EMA Write PMS API Implementation Guide - Enrichments
1.2.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Active as of 2025-10-21 |
<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">100000116066<a name="100000116045-100000116066"> </a></td><td>Informed consent application (Article 13c of Directive No 2001/82/EC)</td></tr><tr><td style="white-space:nowrap">100000116067<a name="100000116045-100000116067"> </a></td><td>Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)</td></tr><tr><td style="white-space:nowrap">100000116068<a name="100000116045-100000116068"> </a></td><td>Ancillary medicinal substance/blood derivative substance (Article 1(4) of both Directives No 93/42/EEC and 90/385/EEC)</td></tr><tr><td style="white-space:nowrap">100000116069<a name="100000116045-100000116069"> </a></td><td>Bibliographical application (stand-alone)</td></tr><tr><td style="white-space:nowrap">100000116070<a name="100000116045-100000116070"> </a></td><td>Informed consent (abridged application) - Council Directive 81/851/EEC</td></tr><tr><td style="white-space:nowrap">100000116071<a name="100000116045-100000116071"> </a></td><td>Fixed combination</td></tr><tr><td style="white-space:nowrap">100000116072<a name="100000116045-100000116072"> </a></td><td>Complete application (stand-alone)</td></tr><tr><td style="white-space:nowrap">100000116073<a name="100000116045-100000116073"> </a></td><td>Complete mixed application</td></tr><tr><td style="white-space:nowrap">100000116074<a name="100000116045-100000116074"> </a></td><td>Generic (abridged application) - art 10(1)</td></tr><tr><td style="white-space:nowrap">100000116075<a name="100000116045-100000116075"> </a></td><td>Last paragraph (abridged application)</td></tr><tr><td style="white-space:nowrap">100000116076<a name="100000116045-100000116076"> </a></td><td>Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93</td></tr><tr><td style="white-space:nowrap">100000116077<a name="100000116045-100000116077"> </a></td><td>Complete application (stand-alone) - Directive No 2001/82/EC</td></tr><tr><td style="white-space:nowrap">100000116078<a name="100000116045-100000116078"> </a></td><td>Generic (abridged application) - art 13(1)</td></tr><tr><td style="white-space:nowrap">100000116079<a name="100000116045-100000116079"> </a></td><td>Informed consent (abridged application) - art 10c</td></tr><tr><td style="white-space:nowrap">100000116080<a name="100000116045-100000116080"> </a></td><td>Complete application (stand-alone) - Council Directive 81/851/EEC</td></tr><tr><td style="white-space:nowrap">100000116081<a name="100000116045-100000116081"> </a></td><td>Article 58 of Regulation (EC) No 726/2004</td></tr><tr><td style="white-space:nowrap">100000116082<a name="100000116045-100000116082"> </a></td><td>Informed consent (abridged application) - Council Regulation 2001/82/EC</td></tr><tr><td style="white-space:nowrap">200000013166<a name="100000116045-200000013166"> </a></td><td>Known human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745)</td></tr><tr><td style="white-space:nowrap">200000013167<a name="100000116045-200000013167"> </a></td><td>Known ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745)</td></tr><tr><td style="white-space:nowrap">200000013168<a name="100000116045-200000013168"> </a></td><td>Unknown human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745)</td></tr><tr><td style="white-space:nowrap">200000013169<a name="100000116045-200000013169"> </a></td><td>Unknown ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745)</td></tr><tr><td style="white-space:nowrap">200000013170<a name="100000116045-200000013170"> </a></td><td>Companion Diagnostics (Article 48 (3), (4), (7), (8) of Regulation (EU) 2017/746)</td></tr><tr><td style="white-space:nowrap">200000013171<a name="100000116045-200000013171"> </a></td><td>Medical device composed of a substance or combinations of substances (Article 52 (11) of Regulation (EU) 2017/745)</td></tr><tr><td style="white-space:nowrap">200000013173<a name="100000116045-200000013173"> </a></td><td>Registered homeopathic medicinal products (Article 17 of Directive No 2001/82/EC)</td></tr><tr><td style="white-space:nowrap">200000013174<a name="100000116045-200000013174"> </a></td><td>Homeopathic medicinal products (Article 19 of Directive No 2001/82/EC)</td></tr><tr><td style="white-space:nowrap">200000013175<a name="100000116045-200000013175"> </a></td><td>Legal basis not covered by Directive 2001/82/EC</td></tr><tr><td style="white-space:nowrap">200000013176<a name="100000116045-200000013176"> </a></td><td>Authorisations for temporary use (article 8 of Directive No 2001/82/EC)</td></tr><tr><td style="white-space:nowrap">200000013177<a name="100000116045-200000013177"> </a></td><td>Legal basis reviewed according to Acquis communautaire</td></tr><tr><td style="white-space:nowrap">200000013178<a name="100000116045-200000013178"> </a></td><td>Full application - new active substance (Article 8 