When the Danish Medicines Agency sends adverse reaction reports via E2B to marketing authorisation holders (MAHs), it sometimes happens that an MAH returns the adverse reaction report to Danish Medicines Agency via E2B.
In such cases, the Danish Medicines Agency requests MAHs to follow the guidelines below:
If the MAH has no new information, but merely translated the adverse reaction report into English, the Danish Medicines Agency requests the MAH not to return the adverse reaction report to the Danish Medicines Agency.
This is to reduce the risk of duplicates. It is especially a problem in cases where the MAH uses its own Worldwide Reference Number instead of using the Worldwide unique case identification number (also called Worldwide Reference Number), which the adverse reaction report has received from the Danish Medicines Agency and which is in accordance with the rules described in the E2B(R2) Guideline.
The problem in such cases is that it is difficult for the Danish Medicines Agency's database to identify when an adverse reaction report is in reality a duplicate of a report already registered in the Danish Medicines Agency's database.
Therefore, the Danish Medicines Agency requests:
- that as long as there is no new information, marketing authorisation holders (MAH) do not return adverse reaction reports to the Danish Medicines Agency via E2B, which have originally been received from the Danish Medicines Agency.
- that when the adverse reaction report is to be returned to the Danish Medicines Agency with new information, marketing authorisation holders (MAH) follow the E2B(R2) Guideline section A.1.10, i.e. that they do not change the Worldwide Reference Number which the adverse reaction report originally received from the Danish Medicines Agency.
