Canadian Institutes of Health Research
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Guidance document: Certificates of supplementary protection (PDF version 518 Kb, 28 pages) Date adopted: September 21, 2017 Revised date: August 19, 2024 Effective date: August 19, 2024 Date Change Location (section, paragraph) Nature of and/or reason for change 2018/09/04…
Notice: Multiple additions to the Prescription Drug List (PDL) [2023-12-22] December 22, 2023 Our file number: 23-111963-914 The purpose of this Notice of Amendment is to notify about the addition of avatrombopag, calaspargase pegol, efgartigimod alfa, evinacumab, odevixibat,…
Guidance on procedures and administrative requirements for master files: Overview Overview Implementing, processing, assessing and updating master files Contact us Definitions and abbreviations References Sample letter templates Document change log: Date adopted: 2008/08/08…
Canadian Generic Pharmaceutical Association (CGPA): Final record of decisions June 7, 2022 Health Canada, Health Products and Food Branch (HPFB) Bilateral Meeting Program Virtual June 7, 2022, 1:00 p.m. to 3:30 p.m. On this page Participants and observers Meeting minutes Next…
Notice: Application of the definition of Canadian Reference Product January 26, 2024 Our file number: 23-111326-154 Generic drugs are generally approved by Health Canada through the Abbreviated New Drug Submission (ANDS) or Abbreviated Extraordinary Use New Drug Submission…
Qualifying notice for Elrexfio (273519) Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney's Pasture, A.L. 0601C Ottawa ON K1A 0K9 Dossier ID: HC6-024-e261096 Control number: 273519 [employee name removed] [employee title removed]…
Notice: Posting information in the Drug Product Database Online Revised date: February 2, 2024 Our reference number: 24-100732-711 This is an updated version of the Health Canada notice posted on June 18, 2015 regarding the posting of information in the Drug Product Database…
Pilot on pediatric development plans and studies On this page About the pilot Additional information for consideration Contact us About the pilot Information and data from clinical trials of drugs in children are essential to support evidence-based pediatric therapies. Without…
Groupement provincial de l’industrie du médicament (GPIM): Final record of decisions April 15, 2021 Health Canada, Health Products and Food Branch (HPFB) Bilateral Meeting Program Virtual April 15, 2021, 1:00 p.m. to 3:30 p.m. On this page Participants Meeting minutes Next…
Canada’s regulations prevent drugs from being distributed outside the country if this could cause or worsen a shortage Access to health products plays an important role in people's ability to stay healthy. Difficulty in accessing these products can cause hardships for individuals…
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