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Narrative

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Source1

{
  "resourceType": "CodeSystem",
  "id": "rtq-questionnaire-type-cs",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "url": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-questionnaire-type-cs",
  "version": "0.1.0",
  "name": "RtqQuestionnaireTypeCS",
  "title": "RTQ Questionnaire Type Code System",
  "status": "draft",
  "experimental": true,
  "date": "2025-11-21",
  "publisher": "HL7 International",
  "contact": [
    {
      "name": "HL7 International",
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org"
        }
      ]
    }
  ],
  "description": "Code system defining the high-level types of regulatory questionnaires exchanged between industry and health authorities.",
  "caseSensitive": true,
  "content": "complete",
  "concept": [
    {
      "code": "list-of-questions",
      "display": "List of Questions",
      "definition": "A formal list of questions raised by a regulator requiring a written response from the marketing authorisation holder."
    },
    {
      "code": "list-of-issues",
      "display": "List of Issues",
      "definition": "A consolidated list of major and minor issues identified during assessment that must be resolved before approval or variation."
    },
    {
      "code": "information-request",
      "display": "Information Request",
      "definition": "A formal request for additional information or clarification during evaluation of a submission (e.g., EMA Day 120/180 LoQ, FDA IR, Health Canada Clarifax)."
    },
    {
      "code": "request-for-clarification",
      "display": "Request for Clarification",
      "definition": "Request seeking clarification on specific points in a submission (often used by PMDA, Health Canada, Swissmedic)."
    },
    {
      "code": "request-for-supplementary-information",
      "display": "Request for Supplementary Information",
      "definition": "Used by some regulators (e.g., Swissmedic RSI, Saudi SFDA) for additional data requests."
    },
    {
      "code": "deficiency-letter",
      "display": "Deficiency Letter",
      "definition": "Formal notification of deficiencies that must be addressed (common in some national procedures)."
    },
    {
      "code": "consolidated-list-of-questions",
      "display": "Consolidated List of Questions",
      "definition": "A single consolidated set of questions from multiple assessment teams (e.g., EMA PRAC/RAPPS/CHMP consolidated LoQ)."
    }
  ]
}