5 April 2018 EMA/197297/2018 Information Management

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide Maintenance operations: Invalidation of an authorised medicinal product (AMP) entity in the XEVMPD

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Table of contents 1.1. Invalidate MA 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/197297/2018

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1.1. Invalidate MA example specification We are going to withdraw the product "LEVELLE 100 mg" because the marketing authorisation was revoked by the competent authority. The date of withdrawal is "30/10/2014"

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/197297/2018

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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/197297/2018

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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 "Authorised Medicinal Products" in the tree view, place you mouse in the search field:

3) Type "Levelle" and press enter; the result(s) of your search will be displayed in the active area:

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/197297/2018

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4) Click inside the box of the result (i.e. the AMP that you wish to invalidate); the information for the AMP will be loaded in the tree view.

5) Click on the AMP information "Levelle 100mg Caps" loaded in the tree view, the dynamic button containing "Other Operations" will appear:

6) Click on "Other Operations" and select "Invalidate MA":

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/197297/2018

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7) You will be prompted to the "Create and Send Product Reports" section. An XEVPRM with an AMP with the assigned operation type "Invalidate MA" will be displayed:

8) As per the applicable business and technical rules, you must change the value in the "Authorisation Status" field:

9) You must also enter information in the "Invalidated date" field:

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/197297/2018

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10) Populate the "Message number" field:

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:

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide EMA/197297/2018

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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". 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/197297/2018

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eXtended EudraVigilance Medicinal Product Dictionary - European ...

Apr 5, 2018 - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide. EMA/197297/2018. Page 6/9. 4) Click inside the box of the result (i.e. the AMP that you wish to invalidate); the information for the. AMP will be loaded in the tree view. 5) Click on the AMP information "Levelle 100mg ...

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