EMA Write PMS API Implementation Guide - Enrichments
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: Marketing Authorisation Application Legal Basis - XML Representation

Active as of 2025-04-04

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="100000116045"/>
  <meta>
    <versionId value="5.0.0"/>
    <lastUpdated value="2023-08-03T11:35:00.198Z"/>
  </meta>
  <text>
    <status value="generated"/>
    <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>
  </text>
  <url value="http://spor.ema.europa.eu/v1/lists/100000116045"/>
  <version value="1.0.0"/>
  <name value="MarketingAuthorisationApplicationLegalBasisCs"/>
  <title value="Marketing Authorisation Application Legal Basis"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2025-04-04T16:15:09+01:00"/>
  <publisher value="EMA"/>
  <contact>
    <name value="EMA"/>
    <telecom>
      <system value="url"/>
      <value value="https://support.ema.europa.eu/esc"/>
    </telecom>
  </contact>
  <description value="Marketing Authorisation Application Legal Basis"/>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <count value="27"/>
  <concept>
    <code value="100000116046"/>
    <display
             value="Full application (Article 8(3) of Directive No 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="100000116047"/>
    <display
             value="New active substance (Article 8(3) of Directive No 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="100000116048"/>
    <display
             value="Known active substance (Article 8(3) of Directive No 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="100000116049"/>
    <display
             value="Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="100000116050"/>
    <display
             value="Generic application (Article 10(1) of Directive No 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="100000116051"/>
    <display
             value="Hybrid application (Article 10(3) of Directive No 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="100000116052"/>
    <display
             value="Similar biological application (Article 10(4) of Directive No 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="100000116053"/>
    <display
             value="Well-established use application (Article 10a of Directive No 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="100000116054"/>
    <display
             value="Fixed combination application (Article 10b of Directive No 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="100000116055"/>
    <display
             value="Informed consent application (Article 10c of Directive No 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="100000116056"/>
    <display
             value="Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="100000116057"/>
    <display
             value="Full application (Article 12(3) of Directive No 2001/82/EC)"/>
  </concept>
  <concept>
    <code value="100000116058"/>
    <display
             value="Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)"/>
  </concept>
  <concept>
    <code value="100000116059"/>
    <display
             value="Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)"/>
  </concept>
  <concept>
    <code value="100000116060"/>
    <display
             value="Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC)"/>
  </concept>
  <concept>
    <code value="100000116061"/>
    <display
             value="Generic application (Article 13(1) of Directive No 2001/82/EC)"/>
  </concept>
  <concept>
    <code value="100000116062"/>
    <display
             value="Hybrid application (Article 13(3) of Directive No 2001/82/EC)"/>
  </concept>
  <concept>
    <code value="100000116063"/>
    <display
             value="Similar biological application (Article 13(4) of Directive No 2001/82/EC)"/>
  </concept>
  <concept>
    <code value="100000116064"/>
    <display
             value="Well-established use application (Article 13a of Directive No 2001/82/EC)"/>
  </concept>
  <concept>
    <code value="100000116065"/>
    <display
             value="Fixed combination application (Article 13b of Directive No 2001/82/EC)"/>
  </concept>
  <concept>
    <code value="200000003511"/>
    <display
             value="Parallel Distributed/Imported medicinal product (Article 76(3) and (4) of Directive No 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="200000003512"/>
    <display
             value="Exceptional Circumstances Marketing Authorisation (Article 14(6) (8) of Regulation (EC) No 726/2004 or Article 22 of Directive 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="200000003513"/>
    <display value="Authorised homeopathic medicinal product"/>
  </concept>
  <concept>
    <code value="200000003514"/>
    <display value="Authorised herbal medicinal product"/>
  </concept>
  <concept>
    <code value="200000003515"/>
    <display
             value="Paediatric Use Marketing Authorisation (PUMA) (Article 30 of Regulation (EC) No 1901/2006)"/>
  </concept>
  <concept>
    <code value="200000003516"/>
    <display
             value="Conditional Marketing Authorisation (Article 14 (7) of Regulation (EC) No 726/2004)"/>
  </concept>
  <concept>
    <code value="200000003517"/>
    <display value="Other"/>
  </concept>
</CodeSystem>