Notice for changes or additional information
Legal Basis:
Section I: Contracting authority/entity
Section II: Object
II.1)Scope of the procurement
II.1.1)Title:
Efficacy and Safety Studies on Medicines
Reference number: EMA/2017/09/PE
II.1.2)Main CPV code73000000 Research and development services and related consultancy services
II.1.3)Type of contractServices
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:12/01/2018
VI.6)Original notice reference Section VII: Changes
VII.1)Information to be changed or added
VII.1.2)Text to be corrected in the original noticeSection number: IV.2.2)
Instead of:
Date: 02/02/2018
Local time: 12:00
Read:
Date: 06/02/2018
Local time: 12:00
Section number: IV.2.7)
Instead of:
Date: 08/02/2018
Local time: 10:00
Read:
Date: 12/02/2018
Local time: 10:00
VII.2)Other additional information: