Health Canada Blood Regulations stakeholder consultation
Tuesday, 29 May 2012 14:10
Notice to Stakeholders — Release of the Draft Guidance Interpreting the Blood Regulations for stakeholder consultation
Health Canada is pleased to announce the release of the Draft Guidance Document Interpreting the Blood Regulations (draft Guidance Document) for stakeholder consultation. This consultation — from May 28 to September 24, 2012 — focusses on receiving stakeholder comment on the draft Guidance Document.
Read or download the draft Guidance Document, English (PDF)
Read or download the draft Guidance Document, French (PDF)
The purpose of the draft Guidance Document is to provide guidance on how to interpret the Blood Regulations to all persons or establishments who perform any of the following activities related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:
o Processing, including donor suitability assessment, collection, testing, and blood component preparation;
o Transforming, including washing, pooling, and irradiating blood;
o Labelling;
o Storing;
o Record keeping;
o Importing, for transfusion;
o Distributing;
o Error and Accident Investigation and Reporting; and
o 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The objective of the consultation on the draft Guidance Document is to obtain stakeholder comments on the guidance text explaining the regulatory provisions of the proposed Blood Regulations. Below are a few questions to consider when reading the draft Guidance Document and providing comment: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?
Stakeholders and interested persons can provide comment on the draft Guidance Document during the 120–day consultation period beginning on May 28, 2012 and concluding on September 24, 2012.
Comments on the draft Guidance Document should be submitted to Health Canada, preferably in electronic format: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: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Please use these templates for your comments: English, French.
As clarification, the consultation on the proposed Blood Regulations published in Canada Gazette, Part I — from March 10 to May 24, 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.
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 to September 24, 2012 — focusses on receiving stakeholder comment on the draft Guidance Document.
Read or download the draft Guidance Document, English (PDF)
Read or download the draft Guidance Document, French (PDF)
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:
o Processing, including donor suitability assessment, collection, testing, and blood component preparation;
o Transforming, including washing, pooling, and irradiating blood;
o Labelling;
o Storing;
o Record keeping;
o Importing, for transfusion;
o Distributing;
o Error and Accident Investigation and Reporting; and
o 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?
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.
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: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Please use these templates for your comments: English, French.
As clarification, the consultation on the proposed Blood Regulations published in Canada Gazette, Part I — from March 10 to May 24, 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.
