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020 |a9780660995779
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-424/2026E-PDF
24500|aGuidance on post-notice of compliance changes : |boverall quality document for biologic and Schedule C drugs for human use.
264 1|aOttawa : |bHealth Canada = Santé Canada, |cMay 15, 2026.
264 4|c©2026
300 |a1 online resource (ii, 26 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 : document de synthèse sur la qualité pour les médicaments biologiques et les médicaments de l'annexe C destinés à l'usage humain.
520 |a"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.
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)9.961956
85640|qPDF|s686 KB|uhttps://publications.gc.ca/collections/collection_2026/sc-hc/H164-424-2026-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/overall-quality-document-biologic-schedule-c-drugs-human-use.html
986 |a260041