The Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions outlines policy and guidance for industry and staff regarding the submission of information for marketing authorisation of new drugs pursuant to the Food and Drugs Act and Food and Drug Regulations.
The purpose of the guidance document is to outline the requirements when preparing submissions that rely on Certificates of Suitability (CEPs) issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM) to support the safety and effectiveness of a drug. It can also be used as guidance on the requirements for related drug submissions (for example, SNDSs, SANDSs, Post-NOC Changes).
This consultation is open for comment starting January 31, 2017 until May 1, 2017. Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:
Bureau of Pharmaceutical Sciences
Therapeutic Products Directorate
Address Locator 0201D
101 Tunney's Pasture Driveway
For your convenience, please find attached a template for your comments.
Interested parties are encouraged to provide comments and suggestions by May 1, 2017.
Health Canada will make the results of this consultation available by email on request.
If you have any questions, contact us at Bureau of Pharmaceutical Sciences.
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