Guidance document : submission of risk management plans and follow-up commitments. : H164-187/2015E-PDF
"Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective. ... This document provides the sponsor/market authorization holder (MAH) with guidance on how to proceed when submitting a Canadian RMP in the European Union (EU) format or other recognized formats (e.g., United States (US) Risk Evaluation and Mitigation Strategy [REMS]), as well as RMP follow-up commitments and updates with Health Canada"--p. i and p. 1.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.801456&sl=1
| Ministère/Organisme | Canada. Health Products and Food Branch. |
|---|---|
| Titre | Guidance document : submission of risk management plans and follow-up commitments. |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| Note(s) | Issued also in French under title: Présentation des plans de gestion des risques et des engagements en matière de suivi. “Effective Date: June 26, 2015.” |
| Information sur la publication | Ottawa : Health Canada, 2015. |
| Description | iii, 17 p. |
| ISBN | 978-0-660-02634-3 |
| Numéro de catalogue |
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| Numéro de catalogue du ministère | 150031 |
| Descripteurs | Drugs Risk management Guidelines |
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