EASY-MPD - The XEVMPD Editor

From July 2nd, 2012, pharmaceutical companies who are developing and marketing drugs in European countries will have to use the new standard XEVMPD (Extended EudraVigilance Medicinal Products Dictionary) for the submission of Medicinal product data to the European Medicines Agency EMA.

The reason for the implementation of this new standard is the new Pharmacovigilance legislation (EU 1235/2010) that imposes EMA solely as the future recipient of all pharmacovigilance submissions arising for Medicinal products registered in any of the European countries. This will replace the current practice of multiple and duplicate submissions to the National Health Authorities and the EMA. In order to prepare for this, EMA requests the relevant product information from all the Marketing Authorization Holders (MAHs) and in a standardized format, the EVMPD format. Once the initial submissions have been carried out, the MAH’s are expected to use the XEVMPD format and message for any consecutive product variation.

For the companies, especially for companies with a large number of registered products (e.g. Generics), this legislation creates an immense work load: Some of the challenges are to company internal data sources that can be used to load data from or from where data can be migrated and merged with other data to provide some parts of XEVMPD data record for the product. Then, there is the challenge to convert the current data representation to the new ISO standard layouts that will also be used by the IDMP format that is to be introduced in 2014. And finally, the relevant labeling documents (Annex I, IIA, IIB, IIIA, IIIB documents) need to be included for 24 official languages of the European Union. For some companies, that will be one of the biggest organizational challenges, since this information is currently only available in the repositories of the affiliates!

A Medicinal product in the EVMPD data model is a complex structure that relates to many other concepts (e.g. packaged product, pharmaceutical product, marketing authorization, manufacturer, clinical particulars etc.) with associated substructures and interdependencies between the concepts.

The complexity and multidisciplinary character of this structure are the reasons why it is so difficult, if not impossible, to generate the data from existing data repositories in order to create the EVMPD datasets. It even will be difficult to find people to verify whether in the EVMPD data is in the right place and that it is correct.

Although the standard might be introduced in phases, as the European Medicines Agency struggles to finance implementing the far reaching pharmacovigilance legislation, it still looks uncertain, what will be mandatory to submit till 02.07.2012. So, this challanging situation still should not be underestimated!