Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions

Name: Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

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.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2023-09-01

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions (French, HTML) HTML
Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions (English, HTML) HTML

Related open data

Health Canada