Supply of 18F-DOPA Radionuclide tracer to NHS England Centres

Tender description

NHS Arden and Greater East Midlands Commissioning Support Unit (AGCSU), on behalf of NHS England (referred to as the Commissioner)) is inviting suitably qualified and experienced suppliers to express an interest in delivering the supply of 18F-DOPA radiotracer. 18F-DOPA PET-CT scans are integral to the clinical pathway, as set out in the service specification. The 18F-DOPA PET-CT scan is used to identify patients who have the focal (rather than diffuse) form of congenital hyperinsulinism (CHI), who would benefit from surgery and the precise location of the focal lesions so that they can be removed. Lot 1: NHS Arden and Greater East Midlands Commissioning Support Unit (AGCSU), on behalf of NHS England (referred to as the Commissioner)) is inviting suitably qualified and experienced suppliers to express an interest in delivering the supply of 18F-DOPA radiotracer. 18F-DOPA PET-CT scans are integral to the clinical pathway, as set out in the service specification. The 18F-DOPA PET-CT scan is used to identify patients who have the focal (rather than diffuse) form of congenital hyperinsulinism (CHI), who would benefit from surgery and the precise location of the focal lesions so that they can be removed. 18F-DOPA PET-CT scans are only performed at Institute of Nuclear medicine, University College London Hospitals NHS Foundation Trust and Manchester University NHS Foundation Trust. At present, about ten 18F-DOPA PET-CT scans are performed annually. NHS England is looking to gauge the potential market interest for providing the 18F- DOPA radiotracer to the two CHI scanning centres in England. Requirements The supplier will be required to manufacture, quality assure and control and deliver 18F-DOPA as required (circa ten doses per year). The supplier will need to be flexible in its scheduling of the production of 18F-DOPA to meet the service needs of the scan providers at University College London Hospital and Manchester University NHS Foundation Trust. The tracer will need to be manufactured and transported to the scan provider in a quantity that ensures that there is sufficient activity in the product to carry out an effective scan. The supplier will need to hold: a valid manufacturer's licence a valid marketing authorisation or a Manufacturer's Specials Licence as applicable issued by the Medicines and Healthcare products Regulatory Agency (MHRA) for the manufacture of the tracer, such licences being subject to renewal following satisfactory MHRA inspection. The supplier will need to demonstrate that the manufacture and supply of the radiotracer will meet the requirements of the Law and related guidance including: Good Manufacturing Practice (GMP) as defined in Commission Directive 2003/94/EC (principles and European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009; and European Pharmaceutical standards for the Quality Control Analysis. Interested parties are encouraged to register their interest and participate in the market questionnaire which will provide feedback to commissioners. Please note that this is not a call for competition although the commissioner would encourage all potential providers to respond to this market engagement exercise. It is possible that, as a result of this exercise, a formal tender process may not be required but instead a simpler supplier selection process may be considered. The outcome of this market engagement will help inform commissioners of the current and future capacity and capability of the market and will be considered with other evidence to inform the commissioning approach. The market engagement includes a clear outline of the service requirements along with a questionnaire for bidders to respond to, including the key requirements to ascertain the capability of providers.  The contract duration for this supply is 5 years with an option to extend for a further two years. The response deadline is 12:00 hrs midday on 18.02.22  To respond to the market engagement exercise please follow this link https://uk.eu-supply.com/ctm/supplier/publictenders?B=UK and either login or register on EU Supply and search from ID number 48184 Please note that an online Webinar will be held on 01.02.22, further details will be shared in due course.