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Services - 467537-2021
17/09/2021    S181

Belgium-Brussels: Establishment of a Network of Ever-warm Production Capacities for Vaccines and Therapeutics manufacturing (EU FAB)

2021/S 181-467537

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 Commission, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (GROW)
Postal address: Avenue d'Auderghem 45
Town: Brussels
NUTS code: BE100 Arr. de Bruxelles-Capitale / Arr. Brussel-Hoofdstad
Postal code: 1040
Country: Belgium
Contact person: Task Force for the Industrial Scale-up of COVID-19 vaccines (TFIS)
E-mail: GROW-TFIS@ec.europa.eu
Internet address(es):
Main address: https://ec.europa.eu/growth/
Address of the buyer profile: https://ec.europa.eu/growth/coronavirus-response/task-force-for-industrial-scale-up-of-covid-19-vaccines_en
I.3)Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at: https://ted.europa.eu/TED/browse/browseByMap.do
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:

Establishment of a Network of Ever-warm Production Capacities for Vaccines and Therapeutics manufacturing (EU FAB)

II.1.2)Main CPV code
85140000 Miscellaneous health services
II.1.3)Type of contract
Services
II.1.4)Short description:

The COVID-19 pandemic showed the challenges for existing EU facilities to ramp-up their production. Thus, as part of strengthening the Health Union, for future health crises the EU must be better prepared and guarantee quicker access to sufficient manufacturing capacities for vaccines and therapeutics, to respond to EU needs and to fulfil our global obligations. As announced in the Communication on the European Health Emergency Preparedness and Response Authority on 16 September 2021, the Commission will set-up EU FAB, a network of ever-warm, single and/or multi-technology production capacities for vaccines and therapeutics. It will ensure heightened supply in case of a surge in demand due to public health emergencies, by reducing the time needed between development and industrial scale-up, and provide for solid supply chains thereto. If needed, access and use can be activated and made available. During ‘non-crisis’ times, these facilities are used for their regular activities.

II.1.5)Estimated total value
II.1.6)Information about lots
This contract is divided into lots: yes
II.2)Description
II.2.1)Title:

Contracts for the Provision of Production Capacity and for the Production and Supply of Vaccines (such as mRNA, Vector-based, Protein-based and Inactivated Virus Vaccines)

Lot No: 1
II.2.2)Additional CPV code(s)
33651600 Vaccines
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: IT Italia
NUTS code: LT Lietuva
NUTS code: LU Luxembourg
NUTS code: LV Latvija
NUTS code: MT Malta
NUTS code: NL Nederland
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:

European Union.

II.2.4)Description of the procurement:

The aim of lot 1 is to award contracts to a number of economic operators for keeping part of their production capacity (single and/or multi-technology sites) at the disposal of EU FAB and, in case of its activation, for the production and supply of vaccines in the European Union. The contracts will ensure that EU FAB has a total EU production capacity of 700 million doses, half of which would need to be made available within the first 6 months following activation of EU FAB. The economic operators need to ensure the entire production chain of the finished product, including fill and finish and packaging of vaccines, according to the specifications of the marketing authorisations and manufacturing authorisations. In addition, manufacturers have to demonstrate access to sufficient quantities of all necessary critical raw materials and consumables, which they will need in order to produce the doses of vaccines to be agreed. The facilities have to be operational during non-crisis time, during which they can be used for their regular activities. In case of activation of EU FAB, they have to be capable to produce and supply the doses of vaccines to be agreed, upon request and within the requested timeframe.

II.2.14)Additional information

The procurement documents will be made available when the call is launched.

II.2)Description
II.2.1)Title:

Contracts for the Provision of Production Capacity and for the Production and Supply of Therapeutics

Lot No: 2
II.2.2)Additional CPV code(s)
33600000 Pharmaceutical products
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: IT Italia
NUTS code: LT Lietuva
NUTS code: LU Luxembourg
NUTS code: LV Latvija
NUTS code: MT Malta
NUTS code: NL Nederland
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:

European Union.

II.2.4)Description of the procurement:

The aim of lot 2 is to award contracts to a number of economic operators for keeping part of their production capacity (single and/or multi-technology sites) at the disposal of EU FAB and, in case of its activation, for the production and supply of therapeutics in the European Union. The economic operators need to ensure the entire production chain of the finished product, including primary and secondary packaging of therapeutics, according to the marketing authorisations and manufacturing authorisations. In addition, manufacturers have to demonstrate access to sufficient quantities of all necessary critical raw materials and consumables, which they will need in order to produce the quantities of therapeutics to be agreed. The facilities have to be operational during non-crisis time, during which they can be used for their regular activities. In case of activation, they have to be capable to produce and supply the quantities of therapeutics to be agreed, upon request and within the requested timeframe.

II.2.14)Additional information

The procurement documents will be made available when the call is launched.

II.3)Estimated date of publication of contract notice:
31/01/2022

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:
VI.5)Date of dispatch of this notice:
10/09/2021