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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.801456&sl=0
| Department/Agency | Canada. Health Products and Food Branch. |
|---|---|
| Title | Guidance document : submission of risk management plans and follow-up commitments. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| 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.” |
| Publishing information | Ottawa : Health Canada, 2015. |
| Description | iii, 17 p. |
| ISBN | 978-0-660-02634-3 |
| Catalogue number |
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| Departmental catalogue number | 150031 |
| Subject terms | Drugs Risk management Guidelines |