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Regulatory Focus™ > News Articles > Canada Implements New Labeling Update Process for Generics

Canada Implements New Labeling Update Process for Generics

Posted 22 February 2013 | By Louise Zornoza

Health Canada has announced that generics companies will have soon have timely access to new safety-labeling changes made to the Product Monographs (PM) for Canadian Reference Products (CRPs), pursuant to a Notifiable Change or Supplemental New Drug Submission made by a branded pharmaceutical company.

The changes, announced 21 February 2013, is intended to improve timeliness of information in order to facilitate the required corresponding updates to generic PMs.  Manufacturers of authorized generic products will be required to file submissions to update their labeling within 30 days of the date of the posting on the table of the labeling change for the CRP. 

The requirement applies to all companies with generic products, including those that are not marketed in Canada but have Drug Identification Numbers (DINs) assigned to them, as well as generic products on Intellectual Property (IP) hold. 

The changes will be available to see through an online table hosted on Health Canada's website. Health Canada intends to assess the effectiveness of this new notification process at some later point in time, and has requested comments on this new initiative.


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