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Guidance document : post-notice of compliance (NOC) : changes : quality document.: H164-281/2019E-PDF

"The first version of Health Canada’s Post‐Notice of Compliance Changes – Quality Document was finalised in 2009. This document has been periodically updated and has an emphasis on applying a science‐based and risk‐based approach to the pharmaceutical quality assessment of these products. As such, updated guidance documents continue to be needed on the information to support quality changes to new drugs which apply a modernized, science‐based, and risk‐based approach to this area"--Page 19.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.875014&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance document : post-notice of compliance (NOC) : changes : quality document.
Variant title
  • Post‐NOC quality
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Ligne directrice : changements survenus après l’avis de conformité (AC) : document sur la qualité.
  • Incorrect catalogue number (H149‐18/2019E‐PDF) and ISBN (978‐0‐660‐31410‐5) printed in this publication.
  • "Publication date: July 2019."
  • Issued also in HTML format.
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, 2019.
  • ©2019
Description1 online resource (271 pages)
ISBN9780660314631
Catalogue number
  • H164-281/2019E-PDF
Departmental catalogue number190126
Subject terms
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