Tabular recap of the procedural steps of a MAA

The table gives an overview of the procedural steps of a Marketing authorisation application (adapted from EMA)

Steps prior to submitting an application                                When

Submission of eligibility request                                             18 to 7 months before submission

Notification of intention to submit an application                      7 months before submission

Appointment of rapporteurs

Pre-submission meetings (recommended)                               6 to 7 months before submission

Re-Confirmation of communicated submission date                  2 to 3 months before submission

Submission of the application

Submission of the application

Validation of the application

Assessment of the application                    

Scientific evaluation                                                                  takes up to 210 active days

CHMP scientific opinion

European Commission decision                                     within 67 days of receipt of CHMP opinion

 

For further reference, please see Lesson 1 of this course.