Notice: Revisions to the Guidance Document: Questions & Answers: Plain Language Labelling Regulations for Prescription Drugs

August 8, 2019
Our reference number: 19-111918-266

Health Canada revised the Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs. 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. A draft of the updated Guidance Document underwent a targeted 30-day industry consultation in the fall of 2018. We received feedback from a number of stakeholders who were generally supportive of the additional clarity and provided specific recommendations where further refinements could be made to improve the Guidance Document. Comments received on the proposed changes, were taken into consideration and further revisions were made to clarify the text, and answer common questions.

The guidance is being updated at this time to reflect the outcome of the consultation and to address common questions from industry identified while implementing the Plain Language Labelling (PLL) Regulations. The proposed changes also provide greater clarity and flexibility to sponsors regarding complying with the PLL regulations for prescription drugs.

Changes include:

1. Updated/clarified outdated information and restructured information to enhance readability, specifically:
   • Removed references to non-prescription drugs, to the appendix on Canadian Drug Facts Table, and to the coming into force information (sections 1-4)
   • Revised mock up requirements to enhance readability (section 5.8)
2. Clarified acceptable flexibilities with respect to complying with PLL requirements, including:
   • what post-approval changes can come in as a supplemental submission versus those that can be addressed through a Level III Notification filing (section 5.11)
   • additional examples of acceptable font type, expiry date format, lot format, and contact information that can be used when preparing mock-ups (section 5)
   • for supplemental and certain administrative submissions, where the labels are not changed, mock ups and package inserts are not required to be filed (section 5.8, and 5.10)

This guidance document comes into effect immediately. Questions or concerns related to this guidance document should be directed to:

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
E-mail: hc.policy.bureau.enquiries.sc@canada.ca