00000cam 2200000zi 4500 9.961957 CaOODSP 20260525121048 m o d f cr cn |||||||| 260416e20260515onc o f000 0 eng d 9780660995793 CaOODSP eng rda CaOODSP n-cn--- H164-425/2026E-PDF Guidance on post-notice of compliance changes : quality for biologics. Ottawa : Health Canada = Santé Canada, May 15, 2026. ©2026 1 online resource (iv, 79 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Ligne directrice sur les changements survenus après l'avis de conformité : qualité des produits biologiques. "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. Biologicals Government policy Canada. Biologicals Law and legislation Canada. Drug approval Canada. Canada. Health Canada, issuing body. Ligne directrice sur les changements survenus après l'avis de conformité : (CaOODSP)9.961958 PDF 1.05 MB https://publications.gc.ca/collections/collection_2026/sc-hc/H164-425-2026-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-biologics.html 260043