Validation
The rMS will validate whether the clinical trial falls within the scope of the CTR and whether the application dossier is complete in accordance with Annex I of the CTR.
In multinational trials, the rMS also have to take into account the considerations of MSc send to the rMS (days 0-7). Within 10 days after submission date the rMS will communicate via CTIS to the sponsor whether the clinical trial falls within the scope of the CTR and whether the application is complete. In case the rMS is of the opinion that the application is not complete or out of scope, it shall inform the sponsor and set a maximum of 10 days for the sponsor to respond. After receipt of the sponsor's reply, the rMS has 5 days to notify the sponsor if the application is valid or not.
If the rMS has not notified the sponsor within the timelines set, the application will be tacitly valid. If the sponsor has not replied within the timeline set, the application will automatically lapse.
Validation date
The validation date is the date on which the sponsor is notified about the conclusion of the validation phase or in case the sponsor is not notified the last day of the validation period.