Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions (English, HTML)

View metadata and access the original English HTML file: Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions.

Format

HTML

Access

file-only

Publisher-reported update

2023-09-01

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.

Access original file