Risk Management Plan (RMP)
As of 1 May 2010 only XML files, generated by Visual Basic Form version 3, will be accepted as EU-RMP Annex 1.
We have the tool and expertise to convert your EU-RMP Annex 1 to the in EU required XML file.
The EU-RMP Annex 1 shall reflect the final version of the EU-RMP as agreed at the time of the initial CHMP Opinion and any following CHMP Opinions referring to updates to the EU-RMP.
The electronic submission to EudraVigilance is due within 15 calendar days after the publication of the European Commission Decision (for new marketing authorisations and updates in the context of line extensions) or 15 calendar days after the receipt of the CHMP Opinion (for all other updates to the EU-RMP).