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 |
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:CodeSystem ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "100000116045"] ; # fhir:meta [ fhir:versionId [ fhir:v "5.0.0" ] ; fhir:lastUpdated [ fhir:v "2023-08-03T11:35:00.198Z"^^xsd:dateTime ] ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir: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\">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>"^^rdf:XMLLiteral ] ; # fhir:url [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000116045"^^xsd:anyURI] ; # fhir:version [ fhir:v "1.2.0"] ; # fhir:name [ fhir:v "MarketingAuthorisationApplicationLegalBasisCs"] ; # fhir:title [ fhir:v "Marketing Authorisation Application Legal Basis"] ; # fhir:status [ fhir:v "active"] ; # fhir:experimental [ fhir:v false] ; # fhir:date [ fhir:v "2025-10-21T12:20:05+01:00"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "EMA"] ; # fhir:contact ( [ fhir:name [ fhir:v "EMA" ] ; ( fhir:telecom [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "https://support.ema.europa.eu/esc" ] ] ) ] ) ; # fhir:description [ fhir:v "Marketing Authorisation Application Legal Basis"] ; # fhir:caseSensitive [ fhir:v true] ; # fhir:content [ fhir:v "complete"] ; # fhir:count [ fhir:v "85"^^xsd:nonNegativeInteger] ; # fhir:concept ( [ fhir:code [ fhir:v "100000116046" ] ; fhir:display [ fhir:v "Full application (Article 8(3) of Directive No 2001/83/EC)" ] ] [ fhir:code [ fhir:v "100000116047" ] ; fhir:display [ fhir:v "New active substance (Article 8(3) of Directive No 2001/83/EC)" ] ] [ fhir:code [ fhir:v "100000116048" ] ; fhir:display [ fhir:v "Known active substance (Article 8(3) of Directive No 2001/83/EC)" ] ] [ fhir:code [ fhir:v "100000116049" ] ; fhir:display [ fhir:v "Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC)" ] ] [ fhir:code [ fhir:v "100000116050" ] ; fhir:display [ fhir:v "Generic application (Article 10(1) of Directive No 2001/83/EC)" ] ] [ fhir:code [ fhir:v "100000116051" ] ; fhir:display [ fhir:v "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" ] ] [ fhir:code [ fhir:v "100000116052" ] ; fhir:display [ fhir:v "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" ] ] [ fhir:code [ fhir:v "100000116053" ] ; fhir:display [ fhir:v "Well-established use application (Article 10a of Directive No 2001/83/EC)" ] ] [ fhir:code [ fhir:v "100000116054" ] ; fhir:display [ fhir:v "Fixed combination application (Article 10b of Directive No 2001/83/EC)" ] ] [ fhir:code [ fhir:v "100000116055" ] ; fhir:display [ fhir:v "Informed consent application (Article 10c of Directive No 2001/83/EC)" ] ] [ fhir:code [ fhir:v "100000116056" ] ; fhir:display [ fhir:v "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" ] ] [ fhir:code [ fhir:v "100000116057" ] ; fhir:display [ fhir:v "Full application (Article 12(3) of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "100000116058" ] ; fhir:display [ fhir:v "Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "100000116059" ] ; fhir:display [ fhir:v "Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "100000116060" ] ; fhir:display [ fhir:v "Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "100000116061" ] ; fhir:display [ fhir:v "Generic application (Article 13(1) of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "100000116062" ] ; fhir:display [ fhir:v "Hybrid application (Article 13(3) of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "100000116063" ] ; fhir:display [ fhir:v "Similar biological application (Article 13(4) of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "100000116064" ] ; fhir:display [ fhir:v "Well-established use application (Article 13a of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "100000116065" ] ; fhir:display [ fhir:v "Fixed combination application (Article 13b of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "100000116066" ] ; fhir:display [ fhir:v "Informed consent application (Article 13c of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "100000116067" ] ; fhir:display [ fhir:v "Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "100000116068" ] ; fhir:display [ fhir:v "Ancillary medicinal substance/blood derivative substance (Article 1(4) of both