Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs

From Health Canada


This document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for prescription products and those administered or obtained through a health professional.

Who this guide is for

  1. Prescription drug sponsors seeking clarification on the Plain Language Labelling Regulations

In this guide

View complete guide
Download PDF (690 KB, 34 pages)

Details and history

April 30, 2015
August 8, 2019
Part of topic(s):
Plain Language Labelling Regulations

For assistance

Contact us:

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

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Address Locator 3102C1
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812

Page details

Date modified: