Risk Management Plan (RMP) in XML

Pharmaceutical eConsulting now also offers to convert your EU-RMP Annex 1 to the in EU required XML file.

As of 1 May 2010 only XML files (generated by Visual Basic Form version 3) will be accepted as EU-RMP Annex 1.

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).

Please contact us at contact@pec-services.com to learn how Pharmaceutical eConsulting can start helping you today and in the future.