Notice: Updates to the Guidance Document Question and Answers: Plain Language Labelling Regulations

February 2, 2016

Our file number: 16-101100-564

Effective immediately, Notifiable Change (NC) and post-authorization Division 1 change (PDC) submissions will no longer require mock-ups of the Product Monograph (PM), package insert, or inner and outer labels as part of their submission package. This applies to pharmaceutical drugs, biologic drugs, and radiopharmaceuticals which are available by prescription or administered/obtained through a health professional. Accordingly, the Guidance Document: Questions and Answers: Plain Language Labelling Regulations has been updated.

In place of mock-ups, annotated written text will be considered acceptable to reflect any proposed changes to the PM, package insert, or inner/outer label. Sponsors are still expected to submit this written text in both official languages, as well as the Mock-up Labels and Packages Certification Form. If sponsors submit mock-ups for these types of submissions, the design elements may not be reviewed.

For NC and PDC submissions that are in review as of the date of this Notice and that contain mock-ups of the PM, package insert or inner/outer label, the written text of the mock-up will be reviewed. Comments may not be provided on the design elements.

All other Plain Language Labelling (PLL) requirements continue to be applicable to all submissions. For products already approved as per the mock-up requirement, sponsors are expected to continue to maintain the compliance of their labels with PLL principles (for example, to maintain font size, legibility, colour, layout, format, plain language, etc.), even in the absence of filing a mock-up with their NC or PDC submission.

Questions or concerns related to this guidance document should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa, Ontario
K1A 0K9

Facsimile: (613) 941-1812

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