| Package | eu.epi.february2025 |
| Resource Type | CodeSystem |
| Id | 300000000002 |
| FHIR Version | R5 |
| Source | https://simplifier.net/resolve?scope=eu.epi.february2025@1.0.0&canonical=http://ema.europa.eu/fhir/CodeSystem/300000000002 |
| URL | http://ema.europa.eu/fhir/CodeSystem/300000000002 |
| Version | 5.0.0 |
| Status | active |
| Name | EUepiannexIIcodesystem |
| Title | EU EPI Annex II QRD code values |
| Description | EU EPI Annex II QRD code values |
| Content | complete |
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{
"resourceType": "CodeSystem",
"status": "active",
"content": "complete",
"name": "EUepiannexIIcodesystem",
"id": "300000000002",
"title": "EU EPI Annex II QRD code values",
"description": "EU EPI Annex II QRD code values",
"version": "5.0.0",
"url": "http://ema.europa.eu/fhir/CodeSystem/300000000002",
"concept": [
{
"code": "000000000000",
"display": "Code for custom sub-sections (reserved)"
},
{
"code": "200000029850",
"display": "ANNEX II"
},
{
"code": "200000029851",
"display": "A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE"
},
{
"code": "200000029852",
"display": "B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE"
},
{
"code": "200000029853",
"display": "Official batch release"
},
{
"code": "200000029854",
"display": "C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION"
},
{
"code": "200000029855",
"display": "Periodic safety update reports (PSURs)"
},
{
"code": "200000029856",
"display": "D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT"
},
{
"code": "200000029857",
"display": "Risk management plan (RMP)"
},
{
"code": "200000029858",
"display": "Additional risk minimisation measures"
},
{
"code": "200000029859",
"display": "Obligation to conduct post-authorisation measures"
},
{
"code": "200000029860",
"display": "E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR <THE CONDITIONAL MARKETING AUTHORISATION> <THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES"
}
],
"experimental": false,
"publisher": "European Medicines Agency",
"jurisdiction": [
{
"text": "European Union"
}
],
"caseSensitive": true,
"count": 12
}