CBRN/00282 - Supply of Pyridostigmine tablets

This Notice confirms commencement of Opportunity: CBRN/00282 Supply of Pyridostigmine Tablets. Details of the scope are set out below. If you are interested in this opportunity, please register as a supplier on the Defence Sourcing Portal (https://contracts.mod.uk). A Pre-Qualification Questionnaire (PQQ) for this opportunity has been published. Once registered, interested Suppliers must submit their response to the PQQ on the Defence Sourcing Portal. The link to the PQQ is set out in the attachments part of this notice. IMPORTANT: the closing date to submit a PQQ response for this opportunity is 7 April 2021, 17:00. Any late submissions will NOT be considered. Scope of Opportunity: The UK Ministry of Defence (UK MOD) has a requirement for the production of Pyridostigmine Bromide tablets for oral consumption. The Chemical Biological Radiological Nuclear Team (CBRN) is seeking to appoint a manufacturer to produce these tablets for which it currently maintains the Marketing Authorisation (MA) on behalf of the Secretary of State for Defence. The Supplier is to be responsible for: 1. Manufacture Pyridostigmine tablets, as per the technical specifications, on behalf of the UK MOD; the Marketing Authorisation Holder. 2. Develop protocols, compliant with ICH guidelines, to support stability studies for the life of the product. 3. Documentation and data, including a technical transfer summary report, to support license changes to ensure the manufacturer is named on the MA as the licensed manufacturer for the product. 4. Manufacture product in accordance with current Good Manufacturing Practice (cGMP) standards as defined by the International Conference on Harmonisation and regulated by the national competent Authority's in Europe and Canada. 5. Storage of the finished product and all product movement between Qualified Person (QP) release and receipt will be carried out in accordance with the requirements of Good Distribution Practice (GDP) and the Guidelines on GDP on Medicinal Products for Human Use (2013/C 343/01) or as subsequently amended. Initial quantity of requirement is estimated to be in the region of 140,00 to 200,000 tablets. Exact quantities to be confirmed at ITN stage. Quantities for Option years are not included within this range, and will also be confirmed at ITN stage. The initial contract period will be 5 years, with the option to extend up to a further 5 years (total estimated contract duration is 10)