Forward Regulatory Plan 2019-2021: Regulations amending the Food and Drug  Regulations (Finished Product Testing)

Title of Regulatory Initiative

Regulations amending the Food and Drug Regulations (Finished Product Testing)

Enabling Act

Food and Drugs Act

Description

This proposal addresses a longstanding regulatory irritant for industry for lower risk products imported from countries having a comparable Good Manufacturing Practices (GMP) compliance program to Canada. The proposal would create a new exemption under the Food and Drug Regulations which would relieve Canadian importers and manufacturers from testing requirements for certain imported products prior to being sold in Canada, and would allow importers to ship finished products directly to retailers, distributors, and wholesalers in Canada.

Regulatory cooperation efforts (domestic and international)

The current proposed amendments stem from experience gained under the Expanded Sunscreen Pilot Project and fully leverage the Pharmaceutical Inspection Co-operation Scheme (PIC/S) regulatory harmonization efforts and international cooperation to monitor regulatory compliance with GMP requirements. It also builds on Health Canada's commitment under the Canada - United States Regulatory Cooperation Council initiative to minimize regulatory burden when it relates to non-prescription drugs.

Potential impacts on Canadians, including businesses

Stakeholders impacted by this proposal include professional associations and industry conducting activities in relation to non-prescription drugs as well as consumer and patient associations. Where testing requirements are already met in a foreign country with a comparable GMP compliance program to Canada, and by an establishment meeting Canada's GMP requirements, this proposal would eliminate costs associated with the retesting and quarantine of finished products imported into Canada. This would also provide the industry with flexibility to streamline its distribution networks and save on operational costs. Finally, this would also allow Canadians in having faster access to exempted products and allow businesses to pass on cost savings to Canadian consumers without compromising the safety and efficacy of imported products.

Consultations

Stakeholders have been extensively consulted throughout the implementation of the Sunscreen Pilot Project, including its expansion to new jurisdictions in February 2019, as well as through a number of other initiatives, including the Canada-U.S. Regulatory Cooperation Council (RCC) Joint Forward Plan, and the Self-Care Framework initiative.

Canadians will have the opportunity to provide further comments during the Canada Gazette, Part I public comment period, which is expected to take place in winter 2020.

Further information

Since 2017, Health Canada has been conducting a pilot project exempting approved Canadian importers of certain sunscreen products from duplicative testing requirements. On February 14, 2019, the Sunscreen Pilot Project was expanded to include qualifying sunscreen products imported from Mexico, Japan, and countries that had a concluded a Mutual Recognition Agreement (MRA) with Canada. Parties registered as participants to the Suncreen Pilot Project are exempted from testing requirements for finished products, that are fabricated, packaged / labeled, tested, and imported directly from a recognized facility which meets Canadian GMP requirements, located in one of the participating countries (e.g., an MRA country).

Additional information can be requested from the Departmental contact.

Departmental contact information

Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada

Telephone: 613-946-6220
Email: hc.prsd-questionsdspr.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:

  • 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:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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