On 31 May 2012 and with the purpose of increasing the transparency of operation and actions in the field of pharmacovigilance, the European Medicines Agency (EMA) began publishing consolidated reports on suspected adverse reactions to medicinal products authorised in the European Union. Data included in the reports are acquired directly from the EudraVigilance database to which national competent authorities and marketing authorisation holders must submit reports on suspected adverse reactions to medicinal products.
Consolidated reports include all suspected adverse drug reactions, but which are not necessarily related to a particular medicinal product. That is why published information is not intended to determine the probability of occurrence of adverse reactions or the safety of the medicinal product. Further detailed and scientific evaluation of all available information is required for the evaluation of the benefits and risks of the medicinal product. Information in consolidated reports is processed according to the following criteria: age group, sex, type of suspected adverse reaction, and its outcome. Adverse drug reactions and their frequency are listed in a summary of product characteristics and in the package leaflet which is included in the packaging of every medicinal product.
A flyer is also published on the website in all official EU languages to encourage patients to report suspected adverse reactions to medicinal products. These reports also significantly contribute to obtaining more information regarding medicinal products on the market. For more information on reporting, see also the instructions on How to report a suspected adverse drug reaction.
For reports, see European database of suspected adverse drug reaction reports.