Corrigendum-Medicines Licensing Assessor Services

The Medicines and Healthcare Products Regulatory Agency (MHRA) is inviting specialist providers to supply Medicines Licensing Assessor Services across three distinct procurement lots. The agency aims to enhance its in‑house expertise by engaging external suppliers capable of carrying out rigorous assessments of complex regulatory data for marketing authorisation, clinical trial applications, and other compliance activities. The procurement is structured to secure experts in pharmaceutical, medical, and non‑clinical assessment, each lot representing a separate focus area in the overall product evaluation framework.

Suppliers must deliver evidence‑based judgments within an MHRA assessment and quality assurance framework, assessing data in accordance with the Common Technical Document modules: Module 3 and the relevant sections of Module 2 for pharmaceutical quality, Module 5 and the relevant sections of Module 2 for clinical, statistical and pharmacological data, and Module 4 for non‑clinical data. Eligibility requires demonstrable capacity and capability to provide flexible, high‑quality assessments that align with MHRA’s patient‑safety and regulatory objectives. Suppliers are expected to meet the stated technical standards and quality expectations as described.

The Medicines and Healthcare products Regulatory Agency is the regulator of medicines, medical devices and blood components for transfusion in the UK. MHRA carries out a wide range of activities to fulfil its role as a patient safety regulator. This includes carrying out assessments of the safety, quality and efficacy of medicines, assessing the safety of proposed clinical trials of medicines and medical devices, inspecting the premises of those manufacturing, supplying or distributing medicines and monitoring the ongoing safety of all medical products, taking swift action where necessary to prevent harm to patients. The MHRA also engages with companies within the regulated sector to provide specific, scientific advice on the development of products. The aim of such advice is to ensure the developer understands the requirements of the regulator, ensuring that the developer can provide the required information to support a properly informed assessment.
With a wide range of critical deliverables, MHRA is seeking opportunities to add to its traditional in-house expertise through the establishment of additional sources of both capacity and capability. These will enable MHRA to deliver innovative, new and improved services at increased pace, safeguarding public health and supporting the growth of life sciences in the UK.
MHRA is seeking suppliers with the capacity and capability to deliver assessments of complex clinical and non-clinical regulatory data and provide carefully evidenced judgements within an MHRA assessment and quality assurance framework. Such assessments may relate to marketing authorisation applications, clinical trial applications and a variety of other compliance activities. Deployment of supplier resources will be on a flexible basis to enable MHRA greater discretion in flexing established capacity as needed to support increased growth in UK life sciences through new and improved advice and support services.
To achieve this ambition, MHRA wishes to establish a framework of specialist providers, which cover 3 Lots. Up to four suppliers, who meet the minimum criteria, may be awarded a place on each Lot.
Lot 1: Pharmaceutical Assessment: Assessment of pharmaceutical/quality data (in compliance with Module 3 and Module 2 (sections relevant to Quality) of the Common Technical Document).
Lot 2: Medical Assessment: Assessment of clinical, statistical and clinical pharmacology data (in compliance with Module 5 and Module 2 (sections relevant to Clinical) of the Common Technical Document).
Lot 3: Non-Clinical Assessment: Assessment of non-clinical data (in compliance with Module 4 of the Common Technical Document).

Communication: Bidders should access the Health Family e-tendering portal to access the full-set of requirements and to submit any tender. Interested suppliers https://atamis-1928.my.site.com/s/Welcome
Amendments:
Other additional information: Amendment to internal reference.

Languages in which tenders or requests to participate may be submitted: En
Enquiry deadline: 2026-07-21T12:00:00+01:00
Submission address and any special instructions: Bidders should access the Health Family e-tendering portal to access the full-set of requirements and to submit any tender. Interested suppliers https://atamis-1928.my.site.com/s/Welcome
Tenders may be submitted electronically: allowed
Award decision date (estimated): 2026-10-01T23:59:59+01:00

Lot number: 1
Description: Assessment of pharmaceutical/quality data (in compliance with Module 3 and Module 2 (sections relevant to Quality) of the Common Technical Document).
Lot value (estimated)
5.000.000,00 GBP excluding VAT
6.000.000,00 GBP including VAT
This contract is subject to renewal: Yes
Description of renewals: The MHRA has the option to extend the Framework Contract by up to 1 year.

Lot number: 2
Description: Assessment of clinical, statistical and clinical pharmacology data (in compliance with Module 5 and Module 2 (sections relevant to Clinical) of the Common Technical Document).
Lot value (estimated)
4.000.000,00 GBP excluding VAT
4.800.000,00 GBP including VAT
This contract is subject to renewal: Yes
Description of renewals: The MHRA has the option to extend the Framework Contract by up to 1 year.

Lot number: 3
Description: Assessment of non-clinical data (in compliance with Module 4 of the Common Technical Document).
Lot value (estimated)
1.000.000,00 GBP excluding VAT
1.200.000,00 GBP including VAT
This contract is subject to renewal: Yes
Description of renewals: The MHRA has the option to extend the Framework Contract by up to 1 year.

Award criteria:

Name	Type	Weighting
Commercial	price	30%
Technical	quality	30%
Lot Specific Technical	quality	30%
Social Value	quality	10%
Social Values	quality	10%