| 000 | 00000cam 2200000zi 4500 |
| 001 | 9.961953 |
|---|
| 003 | CaOODSP |
|---|
| 005 | 20260525121008 |
|---|
| 006 | m o d f |
|---|
| 007 | cr cn |||||||| |
|---|
| 008 | 260416t20262026onc ob f000 0 eng d |
|---|
| 020 | |a9780660995755 |
|---|
| 040 | |aCaOODSP|beng|erda|cCaOODSP |
|---|
| 043 | |an-cn--- |
|---|
| 086 | 1 |aH164-423/2026E-PDF |
|---|
| 245 | 00|aGuidance on post-notice of compliance changes : |bframework for biologic and schedule C drugs for human use. |
|---|
| 264 | 1|aOttawa : |bHealth Canada = Santé Canada, |c2026. |
|---|
| 264 | 4|c©2026 |
|---|
| 300 | |a1 online resource (ii, 16 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 : cadre pour les médicaments biologiques et les médicaments de l'annexe C destinés à l'usage humain. |
|---|
| 500 | |a"Effective date: April 1, 2020. Revised date: May 15, 2026." |
|---|
| 504 | |aIncludes bibliographical references (page 13). |
|---|
| 520 | |a"In this guidance document, Health Canada outlines the overarching authorities, reporting categories and drug submission filing information for post-NOC changes for biologic and Schedule C drugs for human use"--page 1. |
|---|
| 650 | 0|aBiologicals|xGovernment policy|zCanada. |
|---|
| 650 | 0|aBiologicals|xLaw and legislation|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)9.961954 |
|---|
| 856 | 40|qPDF|s649 KB|uhttps://publications.gc.ca/collections/collection_2026/sc-hc/H164-423-2026-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/framework-biologic-schedule-c-drugs-human-use.html |
|---|
| 986 | |a260039 |
|---|