1
The ethics committee shall confirm receipt of the application to the sponsor within 10 days and notify the sponsor of any formal deficiencies in the application documents. It shall give the sponsor 10 days to rectify the deficiencies and inform the sponsor that it shall not admit the application if the deficiencies are not rectified within this period.
2
It shall make its decision within 40 days of confirming receipt of the formally correct application documents.
3
If the ethics committee demands additional information in accordance with Article 10 paragraph 2, the 40-day period shall be paused until the information is received.