Guidance document : post-notice of compliance (NOC) changes : framework document (pharmaceutical, biologic and radiopharmaceutical drugs for human use only). : H13-9/31-2019E-PDF
"After a new drug as defined in section C.08.001 of the Food and Drug Regulations has been granted a Notice of Compliance (NOC), it is not uncommon for sponsors to make changes to the drug. A post-NOC change is any change that is made to a new drug that has received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. Many of these changes may be made to improve the quality of the drug product or the efficiency of the manufacturing process, or they could be made for marketing considerations. Changes to the labelling of a drug product could include adding new indications, improving the management of risk for a product by adding warnings, limiting the target population or changing the dosage regime etc."--Introduction, page 6.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.866456&sl=1
| Ministère/Organisme | Canada. Health Canada, issuing body. |
|---|---|
| Titre | Guidance document : post-notice of compliance (NOC) changes : framework document (pharmaceutical, biologic and radiopharmaceutical drugs for human use only). |
| Variante du titre | Post-notice of compliance (NOC) changes : framework document (pharmaceutical, biologic and radiopharmaceutical drugs for human use only) |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| Note(s) | Cover title. Issued also in HTML format. "Effective date: 2020/04/01." Issued also in French under title: Ligne directrice : changements survenus après l’avis de conformité (AC) : document cadre (médicaments pharmaceutiques, biologiques et radiopharmaceutiques à usage humain seulement). |
| Information sur la publication | Ottawa, ON : Health Canada = Santé Canada, 2019. ©2020 |
| Description | 1 online resource (16 pages) |
| ISBN | 9780660291475 |
| Numéro de catalogue |
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| Numéro de catalogue du ministère | 180707 |
| Descripteurs | Drugs -- Labeling -- Canada. Drug approval -- Canada. |
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