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Guidance on post-notice of compliance changes : framework for biologic and schedule C drugs for human use.H164-423/2026E-PDF

"In this guidance document, Health Canada outlines the overarching authorities, reporting categories and drug submission filing information for post-NOC changes for biologic and Schedule C drugs for human use"--page 1.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.961953&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance on post-notice of compliance changes : framework for biologic and schedule C drugs for human use.
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Ligne directrice sur les changements survenus après l'avis de conformité : cadre pour les médicaments biologiques et les médicaments de l'annexe C destinés à l'usage humain.
  • "Effective date: April 1, 2020. Revised date: May 15, 2026."
  • Includes bibliographical references (page 13).
Publishing information
  • Ottawa : Health Canada = Santé Canada, 2026.
  • ©2026
Description1 online resource (ii, 16 pages)
ISBN9780660995755
Catalogue number
  • H164-423/2026E-PDF
Departmental catalogue number260039
Subject terms
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