- Materially lacking or inadequately organised applications;
- Applications containing inadequate information for one or more indications;
- Applications relying on a single trial to demonstrate effectiveness, if FDA has previously determined that more than one trial is needed;
- Applications missing studies related to the potential abuse of a drug;
- A failure to submit data electronically.
As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.