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Speed up the Development of and Access to Innovative Medical Countermeasures (Бельгия - Тендер #43820636)


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Страна: Бельгия (другие тендеры и закупки Бельгия)
Организатор тендера: European Health and Digital Executive Agency (HaDEA), HADEA.A.2 – EU4Health/SMP Food
Номер конкурса: 43820636
Дата публикации: 17-07-2023
Источник тендера:


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Регистрация
20230705European Institution/Agency or International OrganisationPrior information notice without call for competitionServicesNot applicableEuropean Institution/Agency or International OrganisationNot applicableNot applicableGeneral public servicesAGC01AG
17/07/2023    S135

Belgium-Brussels: Speed up the Development of and Access to Innovative Medical Countermeasures

2023/S 135-432231

Prior information notice

This notice is for prior information only

Services

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

Section I: Contracting authority

I.1)Name and addresses
Official name: European Health and Digital Executive Agency (HaDEA), HADEA.A.2 – EU4Health/SMP Food
Postal address: COV2, Place Charles Rogier 16
Town: Brussels
NUTS code: BE100 Arr. de Bruxelles-Capitale / Arr. Brussel-Hoofdstad
Postal code: 1210
Country: Belgium
E-mail: hadea-procell@ec.europa.eu
Internet address(es):
Main address: https://hadea.ec.europa.eu
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=14933
Additional information can be obtained from 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:

Speed up the Development of and Access to Innovative Medical Countermeasures

Reference number: HADEA/2023/OP/0036-PIN
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:

The subject of this call for tenders is to conclude service contracts for the purchasing of clinical and non-clinical services to speed up availability and access to innovative medical countermeasures (MCMs). The innovative MCMs include promising solutions that are indicated to diagnose/detect, prevent, protect from or treat conditions associated to serious cross border health threats.

II.1.5)Estimated total value
Value excluding VAT: 82 000 000.00 EUR
II.1.6)Information about lots
This contract is divided into lots: yes
II.2)Description
II.2.1)Title:

Vaccines to Combat Antimicrobial Resistance

Lot No: 1
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73300000 Design and execution of research and development
II.2.3)Place of performance
NUTS 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:

This lot will support the assessment of the candidate’s efficacy and further assessment of safety (within Phase II clinical trials), as well as any development that helps identify the most promising preparation, dose, and schedule to be tested in Phase III clinical trials.

II.2.14)Additional information
II.2)Description
II.2.1)Title:

Broad Spectrum Antivirals Targeting Respiratory RNA Viral Families

Lot No: 2
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73300000 Design and execution of research and development
II.2.3)Place of performance
NUTS 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:

This lot foresees support to obtain partial information on drug efficacy, namely ‘Phase IIb’ clinical trials, for contexts where viral diseases occur with relevant incidence. When relevant and duly justified (e.g., lack of commercial interest or another type of market failure that leads to crowding out investments and partnerships), tenderers may also apply for partial support for the assessment of a primary efficacy endpoint of Phase III trials, specifying the measure of the disease-related outcome of public health interest, such as mortality or disease morbidity, that supports the antiviral candidate indication for use.

II.2.14)Additional information
II.2)Description
II.2.1)Title:

Broad Spectrum Antivirals – Viral-haemorrhagic Fevers

Lot No: 3
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73300000 Design and execution of research and development
II.2.3)Place of performance
NUTS 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:

This lot foresees support to obtain partial information on drug efficacy, namely ‘Phase IIb’ clinical trials, for contexts where viral diseases occur with relevant incidence. When relevant and duly justified (e.g., lack of commercial interest or another type of market failure that leads to crowding out investments and partnerships), tenderers may also apply for partial support for the assessment of a primary efficacy endpoint of Phase III trials, specifying the measure of the disease-related outcome of public health interest, such as mortality or disease morbidity, that supports the antiviral candidate indication for use.

II.2.14)Additional information
II.2)Description
II.2.1)Title:

Point of Care Metagenomic Sequencing for Universal Pathogen Detection

Lot No: 4
II.2.2)Additional CPV code(s)
73000000 Research and development services and related consultancy services
73300000 Design and execution of research and development
II.2.3)Place of performance
NUTS 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:

This lot supports the development of a metagenomic next-generation sequencing (mNGS)-based test that can detect any respiratory viral pathogen, including novel and emerging, from any human respiratory sample type.

II.2.14)Additional information
II.3)Estimated date of publication of contract notice:
03/08/2023

Section IV: Procedure

IV.1)Description
IV.1.8)Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: no

Section VI: Complementary information

VI.3)Additional information:

This prior information notice announces the intention of the contracting authority to publish a future call for tenders. No other information or documents are available at this stage. Interested economic operators are invited to subscribe at the address in Section I.3) in order to get notified when the contract notice and all the procurement documents, including the tender specifications, are published.

VI.5)Date of dispatch of this notice:
05/07/2023

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