A new Drug Facts Table for Non-prescription Drugs Guidance Document supporting improved labelling for Canadians

You are invited to provide comments on the Draft version of the Drug Facts Table for Non-prescription Drugs Guidance Document during the 60-day consultation period.

Why

Canadians use non-prescription drugs on a daily basis to:

• care for themselves and their families
• keep healthy and treat minor ailments

You can buy non-prescription drugs without a prescription from your doctor.

The Drug Facts Table for Non-prescription Drugs Guidance Document gives direction for designing safe and clear labels and packages. It is intended to be used by:

• sponsors
• manufacturers
• licence holders

All labelling and packaging regulatory requirements must be met.

Recommendations provided in this guide will assist package designers to organize:

• information required by the regulations
• other information needed by consumers to properly identify, choose, and use the products.

This will help package designers create labels and packages that:

• are clear
• are effective
• minimize the risk of errors causing harm

Who

This consultation seeks comments from:

• industry
• consumers who choose these products
• health care professionals
• all others who have an interest in this matter

What

The purpose of this consultation is to ask for comments on the Drug Facts Table for Non-prescription Drugs Guidance Document.

The guidance document shows examples of Drug Facts Tables for medicinal ingredients that are present in non-prescription drugs in Canada. They are based on the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (June 30, 2016).

What does this mean for Canadians?

The Drug Facts Table provides a standardized format and location (on the label) for important product information. This helps consumers find and compare information quickly and easily.

The revised guidance advises package designers how to create labels that show consumers the information required. 

What does this mean for industry?

Plain Language Labelling amendments to the Food and Drug Regulations for non-prescription drugs will take effect on June 13, 2017. The Regulations impose new obligations on:

• sponsors
• manufacturers
• licence holders

They will have to include a Drug Facts Table on the outer label of products sold in Canada.

The new requirements must be in full compliance at the retail level by June 30, 2021. However, we recommend applying the new process as early as possible.

When and where

The consultation will be available online between February 20 and April 21, 2017.

How to participate

You may submit your comments by filling out the Comment Template and submitting it:

• online
• by email to nnhpd_consultation_dpsnso@hc-sc.gc.ca, in electronic files such as:
  • Microsoft Word
  • Adobe Acrobat
• by mail - to the address listed below in the ‘Contact us’ section

We will review and consider all comments received by April 21, 2017.

Related information

• Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPPG)
• Guidance Document – Questions and Answers: Plain Language Labelling Regulations

Contact us

Health Canada
Health Products and Food Branch
Natural and Non-Prescription Health Products Directorate
250 Lanark Avenue, Address Locator: 2003C
Ottawa, Ontario  K1A 0K9

Attention: Consultations

Email: nnhpd_consultation_dpsnso@hc-sc.gc.ca