The timing and planning of the submission of applications and the timetable for assessment of applications is important for applicants, marketing-authorisation holders (MAHs), the European Medicines Agency, and members and experts of the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Advanced Therapies (CAT).Timing applications appropriately enables the working plan to be as efficient as possible.
The Agency advises applicants to consider the date of submission very carefully, particularly for full applications, and to observe the joint guidance from EMA and Heads of Medicines Agencies below:
- Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines
Applicants should notify the Agency and the CHMP, PRAC or CAT rapporteurs and co-rapporteurs of their actual submission date. For full applications, see also the question on 'How should I notify a change in the intended submission date of my application?' in the pre-submission questions and answers.
Deadlines and timetables
- See the full list of procedural timetables.