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013179<a name="100000116045-200000013179"> </a></td><td>Full application - known active substance (Article 8 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013180<a name="100000116045-200000013180"> </a></td><td>Generic application (Article 18 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013181<a name="100000116045-200000013181"> </a></td><td>Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013182<a name="100000116045-200000013182"> </a></td><td>Combination veterinary medicinal products (Article 20 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013183<a name="100000116045-200000013183"> </a></td><td>Informed Consent application (Article 21 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013184<a name="100000116045-200000013184"> </a></td><td>Bibliographic application (Article 22 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013185<a name="100000116045-200000013185"> </a></td><td>Applications for limited markets (Article 23 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013186<a name="100000116045-200000013186"> </a></td><td>Applications in exceptional circumstances (Article 25 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013187<a name="100000116045-200000013187"> </a></td><td>Registered homeopathic veterinary medicinal products (Article 86 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013188<a name="100000116045-200000013188"> </a></td><td>Permission for national use due to health situation (Article 116 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013189<a name="100000116045-200000013189"> </a></td><td>Authorised homeopathic medicinal products (Article 85(2) of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013906<a name="100000116045-200000013906"> </a></td><td>Veterinary medicinal products intended for animals exclusively kept as pets (article 5(6) of Reg 2019/6)</td></tr><tr><td style="white-space:nowrap">200000013907<a name="100000116045-200000013907"> </a></td><td>Parallel traded products as referred to in article 102 of Regulation 2019/6</td></tr><tr><td style="white-space:nowrap">200000016435<a name="100000116045-200000016435"> </a></td><td>Hybrid application - change in therapeutic indication(s) (Article 19(1)(a) of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000016436<a name="100000116045-200000016436"> </a></td><td>Hybrid application - change in strength (Article 19(1)(a) of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000016437<a name="100000116045-200000016437"> </a></td><td>Hybrid application - change in route of administration (Article 19(1)(a) of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000016438<a name="100000116045-200000016438"> </a></td><td>Hybrid application - change in pharmaceutical form (Article 19(1)(a) of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000016439<a name="100000116045-200000016439"> </a></td><td>Hybrid application - bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000016440<a name="100000116045-200000016440"> </a></td><td>Hybrid application - differences in raw materials or in manufacturing processes of biological VMPs (Article 19(1)(c) of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000016456<a name="100000116045-200000016456"> </a></td><td>Simplified registration application for a homeopathic medicinal product (Article 14 of Directive No 2001/83/EC)</td></tr><tr><td style="white-space:nowrap">200000016457<a name="100000116045-200000016457"> </a></td><td>Medicinal product authorised according to Article 126a of Directive No 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000022794<a name="100000116045-200000022794"> </a></td><td>Simplified registration application for a homeopathic veterinary medicinal product (Article 17 of Directive No 2001/82/EC)</td></tr><tr><td style="white-space:nowrap">200000023331<a name="100000116045-200000023331"> </a></td><td>Authorisation according to Article 5(1) of Directive 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000023341<a name="100000116045-200000023341"> </a></td><td>Authorisation according to Article 5(2) of Directive 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000023342<a name="100000116045-200000023342"> </a></td><td>Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000023343<a name="100000116045-200000023343"> </a></td><td>Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000023344<a name="100000116045-200000023344"> </a></td><td>Available under Article 83(2) of Regulation (EC) No 726/2004</td></tr><tr><td style="white-space:nowrap">200000029645<a name="100000116045-200000029645"> </a></td><td>Hybrid application (Article 19(1) of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000029646<a name="100000116045-200000029646"> </a></td><td>Hybrid application - change in target species (Article 19(1)(a) of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000029648<a