Notice - Publication of the Health Canada Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions

August 21, 2017
Our reference number: 17-109186-659

A final version of the Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions is now available. Comments and suggestions received from the consultation between January 31, 2017 and May 1, 2017 on the draft version of the guidance were reviewed and considered in the finalization of this document. The results of this consultation are available by email on request to: bps_enquiries_enquetes_bsp@hc-sc.gc.ca

The guidance outlines 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.

Should you have any questions or comments regarding the content of the guidance, please contact: Bureau of Pharmaceutical Sciences.

Bureau of Pharmaceutical Sciences
Therapeutic Products Directorate
Health Canada
Address Locator 0201D
101 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9

Email: bps_enquiries_enquetes_bsp@hc-sc.gc.ca
Telephone: 613-948-7350
Facsimile: 613-957-3989