Introduction to EVMPD
On 1 July 2011 the European Medicines Agency announced that the EudraVigilance Medicinal Products Dictionary - the 'EVMPD' - this became mandatory on 2 July 2012.
The new regulations originate in some EU pharmacovigilance legislation dating back from 2004 that was amended in December 2010. These regulations now require Marketing Authorisation Holders to submit the medicinal product data for all products for which they hold the licence for human use in Europe. Details of any development products and substances must also be submitted. The mandate also requires that any existing EVMPD records that have already been submitted are brought up-to-date.
The difference between the old EVMPD and the new one is that there is much more information to be collated and sent, and it must be kept up to date. The EMA have rebranded the EVMPD and called it XEVMPD to draw attention to the fact that it is quite different. In these web pages we use the term 'EVMPD' when talking about the Eudravigilance medicinal products dictionary in general and 'XEVMPD' to refer specifically to the new format.
Please click the following links for more information about what EVMPD and XEVMPD are and what we think pharmaceutical companies need to do about it.
Samarind RMS has included support for EVMPD since 2005 and our existing customers are already benefiting from this now essential feature being updated without incurring additional cost or having to buy a separate system for XEVMPD updates. Samarind RMS will be further developed to support the ISO IDMP / HL7 messaging standards for 2016.
Ensure you meet the requirements of the EU mandate for EVMPD and contact us today.