00000cam 2200000zi 4500 9.961955 CaOODSP 20260525121140 m o d f cr cn |||||||| 260416e20260515onc o f000 0 eng d 9780660995779 CaOODSP eng rda CaOODSP n-cn--- H164-424/2026E-PDF Guidance on post-notice of compliance changes : overall quality document for biologic and Schedule C drugs for human use. Ottawa : Health Canada = Santé Canada, May 15, 2026. ©2026 1 online resource (ii, 26 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 : document de synthèse sur la qualité pour les médicaments biologiques et les médicaments de l'annexe C destinés à l'usage humain. "This guidance document applies to sponsors intending to make changes to drugs that have received a NOC pursuant to Section C.08.004 of the Food and Drug Regulations, that are biologics and Schedule C drugs (radiopharmaceuticals and cold kits) for human use including those submissions for which a NOC has been recommended but the issuance of the NOC has been placed on hold"--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)9.961956 PDF 686 KB https://publications.gc.ca/collections/collection_2026/sc-hc/H164-424-2026-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/overall-quality-document-biologic-schedule-c-drugs-human-use.html 260041