000	00000cam 2200000zi 4500
001	9.961959
003	CaOODSP
005	20260525120744
006	m     o  d f
007	cr cn ||||||||
008	260416e20260515onc     o    f000 0 eng d
020	|a9780660995816
040	|aCaOODSP|beng|erda|cCaOODSP
043	|an-cn---
086	1 |aH164-426/2026E-PDF
245	00|aGuidance on post-notice of compliance changes : |bquality for schedule C drugs.
264	1|aOttawa : |bHealth Canada = Santé Canada, |cMay 15, 2026.
264	4|c©2026
300	|a1 online resource (v, 80 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 médicaments de l'annexe C.
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|aRadiopharmaceuticals|xGovernment policy|zCanada.
650	0|aDrug approval|zCanada.
710	1 |aCanada. |bHealth Canada, |eissuing body.
775	08|tLigne directrice sur les changements survenus après l'avis de conformité : |w(CaOODSP)9.961960
856	40|qPDF|s1.03 MB|uhttps://publications.gc.ca/collections/collection_2026/sc-hc/H164-426-2026-eng.pdf
856	4 |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-schedule-c-drugs.html
986	|a260045