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Seirbhísí - 285302-2020

19/06/2020    S118

Netherlands-Amsterdam: Real World Data Subscription

2020/S 118-285302

Contract notice

Services

Legal Basis:
Directive 2014/24/EU

Section I: Contracting authority

I.1)Name and addresses
Official name: European Medicines Agency
Postal address: PO Box 71010
Town: Amsterdam
NUTS code: NL1 NOORD-NEDERLAND
Postal code: 1008 BA
Country: Netherlands
E-mail: PASS.Tender@ema.europa.eu
Internet address(es):
Main address: https://www.ema.europa.eu/
Address of the buyer profile: https://www.ema.europa.eu/en/about-us/procurement
I.3)Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at: https://etendering.ted.europa.eu/cft/cft-display.html?cftId=6591
Additional information can be obtained from the abovementioned address
Tenders or requests to participate must be submitted electronically via: https://etendering.ted.europa.eu/cft/cft-display.html?cftId=6591
Tenders or requests to participate must be submitted to the abovementioned address
I.4)Type of the contracting authority
European institution/agency or international organisation
I.5)Main activity
General 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 code
72300000 Data services
II.1.3)Type of contract
Services
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 value
Value excluding VAT: 6 000 000.00 EUR
II.1.6)Information about lots
This 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 performance
NUTS 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 criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.6)Estimated value
Value excluding VAT: 6 000 000.00 EUR
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration 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 variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.13)Information about European Union funds
The 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 registers
List and brief description of conditions:

See internet address provided in section I.3)

III.1.2)Economic and financial standing
Selection criteria as stated in the procurement documents
III.1.3)Technical and professional ability
Selection 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 procedure
Open 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 participate
Date: 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 tender
Duration in months: 9 (from the date stated for receipt of tender)
IV.2.7)Conditions for opening of tenders
Date: 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 recurrence
This is a recurrent procurement: yes
VI.3)Additional information:

See internet address provided in section I.3)

VI.4)Procedures for review
VI.4.1)Review body
Official name: General Court
Postal address: rue du Fort Niedergrünewald
Town: Luxembourg
Postal code: 2925
Country: Luxembourg
E-mail: generalcourt.registry@curia.europa.eu
Telephone: +352 4303-1
Fax: +352 4303-2100
Internet address: http://curia.europa.eu
VI.4.3)Review procedure
Precise 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 obtained
Official name: European Medicines Agency
Postal address: PO Box 71010
Town: Amsterdam
Postal code: 1008 BA
Country: Netherlands
E-mail: info@ema.europa.eu
Telephone: +31 88781600
Internet address: https://www.ema.europa.eu
VI.5)Date of dispatch of this notice:
12/06/2020