Updated Plain-Language Labelling Guidance from Health Canada

Overview

Food and Drug Law
Food and Drug Regulatory Law Health Canada has updated its guidance to indicate that 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.

The guidance can be found here.

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