Overview of the format and content for post-market drug benefit-risk assessment in Canada – guidance document

From Health Canada


The objective of this guidance document is to assist Market Authorization Holders (MAHs) in developing a post-market benefit-risk assessment for a marketed drug when requested.

Who this guide is for

  • Market Authorization Holders (MAH) for marketed drugs in Canada
  • Consultants who prepare post market benefit-risk assessments

In this guide

View complete guide
Download PDF (394 KB, 21 pages)

Details and history

Published: February 8, 2019

Consulted: May 15, 2014

For assistance

Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 1912C
Ottawa, Ontario
K1A 0K9
E-mail: hc.mhpd-dpsc.sc@canada.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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