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Good manufacturing practices guide for natural health products (GUI-0158): Overview, about NHP quality systems Overview, about NHP quality systems NHP GMP guidance, sections 43 to 47 NHP GMP guidance, sections 48 to 50 NHP GMP guidance, section 51 NHP GMP guidance, sections 52 to…

Notice of amendment: Addition of melatonin to the Prescription Drug List September 9, 2025 Our file number: 25-105825-747 The purpose of this Notice of Amendment is to announce the addition of "melatonin or its salts" to the human use part of the Prescription Drug List (PDL).…

Closed consultation: Adding melatonin for sleep-related use in the pediatric population to the Prescription Drug List Current status: Closed This consultation ran from September 16, 2025 to December 30, 2025. The purpose of this consultation was to communicate to industry,…

Closed consultation: Draft guidance on the plain language labelling regulations for prescription drugs Current status: Closed This consultation ran from September 25, 2025 to November 7, 2025. Health Canada sought feedback on proposed revisions to the Questions and Answers: Plain…

Qualifying notice for Amtagvi (293019) - Canada.ca

Health CanadaCaptures 9Latest capture Apr 11, 2026en

Qualifying notice for Amtagvi (293019) Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney's Pasture, A.L. 0601C Ottawa ON K1A 0K9 Dossier ID: e279570 Control number: 293019 Iovance Biotherapeutics, Inc. c/o [employee name removed]…

Health Canada updates guidance on management of drug submissions and applications: Notice October 1, 2025 Health Canada has updated the 2022 version of the Guidance on management of drug submissions and applications . The changes to the guidance take effect immediately and will…

Health Canada implementation of International Council for Harmonisation Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management and Q14 Analytical procedure development: Notice January 12, 2026 Our file number: 25-105890 – 674 As a standing…

What we heard: Draft guidance on co-packaged drug products On this page Introduction Stakeholder engagement Key themes Summary of feedback Next steps Contact us Introduction Health Canada published the Draft guidance on co-packaged drug products for public consultation on March…

Enhertu: Qualifying notice (288114) - Canada.ca

Health CanadaCaptures 8Latest capture Apr 11, 2026en

Qualifying notice for Enhertu (288114) Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney’s Pasture, A.L. 0601C Ottawa ON K1A 0K9 Dossier ID: e231047 Control number: 288114 [employee name removed] [employee title removed] Astra Zeneca…

Notice: Multiple additions to the Prescription Drug List (PDL) [2025-10-30] October 30, 2025 Our file number: 25-107098-682 The purpose of this Notice of Amendment is to announce the addition of belantamab mafodotin, bulevirtide, delgocitinib, deutivacaftor, elinzanetant,…

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