The sponsor has the option to withdraw an application for a clinical trial until the decision is made.
In multinational applications, withdrawing the application before the entry of the Part I Conclusion results in withdrawal for all Member States Concerned (MSCs). After the Part I Conclusion, an application can be withdrawn for specific MSCs, but only for MSC that have not yet entered their national decision on the application.
After a withdrawal has taken place, resubmission is possible (CTR article 13). A resubmission is also possible following a negative decision, a lapsed application due to not responding on time to an RFI, or after a negative validation outcome.
If a clinical trial has not started in an MSC within 2 years after the initial authorisation, the authorisation will expire. Otherwise, once the clinical trial has been started, it may be an early termination if the clinical trial does not proceed.
See also question 4.1 and 4.3 of the Q&A CTR.