Consultation on the Revised Inspection Strategy for Licensed Blood Establishments

From: Health Canada

Current status: CLOSED

Health Canada conducts inspections of establishments that process blood for transfusion and for manufacture into a drug for human use. Health Canada will be engaging with Canadians and key stakeholders on the proposed revisions of the Inspection Strategy for Blood Establishments (POL-0039).

Between July 31, 2018 and August 30, 2018, Health Canada is seeking comments on the proposed revisions of the inspection strategy.

How to participate

You can find the consultation document online: draft POL-0039.

You may submit your comments by:

Address Locator 1914C
Rm 1488C, 14th floor, Jeanne Mance Building
200 Eglantine Driveway
Ottawa, ON K1A 0K9

You have 30 days to send us your comments. The consultation period closes on August 30, 2018.

Who is the focus of this consultation

We are seeking comments from:

  • Blood establishments
  • Industry members and associated groups
  • Patient associations
  • Patients
  • Interested Canadians and stakeholders

The licensed blood establishments are those who collect blood and prepare the components. There are currently only 4 licensed establishments in Canada, with many sites across the country.

Please note the proposed approach was already presented to the licensed blood establishments as part of a targeted consultation during which they were invited to provide their initial comments. These establishments are welcome to submit any additional comments during this consultation.

Goals of the consultation

The POL-0039 describes the inspection strategy in order to assess the compliance of establishments that perform activities regulated under the Blood Regulations.  

At this time, the POL-0039 is being revised to update the approach for determining the frequency of inspections only for licensed establishments (see section 5.1 of the document). The main changes in the document are:

  • For licensed sites that have a high level of compliance, a reduction in their inspection frequencies
  • A new section to explain when newly licensed establishments or buildings would be inspected
  • The terminology used to describe the different types of sites (previously included main centres, sub-centres and fixed sites. The draft document now refers to production sites or collection sites)
  • Different sections outlining details about the inspection process have been consolidated into one section (see section 4.1)
  • A paragraph was added to explain the posting online of inspection results on the Drug and Health Product Inspections database

At a later time, Health Canada may revise the inspection strategy for registered blood establishments and establishments that do not require an Establishment Licence or Registration. Health Canada will consult with stakeholders on these new strategies before implementation.

For a copy of the current version of the POL-0039, please contact us at

The input gathered through this consultation process will be taken into consideration when finalizing the inspection strategy outlined in the policy document (POL-0039).

Key questions for discussion

We are looking for comments on the proposed approach for determining the frequency of inspection for licensed establishments.

Related information

Contact us

Biological Product Compliance Program
14th floor, 200 Eglantine Driveway
Address Locator 1914C
Ottawa, ON K1A 0K9


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