EudraVigilance Data Management for European Medicines Agency

These resources will contribute expertise directly to the data management activities (manual recoding, duplicate detection and quality control for both XEVMPD and ICSR data) for EudraVigilance, the Agency’s pharmacovigilance system.

United Kingdom-London: EudraVigilance data management — EMA/2014/30/BD

2014/S 197-347366

Contract notice

Services

Directive 2004/18/EC

Section I: Contracting authority

I.1)Name, addresses and contact point(s)

European Medicines Agency
30 Churchill Place, Canary Wharf
For the attention of: Ms Nina Perovic
E14 5EU London
UNITED KINGDOM
Telephone: +44 2036606000
E-mail: evdatamanagementtender@ema.europa.eu
Fax: +44 2036605555

Internet address(es):

General address of the contracting authority: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000261.jsp&mid=WC0b01ac0580029488

Further information can be obtained from: The above mentioned contact point(s)

Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained from: The above mentioned contact point(s)

Tenders or requests to participate must be sent to: The above mentioned contact point(s)

I.2)Type of the contracting authority

European institution/agency or international organisation

I.3)Main activity

Health

I.4)Contract award on behalf of other contracting authorities

The contracting authority is purchasing on behalf of other contracting authorities: no

Section II: Object of the contract

II.1)Description

II.1.1)Title attributed to the contract by the contracting authority:

EudraVigilance data management — EMA/2014/30/BD.

II.1.2)Type of contract and location of works, place of delivery or of performance

Services
Service category No 27: Other services
Main site or location of works, place of delivery or of performance: European Medicines Agency (EMA), 30 Churchill Place, Canary Wharf, London, E14 5EU, UNITED KINGDOM.

NUTS code UKI12

II.1.3)Information about a public contract, a framework agreement or a dynamic purchasing system (DPS)

The notice involves the establishment of a framework agreement

II.1.4)Information on framework agreement

Framework agreement with a single operator

Duration of the framework agreement

Duration in months: 72
Justification for a framework agreement, the duration of which exceeds four years: This contract involves a lengthy set-up phase for the successful bidder and for the Agency. It has therefore been decided to go for a longer duration of the framework contract, to allow the bidder to take account of the high initial investment cost and time, thus resulting in more favourable conditions for the Agency.

II.1.5)Short description of the contract or purchase(s)

This tender aims to put into place contractual arrangements that will enable the EMA to specify and acquire services provided by resources not employed directly by the EMA. These resources will contribute expertise directly to the data management activities (manual recoding, duplicate detection and quality control for both XEVMPD and ICSR data) for EudraVigilance, the Agency’s pharmacovigilance system.
The results of the work are to be stored electronically on the systems hosted at the Agency. Tracking information in relation to the tasks is to be maintained by the contractor and made available to the EMA electronically. The results of the work are to be presented to EMA weekly, work stream by work stream. The work is to be performed at the contractor’s premises; although the contractor’s staff will be expected to attend meetings at EMA’s premises at 30 Churchill Place, Canary Wharf, London, E14 5EU, UNITED KINGDOM.

II.1.6)Common procurement vocabulary (CPV)

72322000, 72300000, 72310000, 72312000

II.1.7)Information about Government Procurement Agreement (GPA)

The contract is covered by the Government Procurement Agreement (GPA): no

II.1.8)Lots

This contract is divided into lots: no

II.1.9)Information about variants

Variants will be accepted: no

II.2)Quantity or scope of the contract

II.2.1)Total quantity or scope:

The Agency may exercise the option to increase the estimated contract value at a later stage via negotiated procedure with the successful tenderer in accordance with Article 134(1)(f) of the rules of application of the general Financial Regulation.
Estimated value excluding VAT:
Range: between 3 500 000 and 6 000 000 EUR

II.2.2)Information about options

Options: no

II.2.3)Information about renewals

This contract is subject to renewal: yes

II.3)Duration of the contract or time limit for completion

Duration in months: 72 (from the award of the contract)

Section III: Legal, economic, financial and technical information

III.1)Conditions relating to the contract

III.1.1)Deposits and guarantees required:

Not applicable.

III.1.2)Main financing conditions and payment arrangements and/or reference to the relevant provisions governing them:

Not applicable.

