Guidance on post-notice of compliance changes : quality for schedule C drugs.: H164-426/2026E-PDF
"This guidance should be used to assess changes to biological products by the Biologics and Radiopharmaceuticals Drug Directorate (BRDD). This guidance only clarifies the reporting category for the quality related changes. These quality related changes may affect other regulatory aspects of the product such as administrative, labelling, or good manufacturing practices (GMP) requirements. The referenced guidances should be consulted to determine the reporting requirements for these changes"--page 1.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.961959&sl=0
| Department/Agency |
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|---|---|
| Title | Guidance on post-notice of compliance changes : quality for schedule C drugs. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Digital text |
| Electronic document | |
| Note(s) |
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| Publishing information |
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| Description | 1 online resource (v, 80 pages) |
| ISBN | 9780660995816 |
| Catalogue number |
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| Departmental catalogue number | 260045 |
| Subject terms |
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