United Kingdom-London: Efficacy and Safety Studies on Medicines
Contract award notice
Results of the procurement procedure
Section I: Contracting authority
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 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 5 framework contracts for lots 1, 2 and 3 and a maximum of 8 framework contracts for lot 4.
Use of Innovative Methods to Optimise the Utility of Sparse Data to Support Benefit/Risk Assessment
For full description please see section 3.2 of the technical specifications (procurement documents).
Please note that a maximum of 5 framework contracts is foreseen for lot 1.
Please note that a maximum of 5 framework contracts is foreseen for lot 2.
Pharmacoepidemiology Research — Rapid Descriptive Studies
Please note that a maximum of 5 framework contracts is foreseen for lot 3.
Pharmacoepidemiology Research — Association Studies, Including Pregnancy and Breastfeeding Research
Please note that a maximum of 8 framework contracts is foreseen for lot 4.
Section IV: Procedure
Section V: Award of contract
Pharmacoepidemiology Research — Association Studies, Including Pregnancy and Breastfeeding
Use of Innovative Methods to Optimize the Utility of Sparse Data to Support Benefit/Risk Assessment
Section VI: Complementary information
Please note only 1 tender per tenderer per lot may be submitted.
Internet address: http://curia.europa.eu
You may submit any observations concerning the award procedure to the Contracting Authority indicated under heading I.1.
If you believe that there was maladministration, you may lodge a complaint to the European Ombudsman within 2 years of the date when you became aware of the facts on which the complaint is based (see http://www.ombudsman.europa.eu). Such complaint does not have as an effect either to suspend the time limit to launch an appeal or to open a new period for lodging an appeal.
Within 2 months of the notification of the award decision you may lodge an appeal to the body referred to in VI.4.1.
Internet address: http://www.ema.europa.eu/ema/
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