Services - 19945-2018

17/01/2018    S11

United Kingdom-London: Efficacy and Safety Studies on Medicines

2018/S 011-019945


Notice for changes or additional information


(Supplement to the Official Journal of the European Union, 2017/S 240-497343)

Legal Basis:

Section I: Contracting authority/entity

I.1)Name and addresses
Official name: European Medicines Agency
Postal address: 30 Churchill Place
Town: London
NUTS code: UKI4 Not specified
Postal code: E14 5EU
Country: United Kingdom
Internet address(es):
Main address:
Address of the buyer profile:

Section II: Object

II.1)Scope of the procurement

Efficacy and Safety Studies on Medicines

Reference number: EMA/2017/09/PE
II.1.2)Main CPV code
73000000 Research and development services and related consultancy services
II.1.3)Type of contract
II.1.4)Short 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 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

VI.5)Date of dispatch of this notice:
VI.6)Original notice reference
Notice number in the OJ S: 2017/S 240-497343

Section VII: Changes

VII.1)Information to be changed or added
VII.1.2)Text to be corrected in the original notice
Section number: IV.2.2)
Instead of:
Date: 02/02/2018
Local time: 12:00
Date: 06/02/2018
Local time: 12:00
Section number: IV.2.7)
Instead of:
Date: 08/02/2018
Local time: 10:00
Date: 12/02/2018
Local time: 10:00
VII.2)Other additional information: