00000nam 2200000zi 4500 9.867837 CaOODSP 20221107162423 m o d f cr ||||||||||| 190131t20192019onc |o f000 0 eng d 9780660294506 CaOODSP eng rda CaOODSP n-cn--- H164-271/2019E-PDF Guidance document : post-notice of compliance (NOC) changes : safety and efficacy document. Post‐NOC changes: safety & efficacy Ottawa, ON : Health Canada = Santé Canada, 2019. ©2019 1 online resource (20 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier "Publication date: July 2019." "Date adopted: 2009/09/02; revised date: 2019/08/12; effective date: 2019/08/12." Issued also in HTML format. Issued also in French under title: Changements survenus après l’avis de conformité (AC) : document sur l’innocuité et l’efficacité. "This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. These new drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use and pharmaceutical and certain biotechnological products for veterinary use1, including those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold"--Introduction, page 6. Drugs Labeling Canada. Drug approval Canada. Canada. Health Canada, issuing body. Ligne directrice : (CaOODSP)9.867839 PDF 357 KB https://publications.gc.ca/collections/collection_2021/sc-hc/H164-271-2019-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/safety-efficacy-document.html