Asset Publisher

null We have received a report FI-FIMEA-2017XXXX at a subsidiary, but it concerned the product GoodDrug. We are not the MAH for this product in Finland, and do not have any other MAs in Finland for that active substance either. Why has the report been forwarded to us and what should we do about it?

We have received a report FI-FIMEA-2017XXXX at a subsidiary, but it concerned the product GoodDrug. We are not the MAH for this product in Finland, and do not have any other MAs in Finland for that active substance either. Why has the report been forwarded to us and what should we do about it?

Your HQ probably downloaded the report from EudraVigilance database and has a MA for the active substance somewhere elsewhere in the EU. You may enter the report into your database, and in this you are acting in accordance with your company instructions.

The report shall not be sent to the EudraVigilance database again because EudraVigilance will already have that report reported by the other MAH.

24 Jan 2018