Preparing and submitting summary reports for marketed drugs and natural health products : guidance document for industry. : H164-235/2018E-PDF
"This guidance document provides market authorization holders (MAHs) with information on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Products Regulations with respect to preparing and submitting annual summary reports (ASRs) and issue-related summary reports (IRSRs)"--Scope and Application, p. 1.
Lien permanent pour cette publication :
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| Ministère/Organisme | Canada. Health Canada. |
|---|---|
| Titre | Preparing and submitting summary reports for marketed drugs and natural health products : guidance document for industry. |
| Variante du titre | Guidance document for industry |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| Note(s) | "Effective Date: May 23, 2018." Title from cover. "Your health and safety ... our priority." "MedEffect Canada. Together we can improve health product safety." The copy has been replaced on January 21, 2022 as requested by the issuing department. Issued also in French under title: Préparation et présentation de rapports de synthèse pour les drogues et les produits de santé naturels commercialisés : document d’orientation à l’intention de l’industrie. Includes bibliographical references. |
| Information sur la publication | Ottawa : Health Canada, 2018. |
| Description | iii, 25 p. |
| ISBN | 978-0-660-26506-3 |
| Numéro de catalogue |
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| Numéro de catalogue du ministère | Pub.: 180054 |
| Descripteurs | Products Reports Industrial policy |