Consultation - Proposed Regulations Amending Certain Regulations Relating to Access to Diacetylmorphine for Emergency Treatment

Notice to the reader:

The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered. Thank you for your input.

The purpose of this Notice of Consultation is to provide an opportunity to comment on Health Canada’s proposed regulatory amendments to return the regulatory oversight of diacetylmorphine to the Narcotic Control Regulations (NCR) as it was prior to the regulatory amendments made in 2013 through the Regulations Amending Certain Regulations Relating to Access to Restricted Drugs. These proposed regulatory amendments would permit the consideration of applications for the sale of diacetylmorphine for purposes of emergency treatment under the Special Access Programme (SAP).

The SAP allows practitioners to request, in exceptional circumstances, access to non-marketed drugs for specific patients on a case-by-case basis. The SAP considers requests for emergency access to drugs for patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable or unavailable.

The proposed amendments would also reinstate the regulatory controls for diacetylmorphine that were in place under the Controlled Drugs and Substances Act before the 2013 regulatory amendments were made.

How to Get Involved

Proposed amendments are outlined in a Notice to Interested Parties (NTIP). The NTIP was published in the Canada Gazette, Part I, on May 14, 2016, initiating a 30-day comment period ending on June 12, 2016.

Go to the Canada Gazette for further details.

If you are interested in this process or have comments on the proposed changes, please contact:

By mail at:
Legislative and Regulatory Affairs,
Controlled Substances Directorate,
Healthy Environments and Consumer Safety Branch,
Health Canada,
Address Locator: 0302A,
Ottawa, Ontario, K1A 0K9

  

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