Regulatory Initiative: Blood Regulations - Forward Regulatory Plan 2012-2014

Title or working title of the regulatory initiative: Blood Regulations

Description of the objective:
Regulations are needed to respond to Justice Krever's Report which recommended developing specific regulations for blood and blood components and apply to all establishments that perform any of the regulated activities. The proposed regulatory initiative would consolidate the existing requirements in new regulations that will apply to all establishments that perform any of the regulated activities, and apply the level of oversight that is equal to the level of risk of the activities performed by each establishment.

Enabling Act:
Food and Drugs Act

Indication of business impacts:
There are no expected business impacts.

Public consultation opportunities:

Information on previous consultations is available.

Canadians have already participated in  consultations that occurred between March 10, 2012 and May 24, 2012. Comments are currently being reviewed.

Departmental contact:

Liz Anne Gillham-Eisen
Manager
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Health Canada

Telephone number: 613-946-7212

Email address: BGTD.OPIC@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.