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020 |a9780660995793
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-425/2026E-PDF
24500|aGuidance on post-notice of compliance changes : |bquality for biologics.
264 1|aOttawa : |bHealth Canada = Santé Canada, |cMay 15, 2026.
264 4|c©2026
300 |a1 online resource (iv, 79 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aIssued also in French under title: Ligne directrice sur les changements survenus après l'avis de conformité : qualité des produits biologiques.
520 |a"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.
650 0|aBiologicals|xGovernment policy|zCanada.
650 0|aBiologicals|xLaw and legislation|zCanada.
650 0|aDrug approval|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLigne directrice sur les changements survenus après l'avis de conformité : |w(CaOODSP)9.961958
85640|qPDF|s1.05 MB|uhttps://publications.gc.ca/collections/collection_2026/sc-hc/H164-425-2026-eng.pdf
8564 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-notice-compliance-changes/quality-biologics.html
986 |a260043