Guidance Document - Submission of Risk Management Plan and Follow-up Commitments

From: Health Canada

Overview

The objective of this guidance document is to assist industry and interested stakeholders (Market Authorization Holders (MAHs)) in developing a Risk Management Plan and Follow-up commitments when requested.

Notice:

As part of its transparency initiatives, Health Canada indicates for each drug in the Drug Product Database, whether a Risk Management Plan (RMP) has been reviewed and provides a list of additional risk mitigation measures (beyond labelling) and characterization activities for the drug if applicable. 

Who this guide is for

  1. Market Authorization Holders (MAH) for drugs in Canada
  2. Consultants who prepare Risk Management Plan

In this guide

View complete guide      

Download PDF (226  KB, 23 pages)

Details and history

Published: May 18, 2015

Part of topic(s): Guidance on legislation

For assistance

Marketed Health Products Directorate

Health Products and Food Branch

Health Canada

Address Locator 1912C

Ottawa, Ontario

K1A 0K9

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: 613-954-6522

Our service hours are Monday to Friday from 8 a.m. to 6 p.m. (local time) and closed statuary holidays.

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