Medicines Licensing Assessor Services

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    "id": "ocds-h6vhtk-060643-2026-07-01T18:18:26+01:00",
    "date": "2026-07-01T18:18:26+01:00",
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        {
            "id": "GB-PPON-PJLJ-9824-VXPG",
            "name": "MHRA",
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                "postalCode": "E14 4PU",
                "country": "GB",
                "countryName": "United Kingdom",
                "region": "UKI42"
            },
            "contactPoint": {
                "name": "William Reeder",
                "email": "commercial@mhra.gov.uk"
            },
            "roles": [
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            "details": {
                "url": "https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency",
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    "buyer": {
        "id": "GB-PPON-PJLJ-9824-VXPG",
        "name": "MHRA"
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    "planning": {
        "milestones": [
            {
                "id": "engagement",
                "type": "engagement",
                "description": "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.",
                "dueDate": "2026-01-23T23:59:59Z",
                "status": "scheduled"
            }
        ],
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                "description": "Preliminary market engagement notice on Find a Tender",
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                "datePublished": "2026-01-15T09:42:22Z",
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    "tender": {
        "id": "C414098",
        "legalBasis": {
            "id": "2023/54",
            "scheme": "UKPGA",
            "uri": "https://www.legislation.gov.uk/ukpga/2023/54/contents"
        },
        "title": "Medicines Licensing Assessor Services",
        "description": "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).",
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        "aboveThreshold": true,
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                "maximumParticipants": 12,
                "method": "withAndWithoutReopeningCompetition",
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                "hasRenewal": true,
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                "id": "2",
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        "procurementMethodDetails": "Open procedure",
        "submissionMethodDetails": "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",
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        "lotDetails": {
            "awardCriteriaDetails": "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)."
        },
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