1. What is the purpose of RNT?

The content of a DDAE is defined by regulations (see Constituer son dossier d'autorisation [FIC 0020] ). The main aim of the RNT is to make the information contained in the ED easier to understand, particularly for the public. The challenge in drafting the RNT is to produce a summary that is precise, sufficiently detailed and, above all, easy to understand, so that it can be understood by anyone who is not familiar with the regulatory, technical and scientific aspects of the subject of the study.

It is therefore necessary to :