NP42824 Unlicensed Imported Medicines

{
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    "id": "ocds-h6vhtk-042204-2024-05-01T13:12:41+01:00",
    "date": "2024-05-01T13:12:41+01:00",
    "ocid": "ocds-h6vhtk-042204",
    "description": "The estimated value(s) referred to in Section II.I.7 and Section V.2.4 (and within all Lots) covers the twenty-four (24) month framework duration and the forty-eight (48) month extension period of the framework agreement. (SC Ref:764248)",
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        "legalBasis": {
            "id": "32014L0024",
            "scheme": "CELEX"
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        "title": "NP42824 Unlicensed Imported Medicines",
        "status": "complete",
        "classification": {
            "scheme": "CPV",
            "id": "33600000",
            "description": "Pharmaceutical products"
        },
        "mainProcurementCategory": "goods",
        "description": "The supply of unlicensed imported medicines to NHS Scotland.",
        "value": {
            "amount": 8692952,
            "currency": "GBP"
        },
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                "id": "2",
                "title": "Additional Unlicensed Imported Medicines",
                "description": "Supply of additional unlicensed imported medicines incorporating an over labelling and translation service to meet any future requirements as identified by the authority. The scope of these products is unknown at this stage. The authority has awarded this lot as an unranked multi-supplier framework to ten (10) suppliers that have passed the selection criteria for lot 1 and agreed to participate in lot 2 as detailed within the ITT documentation. The award criteria stated within II.2.5) is the criteria used to award lot 1.",
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                "title": "Unlicensed Imported Medicines",
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                    "description": "(a) All goods supplied under the framework agreement must be stored in and distributed from a site holding an MHRA wholesale distribution authorisation (WDA) valid for import and handling unlicensed relevant medicinal products issued by the MHRA and for import from outside of the EEA, a manufacturer's 'specials' licence (MS)valid for import; (b) Potential Framework Participants must be able to demonstrate that all devices tendered and associated ancillaries under this Framework Agreement comply with Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) and have an appropriate declaration of conformity and display a valid CE, CE UKNI or UKCA mark. (c) Potential framework participants and/or sub-contractor(s) must offer a product overlabelling service to meet the NHS pharmaceutical quality assurance committee 'Packaging and labelling for safety: unlicensed imported medicines -- guidance for the overlabelling and provision of translated information, edition 2 December 2018' guidance where original packaging is not in English; (d) Potential framework participants and/or any sub-contractor(s) must offer a translation service for the translation of the SPC, labels and PIL's. Translations must be performed to ISO 17100 for translation services standard or equivalent; (e) Potential framework participants and any sub-contractor(s) must possess valid certification of BS EN ISO9001 or equivalent.",
                    "minimum": "(a) Potential Framework Participants must provide confirmation of a current and valid Wholesale Distribution Authorisation (WDA) valid for importing and handling unlicensed relevant medicinal products issued by the MHRA and for import from outside of the EEA, a Manufacturer's Specials' (Licence) MS valid for import; (b) Confirmation that all devices tendered and associated ancillaries which are classed as medical devices will carry the appropriate declaration of conformity for the UK market and display a valid CE, CE UKNI or UKCA mark prior to the start date of the Framework Agreement. Confirmation for (a) and (b) at the date of submission of the tender should be stated in the Qualification Envelope of the ITT under Part 4C: Quality Control. (c) Potential framework participants must provide confirmation they can offer a product overlabelling service to meet the NHS Pharmaceutical Quality Assurance Committee 'Packaging and labelling for safety: unlicensed imported medicines -- guidance for the overlabelling and provision of translated information, edition 2 December 2018' guidance where original packaging is not in English; (d) Potential framework participants and/or any sub-contractor(s) must provide confirmation they can offer at translation service for the translation of the SPC, labels and PIL's. Translations must be performed to ISO 17100for translation services standard or equivalent; (e) Confirmation of the existence of valid certification of BS EN ISO 9001 or equivalent. Confirmation for (c), (d) and (e) at the date of submission of the tender should be stated in the Qualification Envelope of the ITT under Part 4D: Quality Assurance Schemes.",
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