UK-London: EudraVigilance data management — EMEA/2009/04/PM-PhV

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Summary

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Threshold: 
OJEU
Main activities: 
Health
Type: 
Contract notice
Market: 
Service contract
Award criteria: 
The most economic tender
Published: 
Tuesday, October 6, 2009
Deadline: 
Monday, November 16, 2009 - 12:00
Tender ID: 
2009/S 192-275502

SECTION I: CONTRACTING AUTHORITY

  • I.1) NAME, ADDRESSES AND CONTACT POINT(S):

    For the attention of: Mr Tim Buxton
    European Medicines Agency (EMEA)
    7 Westferry Circus, Canary Wharf
    London
    E14 4HB
    UK

    Tel: +44 2074188400
    Fax: +44 2074188670

    Internet address(es)

    :

    General address of the contracting authority: http://www.emea.europa.eu/.

    Address of the buyer profile: http://www.emea.europa.eu/htms/general/admin/tenders/contracts.htm.

    Further information can be obtained at:
    European Medicines Agency (EMEA) , 7 Westferry Circus, Canary Wharf , Attn: Ms Sherryll Eady , UK -London E14 4HB . Tel. +44 2074188400 . E-mail: . Fax +44 2074188660 . URL: http://www.emea.europa.eu/ .

    Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained at:
    European Medicines Agency (EMEA) , 7 Westferry Circus, Canary Wharf , Attn: Ms Sherryll Eady , UK -London E14 4HB . Tel. +44 2074188400 . E-mail: . Fax +44 2074188660 . URL: http://www.emea.europa.eu/ .

    Tenders or requests to participate must be sent to:

    As in above-mentioned contact point(s).

  • I.2) TYPE OF THE CONTRACTING AUTHORITY AND MAIN ACTIVITY OR ACTIVITIES:

    European institution/agency or international organisation.

    Health.

    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 — EMEA/2009/04/PM-PhV.

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

      Services.

      Service category: No 07.

      Main place of performance: delivery of the services shall be to the European Medicines Agency (EMEA), 7 Westferry Circus, Canary Wharf, London E14 4HB, UNITED KINGDOM. The services shall be carried out on the contractor's premises.

      NUTS code: UKI12.

    • II.1.3) The notice involves:

      The establishment of a framework agreement.

    • II.1.4) Information on framework agreement:

      Framework agreement with several operators.

      Maximum number of participants to the framework agreement envisaged: 5.

      Duration of the framework agreement: Duration in year(s): 4.

      Estimated total value of purchases for the entire duration of the framework agreement:

      Estimated value excluding VAT: 6 500 000 EUR.

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

      This tender aims to put into place contractual arrangements that will enable EMEA to specify and acquire services provided by resources not employed directly by EMEA. These resources will contribute expertise directly to the data management activities (data cleaning, recording, duplicate detection and quality control) for EudraVigilance, the Agency's pharmacovigilance system.

      The results of the work are to be stored electronically on the system hosted at the Agency. Tracking information in relation to the tasks is to be maintained by the contractor and made available to EMEA electronically. The results of the work are to be presented to EMEA weekly, work stream by work stream. The work is to be performed at the contractor's premises, although contractor's staff will be expected to attend meetings at EMEA's premises at 7 Westferry Circus, Canary Wharf, London E14 4HB, UNITED KINGDOM.

    • II.1.6) Common procurement vocabulary (CPV):

      72322000, 72300000, 72310000, 72316000, 72312000, 72312100.

    • II.1.7) Contract covered by the Government Procurement Agreement (GPA):

      Yes.

    • II.1.8) Division into lots:

      No.

    • II.1.9) Variants will be accepted:

      No.

  • II.2) QUANTITY OR SCOPE OF THE CONTRACT

    • II.2.1) Total quantity or scope:

      The total direct effort required to carry out the work, excluding management requirements, is expected to be 144 man-years over 4 years.

      Estimated value excluding VAT: 6 500 000 EUR.

    • II.2.2) Options:

      No.

  • II.3) DURATION OF THE CONTRACT OR TIME-LIMIT FOR COMPLETION:

    Duration in months: 48 (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 regulating 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 to which the performance of the contract is subject:

      No.

  • III.2) CONDITIONS FOR PARTICIPATION

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

      Information and formalities necessary for evaluating if requirements are met: all information required is indicated in the technical specifications and invitation to tender letter which can be downloaded from EMEA web page: http://www.emea.europa.eu/htms/general/admin/tenders/contracts.htm.

    • III.2.2) Economic and financial capacity:

      Information and formalities necessary for evaluating if requirements are met: all information required is indicated in the technical specifications and invitation to tender letter which can be downloaded from EMEA web page: http://www.emea.europa.eu/htms/general/admin/tenders/contracts.htm.

    • III.2.3) Technical capacity:

      Information and formalities necessary for evaluating if requirements are met:

      all information required is indicated in the technical specifications and invitation to tender letter which can be downloaded from EMEA web page: http://www.emea.europa.eu/htms/general/admin/tenders/contracts.htm.

    • III.2.4) Reserved contracts:

      No.

  • III.3) CONDITIONS SPECIFIC TO SERVICES CONTRACTS

    • III.3.1) Execution of the service is reserved to a particular profession:

      No.

    • III.3.2) Legal entities 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:

      Not provided

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

      Not provided

  • 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) An electronic auction will be used:

      No.

  • IV.3) ADMINISTRATIVE INFORMATION

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

      EMEA/2009/04/PM-PhV.

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

      No.

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

      Not provided

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

      16.11.2009 - 12:00.

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

      Not provided

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

      Spanish. Danish. German. Greek. English. French. Italian. Dutch. Portuguese. Finnish. Swedish. Czech. Estonian. Hungarian. Lithuanian. Latvian. Maltese. Polish. Slovak. Slovenian. Irish. Bulgarian. Romanian.

      Other: EMEA will accept documentation in any EU language. EMEA prefers, however, to receive all documentation in English.

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

      Duration in month(s): 12 (from the date stated for receipt of tender).

    • IV.3.8) Conditions for opening tenders:

      Date: 19.11.2009 - 14:00.

      Place: EMEA, 7 Westferry Circus, Canary Wharf, London E14 4HB, UNITED KINGDOM.

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

      1 representative per tenderer is permitted to be present at the opening of the tenders provided that the name of the representative is notified at least 24 hours in advance in writing to the contact given in I.1.

SECTION VI: COMPLEMENTARY INFORMATION

  • VI.1) THIS IS A RECURRENT PROCUREMENT:

    Yes.

    Estimated timing for further notices to be published: 4 years.

  • VI.2) CONTRACT RELATED TO A PROJECT AND/OR PROGRAMME FINANCED BY EU FUNDS:

    No.

  • VI.3) ADDITIONAL INFORMATION:

    Please note that the framework contract will run for an initial period of 2 years and may, at the EMEA's request, be extended for 2 further periods of 1 year each, up to a maximum contract duration of 4 years.

  • VI.4) PROCEDURES FOR APPEAL

    • VI.4.1) Body responsible for appeal procedures:

      Court of First Instance of the European Communities , boulevard Konrad Adenauer , L -2925 L uxembourg . E-mail: . Tel. +352 4303-1 . URL : 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 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 (EMEA) , 7 Westferry Circus, Canary Wharf , UK -London E14 4HB . E-mail: . Tel. +44 2074188400 . URL: http://www.emea.europa.eu . Fax +44 2074188416 .
  • VI.5) DATE OF DISPATCH OF THIS NOTICE:

    24.9.2009.