name="100000116045-200000029648"> </a></td><td>Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000029650<a name="100000116045-200000029650"> </a></td><td>Hybrid application - other (Article 19(1)(a) of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000029651<a name="100000116045-200000029651"> </a></td><td>Full application (Article 8 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000043394<a name="100000116045-200000043394"> </a></td><td>New active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000043395<a name="100000116045-200000043395"> </a></td><td>Known active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000043396<a name="100000116045-200000043396"> </a></td><td>New active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6)</td></tr><tr><td style="white-space:nowrap">200000043397<a name="100000116045-200000043397"> </a></td><td>Known active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6)</td></tr></table></div>
</text>
<url value="http://spor.ema.europa.eu/v1/lists/100000116045"/>
<version value="1.2.0"/>
<name value="MarketingAuthorisationApplicationLegalBasisCs"/>
<title value="Marketing Authorisation Application Legal Basis"/>
<status value="active"/>
<experimental value="false"/>
<date value="2025-10-21T12:20:05+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="85"/>
<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="100000116066"/>
<display
value="Informed consent application (Article 13c of Directive No 2001/82/EC)"/>
</concept>
<concept>
<code value="100000116067"/>
<display
value="Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)"/>
</concept>
<concept>
<code value="100000116068"/>
<display
value="Ancillary medicinal substance/blood derivative substance (Article 1(4) of both Directives No 93/42/EEC and 90/385/EEC)"/>
</concept>
<concept>
<code value="100000116069"/>
<display value="Bibliographical application (stand-alone)"/>
</concept>
<concept>
<code value="100000116070"/>
<display
value="Informed consent (abridged application) - Council Directive 81/851/EEC"/>
</concept>
<concept>
<code value="100000116071"/>
<display value="Fixed combination"/>
</concept>
<concept>
<code value="100000116072"/>
<display value="Complete application (stand-alone)"/>
</concept>
<concept>
<code value="100000116073"/>
<display value="Complete mixed application"/>
</concept>
<concept>
<code value="100000116074"/>
<display value="Generic (abridged application) - art 10(1)"/>
</concept>
<concept>
<code value="100000116075"/>
<display value="Last paragraph (abridged application)"/>
</concept>
<concept>
<code value="100000116076"/>
<display
value="Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93"/>
</concept>
<concept>
<code value="100000116077"/>
<display
value="Complete application (stand-alone) - Directive No 2001/82/EC"/>
</concept>
<concept>
<code value="100000116078"/>
<display value="Generic (abridged application) - art 13(1)"/>
</concept>
<concept>
<code value="100000116079"/>
<display value="Informed consent (abridged application) - art 10c"/>
</concept>
<concept>
<code value="100000116080"/>
<display
value="Complete application (stand-alone) - Council Directive 81/851/EEC"/>
</concept>
<concept>
<code value="100000116081"/>
<display value="Article 58 of Regulation (EC) No 726/2004"/>
</concept>
<concept>
<code value="100000116082"/>
<display
value="Informed consent (abridged application) - Council Regulation 2001/82/EC"/>
</concept>
<concept>
<code value="200000013166"/>
<display
value="Known human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745)"/>
</concept>
<concept>
<code value="200000013167"/>
<display
value="Known ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745)"/>
</concept>
<concept>
<code value="200000013168"/>
<display
value="Unknown human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745)"/>
</concept>
<concept>
<code value="200000013169"/>
<display
value="Unknown ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745)"/>
</concept>
<concept>
<code value="200000013170"/>
<display
value="Companion Diagnostics (Article 48 (3), (4), (7), (8) of Regulation (EU) 2017/746)"/>
</concept>
<concept>
<code value="200000013171"/>
<display
value="Medical device composed of a substance or combinations of substances (Article 52 (11) of Regulation (EU) 2017/745)"/>
</concept>
<concept>
<code value="200000013173"/>
<display
value="Registered homeopathic medicinal products (Article 17 of Directive No 2001/82/EC)"/>
</concept>
<concept>
<code value="200000013174"/>
<display
value="Homeopathic medicinal products (Article 19 of Directive No 2001/82/EC)"/>
</concept>
<concept>
<code value="200000013175"/>
<display value="Legal basis not covered by Directive 2001/82/EC"/>
</concept>
<concept>
<code value="200000013176"/>
<display
value="Authorisations for temporary use (article 8 of Directive No 2001/82/EC)"/>
</concept>
<concept>
<code value="200000013177"/>
<display value="Legal basis reviewed according to Acquis communautaire"/>
</concept>
<concept>
