Pre-submission request form

Request for a European Medicines Agency procedure prior to the submission of a marketing authorisation application or Article 58 Application.

The applicants should use the IRIS platform when applying for eligibility selecting submission type "Eligibility and letter of intent".

Further guidance on the use of the IRIS platform and how to prepare submissions is available on the dedicated IRIS website and in the below documents:

IRIS guide to registration and RPIs

Reference Number: EMA/444925/2018 Version 2.19 Summary:

Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration.

IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants

Reference Number: EMA/444925/2018 Version 3.14