Summary: Guidance Document Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs
From Health Canada
Useful Resources
- Learn more about Industry requirements for non-prescription drug labels
- Learn more about how to use non-prescription drug labels
- Guidance Document: Labelling Requirements for Non-prescription Drugs
- Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products
- Guidance Document: Labelling of Pharmaceutical Drugs for Human Use
- Guidance Document: Post-Drug Identification Number (DIN) Changes
- Guidance Document: Electronic Canadian Drugs Facts Table (eCDFT) Technical Standards
Related acts and regulations
- Food and Drugs Act
- Food and Drug Regulations
Date adopted: 2017/01/19
Date posted: 2020/03/23
Effective date: 2020/04/01
Overview
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
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
Email: nnhpd.consultation-dpsnso@hc-sc.gc.ca