Changed procedure for information on duplicate closed and nullified closed cases (updated)
Update 15 July
The implementation took place on 11 July 2014.
Update 11 July
The new process for dispatching adverse reaction reports (ASPR) will be implemented on 12 and 13 July 2014.
Update 30 June
The implementation of the new process for dispatching adverse reaction reports (ASPR) was scheduled for 28 and 29 June 2014. However, the implementation has been postponed. We will update this page as soon as we have a new date for the implementation.
During the weekend of 28-29 June 2014, the Danish Health and Medicines Authority will implement a new process for dispatching adverse reaction reports (ASPR) to the marketing authorisation holder (MAH) when cases are duplicate closed and when cases are nullified closed.
In future, the information will be sent by way of an updated ASPR to all the MAHs that have previously received versions of the case in question.
The MAH that requests nullification will not receive the information when the case has been nullified closed.
If the Danish Health and Medicines Authority disagrees that a case should be nullified, all MAHs will receive an updated version of the case stating the reason why the case is not nullified, including the MAH that sent the request.
To the extent possible, the MAH must return an Acknowledgement Message (ACK) of duplicate closed and nullified closed cases. If this is not possible, because the case is no longer available in the MAH’s database, the MAH should contact us by email to E2B@dkma.dk