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Canada Updates Labeling Process for Generic Drugs

April 10, 2013

Health Canada announced it will regularly post a table on its website which reflects updated and new safety information in Product Monographs (PM) of brand-name pharmaceutical drug products - only those regulated under Division 8 of the Food and Drug Regulations - to identify the section of the PM that was updated pursuant to Notifiable Change or Supplemental New Drug Submission.

The table is aimed at informing generic drug manufacturers about new safety information for pharmaceutical drug products so that they can update their PMs for health care professionals and Canadians. All manufacturers are required under the Canadian Food and Drug Regulations to ensure drug product labeling, including the PM, is up to date and supports safe conditions of use.

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