Notice to Stakeholders — Release of the Draft Guidance Interpreting the Blood Regulations for stakeholder consultation

The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period.

May 28, 2012

Health Canada is pleased to announce the release of the Draft Guidance Document Interpreting the Blood Regulations (draft Guidance Document) for stakeholder consultation. This consultation - from May 28^th to September 24^th 2012 - focuses on receiving stakeholder comment on the draft Guidance Document.

The purpose of the draft Guidance Document is to provide guidance on how to interpret the Blood Regulations to all persons or establishments who perform any of the following activities related to blood:

• Processing, including donor suitability assessment, collection, testing, and blood component preparation;
• Transforming, including washing, pooling, and irradiating blood;
• Labelling;
• Storing;
• Record keeping;
• Importing, for transfusion;
• Distributing;
• Error and Accident Investigation and Reporting; and
• Adverse Reaction Investigation and Reporting.

The objective of the consultation on the draft Guidance Document is to obtain stakeholder comments on the guidance text explaining the regulatory provisions of the proposed Blood Regulations. Below are a few questions to consider when reading the draft Guidance Document and providing comment:

1. Do you understand how the regulatory provisions are explained?
2. Is there a regulatory provision that is unclear, even after reading the guidance for the provision? If so, what part of the regulatory provision needs to be explained better and what part of the guidance is unclear?
3. Is there a regulatory provision for which guidance text is needed?

How to get involved

Stakeholders and interested persons can provide comment on the draft Guidance Document during the 120-day consultation period beginning on May 28, 2012 and concluding on September 24, 2012.

To request the draft Guidance Document: Interested stakeholders who wish to provide comments may send a request for an electronic copy or a paper copy to bgtd.opic@hc-sc.gc.ca.

Please include in the subject line the title and the preferred language of the draft Guidance Document you wish to receive.

Comments on the draft Guidance Document should be submitted to Health Canada, preferably in electronic format:

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

Fax: 613-952-5364
Email: bgtd.opic@hc-sc.gc.ca

For your convenience, please find attached a template for your comments.

Template for comments

As clarification, the consultation on the proposed Blood Regulations published in Canada Gazette, Part I - from March 10^th to May 24^th 2012 - precedes this consultation pertaining to the draft Guidance Document. Health Canada is currently reviewing comments received on the proposed Blood Regulations. In response to these comments, Health Canada will revise the regulations through the drafting process. It is anticipated that the final version of the Blood Regulations will be published in Canada Gazette, Part II in 2013. Therefore, please note, the boxed regulatory text in the draft Guidance Document does not reflect any upcoming changes to the regulatory provisions.