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 Pharma eReport Blog

Date: 4th May 2012, by: Nicky
Tags: EVMPD, XEVMPD, EMA, EudraVigilance

April 2012 EMA controlled vocabulary update

On 27th April 2012, the European Medicines Agency published a set of updated versions of Extended EudraVigilance product report message (XEVMPD) controlled vocabularies, including updates to the EVPRM formats for organisations, pharmaceutical dose forms, substances, units of presentation and units of measurement.

This is the first in an expected series of regular updates to the controlled vocabularies that will be aimed at improving the standardisation of the terminology used in the electronic submission of medicinal product information to the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD).

Like all XEVMPD software vendors, we have to ensure that our system  - at all times - reflects the very latest versions of the EMA's controlled vocabularies, which are being published by the EMA in Excel spreadsheet format.  For solution vendors, incorporating the updated vocabulary versions can represent a time-consuming task of downloading the EMA's Excel file and manually integrating the new vocabularies - and any fundamental data format changes (for example, the substance controlled vocabulary format in this 27/4/12 update) - into their tool.  At Pharma eReport, we've designed our Centrality software to be totally data format-independent so, no matter how significant the changes to the EMA’s requirements and formats, we can auto-generate a new, completely up-to-date version of the tool within 24 hours of any update being issued.

With more updates on the way, it’s crucial that Marketing Authorisation Holders implement an XEVMPD solution now that will be agile enough to make ongoing submission compliance as seamless, non-disruptive and hassle-free as possible.  

 

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