Regulatory Initiative: Repeal of Arsenic as a Prohibited Substance - Forward Regulatory Plan 2012-2014

Title or working title of the regulatory initiative: Repeal of Arsenic as a Prohibited Substance

Description of the objective:
Arsenic trioxide has undergone clinical trials indicating that it can be a highly effective treatment for patients with relapsed acute promyelocytic leukemia.  A regulatory proposal will be developed to lift its prohibition and permit the sale of drugs containing arsenic trioxide, after proper regulatory review.  This proposal would also seek to add arsenic trioxide as a medicinal ingredient to Schedule F listing thus assigning it prescription status to ensure appropriate oversight.

Enabling Act:
Food and Drugs Act

Indication of business impacts:
There may be business impacts.  The "One-for-One" Rule and/or the Small Business Lens may apply.

Public consultation opportunities:

Canadians have the opportunity to provide input during the  Canada Gazette, Part I public comment period, currently open until February 28, 2013.

Information on previous consultations and details on upcoming opportunities for consultation will be provided on the Health Canada Website for Regulatory Modernization.

Departmental contact:

David K. Lee
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone number: 613-946-6586

Email address: LRM-MLR@hc-sc.gc.ca

For More Information

•  Government-Wide Forward Regulatory Plans
• The  Cabinet Directive on Regulatory Management
• The  Red Tape Reduction Action Plan
• The  Canada-United States Regulatory Cooperation Council

To learn about upcoming or ongoing consultations on proposed federal regulations, visit the  Canada Gazette and  Consulting with Canadians websites.