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 |
@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 "100000155688"] ; # 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 100000155688</b></p><a name=\"100000155688\"> </a><a name=\"hc100000155688\"> </a><a name=\"100000155688-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/100000155688</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\">100000155689<a name=\"100000155688-100000155689\"> </a></td><td>Initial Marketing Authorisation Application</td></tr><tr><td style=\"white-space:nowrap\">100000155690<a name=\"100000155688-100000155690\"> </a></td><td>Variation Type IA</td></tr><tr><td style=\"white-space:nowrap\">100000155691<a name=\"100000155688-100000155691\"> </a></td><td>Variation Type IAIN</td></tr><tr><td style=\"white-space:nowrap\">100000155692<a name=\"100000155688-100000155692\"> </a></td><td>Variation Type IB</td></tr><tr><td style=\"white-space:nowrap\">100000155693<a name=\"100000155688-100000155693\"> </a></td><td>Variation Type II</td></tr><tr><td style=\"white-space:nowrap\">100000155694<a name=\"100000155688-100000155694\"> </a></td><td>National Variation</td></tr><tr><td style=\"white-space:nowrap\">100000155695<a name=\"100000155688-100000155695\"> </a></td><td>Line Extension</td></tr><tr><td style=\"white-space:nowrap\">100000155696<a name=\"100000155688-100000155696\"> </a></td><td>Periodic Safety Update Report</td></tr><tr><td style=\"white-space:nowrap\">100000155697<a name=\"100000155688-100000155697\"> </a></td><td>Renewal</td></tr><tr><td style=\"white-space:nowrap\">100000155698<a name=\"100000155688-100000155698\"> </a></td><td>Follow-up Measure</td></tr><tr><td style=\"white-space:nowrap\">100000155699<a name=\"100000155688-100000155699\"> </a></td><td>Specific Obligation</td></tr><tr><td style=\"white-space:nowrap\">100000155700<a name=\"100000155688-100000155700\"> </a></td><td>Active Substance Master File</td></tr><tr><td style=\"white-space:nowrap\">100000155701<a name=\"100000155688-100000155701\"> </a></td><td>Plasma Master File</td></tr><tr><td style=\"white-space:nowrap\">100000155702<a name=\"100000155688-100000155702\"> </a></td><td>Referral acc. Article 29, 30, 31, 35 or 107i</td></tr><tr><td style=\"white-space:nowrap\">100000155703<a name=\"100000155688-100000155703\"> </a></td><td>Annual Reassessment</td></tr><tr><td style=\"white-space:nowrap\">100000155704<a name=\"100000155688-100000155704\"> </a></td><td>Urgent Safety Restriction</td></tr><tr><td style=\"white-space:nowrap\">100000155705<a name=\"100000155688-100000155705\"> </a></td><td>Paediatric Submission acc. Article 29</td></tr><tr><td style=\"white-space:nowrap\">100000155706<a name=\"100000155688-100000155706\"> </a></td><td>Paediatric Submission acc. Article 46</td></tr><tr><td style=\"white-space:nowrap\">100000155707<a name=\"100000155688-100000155707\"> </a></td><td>WHO Cooperation acc. Article 58</td></tr><tr><td style=\"white-space:nowrap\">100000155708<a name=\"100000155688-100000155708\"> </a></td><td>Notification acc. Article 61(3)</td></tr><tr><td style=\"white-space:nowrap\">100000155709<a name=\"100000155688-100000155709\"> </a></td><td>Transfer of a marketing authorisation</td></tr><tr><td style=\"white-space:nowrap\">100000155710<a name=\"100000155688-100000155710\"> </a></td><td>Lifting of a Suspension</td></tr><tr><td style=\"white-space:nowrap\">100000155711<a name=\"100000155688-100000155711\"> </a></td><td>Withdrawal</td></tr><tr><td style=\"white-space:nowrap\">100000155713<a name=\"100000155688-100000155713\"> </a></td><td>Risk Management Plan</td></tr><tr><td style=\"white-space:nowrap\">100000155714<a name=\"100000155688-100000155714\"> </a></td><td>Correction to the Published Annexes</td></tr><tr><td style=\"white-space:nowrap\">100000155718<a name=\"100000155688-100000155718\"> </a></td><td>Periodic Safety Update Single Assessment</td></tr><tr><td style=\"white-space:nowrap\">200000002290<a name=\"100000155688-200000002290\"> </a></td><td>Certificate of suitability application to EDQM</td></tr><tr><td style=\"white-space:nowrap\">200000002291<a name=\"100000155688-200000002291\"> </a></td><td>Clinical data for publication – Final Version</td></tr><tr><td style=\"white-space:nowrap\">200000002292<a name=\"100000155688-200000002292\"> </a></td><td>Clinical data for publication – Redacted Proposal</td></tr><tr><td style=\"white-space:nowrap\">200000002293<a name=\"100000155688-200000002293\"> </a></td><td>Paediatric investigational plan according to article 7, 8 or 30 of the Reg (EC) 