Order Book National Type IB

The order book for type IB variations is a list of national variations awaiting to be initiated.

The list contains variation applications of various degrees of complexity requiring different skills of the officers reviewing the applications. Some variations may also be given a higher priority, for example because of supply difficulties. Consequently, the cases in this order book will not be reviewed in the order submitted, but will be initiated once the required resources become available.

The variations are sorted by date of receipt with a case number and a CESP submission ID. The individual case number is allocated by the Danish Medicines Agency and communicated to the applicant during the review of the application. When known to the applicant, the case number is cited when making enquiries to the Danish Medicines Agency. The CESP submission ID is an identification number of the first submission for each variation application made through CESP (Common European Submission Portal). The case number and the CESP submission ID are known only to the Danish Medicines Agency and the applicant. The order book is updated daily.

If you have any questions or are unsure which case number to use for the order book, please send an email to: GOD@dkma.dk