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Guidance document : the management of drug submissions and applications.: H164-277/2025E-PDF

"This guidance document gives direction and guidance when managing information submitted in accordance with the Food and Drugs Act and its regulations. This guidance is for sponsors and Health Canada staff from the following directorates and divisions: Medical Devices Directorate (MDD); Pharmaceutical Drugs Directorate (PDD); Marketed Health Products Directorate (MHPD); Business Facilitation and Modernization Directorate (BFMD); Biologic and Radiopharmaceutical Drugs Directorate (BRDD); Office of Submissions and Intellectual Property (OSIP) within MHPD; Non-Prescription Drug Evaluation Division (NDED) of the Natural and Non-prescription Health Products Directorate (NNHPD)"--Overview, page 1.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.945564&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance document : the management of drug submissions and applications.
Publication typeMonograph
Language[English]
Other language editions[French]
Earlier editionGuidance document : 2022
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Ligne directrice : gestion des présentations et des demandes de drogue.
  • Includes bibliographical references (pages 44-45).
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, October 2025.
  • ©2025
Description1 online resource (52 pages)
ISBN9780660746609
Catalogue number
  • H164-277/2025E-PDF
Departmental catalogue numberPub.: 240651
Subject terms
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