CBRN/00282 - Supply of Pyridostigmine tablets

Concepts

• bristol
• medicinal products
• chemical biological radiological nuclear team
• cbrn
• supply of pyridostigmine tablets
• production of pyridostigmine bromide tablets
• tablets
• marketing authorisation
• state for defence
• life of the product

Location

United Kingdom:

Description

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. Quantity or scope: 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)

CPV Codes

• 33661000 - Medicinal products for the nervous system

Indicators

• This is a recurring contract.
• Financial restrictions apply.
• Professional qualifications are sought.
• Technical restrictions apply.

Other Information

** PREVIEW NOTICE, please check Find a Tender for full details. ** The Contracting Authority intends to use an e-Tendering system in this procurement exercise, please visit www.contracts.mod.uk for full details and to register your interest in this procurement. The deadline for submitting your response(s) is detailed within this contract notice. Please ensure that you allow yourself plenty of time when responding to this opportunity prior to the closing date and time, especially if you have been asked to upload documents. The Authority reserves the right to amend any condition related to security of information to reflect any changes in national law or government policy. If any contract documents are accompanied by instructions on safeguarding classified information (e.g. a Security Aspects Letter), the Authority reserves the right to amend the terms of these instructions to reflect any changes in national law or government policy, whether in respect of the applicable protective marking scheme, specific protective markings given, the aspects to which any protective marking applies, or otherwise. The link below to the Gov.uk website provides information on the Government Security Classification. https://www.gov.uk/government/publications/government-security-classifications The Cyber Risk Profile for this requirement identified by the Cyber Risk Assessment is Very low (Ref No: RAR-7TGB4RZX). Electronic Trading: Potential suppliers must note the mandatory requirement for electronic trading using the Contracting, Purchasing and Finance (CP&F) electronic procurement tool. All payments for Contractor Deliverable's under the Contract shall only be made via CP&F. You can find details on CP&F at https://www.gov.uk/government/publications/mod-contracting-purchasing-and-financ.... Interested suppliers are required to complete the Pre-Qualification Questionnaire (PQQ) to provide the Authority with information to evaluate the supplier’s capacity and capability against the selection criteria. The Authority will use the PQQ response to create a shortlist of tenderers who: (1) are eligible to participate; (2) fulfil any minimum economic, financial, professional and technical standards; and (3) best meet in terms of capacity and capability the selection criteria set out in the PQQ. Full details of the method for choosing the tenderers will be set out in the PQQ. For all scored questions Potential Suppliers must achieve a mark of 2 (Satisfactory), if you score below 2 (Satisfactory) the Authority reserves the right to eliminate you from the competition. During the PQQ stage, the intention is to arrive at a short list of a minimum of three (3) and a maximum of six (6) qualified potential suppliers for formal invitation to negotiate. This list of six (6) qualified potential suppliers will be made up of the top six (6) performing PQQ responses.