Guidance document : post-notice of compliance (NOC) changes : safety and efficacy document. : H164-271/2019E-PDF
"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.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.867837&sl=1
| Ministère/Organisme | Canada. Health Canada, issuing body. |
|---|---|
| Titre | Guidance document : post-notice of compliance (NOC) changes : safety and efficacy document. |
| Variante du titre | Post‐NOC changes: safety & efficacy |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| Note(s) | "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. |
| Information sur la publication | Ottawa, ON : Health Canada = Santé Canada, 2019. ©2019 |
| Description | 1 online resource (20 pages) |
| ISBN | 9780660294506 |
| Numéro de catalogue |
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| Descripteurs | Drugs -- Labeling -- Canada. Drug approval -- Canada. |