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
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : post-notice of compliance (NOC) : changes : quality document. |
| Variant title | Post‐NOC quality |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| 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 |
| Description | 1 online resource (271 pages) |
| ISBN | 9780660314631 |
| Catalogue number |
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| Departmental catalogue number | 190126 |
| Subject terms | Drugs -- Labeling -- Canada. Drug approval -- Canada. |
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