulatory Plan 2019-2021: Removing Barriers around Distributing Drugs as  Samples

Title of Regulatory Initiative

Removing Barriers around Distributing Drugs as Samples

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing to amend the Food and Drug Regulations and the Natural Health Products Regulations.

The objective of this regulatory proposal is to permit the distribution of samples to the general public of certain authorized non-prescription drugs and natural health products, provided that regulatory requirements are met. The proposal would also modernize the list of practitioners to whom samples may be distributed.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sectoral Regulatory Review Roadmap. The initiative is expected to address comments made by stakeholders that current prohibitions on the distribution of drug samples unduly restrict the distribution by non-medical staff of direct-to consumer samples of low risk non-prescription drugs and natural health products, and pose a barrier to desirable public health and safety activities, such as distributing samples of sunscreens at outdoor events.

This regulatory initiative is associated with Health Canada’s stock review plan.

Regulatory cooperation efforts (domestic and international)

Health Canada will consider the regimes of relevant international counterparts when developing the regulatory proposal.

Potential impacts on Canadians, including businesses

These regulatory changes are expected to be welcomed by both industry and consumers, as they will allow businesses to provide Canadians with samples of their products, and Canadians to receive such samples.

The changes are also expected to be welcomed by certain practitioners currently unable to receive drug samples.

Significant impacts on international trade or investment are not expected.

Consultations

Targeted consultation sessions were held in winter 2019 on the proposed approach.

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part l public comment period, which is expected to take place in fall 2021.

The publication of the amendments to the regulations in the Canada Gazette, Part II is expected to take place in spring 2022.

Further information

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 Plan

April 1, 2019

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:

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