United Kingdom-London: Efficacy and safety studies on medicines.
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 five 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 III: Legal, economic, financial and technical information
See internet address provided in Section I.3.
Section IV: Procedure
European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom.
Maximum of 1 representative per tenderer is permitted to be present at the opening. For security reasons, tenderers must register within the given deadline (please see the invitation to tender letter) to be allowed to attend the opening session.
Section VI: Complementary information
Please note only 1 tender per tenderer per lot may be submitted.
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.