EMA will shortly announce the requirements for mandatory submission of EVMPD data

It is understood that the March 2011 EMA Management Board agreed as series of proposals related to implementation of the new pharmacovigilance legislation. These were communicated at the DIA Euromeeting in March and will be followed up with official communications over the next few weeks.  EMA will implement the ISO standards for the Individual Case Safety Report (ICSR) and Identification of Medicinal Products (IDMP) by 1 January 2015.

However, the legislation requires a number of things to occur before that date and so interim activities will be necessary.  EMA is legally required to announce the format for submission of medicinal product information by July 2011 and according to the legislation MAHs will need to provide this information to EMA for all authorised products in Europe – some 500,000 the EMA estimate – by July 2012. The ISO standards for Identification of Medicinal Products (IDMP) will not be finalised in time for these dates so in the interim EMA is proposing to mandate EVMPD – but with some modifications that will allow future compatibility with the IDMP standards. The change of note will be to the definition of ‘strength’ which will be much more structured in the ISO standards. EMA currently hold 100,000 EVMPD records and these will need to be resubmitted. However, very importantly, the new legislation also requires the submission of the current product information – which at the moment is being interpreted by EMA as only the SmPC. So they will also be mandating the submission of the SmPCs in local language (in PDF format) for all these 500,000 products