Notice to Stakeholders - Publication of proposed Blood Regulations and amendments to the Food and Drugs Act and Regulations in Canada Gazette, Part I

March 12, 2012

Dear Stakeholders,

Health Canada is proposing stand-alone Blood Regulations - under the authority of the Food and Drugs Act - that will contain safety, quality and efficacy requirements with respect to blood for transfusion or for further manufacture. The proposed Blood Regulations, amendments to the Food and Drugs Act and the Food and Drug Regulations were published in Canada Gazette, Part I (CGI) on March 10, 2012. These documents are also available from the Health Canada website.

The proposed Blood Regulations will apply to all persons or establishments who perform the following activities related to blood: processing (donor suitability assessment, collection, testing and blood component preparation); transforming (washing, pooling and irradiating blood intended for transfusion); labelling; storing; record keeping; importing (for transfusion); distributing; and error, accident and adverse reaction investigation and reporting.

The CGI publication of the proposed Blood Regulations provides for a 75 day comment period with the opportunity for all stakeholders to submit their comments to Health Canada. In response to comments received, the proposed Blood Regulations will be revised through the drafting process with an expectation for final publication in Canada Gazette, Part II in 2013 and a coming into force date one year later.

In 2010, the Canadian Standards Association (CSA) published an updated version of the CSA Z902, Blood and blood components standard (Blood Standard). Since relevant sections of the Blood Standard are referenced in the proposed Blood Regulations, all blood establishments require access to the most current version of the Blood Standard. The Blood Standard is available by ordering it through the  CSA website or by calling 1-800-463-6727. Information on how to receive updates on amendments to the Blood Standard is available on the "CSA Standards Update Service" page of the Blood Standard.

Any establishment who further distributes blood to long-term care facilities for transfusion should forward this notice to ensure that these facilities are aware of the requirements that would apply to them under the proposed Blood Regulations.

All interested persons are encouraged to provide comments and suggestions on the proposed regulations and amendments by May 24, 2012 to bgtd.opic@hc-sc.gc.ca.

Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Health Canada
200 Tunney's Pasture Driveway
Ottawa, ON K1A 0K9
Address Locator: 0702B

Fax number: (613) 952-5364
Email address: bgtd.opic@hc-sc.gc.ca