This call for tenders aims at enhancing the accessibility and availability of Medical Counter-Measures (MCMs) in the EU/EEA. The subject of this call for tenders is to conclude contracts for the reservation of manufacturing capacity and of contractor-managed stockpiles of nitrile examination gloves (lot 1) and FFP2 respiratory masks (lot 2) (hereinafter ‘EU FAB+ PPE Pilot’). The contractor with manufacturing capacity in the EU/EEA will be requested to set up contractor-managed stockpiles with an associated priority right to purchase. Purchased stocks will have to be either replenished in the stockpile or will give rise to an equivalent reservation of manufacturing capacity for the remainder of the contract. The contracting authority and/or the European Commission must have the right to activate the right to purchase the stockpiled or manufactured MCMs, when deemed necessary for preparedness or crisis purposes. Each lot will be awarded to a maximum of three tenderers with each contract awarded lasting for 3 years (36 months). Purchase of the products in scope of this call for tenders shall be done by the contracting authority and/or the European Commission, if needed on behalf of any EU/EEA countries or any EU4Health associated countries, via a separate procedure.

Nitrile examination gloves

The products in scope of Lot 1 are nitrile examination gloves. Nitrile examination gloves shall comply with the EN ISO 21420, EN 455 (parts 1-4) and EN 374-1 type C, EN 374-4 and EN 374-5 standards, with valid CE marking.

FFP2 masks

The products in scope of Lot 2 are FFP2 respiratory masks. FFP2 masks shall comply with the EN 149:2001+A1:2009 standard, with valid CE marking. They shall not have an exhalation valve and shall not rely on ear loops. Securing the mask shall rely on straps around the head and/or neck to provide a good seal with the user’s face.