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Services - 170111-2021

Submission deadline has been amended by:  245715-2021
06/04/2021    S66

Netherlands-Amsterdam: Monitoring of Scientific and Medical Literature and the Entry of Relevant Information into EudraVigilance

2021/S 066-170111

Contract notice

Services

Legal Basis:
Regulation (EU, Euratom) No 2018/1046

Section I: Contracting authority

I.1)Name and addresses
Official name: European Medicines Agency
Postal address: Domenico Scarlattilaan 6
Town: Amsterdam
NUTS code: NL1 Noord-Nederland
Postal code: 1083 HS
Country: Netherlands
E-mail: procurement@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=7639
Additional 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 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:

Monitoring of Scientific and Medical Literature and the Entry of Relevant Information into EudraVigilance

Reference number: EMA/2020/17/TDA
II.1.2)Main CPV code
73000000 Research and development services and related consultancy services
II.1.3)Type of contract
Services
II.1.4)Short description:

Provision of monitoring of scientific and medical literature and the entry of relevant information into EudraVigilance required by Article 27 of Regulation (EC) No 726/2004.

II.1.5)Estimated total value
II.1.6)Information about lots
This contract is divided into lots: no
II.2)Description
II.2.2)Additional CPV code(s)
72314000 Data collection and collation services
II.2.3)Place of performance
NUTS code: NL1 Noord-Nederland
Main site or place of performance:

Contractor's premises.

II.2.4)Description of the procurement:

Provision of monitoring of scientific and medical literature and the entry of relevant information into EudraVigilance required by Article 27 of Regulation (EC) No 726/2004.

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
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 12 months with the possibility of five 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

The estimated contract volume will initially be for substance groups 1-309 and herbal substance groups 1-100.

The Agency may use the negotiated procedure under point 11.1.e of Annex 1 to the General Financial Regulation to procure new services from the contractors up to a maximum of 50 % of the initial framework contract ceiling.

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

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
The procurement involves the establishment of a framework agreement
Framework agreement with several operators
Envisaged maximum number of participants to the framework agreement: 3
In the case of framework agreements, provide justification for any duration exceeding 4 years:

This service creates and transmits data to Marketing Authorisation Holders and national Competent Authorities. There is a large investment required by the contractor (both organisational and financial) in the set-up of the services, which would take about 6 months. Thus, to reduce the incumbency advantage and ensure a level playing-field for all bidders, the Agency is offering a six year contract.

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: 19/05/2021
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:
Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
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: 20/05/2021
Local time: 10:00
Place:

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: no
VI.3)Additional information:
VI.4)Procedures for review
VI.4.1)Review body
Official name: General Court
Postal address: rue du Fort Niedergrünewald
Town: Luxembourg
Postal code: L-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.4.4)Service from which information about the review procedure may be obtained
Official name: European Medicines Agency
Postal address: Domenico Scarlattilaan 6
Town: Amsterdam
Postal code: 1083 HS
Country: Netherlands
E-mail: info@ema.europa.eu
Telephone: +31 887816000
Internet address: http://www.ema.europa.eu
VI.5)Date of dispatch of this notice:
30/03/2021