ANNEX 1 OF THE EU RISK-MANAGEMENT PLAN

The EU-RMP Annex 1 is the structured electronic representation of the EU Risk Management Plan as referred to in Volume 9A of the Rules Governing Medicinal Products in the European Union (Chapter 5.1.1):

Template for the EU Risk Management Plan (EU-RMP) (Doc.Ref. EMEA/192632/2006)

The template for the electronic representation is also referred to as “Interface between EU-RMP and EudraVigilance” with two main purposes. Firstly, it facilitates the monitoring of identified and potential risks and important missing information in relation to suspected adverse reactions reported to EudraVigilance for centrally authorised medicinal products in line with Regulation No. 726/2004. Secondly, with release of version 3, the EU-RMP Annex 1 also supports the monitoring of risk management activities by means of the European Pharmacovigilance Issues Tracking Tool (EPITT).

Both EudraVigilance and EPITT are accessible to all Medicines Regulatory Agencies in the EEA and the European Medicines Agency.

EU-RMP Annex I: Interface between EU-RMP and EudraVigilance (Visual Basic Form Version 3)

The EU-RMP Annex 1 is set up as a form in Visual Basic. Following completion of the form an XML file will be generated. For further guidance please consult the user manual available at the bottom of this page.
This XML file should be sent via EudraLink to h-eurmp-evinterface@ema.europa.eu.

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

When to submit the 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 30 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).

EU-RMP Annex 1 Computer setup
Security systems installed on your computer may prevent you from opening the setup package (zip file) directly. If this occurs, please choose the option 'save' to save the file on your PC, and then open the saved copy. The setup package contains risksetup.msi and setup.exe that will install the application on you local system. Please save both files to your local system in the same place and then run setup.exe by double clicking on it. For further guidance please consult the user manual.

EU-RMP Annex 1 User Manual
Download user manual (PDF) for creation, follow-up and sending of EU-RMP Annex 1 (Interface for EudraVigilance).

EU-RMP Annex 1 Updates
Version 3 of the Visual Basic Form application will automatically check for available updates to the application and dictionary files. Available updates will be highlighted and the application updated by using the ‘Download Updates’ function. For further guidance please consult the user manual.

EU-RMP Annex 1 Updating From Version 1.0 or 1.1 to 3 (01/05/2010)
If you have previously installed an older version of the EU-RMP Annex 1 application please save all you current work and uninstall the older software before installing the new version of the application. It is also advisable before you do this for you to make back-up copies of any EU-RMP Annex 1 files you have previously created. To uninstall the application please select “Control Panel” from the Windows start menu and then select “Add/Remove Program”. From the list of applications shown you should be able to choose and remove the previous “RMP Annex 1” application.

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Last update: Wednesday, 30 November 2011.