Project 28735 - Manufacture and Supply of Avian and Bovine PPD Tuberculin

Tender description

The requirement is for the Manufacture and Supply of Avian and Bovine Purified Protein Derivatives (PPD) Tuberculin to the Animal and Plant Health Agency (APHA). This product is for use in its bovine tuberculosis (bTB) testing scheme, which is the cornerstone of the bTB eradication programmes in England, Wales and Northern Ireland and the surveillance programme in Scotland. Lot 1: Avian and Bovine Purified Protein Derivatives (PPD) Tuberculins are used in Defra's bovine tuberculosis (bTB) testing scheme, which is the cornerstone of the bTB eradication programmes in England, Wales and Northern Ireland and the surveillance programme in Scotland. APHA's current requirement is for approximately 3,300 litres of PPD Tuberculin on an annual basis. Deliveries will be required on a monthly basis, with the avian and bovine PPD Tuberculins supplied in a paired presentation, available in two vial sizes (2ml and 5 ml). The following quantities are required for the duration of the Contract: • a minimum of 140 litres of avian PPD Tuberculin per month up to a maximum of 190 litres per month; and • a minimum of 140 litres of bovine PPD Tuberculin per month up to a maximum of 190 litres per month. The contract will start on 01/01/2023 and the contract period will be 5 years (with a further 24 months allowable extension to 31/12/2029). (Note that the value shown on this notice is approximate and covers the full 7-year period.) Key manufacturing and supply standards are as follows: - UK Marketing Authorisation (MA) for both bovine and avian PPD Tuberculin products; - A current Good Manufacturing Practice (GMP) certificate recognized by the UK's Veterinary Medicines Directorate (VMD) for the duration of the contract; - Product tested according to, and at the time of delivery compliant with, the general standards defined in the European Pharmacopoeia Current Edition (monographs 0536 and 0535).