IUCLID 6.9 MRL Application manual

This manual provides an introduction to the regulatory framework for MRL submissions and the requirements describing the conditions in which a IUCLID MRL application is needed. It provides instructions on the information required in each field for every IUCLID 6.9 document it includes. IUCLID documents are based on standardised formats and several sections, called common blocks, are reused in many documents throughout the dossier (e.g. information on the test material). The manual also describes how to provide the information in Entities e.g. the literature reference entity, which can be reused in different IUCLID documents. 

The manual can be used by applicants when preparing an application for an "MRL Application" and by evaluators when reviewing these applications.

This manual is updated annually to ensure alignment with the latest IUCLID format release, the last one being May 2025.