Directives No 93/42/EEC and 90/385/EEC)" ] ] [ fhir:code [ fhir:v "100000116069" ] ; fhir:display [ fhir:v "Bibliographical application (stand-alone)" ] ] [ fhir:code [ fhir:v "100000116070" ] ; fhir:display [ fhir:v "Informed consent (abridged application) - Council Directive 81/851/EEC" ] ] [ fhir:code [ fhir:v "100000116071" ] ; fhir:display [ fhir:v "Fixed combination" ] ] [ fhir:code [ fhir:v "100000116072" ] ; fhir:display [ fhir:v "Complete application (stand-alone)" ] ] [ fhir:code [ fhir:v "100000116073" ] ; fhir:display [ fhir:v "Complete mixed application" ] ] [ fhir:code [ fhir:v "100000116074" ] ; fhir:display [ fhir:v "Generic (abridged application) - art 10(1)" ] ] [ fhir:code [ fhir:v "100000116075" ] ; fhir:display [ fhir:v "Last paragraph (abridged application)" ] ] [ fhir:code [ fhir:v "100000116076" ] ; fhir:display [ fhir:v "Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93" ] ] [ fhir:code [ fhir:v "100000116077" ] ; fhir:display [ fhir:v "Complete application (stand-alone) - Directive No 2001/82/EC" ] ] [ fhir:code [ fhir:v "100000116078" ] ; fhir:display [ fhir:v "Generic (abridged application) - art 13(1)" ] ] [ fhir:code [ fhir:v "100000116079" ] ; fhir:display [ fhir:v "Informed consent (abridged application) - art 10c" ] ] [ fhir:code [ fhir:v "100000116080" ] ; fhir:display [ fhir:v "Complete application (stand-alone) - Council Directive 81/851/EEC" ] ] [ fhir:code [ fhir:v "100000116081" ] ; fhir:display [ fhir:v "Article 58 of Regulation (EC) No 726/2004" ] ] [ fhir:code [ fhir:v "100000116082" ] ; fhir:display [ fhir:v "Informed consent (abridged application) - Council Regulation 2001/82/EC" ] ] [ fhir:code [ fhir:v "200000013166" ] ; fhir:display [ fhir:v "Known human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745)" ] ] [ fhir:code [ fhir:v "200000013167" ] ; fhir:display [ fhir:v "Known ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745)" ] ] [ fhir:code [ fhir:v "200000013168" ] ; fhir:display [ fhir:v "Unknown human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745)" ] ] [ fhir:code [ fhir:v "200000013169" ] ; fhir:display [ fhir:v "Unknown ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745)" ] ] [ fhir:code [ fhir:v "200000013170" ] ; fhir:display [ fhir:v "Companion Diagnostics (Article 48 (3), (4), (7), (8) of Regulation (EU) 2017/746)" ] ] [ fhir:code [ fhir:v "200000013171" ] ; fhir:display [ fhir:v "Medical device composed of a substance or combinations of substances (Article 52 (11) of Regulation (EU) 2017/745)" ] ] [ fhir:code [ fhir:v "200000013173" ] ; fhir:display [ fhir:v "Registered homeopathic medicinal products (Article 17 of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "200000013174" ] ; fhir:display [ fhir:v "Homeopathic medicinal products (Article 19 of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "200000013175" ] ; fhir:display [ fhir:v "Legal basis not covered by Directive 2001/82/EC" ] ] [ fhir:code [ fhir:v "200000013176" ] ; fhir:display [ fhir:v "Authorisations for temporary use (article 8 of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "200000013177" ] ; fhir:display [ fhir:v "Legal basis reviewed according to Acquis communautaire" ] ] [ fhir:code [ fhir:v "200000013178" ] ; fhir:display [ fhir:v "Full application - new active substance (Article 8 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000013179" ] ; fhir:display [ fhir:v "Full application - known active substance (Article 8 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000013180" ] ; fhir:display [ fhir:v "Generic application (Article 18 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000013181" ] ; fhir:display [ fhir:v "Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000013182" ] ; fhir:display [ fhir:v "Combination veterinary medicinal products (Article 20 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000013183" ] ; fhir:display [ fhir:v "Informed Consent application (Article 21 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000013184" ] ; fhir:display [ fhir:v "Bibliographic application (Article 22 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000013185" ] ; fhir:display [ fhir:v "Applications for limited markets (Article 23 