Non-clinical documentation for mixed marketing authorisation applications - Scientific guideline

This document aims to give advice to applicants who plan to submit a mixed marketing authorisation application for medicinal products for human use. It applies to conventional chemical active substances of defined structure.

Keywords: Mixed marketing authorisation application, documentation, non-clinical

Current effective version

Guideline on the non-clinical documentation for mixed marketing authorisation applications - First version

Adopted Reference Number: CPMP/SWP/799/95 Legal effective date: 30/04/2006