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 Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems  (Doc.Ref. EMA/838713/2011)

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 missing information in relation to suspected adverse reactions reported to EudraVigilance for centrally authorised medicinal products in line with Regulation No. 726/2004. 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 (version 5): Interface between EU-RMP and EudraVigilance is available in three different versions to suit your operating system:

• Windows 32-bit,(requires .net version 4)
• Windows 64-bit (requires .net version 4)                         

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 August 2013, the content of the template of the EU-RMP Annex 1 has been simplified and improved to capture the core elements of the RMP (i.e. risks, pharmacovigilance and risk minimisation activities, interactions), in addition to some basic administrative information. Please be advised that, from this date, the previous RMP Annex 1 template will not be valid for data submission.

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 30 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 your 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
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.

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Last update: Wednesday, 6 July 2016.