III.1.3)Legal form to be taken by the group of economic operators to whom the contract is to be awarded:

All members of the grouping must be jointly and severally liable for the execution of the contract.

III.1.4)Other particular conditions

The performance of the contract is subject to particular conditions: no

III.2)Conditions for participation

III.2.1)Personal situation of economic operators, including requirements relating to enrolment on professional or trade registers

III.2.2)Economic and financial ability

Information and formalities necessary for evaluating if the requirements are met: All information required is indicated in the technical specifications and invitation to tender letter which can be downloaded at the address of the buyer profile given in point I.1 of this notice.
Minimum level(s) of standards possibly required: Tenderers are required to demonstrate that their average annual turnover is in excess of 2 000 000 EUR for each of the last 3 financial years.

III.2.3)Technical capacity

III.2.4)Information about reserved contracts

III.3)Conditions specific to services contracts

III.3.1)Information about a particular profession

Execution of the service is reserved to a particular profession: no

III.3.2)Staff responsible for the execution of the service

Legal persons should indicate the names and professional qualifications of the staff responsible for the execution of the service: no

Section IV: Procedure

IV.1)Type of procedure

IV.1.1)Type of procedure

Open

IV.1.2)Limitations on the number of operators who will be invited to tender or to participate

IV.1.3)Reduction of the number of operators during the negotiation or dialogue

IV.2)Award criteria

IV.2.1)Award criteria

The most economically advantageous tender in terms of the criteria stated in the specifications, in the invitation to tender or to negotiate or in the descriptive document

IV.2.2)Information about electronic auction

An electronic auction will be used: no

IV.3)Administrative information

IV.3.1)File reference number attributed by the contracting authority:

EMA/2014/30/BD.

IV.3.2)Previous publication(s) concerning the same contract

IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document

IV.3.4)Time limit for receipt of tenders or requests to participate

19.11.2014 – 12:00

IV.3.5)Date of dispatch of invitations to tender or to participate to selected candidates

IV.3.6)Language(s) in which tenders or requests to participate may be drawn up

Any EU official language
Other: The Agency will accept documentation in any EU language. The Agency prefers, however, to receive all documentation in English.

IV.3.7)Minimum time frame during which the tenderer must maintain the tender

Duration in months: 6 (from the date stated for receipt of tender)

IV.3.8)Conditions for opening of tenders

Date: 24.11.2014 – 14:00

Place:

European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, UNITED KINGDOM.

Persons authorised to be present at the opening of tenders: yes

Additional information about authorised persons and opening procedure: 1 representative per tenderer is permitted to be present at the opening of tenders. The name of any such representative is to be notified at least 24 hours in advance in writing to evdatamanagementtender@ema.europa.eu

Section VI: Complementary information

VI.1)Information about recurrence

This is a recurrent procurement: yes
Estimated timing for further notices to be published: 6 years.

VI.2)Information about European Union funds

The contract is related to a project and/or programme financed by European Union funds: no

VI.3)Additional information

Please note that only 1 tender may be submitted per tenderer. Please note that the framework contract will run for an initial period of 2 years and may, at the Agency’s request, be extended for 2 further periods of 2 years, up to a maximum contract duration of 6 years.

VI.4)Procedures for appeal

VI.4.1)Body responsible for appeal procedures

General Court of the European Union
rue du Fort Niedergrünewald
2925 Luxembourg
LUXEMBOURG
E-mail: generalcourt.registry@curia.europa.eu
Telephone: +352 4303-1
Internet address: http://curia.europa.eu
Fax: +352 4303-2100

VI.4.2)Lodging of appeals

Precise information on deadline(s) for lodging appeals: Within 2 months of the notification to the plaintiff, or, in absence thereof, of the day on which it came to the knowledge. A complaint to the European Ombudsman does not have as an effect either to suspend this period or to open a new period for lodging appeals.

VI.4.3)Service from which information about the lodging of appeals may be obtained

European Medicines Agency
30 Churchill Place, Canary Wharf
E14 5EU London
UNITED KINGDOM
E-mail: info@ema.europa.eu
Telephone: +44 2036606000
Internet address: http://www.ema.europa.eu
Fax: +44 2036605555

VI.5)Date of dispatch of this notice:

2.10.2014