Draft guidance on the plain language labelling regulations for prescription drugs: Overview
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Published: 2025-09-25
Date adopted: April 30, 2015
Effective date: September 25, 2025
Replaces: Guidance Document Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs
Document change log:
| Version | Location of change | Change made | Effective date |
|---|---|---|---|
| 1 | not applicable | Issued guidance | June 13, 2015 |
| 2 | Section 5: Mock-up requirement clarification around DIN-As and DIN-Bs |
Removed notifiable change (NC) and post-authorization Division 1 change (PDC) submissions from the mock-up requirement | February 2, 2016 |
| 3 | Section 5: Mock-up requirement | Clarified the submission of annotated text for notifiable changes | April 12, 2016 |
| 4 | Section 5: Mock-up requirement | Reorganized section on mock-ups Included text on recommended font size for labels and package inserts Added requirement to declare font size and style for labels and to provide a rationale, if expected font size is not met Removed requirement to submit package inserts for notifiable change and post-authorization Division 1 change submissions |
September 8, 2016 |
| 5 | Appendices | Added guidelines on abbreviated package inserts added as an Appendix | September 8, 2016 |
| 6 | Changes throughout and in section 5 | Clarified existing content Clarified what types of plain language labelling changes should be submitted for review and what are considered Level III – Annual Notification/Post-DIN notifications Captured Division 1 submissions |
August 8, 2019 |
| 7 | Changes throughout and in section 5 | Revised to accommodate notifiable changes to supplemental (abbreviated) new drug submissions | February 15, 2020 |
| 8 | Changes throughout and in section 5 | Revised and simplified to accommodate current style and format standards for web publication Added more examples of what types of plain language labelling changes should be submitted for review and what are considered Level III - Annual/Post-DIN notifications Clarified submission of second-language labelling materials Removed reference to safety and efficacy NCs Updated guidance for abbreviated package inserts |
September 25, 2025 |
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Purpose
This document explains how Health Canada interprets and applies the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for:
- prescription products
- products administered or obtained through a health care provider
Products include prescription pharmaceutical drugs, biologic drugs (Schedule D) and radiopharmaceuticals (Schedule C). The plain language labelling requirements for non-prescription products are set out in the following guidance document:
Note: The 2014 regulatory amendments are commonly referred to as “plain language labelling” in the Food and Drug Regulations (regulations).
Purpose of the regulations
The regulations aim to improve the safe use of drugs by making drug labels and packaging easier to read and understand. They impose obligations on health product sponsors to:
- provide information in plain language and an easy-to-read format
- assess the names of their health products to avoid confusion
- submit mock-ups of labels and packages for review
- indicate how to report harms on their product’s label
While these obligations form a coherent set of regulatory obligations, not all of them will apply to all health products. Also, some obligations came into effect at a different date (for instance, non-prescription drugs).
Scope
The regulations apply to prescription and non-prescription pharmaceutical drugs, biologic drugs and radiopharmaceuticals. There are also specific requirements that only apply to non-prescription drugs. These regulations do not apply to medical devices, veterinary drugs or natural health products.
The regulations for prescription pharmaceutical drugs, biologic drugs, radiopharmaceuticals and those administered or obtained through a health care professional came into force on June 13, 2015.
New requirements will be applied to submissions received on or after the coming-into-force dates. Labels and packages will be updated to reflect the new requirements as part of the life‑cycle of label and package revisions.
Note about guidance documents in general
Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.
Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read along with the accompanying notice and the relevant sections of other applicable guidance documents.
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