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Notice - Release of guidance document: Regulatory framework for unauthorized new allergenic products of biological origin used for the diagnosis or treatment of allergic diseases Date: November 13, 2012 (PDF Version - 175 K) Health Canada is pleased to announce the release of the…
Lot Release - Guidance Documents - Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies Section C.04.015 of the Food and Drugs Act and Regulations , states that "on written request from the Director, every fabricator, packager/labeller, tester,…
CV commun canadien (CVC) Protéger nos systèmes et la vie privée des utilisateurs : l’authentification multifactorielle est désormais en service dans le CV commun canadien. En savoir plus Le CV commun canadien (CVC) est une application Web qui fournit aux chercheurs une approche…
Preparation of Drug Submissions - Guidance Documents - Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies Notice: Validation rules for regulatory transactions provided to Health Canada in the “non-eCTD electronic-only” format [2017-07-28] Notice…
Blood Regulations Guidance Document: Blood Regulations (modified March 8, 2016) The Establishment Licence Application Form and Registration Application Form can be obtained by sending an email to blood_sang_questions@hc-sc.gc.ca . Related documents The Inspection Strategy for…
DRAFT Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs This guidance is a draft version for consultation purposes only. It is not to be implemented at this time. Please refer to the Consultation on Guidance Document: Information and…
Risk Classification of Observations to Donor Semen Establishments (GUI-0053) - Summary We have archived this page and will not be updating it. You can use it for research or reference. We have archived this page and will not be updating it. You can use it for research or…
Donor semen Note: The information on this page will change as a result of the new Safety of Sperm and Ova Regulations under the Assisted Human Reproduction Act coming into force in February 2020. For more information visit the Assisted Human Reproduction web page. The Processing…
What We Heard Report: A Summary of Feedback from the Consultation: Toward a Strengthened Assisted Human Reproduction Act Download the alternative format ( PDF format, 412 KB, 10 pages ) Organization: Health Canada Published: 2018-01-12 Executive Summary On July 12, 2017, Health…
Archived Health Canada Directives: Technical Requirements for Conducting the Suitability Assessment of Sperm and Ova Donors Links to previous versions of this directive are provided below for information and reference purposes. For the most current version of the directive,…
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