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Qualified Person Service for Investigational Medicinal Products (IMP)

NHS Blood and Transplant

This public procurement record has 1 release in its history.

Planning

07 Oct 2026 at 14:21

UK2 - Preliminary Market Engagement Notice
Summary of the contracting process

NHS Blood and Transplant plans to procure Qualified Person services for its portfolio of Investigational Medicinal Product manufacturing projects. The work may cover regulatory and quality input to submissions; advice on UK regulatory, Good Manufacturing Practice and quality requirements for biological and advanced therapy medicinal products; input to manufacturing processes and facilities; and review and certification of batches for approved clinical trials. The supplier may also advise on manufacture, certification and release, help NHSBT apply relevant requirements, and mentor staff seeking Qualified Person registration. This is specialist pharmaceutical quality and regulatory support, rather than general pharmacy provision. At least half of the work is expected to take place at NHSBT premises, with the remainder delivered remotely by agreement.

This procurement is at the planning stage: NHSBT has set out its intention to buy the service and is conducting preliminary market engagement, not inviting tenders. NHSBT expects to publish a further notice on 4 December 2026. It anticipates having the replacement arrangement in place by 31 March 2027, ahead of the current contract ending on 30 June 2027. The expected contract period runs from 31 March 2027 to 31 March 2030, with a possible extension to 31 March 2032. The stated estimated value is £216,000 excluding VAT (£259,200 including VAT). There is one lot. The final scope, service volume and delivery arrangements may be refined after engagement; no procurement method or evaluation criteria are set out at this stage.

This work is suited to specialist suppliers able to provide appropriately qualified and experienced UK Qualified Persons for Investigational Medicinal Products. Each proposed QP is expected to maintain the qualifications, professional eligibility and regulatory status needed to act in this role in the UK, and may need to provide evidence of these credentials and relevant experience. NHSBT is looking for recent, demonstrable experience acting as a named QP on a UK Manufacturing and Import Authorisation for IMPs and reviewing and certifying IMP batches. Experience with biological and biotechnology medicines, cell and gene therapies, complex manufacturing projects and associated quality systems is relevant. Suppliers should be able to provide flexible professional support, including on NHSBT premises and remotely, and potentially mentor NHSBT staff pursuing QP registration. SMEs and voluntary, community or social enterprises are considered suitable.

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Notice Information

Notice Title

Qualified Person Service for Investigational Medicinal Products (IMP)

Notice Description

NHS Blood and Transplant is seeking to appoint a suitably qualified and experienced supplier to provide Qualified Person services in support of its portfolio of Investigational Medicinal Product manufacturing projects. The proposed service may include: reviewing and providing regulatory and quality input into selected regulatory submissions; advising on applicable regulatory, Good Manufacturing Practice and quality-compliance requirements for biological and Advanced Therapy Medicinal Product manufacturing projects; providing regulatory, GMP and quality input into the design and development of selected manufacturing processes and facilities; reviewing assigned batches and, where all applicable legal, regulatory, GMP, Clinical Trial Authorisation, Product Specification File and NHSBT quality-system requirements have been met, certifying batches for use in approved clinical trials; mentoring selected NHSBT staff undertaking the process of obtaining Qualified Person registration; and providing associated professional, regulatory and quality advice as required. Each Qualified Person proposed by the supplier will be expected to hold and maintain the qualifications, professional eligibility and regulatory status required to act as a Qualified Person for Investigational Medicinal Products in the UK. Proposed personnel should have recent and demonstrable experience of acting as a named Qualified Person on a UK Manufacturing and Import Authorisation for Investigational Medicinal Products, MIA(IMP), and of certifying IMP batches. Experience relating to biological, biotechnology, cell therapy and gene therapy medicinal products may also be required. The current anticipated level of support is approximately 24 to 48 days per year, with at least 50% of the support delivered on NHSBT premises and the remaining support delivered remotely, subject to agreement. The scope and requirements described in this notice are indicative and may be refined following preliminary market engagement.

