European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
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: 03 Annex II Code Value Set - JSON Representation

Active as of 2025-04-02

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{
  "resourceType" : "ValueSet",
  "id" : "EUepiannexqrdcodesVs",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet EUepiannexqrdcodesVs</b></p><a name=\"EUepiannexqrdcodesVs\"> </a><a name=\"hcEUepiannexqrdcodesVs\"> </a><a name=\"EUepiannexqrdcodesVs-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"CodeSystem-200000029659.html\"><code>http://ema.europa.eu/fhir/CodeSystem/200000029659</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-000000000000\">000000000000</a></td><td style=\"color: #cccccc\">Code for custom sub-sections (reserved)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029850\">200000029850</a></td><td style=\"color: #cccccc\">ANNEX II</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029851\">200000029851</a></td><td style=\"color: #cccccc\">A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029852\">200000029852</a></td><td style=\"color: #cccccc\">B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029853\">200000029853</a></td><td style=\"color: #cccccc\">Official batch release</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029854\">200000029854</a></td><td style=\"color: #cccccc\">C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029855\">200000029855</a></td><td style=\"color: #cccccc\">Periodic safety update reports (PSURs)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029856\">200000029856</a></td><td style=\"color: #cccccc\">D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029857\">200000029857</a></td><td style=\"color: #cccccc\">Risk management plan (RMP)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029858\">200000029858</a></td><td style=\"color: #cccccc\">Additional risk minimisation measures</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029859\">200000029859</a></td><td style=\"color: #cccccc\">Obligation to conduct post-authorisation measures</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029860\">200000029860</a></td><td style=\"color: #cccccc\">E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES</td></tr></table></li></ul></div>"
  },
  "url" : "http://ema.europa.eu/fhir/ValueSet/EUepiannexqrdcodesVs",
  "version" : "1.0.0",
  "name" : "EUepiannexqrdcodesVs",
  "title" : "03 Annex II Code Value Set",
  "status" : "active",
  "experimental" : false,
  "date" : "2025-04-02T11:27:42+01:00",
  "publisher" : "European Medicines Agency",
  "contact" : [
    {
      "name" : "European Medicines Agency",
      "telecom" : [
        {
          "system" : "url",
          "value" : "https://ema.europa.eu/fhir"
        }
      ]
    },
    {
      "name" : "FHIR at EMA",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://ema.europa.eu/fhir"
        }
      ]
    }
  ],
  "description" : "List of section codes allowed in Annex II documents, defined in EMA's Referentials Management Service.",
  "compose" : {
    "include" : [
      {
        "system" : "http://ema.europa.eu/fhir/CodeSystem/200000029659",
        "concept" : [
          {
            "code" : "000000000000"
          },
          {
            "code" : "200000029850"
          },
          {
            "code" : "200000029851"
          },
          {
            "code" : "200000029852"
          },
          {
            "code" : "200000029853"
          },
          {
            "code" : "200000029854"
          },
          {
            "code" : "200000029855"
          },
          {
            "code" : "200000029856"
          },
          {
            "code" : "200000029857"
          },
          {
            "code" : "200000029858"
          },
          {
            "code" : "200000029859"
          },
          {
            "code" : "200000029860"
          }
        ]
      }
    ]
  }
}