Summary: Guidance Document Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs

From Health Canada

Date adopted: 2017/01/19
Date posted: 2020/03/23
Effective date: 2020/04/01


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 non-prescription (Over-the-Counter, OTC) drug products. These amendments are commonly referred to as the Plain Language Labelling (PLL) Regulations.

Who this guide is for

Non-prescription drug sponsors seeking clarification on the Plain Language Labelling Regulations

View complete guide

Download PDF (381 KB, 36 pages) 

For assistance

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

Contact us:

Bureau of Product Review and Assessment
Natural and Non-prescription Health Products Directorate
Health Products and Food Branch
Health Canada
250 Lanark Avenue
Address Locator 2002B
Ottawa, Ontario
K1A 0K9 (Canada Post delivery including Xpress Post)
K1Z 1G4 (Courier service excluding Xpress Post)

Telephone: 613-960-8827

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