Notice to Stakeholders - Update - Upcoming Blood Regulations and the CSA National Blood Standard

To: Stakeholders

Health Canada is pleased to announce that the draft Blood Regulations are anticipated to be published in Canada Gazette Part I (CGI) in 2011. The stand-alone Blood Regulations -- under the authority of the Food and Drugs Act -- will contain safety, quality and efficacy requirements with respect to blood for transfusion or for further manufacture.

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. Under the New Blood Regulations not only blood operators but also hospital blood banks and transfusion medicine laboratories that carry out activities under federal jurisdiction will be required to comply.

The CGI publication of the draft 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 draft Blood Regulations will be revised through the drafting process with an expectation for final publication in Canada Gazette, Part II in 2012 and a coming into force date one year later.

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

Upon publication of the Blood Regulations in Canada Gazette II, each establishment will be responsible for ensuring that they follow the requirements of the Blood Regulations and the most current version of the CSA Z902, Blood and blood components standard incorporated by reference into the Blood Regulations.

Health Canada will continue to report on the progress of this important regulatory initiative. You may also find more information on the Health Canada website. Any comments or queries you may have regarding this update or the status of the Blood Regulations may be directed to bgtd.opic.bpci@hc-sc.gc.ca.