Efficacy and Safety Studies on Medicines

Description

Post-authorisation effectiveness and pharmacoepidemiology studies to generate data and information to support regulatory decision-making. Research may also focus on the effectiveness of regulatory measures taken and on the impact of relevant legislation. The range of research topics is limited to those with high public health relevance and with a European impact. The scope of the funding covers both nationally and centrally authorised products, including vaccines. The results obtained from this research will subsequently be assessed by the responsible Agency Committee regarding the need for regulatory action and further research may subsequently also be conducted to measure the effectiveness of regulatory actions taken. The research may concern four different lots, with a maximum of five framework contracts for lots 1, 2 and 3 and a maximum of eight framework contracts for lot 4. For full description please see section 3.2 of the technical specifications (procurement documents).