Information

Tender reference number	EMA/2020/46/TDA
Title	Quality, Efficacy and Safety Studies on Medicines
Description	Performance of pre- and post-authorisation quality, efficacy and safety research on medicines to generate data and information to support regulatory decision-making in the human and veterinary medicines regulatory domain.
Contract type	Services
Procedure type	Open procedure
Status	Open
Published on TED
Submission Method	Electronic
Tenders may be submitted	All lots
Maximum number of lots	6
Information about a public contract, a framework agreement or a dynamic purchasing system (DPS)	Framework agreement
Address of the buyer profile: (URL)	https://www.ema.europa.eu/en/about-us/procurement
Estimated total value	33000000.00 EUR
Main CPV	73000000

Conditions for participation

Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers	See internet address provided in section I.3).
Economic and financial standing - List and brief description of selection criteria	Selection criteria as stated in the procurement documents
Economic and financial standing- Minimum level(s) of standards possibly required	Selection criteria as stated in the procurement documents
Technical and professional ability - List and brief description of selection criteria	Selection criteria as stated in the procurement documents
Technical and professional ability - Minimum level(s) of standards possibly required	Selection criteria as stated in the procurement documents

Milestones

TED publication date	12/03/2021 00:00
Question deadline	21/04/2021 23:59 UTC+02:00
Answer deadline	N/A
Time limit for receipt of tenders	30/04/2021 12:00
Conditions for opening tenders (date)	03/05/2021 10:00

Lots

Lot number	Title	Description
Lot 1	Pre-clinical Research	See internet address provided in section I.3).
Lot 2	Veterinary Studies	See internet address provided in section I.3).
Lot 3	Statistical Research	See internet address provided in section I.3).
Lot 4	Qualitative Research	See internet address provided in section I.3).
Lot 5	Pharmacoepidemiological Research	See internet address provided in section I.3).
Lot 6	Quality of Medicines	See internet address provided in section I.3).

Notices

Reference	Notice type	Publication date
2021/S 056-140313	Corrigendum	22/03/2021 00:00
2021/S 050-122187	Contract notice	12/03/2021 00:00