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Label Safety Assessment Update - Sponsor Attestation This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to use the form, you must use the alternate format below. Help on accessing alternative…

Basic Product Monograph Information for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) (PDF Version - 88 KB) Contact: Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS) Notice November 23, 2006 Our file number: 06-125744-338 The final version of this Health Canada…

Overview of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry Update: Please note that a new notice to industry has been published February 19, 2026, providing additional details related to sections “2.1.2 Foreign Adverse Reaction…

Guidance documents: Biologics, radiopharmaceuticals, cell and gene therapies The following guidance documents have been prepared to assist in the interpretation of the policies governing statutes and regulations. Consultation: Draft guidance on decentralized clinical trials…

Guidance Document : Post-Notice of Compliance (NOC) Changes: Quality Document (PDF Version - 1.32 MB) Contact: Bureau of Policy, Science and International Programs Enquiries The next version of this guidance document will be updated to align with the Regulations Amending Certain…

Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only) Date Adopted: 2009/09/02 Date Posted: 2020/03/23 Effective Date: 2020/04/01 PDF version Document change log…

Nouvelles des IRSC Votre accès aux produits de communication et plus récentes nouvelles des Instituts de recherche en santé du Canada. Suivez : Facebook Twitter YouTube LinkedIn Instagram Communiqués et Déclarations Toute l’actualité afférente aux Instituts de recherche en santé…

LABELLING OF SPECIAL CONTAINERS Contact BGIVD Enquiries PDF Version Policy Issues From the Drugs Directorate April 4, 1990 900404.EXT This policy provides labelling guidelines for special containers that are too small to accommodate a full label and containers whose design causes…

Guidance Document: Labelling of Pharmaceutical Drugs for Human Use (PDF Version - 323 K) Health Canada is seeking feedback on proposed revisions to this guidance. Please visit the Consultation on proposed agile regulations and guidance for licensing drugs and medical devices for…