European Medicines Agency publishes new versions of controlled vocabularies used to comply with Article 57 (2) requirements on submission of information on medicines

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27/04/2012

European Medicines Agency publishes new versions of controlled vocabularies used to comply with Article 57 (2) requirements on submission of information on medicines

The European Medicines Agency has published a set of updated versions of Extended EudraVigilance product report message (XEVMPD) controlled vocabularies. These vocabularies support marketing authorisation holder compliance with Article 57(2) of the 2010 pharmacovigilance legislation, which requires marketing-authorisation holders to submit information to the Agency electronically on all medicines for human use authorised in the European Union by 2 July 2012.

The following controlled vocabularies have been updated: 

The controlled vocabularies will be updated regularly to improve the standardisation of the terminology used in the electronic submission of medicinal product information to the Agency. 

A marketing-authorisation holder that has already submitted medicine information to the Agency using the previous version of the controlled vocabularies is not required to resubmit this information. Marketing-authorisation holders are required to use the latest versions of the controlled vocabularies for submissions of medicine information as soon as they are published on the Agency's website.  

Related information

Contact point:

E-mail: art57@ema.europa.eu
Dedicated helpline: +44 (0)20 7523 7010