New EMA guidance on the IRIS platform

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure This guide has been produced to help new users of IRIS to complete the prerequisite steps before accessing the platform. Most of these steps are independent from the IRIS platform and are similar to those to obtain registration to use other European Medicines Agency (EMA) systems, such as Management Services for Substances, Products, Organisation and Referentials (SPOR).

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes This guidance document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the EMA’s position on issues that are typically addressed during the course of pre-submission meetings.