Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs

From Health Canada

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 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

• Section 1: Overview
  • 1.1 What is the purpose of this document?
  • 1.2 What are the Regulations and what is their purpose?
  • 1.3 What products are within the scope of the Regulations?
  • 1.4 When do the Regulations come into force?
  • 1.5 Will the Regulations be applied retroactively?
• Section 2: General Plain Language Requirement
  • 2.1 What is the purpose of the general plain language requirement?
• Section 3: Brand Name Assessment Requirement
  • 3.1 What is the purpose of the brand name assessment requirement?
  • 3.2 How are brand names assessed by Health Canada?
  • 3.3 What is the meaning of Look-Alike Sound-Alike (LASA) health product names?
  • 3.4 Where can we find more information about brand name assessments?
• Section 4: Contact Information Requirement
  • 4.1 What is the purpose of the contact information requirement?
  • 4.2 To which prescription products does this contact information requirement apply?
  • 4.3 In order to comply with this requirement, how many means of contact must be listed?
  • 4.4 Is there particular wording that is required?
  • 4.5 Who can the contact person be?
  • 4.6 Where does the contact information need to appear?
  • 4.7 Does the current regulatory exemption (C.01.004 (3)) for special containers (e.g. blister packs) and for small containers still apply?
  • 4.8 Should contact information be added to existing approved labels?
• Section 5: Mock-up Requirement
  • 5.1 What is the purpose of the mock-up requirement?
  • 5.2 How will Health Canada review mock-ups?
    • What will be reviewed?
    • When should a Note to Reviewer be filed?
    • Timing of the review
    • Clarification requests
  • 5.3 When do final mock ups need to be provided?
  • 5.4 Are DINs required to appear on the final bilingual mock-ups?
  • 5.5 What is an acceptable format for listing the expiration date and lot number?
  • 5.6 What is an acceptable format in which to submit electronic mock-up labels?
  • 5.7 What Health Canada guidance documents will help sponsors prepare and file mock ups?
  • 5.8 What type of mock-ups and documents should sponsors submit for prescription products and products administered or obtained through a health professional?
    • (a) The Labels and Packages Certification Form for Prescription Drugs
    • (b) Inner/Outer Label Mock-ups of the inner/outer label(s) should be bilingual, in full colour, actual size and editable (e.g., PDF)
    • (c) Package Insert Mock-Ups
    • (d) Product Monograph/Prescribing Information
  • 5.9 What should be submitted and when for all submission types*?
  • 5.10 How will the mock-up provision be applied for other submission types?
    • (a) Notifiable Change -Safety and Efficacy
    • (b) Notifiable Change submissions or Post-Authorization Division 1 Change submissions (PDCs)
    • (c) Administrative Submissions
  • 5.11 What changes to the package label mock-ups will require the filing of a labelling only S(A)NDS submission/DINA and what can be filed as a Level III Annual Notification/ Post-authorization Division 1 Notification?
  • 5.12 How should a Level III Annual Notification or a Post-authorization Division 1 Notification be filed/submitted?
  • 5.13 What should sponsors file for multiple products that are making the same labelling changes?
• Section 6: Glossary
• Appendix A: Abbreviated Package Inserts

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Details and history

Published:

April 30, 2015

Updated:

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