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LABEL AND INGREDIENT REVIEW

MEDERA can also handle the associated review of product labels to ensure compliance with Canadian labelling regulations as found in the Food and Drugs Act (FDA).

All labelling materials must be compliant with Canadian Regulations and the marketing authorization for the product including:

  • Package labels
  • Cartons
  • Product inserts
  • Product monographs

Our Canadian Regulatory services include pre-approval label reviews or label development to guide, and advise you on changes to labelling which will help maximize claims and/or expedite product approvals

MEDERA also offers post-approval label reviews to ensure compliance with the marketing authorization or to help identify where supplemental filings to Health Canada may be required

Pursuant to the New Substances Notification Regulations (NSNR), the Domestic Substances List provides an exhaustive listing of substances which are known to be in commerce for the manufacture of products regulated under the Food and Drugs Act (FDA). Products not on the DSL list are therefore subject to the NSNR. A submission is prepared to Health Canada and Environment Canada who jointly determine, based on our submission, whether the manufacturing or importing of the substance poses any risk to the health of Canadians or the environment.

Contact us to find out more about our regulatory consulting services or to receive a free copy of our white paper on marketing a healthcare product in Canada, click here.