00000nam 2200000zi 4500 9.875014 CaOODSP 20221107164339 m o d f cr ||||||||||| 190617t20192019onc o f000 0 eng d 9780660314631 9780660314105 CaOODSP eng rda CaOODSP n-cn--- H164-281/2019E-PDF H149‐18/2019E‐PDF Guidance document : post-notice of compliance (NOC) : changes : quality document. Post‐NOC quality Ottawa, ON : Health Canada = Santé Canada, 2019. ©2019 1 online resource (271 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier 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. "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. Drugs Labeling Canada. Drug approval Canada. Canada. Health Canada, issuing body. Ligne directrice : (CaOODSP)9.875018 PDF 1.43 MB https://publications.gc.ca/collections/collection_2021/sc-hc/H164-281-2019-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-notice-compliance-changes/quality-document/guidance.html 190126