EVMPD

On 1 July 2011 the EMA announced the mandate for EVMPD (EudraVigilance Medicinal Products Dictionary) updates, which will come into force from 2 July 2012.

The new EMA pharmacovigilance regulations require the submission of medicinal product data for all products licensed for human use in Europe. The mandate also requires that any previously-submitted EVMPD records are also brought up-to-date.

Samarind RMS has included an EVMPD upload facility since 2005 and all our existing customers will benefit from this now essential feature being updated without incurring additional cost or having to buy a separate system for XEVMPD submissions. In this section of our website we aim to demystify the subject and give some guidance on what's required.

• In our Introduction to EVMPD we outline the background of the EudraVigilance Medicinal Product Dictionary and what's changing for the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD), which is becoming mandatory on 2 July 2012.
• What is EVMPD? And XEVMPD? gives a more in-depth explanation of the history of EVMPD and how it's developed along the way, and includes links to the relevant legislation.
• 'What do we have to do' is a systems person's view on what MA Holders need to actually do, and tries to answer 'who has to do it' too - is it a regulatory or a pharmacovigilance task?
• In case you were wondering what some of the terminology means, we explain what XEVPRM and EV Codes are and what you need to do with them. 

Ensure you meet the requirements of the pending EU mandate for EVMPD and contact us today to find out more about Samarind's xEVMPD software.