✓Tender information last checkedLast checked 13 Oct 2026, 13:01.
Opportunity overview
The North East and Yorkshire NHS Pharmaceutical Purchasing Consortium intends to establish a framework agreement for the supply of Unlicensed Imported Medicines on behalf of NHS organisations and other eligible public sector bodies.
The framework will provide access to a defined range of unlicensed imported medicines, including products requiring over-labelling and translation. These medicines do not hold a UK Marketing Authorisation but are licensed in their country of origin and may be imported and supplied in accordance with Regulation 167 of the Human Medicines Regulations 2012 where a patient's clinical needs cannot be met by a suitable licensed alternative.
Suppliers will be required to hold all relevant MHRA licences, authorisations and approvals necessary to import, distribute and supply unlicensed medicines within the UK, and to demonstrate compliance with applicable Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards.
The framework will provide participating organisations with access to safe, compliant and quality-assured products through a robust and competitive procurement arrangement. Products and suppliers will be subject to comprehensive quality, risk and commercial assessment to support regulatory compliance, supply chain resilience, continuity of patient care and value for money across the NHS.
Invitation to Tender for Unlicensed Imported MedicinesOpen source ↗
Published notice details
Additional information from the published procurement release. Fields appear only when supplied by the source; check the original notice and tender documents before acting.
Scope, procedure and submissions
Id
C475795
Status
active
Procurement Method
open
Procurement Method Details
Competitive flexible procedure
Main Procurement Category
goods
Above Threshold
Yes
How to submit
To express interest and participate in the tender, please register and apply via Atamis e-sourcing portal
https://health-family.force.com/s/Welcome
Should Tenderers have any queries, or having problems using the portal, they should contact Helpdesk at:
Phone: 0800 9956035
E-mail: support-health@atamis.co.uk
The procurement will be conducted using the Competitive Flexible Procedure in accordance with the Procurement Act 2023. Tenderers are required to submit their complete Tender by the Tender Submission Deadline. The evaluation will be undertaken sequentially in accordance with the stages set out in the procurement documents. A Tender that does not satisfy the requirements of a preceding stage will not progress to subsequent stages of evaluation.
3 published notice versions reviewed by ProcuraAxis.
3 VERSIONS
1
090106-2026Pipeline notice on Find a Tender ·
2
090112-2026Preliminary market engagement notice on Find a Tender ·
3
096479-2026Tender notice on Find a Tender ·
PROCURAAXIS ANALYSIS
ProcuraAxis Analysis
Our approved analysis of the opportunity appears below the official tender information.
ANALYSIS PREVIEW
Opportunity intelligence at a glance
Leeds Teaching Hospitals NHS Trust is running an open tender to establish a framework for unlicensed imported medicines for NHS organisations and other eligible public sector bodies. Products may require over-labelling and translation and must be imported and supplied in line with the stated regulatory basis.
Who this may suit
Suitable for suppliers able to import, distribute and supply unlicensed medicines in the UK, with the necessary MHRA permissions and GMP/GDP compliance.
Key points identified
Product scopeSupply a defined range of unlicensed imported medicines.Evidence: The framework is for “the supply of Unlicensed Imported Medicines” and provides access to “a defined range of unlicensed imported medicines.”
Product regulatory statusMedicines do not hold a UK Marketing Authorisation, are licensed in their country of origin, and may be imported and supplied under Regulation 167 where clinical needs cannot be met by a suitable licensed alternative.Evidence: Description states the medicines “do not hold a UK Marketing Authorisation but are licensed in their country of origin” and references “Regulation 167 of the Human Medicines Regulations 2012.”
Over-labelling and translationSupply products requiring over-labelling and translation.Evidence: The scope includes “products requiring over-labelling and translation.”
96% approved-analysis confidence11 supplier criteria identified5 risks or unknowns
ProcuraAxis structures information found in published procurement records, checks the result for consistency and publishes only approved analysis. Confidence describes the completeness and consistency of the available source information; it is not a guarantee of eligibility or contract award.
Leeds Teaching Hospitals NHS Trust is running an open tender to establish a framework for unlicensed imported medicines for NHS organisations and other eligible public sector bodies. Products may require over-labelling and translation and must be imported and supplied in line with the stated regulatory basis.
Who this may suit
Suitable for suppliers able to import, distribute and supply unlicensed medicines in the UK, with the necessary MHRA permissions and GMP/GDP compliance.
Key deliverables
Supply a defined range of unlicensed imported medicines
Provide products requiring over-labelling and translation where required
Maintain compliant, quality-assured supply supporting continuity of patient care
SUPPLIER REQUIREMENTS
11 criteria identified
MHRA licences, authorisations and approvals
99% confidence
Mandatory · 1
View supporting evidence
“Suppliers will be required to hold all relevant MHRA licences, authorisations and approvals necessary to import, distribute and supply unlicensed medicines within the UK.”
Good Manufacturing Practice (GMP) compliance
98% confidence
Mandatory · 1
View supporting evidence
Suppliers must “demonstrate compliance with applicable Good Manufacturing Practice (GMP) ... standards.”
