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Browse and search historical snapshots. This is an archive — not current guidance or medical advice. Archived content may be incomplete, outdated, or superseded. For up-to-date recommendations, always consult the official source website.

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ARCHIVED - How to Pay Fees for Health Products Notice to Reader: This is an archived page. Please refer to the most current version of this page. Contact: Cost Recovery Note: Click here for instructions on how to pay your Establishment Licence Fees Fee payable to Health Canada…

Guidance for Completing the Drug Submission Application Form Important notice This guidance is posted for information purposed at this time and will come into effect as of April 1, 2020. Please refer to the current version of this Guidance for filing/ cost recovery requirements…

Summary: Guidance Document - Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs Date adopted: 2017/10/27 Date posted: 2020/10/01 Effective date: 2020/10/01 Overview To clarify the requirements for eligible drug submissions and…

Updated: Notice - Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products Our file number: 20-102628-584 March 23, 2020 Subject - Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products On…

Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only) Find information regarding submission requirements at Guidance Document: Management of Drug Submissions and…

Summary: Guidance Document Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs From Health Canada Useful Resources Learn more about Industry requirements for non-prescription drug labels Learn more about how to use non-prescription drug labels…

Centre pour la recherche sur la préparation en cas de pandémie et d'urgence sanitaire Hébergé aux Instituts de recherche en santé du Canada (IRSC), le Centre pour la recherche sur la préparation en cas de pandémie et d’urgence sanitaire (CRPPUS) est une initiative horizontale du…

Summary: Guidance Document - Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits) Regulatory Requirements for Drug Identification Numbers (DINs) Food and Drugs Act Food and Drug Regulations Date adopted: 2017/01/19 Date posted: 2020/03/23 Effective…

Guidance Document on the Distribution of Drugs as Samples - Summary Overview The purpose of this document is to assist stakeholders with the interpretation of legislation and regulatory requirements about distributing samples of prescription drugs, non-prescription drugs and…

Drug and medical device highlights 2019: Helping you maintain and improve your health Download the alternative format (PDF format, 9.7 MB, 97 pages) Organization: Health Canada Type: Publication Published: 2020-05-28 Learn about the new drugs and medical devices that Health…

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Early release: coverage and features are still expanding.