The smarter way to manage your licences

How will you maintain your XEVMPD data?

Most people now know what XEVMPD is, and the July 2012 deadline has come and gone.

If you are already familiar with XEVMPD you might be interested in the following pages.

For others who are not so familiar with the subject, our original set of pages remains below for your information.

On 1 July 2011 the EMA announced the mandate for EVMPD (EudraVigilance Medicinal Products Dictionary) updates, which came 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 support for EVMPD since 2005 and we were first to market with a fully working, automated XEVMPD compilation and processing solution in Spring 2012. 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 changed for the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD), which became 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. 
  • Last but not least we discuss the challenges of XEVMPD data maintenance, and have some good news for those who used EV WEB to submit their initial set of data.

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.