Good Distribution Practice (GDP) compliance
98% confidence
Mandatory · 1
View supporting evidence
Suppliers must “demonstrate compliance with applicable ... Good Distribution Practice (GDP) standards.”
Product scope
99% confidence
Supply a defined range of unlicensed imported medicines.
View supporting evidence
The framework is for “the supply of Unlicensed Imported Medicines” and provides access to “a defined range of unlicensed imported medicines.”
Product regulatory status
98% confidence
Medicines do not hold a UK Marketing Authorisation, are licensed in their country of origin, and may be imported and supplied under Regulation 167 where clinical needs cannot be met by a suitable licensed alternative.
View supporting evidence
Description states the medicines “do not hold a UK Marketing Authorisation but are licensed in their country of origin” and references “Regulation 167 of the Human Medicines Regulations 2012.”
Over-labelling and translation
98% confidence
Supply products requiring over-labelling and translation.
View supporting evidence
The scope includes “products requiring over-labelling and translation.”
Quality, risk and commercial assessment
99% confidence
Products and suppliers will be subject to comprehensive quality, risk and commercial assessment.
View supporting evidence
“Products and suppliers will be subject to comprehensive quality, risk and commercial assessment.”
Eligible customers
98% confidence
NHS organisations and other eligible public sector bodies.
View supporting evidence
Framework is being established “on behalf of NHS organisations and other eligible public sector bodies.”
Supplier eligibility
99% confidence
Suppliers must hold relevant MHRA licences, authorisations and approvals needed for UK import, distribution and supply of unlicensed medicines.
View supporting evidence
Explicit supplier requirement in the opportunity description.
SME suitability
99% confidence
Unknown.
View supporting evidence
Suitable-for-SME field is not stated.
VCSE suitability
99% confidence
Unknown.
View supporting evidence
Suitable-for-VCSE field is not stated.
COMMERCIAL AND DELIVERY
Contract intelligence
Commercial
Framework value
99% confidence
Up to GBP 36,095,686.53.
View supporting evidence
Opportunity value maximum and Lot 1 value are both stated as 36,095,686.53 GBP.
Commercial assessment
99% confidence
Suppliers and products will undergo commercial assessment.
View supporting evidence
Description refers to “comprehensive quality, risk and commercial assessment.”
Contract duration
99% confidence
Unknown.
View supporting evidence
Contract start and end dates are not provided.
Delivery
Delivery requirement
97% confidence
Maintain safe, compliant and quality-assured product supply, supporting supply-chain resilience and continuity of patient care.
View supporting evidence
Framework aims to provide “safe, compliant and quality-assured products” and support “supply chain resilience, continuity of patient care and value for money.”
Delivery locations
99% confidence
Unknown.
View supporting evidence
Only buyer location is supplied; no delivery locations are stated.
Buyer location
99% confidence
Leeds, United Kingdom (LS1 3EX; UKE42).
View supporting evidence
Supplied location is labelled “Buyer location.”
PROCEDURE
How to respond
Notice status
99% confidence
Open tender.
View supporting evidence
Display status is “open”; stage is “tender”; source status is “active.”
Procurement method
99% confidence
Open.
View supporting evidence
Procurement method is stated as “open.”
Procedure detail
99% confidence
Competitive flexible procedure.
View supporting evidence
Procurement method details are stated as “Competitive flexible procedure.”
Submission deadline
99% confidence
30 November 2026, 12:00 UTC.
View supporting evidence
Opportunity and Lot 1 submission deadline: 2026-11-30T12:00:00Z.
Tender documents
95% confidence
Invitation to Tender for Unlicensed Imported Medicines is referenced via the Atamis portal.
View supporting evidence
Bidding-document title and URL supplied: “Invitation to Tender for Unlicensed Imported Medicines”, https://atamis-1928.my.site.com/s/Welcome.
RISKS AND UNKNOWNS
Points requiring attention
Regulatory compliance risk
99% confidence
High regulatory threshold: suppliers must have relevant MHRA permissions and demonstrate applicable GMP and GDP compliance.
View supporting evidence
Explicit mandatory MHRA, GMP and GDP requirements.
Supply continuity risk
96% confidence
Supply-chain resilience and continuity of patient care are stated procurement objectives, indicating these will be material assessment considerations.
View supporting evidence
Description references “supply chain resilience” and “continuity of patient care.”
Product and labelling risk
98% confidence
Some products require over-labelling and translation, creating additional compliance and operational obligations.
View supporting evidence
Scope includes “products requiring over-labelling and translation.”
Lot information limitation
99% confidence
Only one active lot is supplied, with no lot title or description.
View supporting evidence
Lot 1 has null title and description.
Procedure metadata ambiguity
99% confidence
The source labels the procurement method as “open” while also describing it as a “Competitive flexible procedure”; the supplied data does not explain the relationship between these labels.
View supporting evidence
Both procedure fields are supplied with those values.
ProcuraAxis analysis supplements, but does not replace, the original notice and tender documents. Always verify eligibility, deadlines and commercial terms with the issuing authority.
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