EMA announce mandatory submission of medicinal product information

On 1 July 2011, EMA announced a requirement to submit EVMPD data for all authorised products in the European Union regardless of the procedure by which they are approved.  This means that 500,000 records need to be submitted/resubmitted by 2 July 2012.  Also as part of the announcement EMA indicated the intent to adopt ISO standards for this information by 2015 with further requirements on MAHs to update submitted information to this new standard.