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Guidance Document: Patented Medicines (Notice of Compliance) Regulations Download the alternative format (PDF format, 508 Kb, 36 pages) Organization: Health Canada Date published: 2025-01-14 Date Adopted: 2000/02/14 Revised Date: 2025/01/14 Effective Date: 2025/01/14 Foreword…

Notice of intent to amend: Prescription Drug List (PDL): Epinephrine (Topical Solution) June 4, 2021 Our file number: 21-110492-852 The purpose of this Notice of Intent to Amend is to announce that Health Canada will add Epinephrine topical solution for hemostasis when sold at a…

Scientific Advisory Committee on Health Products for Women (SAC-HPW): Summary of Findings and Advice February 23rd, 2021 Virtual Meeting via Zoom Context The Medical Devices Action Plan (MDAP) Footnote 1 was launched in December 2018 to communicate on Health Canada’s strategies…

Scientific Advisory Committee on Health Products for Women (SAC-HPW): Agenda Date and Time: June 23, 2021- 11:00 am-4:15 pm, EST Location: Virtual Chairperson: Lorraine Greaves (Chair), Louise Pilote (Vice-chair) Secretariat: Jenna Griffiths, Laetitia Guillemette, Roslyn Neals,…

Notice: Revision to the Guidance Document: Management of Drug Submissions and Applications July 7, 2021 Our file number: 21-112595-270 Health Canada is revising the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA) . This document provides…

Notice: Prescription Drug List (PDL): Multiple Additions Date: July 23, 2021 Our file number: 21-113607-73 The purpose of this Notice of Amendment is to notify about the additions of the following medicinal ingredients on the Prescription Drug List (PDL) for human and veterinary…

Drug and medical device highlights 2020: Helping you maintain and improve your health Overview Drugs for human use Medical devices Drugs for veterinary use Approved in 2020: Drugs for human use Approved in 2020: Medical devices Approved in 2020: Drugs for veterinary use Download…

Notice: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality, for stakeholder consultation August 6, 2021 Our file number: 21-113843-585 Health Canada is pleased to announce the release of five associated revised draft guidance…

The Drug Establishment Licensing Bulletin The Health Product Compliance Directorate (HPCD) within the Regulatory Operations and Enforcement Branch oversees the national compliance and enforcement program for health products. HPCD manages the risk that health products pose to…

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