Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs
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From Health Canada
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
- Prescription drug sponsors seeking clarification on the Plain Language Labelling Regulations
In this guide
- Section 1: Overview
- Section 2: General Plain Language Requirement
- Section 3: Brand Name Assessment Requirement
- 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?
- 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?
- 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?
- 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
- April 30, 2015
- August 8, 2019
- Part of topic(s):
- Plain Language Labelling Regulations
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