The sponsor has the option to withdraw an application for a clinical trial until the decision is made.

In cases of withdrawal of an application before the reporting date of part I, the withdrawal will apply to the entire application in all MSc. After the reporting date, but before the decision is taken by a particular MSc, the sponsor has the option to withdraw the application in one, two or all MSc. Once the decision regarding an application is taken, a sponsor no longer has the possibility to withdraw the application.

After a withdrawal has taken place, resubmission is possible (CTR article 13). A resubmission is also possible following the refusal to grant an authorization.

If a clinical trial does not start and the sponsor decides not to carry out the clinical trial in a MSc, the application will expire after 2 years from the date of decision. 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.