<code value="200000013178"/>
<display
value="Full application - new active substance (Article 8 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000013179"/>
<display
value="Full application - known active substance (Article 8 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000013180"/>
<display
value="Generic application (Article 18 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000013181"/>
<display
value="Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000013182"/>
<display
value="Combination veterinary medicinal products (Article 20 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000013183"/>
<display
value="Informed Consent application (Article 21 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000013184"/>
<display
value="Bibliographic application (Article 22 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000013185"/>
<display
value="Applications for limited markets (Article 23 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000013186"/>
<display
value="Applications in exceptional circumstances (Article 25 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000013187"/>
<display
value="Registered homeopathic veterinary medicinal products (Article 86 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000013188"/>
<display
value="Permission for national use due to health situation (Article 116 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000013189"/>
<display
value="Authorised homeopathic medicinal products (Article 85(2) of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000013906"/>
<display
value="Veterinary medicinal products intended for animals exclusively kept as pets (article 5(6) of Reg 2019/6)"/>
</concept>
<concept>
<code value="200000013907"/>
<display
value="Parallel traded products as referred to in article 102 of Regulation 2019/6"/>
</concept>
<concept>
<code value="200000016435"/>
<display
value="Hybrid application - change in therapeutic indication(s) (Article 19(1)(a) of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000016436"/>
<display
value="Hybrid application - change in strength (Article 19(1)(a) of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000016437"/>
<display
value="Hybrid application - change in route of administration (Article 19(1)(a) of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000016438"/>
<display
value="Hybrid application - change in pharmaceutical form (Article 19(1)(a) of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000016439"/>
<display
value="Hybrid application - bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000016440"/>
<display
value="Hybrid application - differences in raw materials or in manufacturing processes of biological VMPs (Article 19(1)(c) of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000016456"/>
<display
value="Simplified registration application for a homeopathic medicinal product (Article 14 of Directive No 2001/83/EC)"/>
</concept>
<concept>
<code value="200000016457"/>
<display
value="Medicinal product authorised according to Article 126a of Directive No 2001/83/EC"/>
</concept>
<concept>
<code value="200000022794"/>
<display
value="Simplified registration application for a homeopathic veterinary medicinal product (Article 17 of Directive No 2001/82/EC)"/>
</concept>
<concept>
<code value="200000023331"/>
<display
value="Authorisation according to Article 5(1) of Directive 2001/83/EC"/>
</concept>
<concept>
<code value="200000023341"/>
<display
value="Authorisation according to Article 5(2) of Directive 2001/83/EC"/>
</concept>
<concept>
<code value="200000023342"/>
<display
value="Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC"/>
</concept>
<concept>
<code value="200000023343"/>
<display
value="Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC"/>
</concept>
<concept>
<code value="200000023344"/>
<display
value="Available under Article 83(2) of Regulation (EC) No 726/2004"/>
</concept>
<concept>
<code value="200000029645"/>
<display
value="Hybrid application (Article 19(1) of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000029646"/>
<display
value="Hybrid application - change in target species (Article 19(1)(a) of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000029648"/>
<display
value="Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000029650"/>
<display
value="Hybrid application - other (Article 19(1)(a) of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000029651"/>
<display value="Full application (Article 8 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000043394"/>
<display
value="New active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000043395"/>
<display
value="Known active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000043396"/>
<display
value="New active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6)"/>
</concept>
<concept>
<code value="200000043397"/>
<display
value="Known active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6)"/>
</concept>
</CodeSystem>