Legal Basis:
Directive 2014/24/EU
Section I: Contracting authority
I.3)CommunicationAdditional information can be obtained from the abovementioned address
Tenders or requests to participate must be submitted to the abovementioned address
I.4)Type of the contracting authorityEuropean institution/agency or international organisation
I.5)Main activityGeneral public services
Section II: Object
II.1)Scope of the procurement
II.1.1)Title:
Real World Data Subscription
Reference number: EMA/2020/12/TDA
II.1.2)Main CPV code72300000 Data services
II.1.3)Type of contractServices
II.1.4)Short description:
The European Medicines Agency (EMA) is seeking to sign a contract for access to and use of a set of individual patient-level databases drawn from the population receiving primary care, specialist care and/or hospital care in EU/EEA countries. The Agency must have direct electronic access to data in-house or remotely (from EMA premises), immediately, and on its own initiative.
The set of individual patient-level databases may include electronic health care or claims databases and longitudinal drug prescription, dispensing or other drug utilisation databases.
II.1.5)Estimated total valueValue excluding VAT: 6 000 000.00 EUR
II.1.6)Information about lotsThis contract is divided into lots: no
II.2)Description
II.2.2)Additional CPV code(s)72319000 Data supply services
72321000 Added-value database services
II.2.3)Place of performanceNUTS code: NL1 NOORD-NEDERLAND
Main site or place of performance:
European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, THE NETHERLANDS
II.2.4)Description of the procurement:
The European Medicines Agency (EMA) is seeking to sign a contract for access to and use of a set of individual patient-level databases drawn from the population receiving primary care, specialist care and/or hospital care in EU/EEA countries. The Agency must have direct electronic access to data in-house or remotely (from EMA premises), immediately, and on its own initiative.
The set of individual patient-level databases may include electronic health care or claims databases and longitudinal drug prescription, dispensing or other drug utilisation databases.
The Agency wishes to conclude one contract covering:
1) ‘baseline services’ (fixed component), and
2) ‘additional services’ (i.e. access to further databases) as and when required.
II.2.5)Award criteriaPrice is not the only award criterion and all criteria are stated only in the procurement documents
II.2.6)Estimated valueValue excluding VAT: 6 000 000.00 EUR
II.2.7)Duration of the contract, framework agreement or dynamic purchasing systemDuration in months: 72
This contract is subject to renewal: yes
Description of renewals:
The contract will be concluded for an initial period of 4 years with the possibility of two renewals each of 1 year (maximum contract duration is 6 years).
II.2.10)Information about variantsVariants will be accepted: no
II.2.11)Information about optionsOptions: no
II.2.13)Information about European Union fundsThe procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
See internet address provided in section I.3)
Section III: Legal, economic, financial and technical information
III.1)Conditions for participation
III.1.1)Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registersList and brief description of conditions:
See internet address provided in section I.3)
III.1.2)Economic and financial standingSelection criteria as stated in the procurement documents
III.1.3)Technical and professional abilitySelection criteria as stated in the procurement documents
III.2)Conditions related to the contract
III.2.2)Contract performance conditions:
See internet address provided in section I.3)
Section IV: Procedure
IV.1)Description
IV.1.1)Type of procedureOpen procedure
IV.1.3)Information about a framework agreement or a dynamic purchasing system
IV.1.8)Information about the Government Procurement Agreement (GPA)The procurement is covered by the Government Procurement Agreement: no
IV.2)Administrative information
IV.2.2)Time limit for receipt of tenders or requests to participateDate: 20/07/2020
Local time: 12:00
IV.2.3)Estimated date of dispatch of invitations to tender or to participate to selected candidates
IV.2.4)Languages in which tenders or requests to participate may be submitted:English, Bulgarian, Danish, German, Greek, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Latvian, Lithuanian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish, Czech
IV.2.6)Minimum time frame during which the tenderer must maintain the tenderDuration in months: 9 (from the date stated for receipt of tender)
IV.2.7)Conditions for opening of tendersDate: 21/07/2020
Local time: 14:00
Place:
European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, THE NETHERLANDS
Information about authorised persons and opening procedure:
See internet address provided in section I.3)
Section VI: Complementary information
VI.1)Information about recurrenceThis is a recurrent procurement: yes
VI.3)Additional information:
See internet address provided in section I.3)
VI.4)Procedures for review
VI.4.3)Review procedurePrecise information on deadline(s) for review procedures:
See internet address provided in section I.3)
VI.4.4)Service from which information about the review procedure may be obtainedOfficial name: European Medicines Agency
Postal address: PO Box 71010
Town: Amsterdam
Postal code: 1008 BA
Country: Netherlands
E-mail:
info@ema.europa.euTelephone: +31 88781600
Internet address:
https://www.ema.europa.eu VI.5)Date of dispatch of this notice:12/06/2020