The document below provides guidance on practical aspects of the implementation of the Agency's policy on the publication of clinical data for medicinal products for human use.

It covers guidance regarding:

- procedural aspects of the submission of clinical reports,

- the anonymisation of clinical reports, and

- the identification and redaction of commercially confidential information in clinical reports.

This document includes a checklist for the 'Redaction Proposal Document' package. The newest and running version published on 12/04/2017 as Revision 2, can be downloaded here.