Information for Marketing Authorisation Holders (MAHs)

The reporting of suspected serious adverse reactions is defined in the Community legislation. This process involves healthcare professionals, the EMA, National Competent Authorities (NCAs) and Marketing Authorisation Holders (MAHs) and is applicable to all medicinal products authorised in the EEA. The reporting includes suspected serious adverse reactions occurring both within and outside the EEA.

The electronic reporting of suspected serious adverse reactions is mandatory. The legal basis for this requirement is provided in Regulation (EC) No 726/2004, Directive 2001/83/EC as amended and Module VI – Management and reporting of adverse reactions to medicinal products of the Good pharmacovigilance practices (GVP).

Marketing authorisation holders should prepare for the electronic reporting of suspected adverse reactions to the EMA and:

• Follow the detailed instructions outlined in 6 steps required for the implementation of electronic transmission of pharmacovigilance data, where the procedure for the initiation of the electronic transmission of ICSRs is described.
• Register with EudraVigilance (see section How to register).
  

Please note that a MedDRA license is required for electronic reporting of ICSRs. For further information on the EudraVigilance MedDRA Licensing Policy, please refer to MedDRA licensing Policy in this website.

Provide the required information for the EudraVigilance Medicinal Product Dictionary. See the Agency's website for further information.

The business requirements for the electronic reporting to EudraVigilance are described in the Note for guidance - EudraVigilance Human - Processing of safety messages and individual case safety (ICSRs) Revision 2.
Reporting through the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB),  which is a web based tool for reporting individual case reports,  can be achieved when the marketing authorisation holder fulfils criteria given in the EVWEB section.
If you require more information about EVWEB, please refer to the EudraVigilance Web Reporting Application.

Please note that the EVWEB application currently only supports Internet Explorer 8. If you cannot use this older version of IE, you can still use EVWEB with IE9 & IE10 using the link here to access the XHTML version of the application directly. You will need to set your IE browser to compatibility view. More information on how to change Internet Explorer compatibility view settings is available from the Microsoft website.

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Last update: Tuesday, 23 February 2016.