What is EVMPD? And XEVMPD?
EVMPD stands for EudraVigilance Medicinal Product Dictionary and EudraVigilance stands for European Union Drug Regulating Authorities Pharmacovigilance - basically it's the European Medicine Agency's pharmacovigilance system.
XEVMPD stands for Extended EudraVigilance Medicinal Product Dictionary - see below for what this is.
EudraVigilance launched 2001
EudraVigilance was launched by the EMA in December 2001. It's a data processing management system for reporting and evaluating suspected adverse drug reactions (ADRs) during the development and post marketing authorisation approval of medicinal products for human use in the European Economic Area (EEA) (ie all the countries in the EU plus Norway, Iceland and Lichtenstein).
EudraVigilance's original brief was to allow details of adverse reaction reports to be exchanged electronically between the EMA, national competent authorities and (where appropriate) marketing authorisation holders and clinical trial sponsors. It aims to make possible early detection of safety signals related to medicinal products for human use and facilitate continuous monitoring and evaluation of any potential safety issues, so that risks to patients can be detected, assessed and minimised. The full text of the European legislation that started this off (Regulation (EC) No. 726/2004) can be found here - it's Article 57(2) that is particularly relevant.
EVMPD launched 2005
The Medicinal Product Dictionary has actually been in existence since 2005 and since then all MA Holders have been able to submit basic details of their products to the EMA, either electronically or by manually by entering their data into the EudraVigilance web portal, EVWEB. However it was not mandatory to do so, so consequently the EVMPD currently contains less than 25% of the estimated 528,000 products authorised for use in the EU, and the data that is there is likely to be out of date.
2010 amendments - more information now required, including documents - XEVMPD
The original legislation was amended in December 2010 by Regulation (EU) No. 1235/2010, which describes the pharmacovigilance required for medicinal products for human use. This decrees that the EMA shall set up a list of all medicinal products for human use authorised in the EU, and that marketing authorisation holders were required, by 2 July 2012 at the latest, to electronically submit to the EMA information on all medicinal products for human use authorised or registered in the EU using the format defined by the EMA, and keep it up to date thereafter.
Crucially, the amount of information required by the EMA is significantly more than requested by the original version. For example information about excipients and adjuvents and their concentrations within the finished product is now required, as is a document containing the printed product information. The has also been guidance suggesting that very detailed and technical substance information will also be required, but we are waiting for clarification on this.
The EMA has now rebranded the EVMPD to be called XEVMPD (Extended Eudravigilance Medicinal Product Dictionary) to draw attention to the fact that this is a new version and requires a lot more information than the original.
XEVMPD became mandatory for all MAHs from 2 July 2012
The new legislation means that submitting product data to the EVMPD is no longer voluntary and became mandatory from 2 July 2012. The onus is on marketing authorisation holders to provide details of all their authorised products, either electronically from other systems or by manually typing the information using the web portal.
For companies with small numbers of products (less than 10 say, remembering that each strength counts at one product) it's feasible to use the web portal but for those with many products a proper database application will be required - like Samarind RMS, which has supported EVMPD since 2005 and which aims to be first to market with full support for the new XEVMPD. Remember that even after the initial data entry has been completed, the information has to be kept up to date in order for companies to remain in compliance; in many ways this is a more arduous and time consuming task that the initial data load if it is being done manually.
Pharmaceutical companies with registered products for human use within Europe faced a hugely significant challenge in complying with 2 July 2012 deadline; do not under-estimate the amount of effort involved in maintaining this data.
Beyond July 2012, Samarind will continue to develop its software in order to meet the requriements for ISO IDMP standards, which will be implemented for 2016.
To discuss how Samarind can help you meet your Eudravigilance obligations please contact us today.