2. Pre-submission


1. Pre-submission

The applicant should carefully consider all regulatory and logistical issues prior to submission of a marketing authorisation application (MAA), notably, which procedural approach to take. In the following, we will concentrate on the application for a centralised procedure, bearing in mind, that the principles apply to strictly national, mutual recognition procedure (MRP) and decentralised procedure (DCP) as well and addressing differences where appropriate.

To find out whether a product can be evaluated under the centralised procedure, an eligibility request should always be submitted using the Pre-submission request form (Eligibility) accompanied by a justification between 18 and, at the latest, 7 months before the MAA is filed with the EMA. At this point it could be submitted as part of the letter of intent to submit (pre-submission request form (intent to submit MAA)). Re-confirmation of the submission date initially communicated to EMA in this very letter, or information to EMA of any delays or cancellations should be carried out.

Appointment of Rapporteurs
The Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) appoint (co-)rapporteurs to conduct the scientific assessment. Additionally for advanced therapy medicinal products, the Committee for Advanced Therapies (CAT) is also involved in appointing (co-)rapporteurs.