5 April 2018 EMA/177298/2018 Information Management

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide Maintenance operations: Update of a marketing authorisation holder (MAH) organisation entity in the XEVMPD

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Table of contents 1.1. Update MAH information Example specification ........................................................ 3 1.2. Create an XEVPRM ................................................................................................ 4 1.3. Validate and send an XEVPRM ................................................................................ 8

All examples used in this step-by-step guide are fictitious and intended for demonstration purposes only.

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/177298/2018

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1.1. Update MAH information Example specification In this step by step guide, we are going to update the telephone number of an existing MAH organisation (i.e. an EV Code has been assigned in the XEVMPD) called 'Nobel Company'. The new telephone number is "+44 1234 1234".

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/177298/2018

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1.2. Create an XEVPRM 1) Log in to the requested EVWEB environment: EVWEB production:

https://eudravigilance.ema.europa.eu/x

XCOMP (test) environment:

https://evtest.ema.europa.eu/x

EVWEB training environment: https://eudravigilance-training.ema.europa.eu/x/

In the restricted area, click on "EVWEB":

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/177298/2018

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You are now logged in EVWEB – the organisation ID under which you are logged in is shown in the top right corner:

2) Go to "Medicinal Products" section, select MAH in the tree view, place you mouse in the search field:

3) Type "Nobel" and press enter, the results of your search will be displayed in the active area:

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/177298/2018

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4) Select the organisation which you wish to update by clicking inside the relevant box; the information for the MAH will be loaded in the tree view.

5) Click on the Organisation information corresponding to "Nobel Company" already loaded in the tree view, the dynamic buttons with different operation types will appear:

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/177298/2018

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6) Click on "Update"; you will be prompted to the "Create and Send Product Reports" Section with operation type "Update":

7) Enter the new information regarding the telephone number:

8) Finally, populate the Message number field:

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/177298/2018

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1.3. Validate and send an XEVPRM 1) Validate your XEVPRM by clicking on the "Validate" button.

New window will be displayed on your screen, showing the result of your validation.

You can dismiss the message by clicking on "OK". 2) Save the XEVPRM for your reference by clicking on the relevant button:

3) Send the XEVPRM by clicking on the "Send" button:

The below message will confirm that your XEVPRM has been sent:

If you want to view/save your file, click on "OK".

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/177298/2018

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The below message will be displayed, enabling you to save your XEVPRM file on your computer:

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/177298/2018

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eXtended EudraVigilance Medicinal Product Dictionary - European ...

Apr 5, 2018 - 4) Select the organisation which you wish to update by clicking inside the relevant box; the information for the MAH will be loaded in the tree view. 5) Click on the Organisation information corresponding to "Nobel Company" already loaded in the tree view, the dynamic buttons with different operation types ...

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