Legal Basis:
Regulation (EU, Euratom) No 2018/1046
Section I: Contracting authority
I.1)Name and addressesOfficial name: European Health and Digital Executive Agency (HaDEA), HADEA.A.2.001 – EU4Health III
Postal address: COV2, Place Charles Rogier 16
Town: Brussels
NUTS code:
BE100 Arr. de Bruxelles-Capitale / Arr. Brussel-HoofdstadPostal code: 1210
Country: Belgium
E-mail:
hadea-procell@ec.europa.euInternet address(es): Main address:
https://hadea.ec.europa.eu I.3)CommunicationAdditional information can be obtained from 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:
HADEA/2022/OP/0024 – Recommendations and Guidance Documents for the Management of Substances of Human Origin in Hospitals
Reference number: HADEA/2022/OP/0024
II.1.2)Main CPV code73000000 Research and development services and related consultancy services
II.1.3)Type of contractServices
II.1.4)Short description:
Recommendations and guidance documents for the management of substances of human origin in hospitals.
II.1.5)Estimated total valueValue excluding VAT: 750 000.00 EUR
II.1.6)Information about lotsThis contract is divided into lots: no
II.2)Description
II.2.2)Additional CPV code(s)73000000 Research and development services and related consultancy services
II.2.3)Place of performanceNUTS code: AT Österreich
NUTS code: BE Belgique / België
NUTS code: BG България / Bulgaria
NUTS code: CY Κύπρος / Kýpros
NUTS code: CZ Česko
NUTS code: DE Deutschland
NUTS code: DK Danmark
NUTS code: EE Eesti
NUTS code: EL Ελλάδα / Elláda
NUTS code: ES España
NUTS code: FI Suomi / Finland
NUTS code: FR France
NUTS code: HR Hrvatska
NUTS code: HU Magyarország
NUTS code: IE Éire / Ireland
NUTS code: IS Ísland
NUTS code: IT Italia
NUTS code: LI Liechtenstein
NUTS code: LT Lietuva
NUTS code: LU Luxembourg
NUTS code: LV Latvija
NUTS code: MT Malta
NUTS code: NL Nederland
NUTS code: NO Norge
NUTS code: PL Polska
NUTS code: PT Portugal
NUTS code: RO România
NUTS code: SE Sverige
NUTS code: SI Slovenija
NUTS code: SK Slovensko
Main site or place of performance:
The services will be performed at the contractor’s premises or, for the purposes of the activities required (e.g. organisation of meetings) at any other location agreed with the contracting authority.
II.2.4)Description of the procurement:
The subject of this call for tenders is the development of recommendations and guidance documents for the management of substances of human origin (SoHO) in hospitals.
These should support the quality, safety, efficacy and optimal use of SoHO in hospitals and cover existing requirements under EU law as well as taking into account the provisions in the proposed ‘Regulation on standards for quality and safety of substances of human origin intended for human application’.
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: 750 000.00 EUR
II.2.7)Duration of the contract, framework agreement or dynamic purchasing systemDuration in months: 24
This contract is subject to renewal: no
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: yes
Identification of the project:
Regulation (EU) 2021/522 establishing a programme for the Union’s action in the field of health (‘EU4Health programme’) for the period 2021-2027.
II.2.14)Additional information
Please consult the procurement documents available at the address indicated 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:
Please consult the procurement documents available at the address indicated 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:
Please consult the procurement documents available at the address indicated 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.2.1)Previous publication concerning this procedure IV.2.2)Time limit for receipt of tenders or requests to participateDate: 15/02/2023
Local time: 16:00
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 tenderDuration in months: 6 (from the date stated for receipt of tender)
IV.2.7)Conditions for opening of tendersDate: 16/02/2023
Local time: 11:00
Place:
Tenders will be opened electronically on the date and time indicated in the contract notice. It is possible to attend the opening by videoconference.
Information about authorised persons and opening procedure:
Please consult the procurement documents available at the address indicated in Section I.3).
Section VI: Complementary information
VI.1)Information about recurrenceThis is a recurrent procurement: no
VI.2)Information about electronic workflowsElectronic invoicing will be accepted
Electronic payment will be used
VI.3)Additional information:
Please consult the procurement documents available at the address indicated in Section I.3). In case of unavailability or disruptions in the functioning of the electronic means of communication provided in Section I.3) in the last 5 calendar days before the time limit for receipt indicated in Section IV.2.2), the contracting authority reserves the right to extend this time limit and publish the extension at the internet address provided in Section I.3), without a preceding publication of a corrigendum to this notice. Economic operators interested in this procurement are invited to subscribe to the call for tenders at the address in Section I.3) in order to get notified when new information or documents are published.
VI.4)Procedures for review
VI.4.1)Review bodyOfficial name: General Court of the European Union
Postal address: rue du Fort Niedergrünewald
Town: Luxembourg
Postal code: L-2925
Country: Luxembourg
Telephone: +352 4303-1
Internet address:
http://curia.europa.eu VI.4.3)Review procedurePrecise information on deadline(s) for review procedures:
Please consult the procurement documents available at the address indicated in Section I.3).
VI.5)Date of dispatch of this notice:14/12/2022