--- title: "Medicines Licensing Assessor Services" ocid: "ocds-h6vhtk-060643" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-060643" markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-060643.md" json_url: "https://d3tenders.com/contract/ocds-h6vhtk-060643.json" source: "Find A Tender Service" current_stage: "Tender" buyer: "MHRA" published: "2026-07-01" --- # Medicines Licensing Assessor Services Buyer: MHRA Current stage: Tender OCID: ocds-h6vhtk-060643 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-h6vhtk-060643) [Download OCDS JSON](https://d3tenders.com/contract/ocds-h6vhtk-060643.json) ## Summary The Medicines and Healthcare products Regulatory Agency (MHRA), a central government public authority located in London, is actively soliciting bids for its "Medicines Licensing Assessor Services" tender. This procurement is in the Tender stage and falls under services with a focus on medical analysis and research and development services. The framework aims to enhance MHRA's internal capabilities with supplementary expertise to protect public health and boost the UK's life sciences sector. The procurement method is an open procedure with suppliers required to submit their tenders via the Health Family e-tendering portal by 6th August 2026. The framework will be divided into three distinct lots: Pharmaceutical Assessment, Medical Assessment, and Non-Clinical Assessment, with a total value of £12,000,000 and a framework duration from October 2026 to October 2029, potentially extendable by one year. This tender presents key opportunities for businesses specialising in the assessment of pharmaceutical, clinical, and non-clinical data. The MHRA seeks partners with the capacity to deliver flexible, high-quality analysis services that align with rigorous regulatory frameworks. This framework allows up to four suppliers per lot, making it ideal for companies with solid expertise in regulatory science who can support MHRA in delivering advanced services more efficiently. Small to medium enterprises (SMEs) with experience in the life sciences, particularly those adept at handling complex data and compliance, will find this tender a substantial avenue for growth and expansion in government contracting. The collaborative framework provides a strategic platform for businesses to innovate and contribute to the UK's health sector advancements. ## Notice 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). ### Lot Information Pharmaceutical Assessment Assessment of pharmaceutical/quality data (in compliance with Module 3 and Module 2 (sections relevant to Quality) of the Common Technical Document). Renewal: The MHRA has the option to extend the Framework Contract by up to 1 year. 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). Renewal: The MHRA has the option to extend the Framework Contract by up to 1 year. Non-Clinical Assessment Assessment of non-clinical data (in compliance with Module 4 of the Common Technical Document). Renewal: The MHRA has the option to extend the Framework Contract by up to 1 year. ### Planning Information MHRA will hold a virtual pre-market engagement event on Monday 26th January at 2pm inviting suitably qualified and experienced suppliers to attend a presentation by the Healthcare Quality and Access team where high-level information about the requirements will be shared followed by an opportunity to participate in a Q&A session. The objective of this session will be to: • Understand supplier appetite and opinion and gain an understanding on the viability of the concept • Understand barriers, risks and issues and any potential innovative solutions • Inform a high-quality specification, procurement strategy and the structure of the contract/framework Suppliers are also invited to express their interest in a separate 1:1 engagement session immediately following the event to share any useful intelligence. Requests will be accommodated based on capacity and no guarantees are made. Suppliers attending the event will not have any advantage over organisations who do not participate, and this market consultation is in no way a guarantee of future work. Material shared at this event including a summary of the Q&A will be made available as part of any future tender pack ensuring all participating suppliers have access to the same information. Suppliers wishing to attend the event should email Commercial@MHRA.gov.uk to receive joining instructions. ## Key Details | Field | Value | | --- | --- | | Publication source | Find A Tender Service | | Latest notice | https://www.find-tender.service.gov.uk/Notice/061976-2026 | | Notice type | UK4 - Tender Notice | | Procurement type | Framework | | Procurement category | Services | | Procurement method | Open | | Procurement method details | Open procedure | | Tender suitability | SME | | Awardee scale | Not specified | | All stages | Planning, Tender | ## Dates | Field | Value | | --- | --- | | Publication date | 1 Jul 2026 | | Submission deadline | 6 Aug 2026 | | Future notice date | 2 Mar 2026 | | Award date | Not specified | | Contract period | 15 Oct 2026 - 15 Oct 2029 | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | £10,000,000 | | Lots value | £10,000,000 | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Active | | Lots status | Active | | Awards status | Not specified | | Contracts status | Not specified | ## Buyer | Field | Value | | --- | --- | | Main buyer | MHRA | | Locality | LONDON | | Post town | East London | | Postcode | E14 4PU | | Country | England | | ITL 1 | TLI London | | ITL 2 | TLI4 Inner London - East | | ITL 3 | TLI42 Tower Hamlets | | Local authority | Tower Hamlets | | Electoral ward | Canary Wharf | | Westminster constituency | Poplar and Limehouse | | Delivery location | Not specified | ## CPV Codes ### Divisions - 73 - Research and development services and related consultancy services - 85 - Health and social work services ### Codes - 73000000 - Research and development services and related consultancy services - 85148000 - Medical analysis services ## Release History - 1 Jul 2026 at 17:18 - Tender - UK4 - Tender Notice - https://www.find-tender.service.gov.uk/Notice/061976-2026 - 15 Jan 2026 at 09:42 - Planning - UK2 - Preliminary Market Engagement Notice - https://www.find-tender.service.gov.uk/Notice/003329-2026 ## Documents - https://www.find-tender.service.gov.uk/Notice/061976-2026 1st July 2026 - Tender notice on Find a Tender - https://www.find-tender.service.gov.uk/Notice/003329-2026 15th January 2026 - Preliminary market engagement notice on Find a Tender ## Notice URLs - https://atamis-1928.my.site.com/s/Welcome - https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency - https://www.legislation.gov.uk/ukpga/2023/54/contents ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-h6vhtk-060643. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-060643.json.