What is the most appropriate next regulatory step after a clinical trial for a medicinal product has been finalized in several European countries?

After the conclusion of a clinical trial for a medicinal product in several European countries, the most appropriate next step is to file a declaration on the end of the clinical trial to the Competent Authorities (CAs) and the ethics committees of the participating countries. This step is crucial in ensuring compliance with regulations governing the conduct of clinical trials and maintaining transparency with health authorities regarding the trial's status.

Filing this declaration serves multiple purposes: it provides formal confirmation that the trial has concluded, it may involve the submission of results or findings, and it fulfills regulatory obligations under the Clinical Trials Regulation in the European Union. Properly notifying the CAs and ethics committees allows these bodies to monitor the conduct of clinical trials, assess the safety of participants, and keep track of ongoing research activities.

Additionally, following this step, further actions such as analysis of data, preparations for regulatory submissions, and potential applications for marketing authorization would typically follow, but these would occur only after the necessary notifications have been completed.

The other options are not suitable in this context. Filing a quality report or submitting a new marketing application are steps that follow the completion of all clinical trial obligations and necessary analyses, while conducting further trials based on preliminary results is not appropriate immediately after trial completion—those decisions