Forward Regulatory Plan 2019-2021: Amendment to Regulations under the Controlled Drugs and Substances Act with respect to Licences and Permits

Title of Regulatory Initiative

Amendment to Regulations under the Controlled Drugs and Substances Act with respect to Licences and Permits

Enabling Act

Controlled Drugs and Substances Act

Description

New and amended provisions pertaining largely to the activities of licensed dealers under the Narcotic Control Regulations, the Benzodiazepines and Other Targeted Substances Regulations, Part G (Controlled Drugs) to the Food and Drug Regulations, Part J (Restricted Drugs) to the Food and Drug Regulations are being proposed.

The objective of this regulatory proposal is to address various issues, gaps and inconsistencies in these regulations in order to improve the administration of and compliance with these regulations.

These amendments will streamline processes for the issuance, amendment, renewal, suspension and revocation of a licence or permit by aligning these processes among the affected regulations. They will further enhance and clarify requirements for licensed dealers with respect to record keeping, reporting and security. Additionally, the amendments will strengthen the power of the Minister of Health to address urgent public health and safety issues caused by the risk of diversion or misuse of controlled substances.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap.

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

Regulatory cooperation efforts (domestic and international)

Not Applicable

Potential impacts on Canadians, including businesses

The proposed regulatory amendment applies to the health care sector and will address various issues, gaps and inconsistencies in these regulations in order to improve the administration of and compliance with these regulations.

Stakeholders that may be impacted by the change include: pharmacies, industry, health professionals.

Consultations

A Notice to Interested Parties was published in Canada Gazette, Part I on May 23, 2015 for a 30 day public comment period, to obtain feedback on regulatory amendments pertaining to licences and permits.

Canadians had the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which took place on June 23, 2018 with a 75 day public comment period.

The publication of the amendments to the regulations in the Canada Gazette, Part ll, is expected to take place in spring 2019.

Information on previous consultations and details on upcoming opportunities for consultation in the area of Controlled Substances can be found on the Canada.ca website.

Further information

Additional information can be requested from the Departmental contact.

Departmental contact information

Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Health Canada

Email address: hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

April 1, 2016

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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