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Guidance on classification of observations for inspecting cells, tissues and organs establishments (GUI-0101): Overview Date issued: August 29 th , 2025 Replaces: Guidance on Classification of Observations for Inspection of Cells, Tissues and Organs establishments (March 15,…
Archived Inspection Policy for Cells, Tissues and Organs Establishments (POL-0057) (PDF Version - 262 K) Introduction POL-0057 details the strategy for the effective and uniform implementation of a national program for scheduling the inspections of Canadian registered…
Guidance Document: Blood Regulations Download in PDF format (3.19 MB, 185 pages) Organization: Health Canada Published: 2023-05-19 Date Adopted: 2014-05-12 Effective Date: 2014-10-23 Modified Date: 2023-02-21 Foreword Guidance documents are meant to provide assistance to industry…
Pre-Inspection Package for Blood Establishments (FRM-0414) - Summary The Pre-Inspection Package for Blood Establishments provides information and advice on: frequently asked questions on complying with the Blood Regulations the blood inspection process key elements of an…
Risk classification of observations made during blood establishment inspections (GUI-0061) Download the alternative format (PDF format, 1.60 MB, 44 pages) Organization: Health Canada Published: 2022 Date issued: 31 January 2022 Date implemented: 31 January 2022 Replaces:…
Inspection approach for blood establishments (POL-0039) Download the alternative format (PDF format, 280 KB, 12 pages) Author: Health Canada Date issued: June 28, 2019 Date implemented: June 28, 2019 Replaces: Inspection strategy for blood establishments (POL-0039) (October 23,…
Blood Regulations - Error or Accident Investigation Preliminary Report Form (FRM-0337) (PDF Version - 986 K) Introduction As per section 107 of the Blood Regulations , establishments conducting an investigation must file a preliminary error or accident report with Health Canada…
Blood Establishment Licensing Application Form and Instructions - (FRM-0354) Blood Establishment Licence The Blood Establishment Licensing (BEL) Application Form and Instructions are used by establishments in Canada that conduct activities requiring a licence under the Blood…
Blood Establishment Registration Application: Form and Instructions - (FRM-0353) Blood Establishment Registration The Blood Establishment Registration (BER) Application Form is used by establishments in Canada that conduct activities requiring a registration under the Blood…
Advance notice of importation process for cosmetics and drugs The advance notice of importation process applies to cosmetics and drugs that need to be modified or relabelled to be sold in Canada. On this page: Background Scope Advance notice of importation At the border…
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