Storage & Distribution of Human Medicines, Vaccines & Associated Medical Product

The purpose of this Preliminary Market Engagement Notice is to publicise updates following the Market Engagement event held on 13th May 2025 following the previous notice: Storage & Distribution of Human Medicines, Vaccines & Associated Medical Products - www.find-tender.service.gov.uk/Notice/015899-2025 ↗ Project Background The UK Health Security Agency (UKHSA or the Agency) wishes to establish a contract with a pharmaceutical wholesaler for human medicines who can act as a third party on behalf of the Agency for the UK storage and distribution of the Agency's vaccines, other medicines and associated medical products (ownership remains with the UKHSA). Market Engagement UKHSA have conducted various rounds of Market Engagement activities prior to the Procurement Act 2023 going live. Details of which can be found: 2023 - Storage & Distribution of Human Medicines, Vaccines & Associated Medical Product - www.contractsfinder.service.gov.uk/Notice/9f7f2e0f-8d01… ↗ 2024 - Storage & Distribution of Human Medicines, Vaccines & Associated Medical Product - www.contractsfinder.service.gov.uk/Notice/489da396-c46d… ↗ A Preliminary Market Engagement Notice was published, through the Find a Tender Service, under the Procurement Act 2023 on 17th April 2025. The notice invited suppliers to register their interest in attending and participating in an online Market Engagement Event. UKHSA required attendees to return a signed NDA to attend. 17 Suppliers registered interest in attending the event. 12 suppliers returned signed NDA’s and attended the event. The one-hour online event took place on Tuesday 13th May 2025 with a presentation of the requirements already set out in the Preliminary Market Engagement Notice delivered by: Director Commercial, Vaccines and Countermeasures Delivery Deputy Director Vaccines Programme and Operations Deputy Director Commercial – Major Programmes Senior Commercial Manager – Major Programmes Head of Quality and Regulatory New information shared The following licence requirements will be a Condition of Participation in the procurement:

• Wholesale Distribution Authorisation (WDA (H))
• Good Distribution Practice (GDP) Certificate
• Home Office Controlled Drugs Licence The following audits are required after evaluation, prior to award recommendation:
• GDP Audit
• GMP Audit if MS and MIA are available The following licence and audit requirements will be required before end of transition:
• Manufacturing Specials (MS) Licence
• Manufacturing and/or Import Authorisation (MIA) Licence
• Good Manufacturing Practice (GMP) Certificate
• GMP Audit if MS and MIA are obtained during this period Q&A Infrastructure Does any of the existing infrastructure with the incumbent form part of the tender process, or is the expectation that the new supplier will procure the required assets to store the ULT temperature regimes and controlled drugs? Existing infrastructure is owned by the incumbent and is not part of the tender. Is it essential that as part of this Contract, there is a Northern Ireland MHRA approved warehouse operation, in order to meet service level requirements? Yes, it is an essential part of the contract as we have products that need to be distributed within certain timeframes. Will any successful bidder be required to have the ability to interface with the authority’s web based ordering platform as outlined in the PIN (ImmForm) ahead of contract commencement? Yes, there will be a requirement prior to contract commencement which will include stress testing. Will licence requirements apply to the facility in Northern Ireland? Yes, licence requirements will be the same in Northern Ireland as they are in the UK. Is this inclusive of freezers? As asset register will be provided detailing what is owned as part of the tender pack. The supplier may choose to utilise these assets or provide an alternative solution. Stock Is PPE still in scope or is the contract now purely focussed on vaccines/medicines? There is no requirement for PPE currently under this contract, it is just vaccines, medicines and ancillaries. Will the provider be expected to procure the products from the authority? No, the stock remains the property of UKHSA. Will the provider or the authority own the stock? The stock remains the property of UKHSA. Transportation Bidders will be required to provide the service to and within Northern Ireland? Yes, it is expected to provide a service in Northern Ireland as well as UK-wide. Will passive shippers be accepted? Yes they would be accepted for specific products, so long as there are no deviations in temperature control. Does the tender include the final mile distribution of the COVID vaccines in England? We are currently unable to give a view as to which specific products are in or out of scope as the contract doesn’t go live until quarter 3 of 2027. Is it essential that providers must have demonstrable experience of operating a fleet of temperature-controlled vehicles on a national basis or will this capability transfer? We assume this is relating to the fleet and not the personnel. Experience of operating a fleet of temperature-controlled vehicles on a national basis is very important, due mainly to the high value of products that are temperature-controlled and the risk of any deviations which result in disposal of stock. Is it essential all providers have proven capability for managing the storage and transportation of frozen and ULT pharma/vaccine products? Yes, we do need suppliers to have the capability for managing the storage and distribution of ULT. Contact/Commercial The contract has an extension up to 10 years, but please could we clarify the minimum contract period? Minimum term of 6 years, with extension options up to 10 years in total. When will the tender be issued and due? It is anticipated to be issued Summer this year. Will bidders be offered the opportunity to 1-2-1 engagement sessions with the authority? Yes, that is one of the flexibilities and benefits of the new Procurement Act and the procedure that we’re going to be following. There will be 1-2-1 sessions/negotiations as part of the tender. If there is an appetite within the market to do pre-market 1-2-1 engagement sessions then we would welcome that. When will the tender be issued and due? Timelines are ambitious. It is anticipated to be issued Summer this year. When will we receiver the tender pack and how? The opportunity will be published via the Find a Tender Service. What are the Delivery SLA’s expected for Jersey/Guernsey and Isle of Man? These will be detailed in the tender pack. Other Does the authority know at this stage what the security and pre-employment check requirements for all colleagues working on the contracts are? A minimum of BPSS, but for certain product ranges or areas may require CTC or SC. Can you elaborate on what is not working as well as you want and you would like to fix/address? And also what challenges going forward do you envisage that you want suppliers to support with? While our current setup is generally functional, we believe there are opportunities to enhance agility, visibility across the supply chain and overall operational efficiency. We're also reviewing how well our logistics model supports our future growth and customer expectations, particularly in terms of flexibility and innovation. Looking ahead, we anticipate needing support in areas such as adapting to seasonal volume fluctuations and improving data-driven decision-making. We’re also interested in exploring how a 3PL can help us manage risk, maintain service levels during periods of change and introduce proactive solutions that align with our long-term strategy. This Market Engagement Activity has concluded and the project is continuing to progress towards tender. UKHSA anticipates the publication of this tender in Summer 2025 via Find a Tender.