eCTD Solution

{
  "id": "033565-2022",
  "tag": [
    "tender"
  ],
  "date": "2022-11-25T16:53:30Z",
  "ocid": "ocds-h6vhtk-038895",
  "buyer": {
    "id": "GB-FTS-9601",
    "name": "MHRA"
  },
  "tender": {
    "id": "ocds-h6vhtk-038895",
    "lots": [
      {
        "id": "1",
        "value": {
          "amount": 6000000,
          "currency": "GBP"
        },
        "status": "active",
        "options": {
          "description": "Please see section VI.3 of this notice."
        },
        "renewal": {
          "description": "The Contract will have an initial duration of 5 years, with an option for the Agency to extend it for a further period of up to 5 years more."
        },
        "hasOptions": true,
        "hasRenewal": true,
        "description": "Please see section VI.3 of this notice.",
        "secondStage": {
          "maximumCandidates": 5,
          "minimumCandidates": 3
        },
        "contractPeriod": {
          "durationInDays": 1800
        },
        "submissionTerms": {
          "variantPolicy": "allowed"
        },
        "selectionCriteria": {
          "description": "Criteria to be used for selecting the candidates appear in the Standard Selection Questionnaire Guidance document."
        }
      }
    ],
    "items": [
      {
        "id": "1",
        "relatedLot": "1",
        "deliveryAddresses": [
          {
            "region": "UKI"
          }
        ],
        "additionalClassifications": [
          {
            "id": "48517000",
            "scheme": "CPV",
            "description": "IT software package"
          },
          {
            "id": "48100000",
            "scheme": "CPV",
            "description": "Industry specific software package"
          }
        ]
      }
    ],
    "title": "eCTD Solution",
    "value": {
      "amount": 6000000,
      "currency": "GBP"
    },
    "status": "active",
    "coveredBy": [
      "GPA"
    ],
    "legalBasis": {
      "id": "32014L0024",
      "scheme": "CELEX"
    },
    "description": "MHRA is embarking on the development of a next generation Regulatory Management System (RMS) that will replace multiple legacy systems with converged technology platforms to support the agency regulation of medicinal products and medical devices.<br/><br/>In order to support medicinal regulatory management, one component of the new platform identified is a technology solution to facilitate the management of information using the eCTD format (ICH electronic Common Technical Document).",
    "secondStage": {
      "successiveReduction": true,
      "noNegotiationNecessary": true
    },
    "tenderPeriod": {
      "endDate": "2022-12-28T16:00:00Z"
    },
    "communication": {
      "atypicalToolUrl": "https://health-family.force.com/s/Welcome"
    },
    "contractTerms": {
      "hasElectronicPayment": true,
      "hasElectronicOrdering": true,
      "electronicInvoicingPolicy": "allowed"
    },
    "hasRecurrence": false,
    "classification": {
      "id": "72261000",
      "scheme": "CPV",
      "description": "Software support services"
    },
    "submissionTerms": {
      "languages": [
        "en"
      ],
      "bidValidityPeriod": {
        "durationInDays": 270
      }
    },
    "submissionMethod": [
      "electronicSubmission",
      "written"
    ],
    "procurementMethod": "selective",
    "selectionCriteria": {
      "criteria": [
        {
          "type": "economic",
          "appliesTo": [
            "supplier"
          ],
          "description": "Selection criteria as stated in the procurement documents"
        },
        {
          "type": "technical",
          "appliesTo": [
            "supplier"
          ],
          "description": "Selection criteria as stated in the procurement documents"
        }
      ]
    },
    "mainProcurementCategory": "services",
    "submissionMethodDetails": "https://health-family.force.com/s/Welcome",
    "procurementMethodDetails": "Competitive procedure with negotiation"
  },
  "parties": [
    {
      "id": "GB-FTS-9601",
      "name": "MHRA",
      "roles": [
        "buyer"
      ],
      "address": {
        "region": "UK",
        "locality": "London",
        "postalCode": "E14 4PU",
        "countryName": "United Kingdom",
        "streetAddress": "10 South Colonnade"
      },
      "details": {
        "url": "https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency",
        "buyerProfile": "https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency",
        "classifications": [
          {
            "id": "NATIONAL_AGENCY",
            "scheme": "TED_CA_TYPE",
            "description": "National or federal agency/office"
          },
          {
            "id": "07",
            "scheme": "COFOG",
            "description": "Health"
          }
        ]
      },
      "identifier": {
        "legalName": "MHRA"
      },
      "contactPoint": {
        "url": "https://health-family.force.com/s/Welcome",
        "name": "Purchasing",
        "email": "Purchasing@mhra.gov.uk",
        "telephone": "+44 2030806000"
      }
    },
    {
      "id": "GB-FTS-88",
      "name": "Royal Courts of Justice",
      "roles": [
        "reviewBody"
      ],
      "address": {
        "locality": "London",
        "postalCode": "WC2A 2LL",
        "countryName": "United Kingdom",
        "streetAddress": "Strand"
      },
      "details": {
        "url": "https://www.gov.uk/"
      },
      "identifier": {
        "legalName": "Royal Courts of Justice"
      },
      "contactPoint": {
        "email": "royalcourtsofjustice.jc@gov.uk"
      }
    },
    {
      "id": "GB-FTS-3081",
      "name": "Centre for Effective Dispute Resolution",
      "roles": [
        "mediationBody"
      ],
      "address": {
        "locality": "London",
        "postalCode": "EC4Y 1EU",
        "countryName": "United Kingdom",
        "streetAddress": "70 Fleet Street"
      },
      "details": {
        "url": "https://www.cedr.com/"
      },
      "identifier": {
        "legalName": "Centre for Effective Dispute Resolution"
      },
      "contactPoint": {
        "email": "info@cedr.com"
      }
    }
  ],
  "language": "en",
  "description": "The Agency is seeking an eCTD solution and subsequent support for that solution. Bidders must be aware that there are; supply, implementation, and support requirements.<br/><br/>Please indicate your interest by registering at https://health-family.force.com/s/Welcome, this is the address at which the procurement documents will be available for unrestricted and full direct access, free of charge.<br/><br/>Options for the procurement are shown in the procurement documents.<br/><br/>The contracting authority is not a centralised purchasing body, and no other form of joint procurement is or may be involved.<br/><br/>Estimated nature and quantity or value of supplies: Industry specific software package, Software support services; between £5,000,000.00 and £6,000,000.00.<br/><br/>Please note, the above value is for the initial period; depending on the renewals and options taken the total contract value over the entire term may be up to £12,000,000.00.<br/><br/>Please contact purchasing@mhra.gov.uk and quote \"Procurement Project Ref: eCTD Solution\" for further information.<br/><br/>The Agency reserves the right to terminate, discontinue, suspend and/or abandon this Procurement Exercise (in whole or in part) at any time prior to contract award without incurring any liability to the affected Applicants and/or Bidders.<br/><br/>The Agency may have an affordability cap but this is not currently known. Bidders will be made aware of any known affordability caps that affect evaluation when evaluation exercises are undertaken",
  "initiationType": "tender"
}