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000013186" ] ; fhir:display [ fhir:v "Applications in exceptional circumstances (Article 25 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000013187" ] ; fhir:display [ fhir:v "Registered homeopathic veterinary medicinal products (Article 86 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000013188" ] ; fhir:display [ fhir:v "Permission for national use due to health situation (Article 116 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000013189" ] ; fhir:display [ fhir:v "Authorised homeopathic medicinal products (Article 85(2) of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000013906" ] ; fhir:display [ fhir:v "Veterinary medicinal products intended for animals exclusively kept as pets (article 5(6) of Reg 2019/6)" ] ] [ fhir:code [ fhir:v "200000013907" ] ; fhir:display [ fhir:v "Parallel traded products as referred to in article 102 of Regulation 2019/6" ] ] [ fhir:code [ fhir:v "200000016435" ] ; fhir:display [ fhir:v "Hybrid application - change in therapeutic indication(s) (Article 19(1)(a) of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000016436" ] ; fhir:display [ fhir:v "Hybrid application - change in strength (Article 19(1)(a) of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000016437" ] ; fhir:display [ fhir:v "Hybrid application - change in route of administration (Article 19(1)(a) of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000016438" ] ; fhir:display [ fhir:v "Hybrid application - change in pharmaceutical form (Article 19(1)(a) of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000016439" ] ; fhir:display [ fhir:v "Hybrid application - bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000016440" ] ; fhir:display [ fhir:v "Hybrid application - differences in raw materials or in manufacturing processes of biological VMPs (Article 19(1)(c) of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000016456" ] ; fhir:display [ fhir:v "Simplified registration application for a homeopathic medicinal product (Article 14 of Directive No 2001/83/EC)" ] ] [ fhir:code [ fhir:v "200000016457" ] ; fhir:display [ fhir:v "Medicinal product authorised according to Article 126a of Directive No 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000022794" ] ; fhir:display [ fhir:v "Simplified registration application for a homeopathic veterinary medicinal product (Article 17 of Directive No 2001/82/EC)" ] ] [ fhir:code [ fhir:v "200000023331" ] ; fhir:display [ fhir:v "Authorisation according to Article 5(1) of Directive 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000023341" ] ; fhir:display [ fhir:v "Authorisation according to Article 5(2) of Directive 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000023342" ] ; fhir:display [ fhir:v "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000023343" ] ; fhir:display [ fhir:v "Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000023344" ] ; fhir:display [ fhir:v "Available under Article 83(2) of Regulation (EC) No 726/2004" ] ] [ fhir:code [ fhir:v "200000029645" ] ; fhir:display [ fhir:v "Hybrid application (Article 19(1) of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000029646" ] ; fhir:display [ fhir:v "Hybrid application - change in target species (Article 19(1)(a) of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000029648" ] ; fhir:display [ fhir:v "Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000029650" ] ; fhir:display [ fhir:v "Hybrid application - other (Article 19(1)(a) of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000029651" ] ; fhir:display [ fhir:v "Full application (Article 8 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000043394" ] ; fhir:display [ fhir:v "New active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000043395" ] ; fhir:display [ fhir:v "Known active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000043396" ] ; fhir:display [ fhir:v "New active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6)" ] ] [ fhir:code [ fhir:v "200000043397" ] ; fhir:display [ fhir:v "Known active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6)" ] ] ) . #
IG © 2025 EMA. Package emavar#1.2.0 based on FHIR 5.0.0. Generated 2025-10-21
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