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:Reference number: EMA/2018/30/CO
II.1.2)Main CPV code72300000 Data services
II.1.3)Type of contractServices
II.1.4)Short description:
The Agency requires access to current, comprehensive and complete drug databases to provide scientific, economic and industry-related information of the medicines and medical devices for human use in clinical practice and in research and development worldwide and of their developers and marketing authorisation holders, to inform the assessment and monitoring of these products by the Agency and to support its work forecast. The Agency is also looking for abstracted adverse reaction reports to find and/or evaluate adverse reactions of medicines for human use licensed in the EEA.
II.1.5)Estimated total valueValue excluding VAT: 600 000.00 EUR
II.1.6)Information about lotsThis contract is divided into lots: no
II.2)Description
II.2.2)Additional CPV code(s)73210000 Research consultancy services
72320000 Database services
79980000 Subscription 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
II.2.4)Description of the procurement:
Subscription to one or several databases containing lifecycle and adverse reaction report data about medicinal products and medical devices for human use worldwide from pre-clinical to clinical studies phase IV up to and including marketing and discontinued projects; including scientific (therapeutic areas, mechanisms of action, indications in development, (bio-)chemical class, INN and product names, product safety and efficacy, routes of administration, formulations, orphan status, generics and biosimilars, abstracted public adverse reaction reports, etc.), economic (patent expiration, M&A, reimbursement status, etc.) and industry related information (company revenue, company deals, company pipeline, etc.) divided by major regional markets (EU, USA, Japan, BRIC).
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: 600 000.00 EUR
II.2.7)Duration of the contract, framework agreement or dynamic purchasing systemDuration in months: 48
This contract is subject to renewal: yes
Description of renewals:
See Internet address provided in Section I.3.
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: 24/04/2019
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: 6 (from the date stated for receipt of tender)
IV.2.7)Conditions for opening of tendersDate: 26/04/2019
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.4.4)Service from which information about the review procedure may be obtainedOfficial name: European Medicines Agency
Postal address: Domenico Scarlattilaan 6
Town: Amsterdam
Postal code: 1083 HS
Country: Netherlands
E-mail:
info@ema.europa.euTelephone: +31 887816000
Internet address:
http://www.ema.europa.eu VI.5)Date of dispatch of this notice:18/03/2019
