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null We have downloaded a report X from the EudraVigilance database to our own database, on active substance simvastatin, for which we have a MA in Finland. Shall we submit our own report to the EudraVigilance database?

We have downloaded a report X from the EudraVigilance database to our own database, on active substance simvastatin, for which we have a MA in Finland. Shall we submit our own report to the EudraVigilance database?

You shall not submit the case again to the EudraVigilance database. By doing so you will create a duplicate, making extra work for the EMA and the national authority.
24 Jan 2018