EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Active as of 2025-04-04 |
{
"resourceType" : "CodeSystem",
"id" : "100000116045",
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"lastUpdated" : "2023-08-03T11:35:00.198Z"
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"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem 100000116045</b></p><a name=\"100000116045\"> </a><a name=\"hc100000116045\"> </a><a name=\"100000116045-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 5.0.0; Last updated: 2023-08-03 11:35:00+0000</p></div><p>This case-sensitive code system <code>http://spor.ema.europa.eu/v1/lists/100000116045</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style=\"white-space:nowrap\">100000116046<a name=\"100000116045-100000116046\"> </a></td><td>Full application (Article 8(3) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116047<a name=\"100000116045-100000116047\"> </a></td><td>New active substance (Article 8(3) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116048<a name=\"100000116045-100000116048\"> </a></td><td>Known active substance (Article 8(3) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116049<a name=\"100000116045-100000116049\"> </a></td><td>Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116050<a name=\"100000116045-100000116050\"> </a></td><td>Generic application (Article 10(1) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116051<a name=\"100000116045-100000116051\"> </a></td><td>Hybrid application (Article 10(3) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116052<a name=\"100000116045-100000116052\"> </a></td><td>Similar biological application (Article 10(4) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116053<a name=\"100000116045-100000116053\"> </a></td><td>Well-established use application (Article 10a of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116054<a name=\"100000116045-100000116054\"> </a></td><td>Fixed combination application (Article 10b of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116055<a name=\"100000116045-100000116055\"> </a></td><td>Informed consent application (Article 10c of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116056<a name=\"100000116045-100000116056\"> </a></td><td>Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116057<a name=\"100000116045-100000116057\"> </a></td><td>Full application (Article 12(3) of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116058<a name=\"100000116045-100000116058\"> </a></td><td>Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116059<a name=\"100000116045-100000116059\"> </a></td><td>Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116060<a name=\"100000116045-100000116060\"> </a></td><td>Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116061<a name=\"100000116045-100000116061\"> </a></td><td>Generic application (Article 13(1) of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116062<a name=\"100000116045-100000116062\"> </a></td><td>Hybrid application (Article 13(3) of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116063<a name=\"100000116045-100000116063\"> </a></td><td>Similar biological application (Article 13(4) of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116064<a name=\"100000116045-100000116064\"> </a></td><td>Well-established use application (Article 13a of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116065<a name=\"100000116045-100000116065\"> </a></td><td>Fixed combination application (Article 13b of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000003511<a name=\"100000116045-200000003511\"> </a></td><td>Parallel Distributed/Imported medicinal product (Article 76(3) and (4) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000003512<a name=\"100000116045-200000003512\"> </a></td><td>Exceptional Circumstances Marketing Authorisation (Article 14(6) (8) of Regulation (EC) No 726/2004 or Article 22 of Directive 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000003513<a name=\"100000116045-200000003513\"> </a></td><td>Authorised homeopathic medicinal product</td></tr><tr><td style=\"white-space:nowrap\">200000003514<a name=\"100000116045-200000003514\"> </a></td><td>Authorised herbal medicinal product</td></tr><tr><td style=\"white-space:nowrap\">200000003515<a name=\"100000116045-200000003515\"> </a></td><td>Paediatric Use Marketing Authorisation (PUMA) (Article 30 of Regulation (EC) No 1901/2006)</td></tr><tr><td style=\"white-space:nowrap\">200000003516<a name=\"100000116045-200000003516\"> </a></td><td>Conditional Marketing Authorisation (Article 14 (7) of Regulation (EC) No 726/2004)</td></tr><tr><td style=\"white-space:nowrap\">200000003517<a name=\"100000116045-200000003517\"> </a></td><td>Other</td></tr></table></div>"
},
"url" : "http://spor.ema.europa.eu/v1/lists/100000116045",
"version" : "1.0.0",
"name" : "MarketingAuthorisationApplicationLegalBasisCs",
"title" : "Marketing Authorisation Application Legal Basis",
"status" : "active",
"experimental" : false,
"date" : "2025-04-04T16:15:09+01:00",
"publisher" : "EMA",
"contact" : [
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"name" : "EMA",
"telecom" : [
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"system" : "url",
"value" : "https://support.ema.europa.eu/esc"
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],
"description" : "Marketing Authorisation Application Legal Basis",
"caseSensitive" : true,
"content" : "complete",
"count" : 27,
"concept" : [
{
"code" : "100000116046",
"display" : "Full application (Article 8(3) of Directive No 2001/83/EC)"
},
{
"code" : "100000116047",
"display" : "New active substance (Article 8(3) of Directive No 2001/83/EC)"
},
{
"code" : "100000116048",
"display" : "Known active substance (Article 8(3) of Directive No 2001/83/EC)"
},
{
"code" : "100000116049",
"display" : "Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC)"
},
{
"code" : "100000116050",
"display" : "Generic application (Article 10(1) of Directive No 2001/83/EC)"
},
{
"code" : "100000116051",
"display" : "Hybrid application (Article 10(3) of Directive No 2001/83/EC)"
},
{
"code" : "100000116052",
"display" : "Similar biological application (Article 10(4) of Directive No 2001/83/EC)"
},
{
"code" : "100000116053",
"display" : "Well-established use application (Article 10a of Directive No 2001/83/EC)"
},
{
"code" : "100000116054",
"display" : "Fixed combination application (Article 10b of Directive No 2001/83/EC)"
},
{
"code" : "100000116055",
"display" : "Informed consent application (Article 10c of Directive No 2001/83/EC)"
},
{
"code" : "100000116056",
"display" : "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)"
},
{
"code" : "100000116057",
"display" : "Full application (Article 12(3) of Directive No 2001/82/EC)"
},
{
"code" : "100000116058",
"display" : "Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)"
},
{
"code" : "100000116059",
"display" : "Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)"
},
{
"code" : "100000116060",
"display" : "Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC)"
},
{
"code" : "100000116061",
"display" : "Generic application (Article 13(1) of Directive No 2001/82/EC)"
},
{
"code" : "100000116062",
"display" : "Hybrid application (Article 13(3) of Directive No 2001/82/EC)"
},
{
"code" : "100000116063",
"display" : "Similar biological application (Article 13(4) of Directive No 2001/82/EC)"
},
{
"code" : "100000116064",
"display" : "Well-established use application (Article 13a of Directive No 2001/82/EC)"
},
{
"code" : "100000116065",
"display" : "Fixed combination application (Article 13b of Directive No 2001/82/EC)"
},
{
"code" : "200000003511",
"display" : "Parallel Distributed/Imported medicinal product (Article 76(3) and (4) of Directive No 2001/83/EC)"
},
{
"code" : "200000003512",
"display" : "Exceptional Circumstances Marketing Authorisation (Article 14(6) (8) of Regulation (EC) No 726/2004 or Article 22 of Directive 2001/83/EC)"
},
{
"code" : "200000003513",
"display" : "Authorised homeopathic medicinal product"
},
{
"code" : "200000003514",
"display" : "Authorised herbal medicinal product"
},
{
"code" : "200000003515",
"display" : "Paediatric Use Marketing Authorisation (PUMA) (Article 30 of Regulation (EC) No 1901/2006)"
},
{
"code" : "200000003516",
"display" : "Conditional Marketing Authorisation (Article 14 (7) of Regulation (EC) No 726/2004)"
},
{
"code" : "200000003517",
"display" : "Other"
}
]
}