Procedures for the release and delivery of vaccines formulated from the antigens of the foot and mouth disease virus as referred to in Article 6(2)
ANNEX IVSupplementary provisions
ANNEX IV Procedures for the release and delivery of vaccines formulated from the antigens of the foot and mouth disease virus as referred to in Article 6(2) 1. Following notice of the request for delivery by the Commission, the contracted manufacturer shall comply with the following deadlines for delivery: (a) for urgent but not immediate supply: a period of 7 to 15 working days for formulation, bottling and labelling, plus 3 working days for delivery; (b) for immediate supply: a period of 6 working days for formulation, bottling and labelling, plus 3 working days for delivery; (c) in cases of extreme urgency: the contracted manufacturer shall deliver quicker than at the deadlines referred to in points (a) and (b), subject to the necessary documentation, such as an Early Release Certificate or an introduction permit granted by the Member State, third country or territory of destination, being provided and subject to any enforced delays caused by or restrictions imposed by the shipping company. The contracted manufacturer shall take the necessary steps to facilitate the sourcing of any permit or licence required for performance of the contract under the laws and regulations in force at the place where the contract referred to in Article 3(1) or 4(1) of Delegated Regulation (EU) 2022/139 is to be executed. However, the contracted manufacturer shall not be held responsible for obtaining documents that are dependent on other legal entities and authorities which do not exercise direct control over or influence him/her. 2. For the shipment to the destination the vaccines shall be packaged in insulated cardboard boxes containing 6 cool-packs per standard sized box (45x42x45 cm) or equivalent. This combination must ensure cold-chain conditions for up to 72 hours. Where specifically requested by the Commission, the contracted manufacturer shall furnish the shipment of vaccines with WHO approved vaccine cold-chain monitors ( 1 ) in each standard box of vaccines. The vaccine cold-chain monitor card must have a time-temperature indicator with the threshold response temperatures of +10 °C and +34 °C. The vaccine cold-chain monitor card must show a blue colouration of the indicator if the temperature has been exceeded during transport or storage. ( 1 ) WHO, World Health Organisation, ‘Temperature monitors for vaccines and the cold chain’, document WHO/V&B/99.15 (1999).