Planning Information

NHS Blood and Transplant, NHSBT, is undertaking preliminary market engagement in connection with a proposed procurement for the provision of Qualified Person, QP, services for Investigational Medicinal Products, IMPs. NHSBT is seeking to understand the capability, capacity and interest available within the market to provide suitably qualified and experienced QP support for its active portfolio of IMP manufacturing projects. The proposed service may include: Reviewing and providing regulatory and quality input into selected regulatory submissions, as requested by NHSBT. Advising on applicable regulatory, Good Manufacturing Practice, GMP, and quality-compliance requirements for biological and Advanced Therapy Medicinal Product, ATMP, manufacturing projects. Providing regulatory, GMP and quality input into the design and development of selected manufacturing processes and facilities. Reviewing assigned batches and, where satisfied that all applicable legal, regulatory, GMP, Clinical Trial Authorisation, Product Specification File and NHSBT quality-system requirements have been met, certifying the batches for use in approved clinical trials. Providing advice and guidance relating to the manufacture, certification and release of IMP batches. Supporting NHSBT with the interpretation and application of relevant regulatory and quality requirements. Mentoring selected NHSBT staff through the process of obtaining Qualified Person registration. Each Qualified Person proposed by the supplier will be expected to hold and maintain the qualifications, professional eligibility and regulatory status required to act as a Qualified Person for Investigational Medicinal Products in the United Kingdom. The supplier may be required to provide supporting evidence of the proposed Qualified Person’s qualifications, professional eligibility, regulatory status and relevant experience. Proposed personnel should have recent and demonstrable experience of: acting as a named Qualified Person on a UK Manufacturing and Import Authorisation for Investigational Medicinal Products, MIA(IMP); reviewing and certifying IMP batches; applying UK regulatory, GMP and quality requirements; supporting biological and biotechnology medicinal-product manufacturing; supporting cell therapy and gene therapy medicinal products; and working with complex IMP manufacturing projects and associated quality systems. The current anticipated level of support is approximately 24 to 48 days per year. NHSBT currently anticipates that at least 50% of the required support will be delivered on NHSBT premises, with the remaining support delivered remotely by agreement. The final scope, service-delivery arrangements, volume of activity and contract requirements may be refined following the preliminary market engagement exercise. The current contract ends on 30 June 2027. NHSBT intends to have the replacement contractual arrangement in place by 31 March 2027 to support an appropriate transition period.

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-h6vhtk-0782d2
Publication Source
Find A Tender Service
Latest Notice
https://www.find-tender.service.gov.uk/Notice/094795-2026
Current Stage
Planning
All Stages
Planning

Procurement Classification

Notice Type
UK2 - Preliminary Market Engagement Notice
Procurement Type
Standard
Procurement Category
Services
Procurement Method
Not Specified
Procurement Method Details
Not specified
Tender Suitability
SME, VCSE
Awardee Scale
Not specified

Common Procurement Vocabulary (CPV)

CPV Divisions

85 - Health and social work services

CPV Codes

85149000 - Pharmacy services

Notice Value(s)

Tender Value
£216,000 £100K-£500K
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
7 Oct 20262 weeks ago
Submission Deadline
Not specified
Future Notice Date
4 Dec 20262 months to go
Award Date
Not specified
Contract Period
31 Mar 2027 - 31 Mar 2030 3-4 years
Recurrence
Not specified

Notice Status

Tender Status
Planning
Lots Status
Planning
Awards Status
Not Specified
Contracts Status
Not Specified

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
NHS Blood and Transplant
Contact Name
Available with D3 Tenders Premium →
Contact Email
Available with D3 Tenders Premium →
Contact Phone
Available with D3 Tenders Premium →

Buyer Location

Locality
BRISTOL
Postcode
BS34 7QH
Postcode Area
Bristol
Country
England
Major Region (ITL 1)
TLK South West (England)
Basic Region (ITL 2)
TLK5 West of England
Small Region (ITL 3)
TLK52 Bath & North East Somerset and South Gloucestershire
Delivery Location
Not specified
Local Authority
South Gloucestershire
Electoral Ward
Filton
Westminster Constituency
Filton and Bradley Stoke

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.

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