Important to know: A registration and use of the "OMS, Organisation Management Service", has been obligatory since 1 November 2021. Registration is a must before submitting of any application for admission.

Which questions are new or have been updated?

All revised questions concern section 2 "Steps prior to submitting the application":

• 2.2 How and when should the eligibility request be sent to EMA?
• 2.4 What is the procedure for appointment of Rapporteurs/Co-Rapporteurs and their assessment teams?
• 2.6 When should I submit my marketing authorization application?
• 2.7 How should I notify a change in the contact person and/or intended submission date of my application?
• 2.8 Is my product eligible for an accelerated assessment?
• 2.9 How are marketing authorisation application pre-submission interactions structured at the EMA?

Source:

EMA: Q&A for users of the centralised procedure

EMA: QMS