United Kingdom-London: Efficacy and Safety Studies on Medicines
Notice for changes or additional information
(Supplement to the Official Journal of the European Union, 2017/S 240-497343)
Section I: Contracting authority/entity
Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487
Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487
Section II: Object
Efficacy and Safety Studies on Medicines
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 an 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 4 different lots, with a maximum of 5 framework contracts for lots 1, 2 and 3 and a maximum of 8 framework contracts for lot 4.
Section VI: Complementary information
Section VII: Changes