1901/2006</td></tr><tr><td style=\"white-space:nowrap\">200000002294<a name=\"100000155688-200000002294\"> </a></td><td>Paediatric investigational plan compliance check</td></tr><tr><td style=\"white-space:nowrap\">200000002295<a name=\"100000155688-200000002295\"> </a></td><td>Paediatric investigational plan deferral</td></tr><tr><td style=\"white-space:nowrap\">200000002296<a name=\"100000155688-200000002296\"> </a></td><td>Paediatric investigational plan submission (Module 1.10)</td></tr><tr><td style=\"white-space:nowrap\">200000002297<a name=\"100000155688-200000002297\"> </a></td><td>Paediatric investigational plan partial waiver</td></tr><tr><td style=\"white-space:nowrap\">200000002298<a name=\"100000155688-200000002298\"> </a></td><td>Paediatric investigational plan waiver</td></tr><tr><td style=\"white-space:nowrap\">200000002299<a name=\"100000155688-200000002299\"> </a></td><td>Annex II condition related to a post-authorisation measure</td></tr><tr><td style=\"white-space:nowrap\">200000002300<a name=\"100000155688-200000002300\"> </a></td><td>Corrective Action/Preventive Action related to a post-authorisation measure</td></tr><tr><td style=\"white-space:nowrap\">200000002301<a name=\"100000155688-200000002301\"> </a></td><td>Legally binding measure related to a post-authorisation measure</td></tr><tr><td style=\"white-space:nowrap\">200000002302<a name=\"100000155688-200000002302\"> </a></td><td>Additional pharmacovigilance activity in the risk-management plan</td></tr><tr><td style=\"white-space:nowrap\">200000002303<a name=\"100000155688-200000002303\"> </a></td><td>Submission of a post-authorisation efficacy study</td></tr><tr><td style=\"white-space:nowrap\">200000002305<a name=\"100000155688-200000002305\"> </a></td><td>Recommendation related to a post-authorisation measure</td></tr><tr><td style=\"white-space:nowrap\">200000002306<a name=\"100000155688-200000002306\"> </a></td><td>Cumulative review following a request related to a post-authorisation measure</td></tr><tr><td style=\"white-space:nowrap\">200000002307<a name=\"100000155688-200000002307\"> </a></td><td>Specific obligation related to a post-authorisation measure</td></tr><tr><td style=\"white-space:nowrap\">200000002308<a name=\"100000155688-200000002308\"> </a></td><td>Submission of a post-authorisation safety study protocol (according article 107n Dir. 2001/83/EC).</td></tr><tr><td style=\"white-space:nowrap\">200000002309<a name=\"100000155688-200000002309\"> </a></td><td>Submission of a post-authorisation safety study report (according article 107o Dir. 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000002310<a name=\"100000155688-200000002310\"> </a></td><td>Submission of a post-authorisation safety study report (according to article 107q Dir. 2001/83/EC).</td></tr><tr><td style=\"white-space:nowrap\">200000002311<a name=\"100000155688-200000002311\"> </a></td><td>Referral under Article 107i Dir. 2001/83/EC</td></tr><tr><td style=\"white-space:nowrap\">200000002312<a name=\"100000155688-200000002312\"> </a></td><td>Referral under Article 16c (1c) Dir. 2001/83/EC</td></tr><tr><td style=\"white-space:nowrap\">200000002313<a name=\"100000155688-200000002313\"> </a></td><td>Referral under Article 16c(4) Dir. 2001/83/EC</td></tr><tr><td style=\"white-space:nowrap\">200000002314<a name=\"100000155688-200000002314\"> </a></td><td>Referral under Article 20 Reg (EC) 726/2004</td></tr><tr><td style=\"white-space:nowrap\">200000002315<a name=\"100000155688-200000002315\"> </a></td><td>Referral under Article 29(4) Dir. 2001/83/EC</td></tr><tr><td style=\"white-space:nowrap\">200000002316<a name=\"100000155688-200000002316\"> </a></td><td>Referral under Article 29(1) Dir. 2001/83/EC</td></tr><tr><td style=\"white-space:nowrap\">200000002317<a name=\"100000155688-200000002317\"> </a></td><td>Referral under Article 13 Commission Reg (EC) 1234/2008</td></tr><tr><td style=\"white-space:nowrap\">200000002318<a name=\"100000155688-200000002318\"> </a></td><td>Referral under Article 29 paediatric Reg (EC) 1901/2006</td></tr><tr><td style=\"white-space:nowrap\">200000002319<a name=\"100000155688-200000002319\"> </a></td><td>Referral under Article 30 Dir. 2001/83/EC</td></tr><tr><td style=\"white-space:nowrap\">200000002320<a name=\"100000155688-200000002320\"> </a></td><td>Referral under Article 31 Dir. 2001/83/EC</td></tr><tr><td style=\"white-space:nowrap\">200000002321<a name=\"100000155688-200000002321\"> </a></td><td>Referral under Article 35 Dir. 2001/83/EC</td></tr><tr><td style=\"white-space:nowrap\">200000002322<a name=\"100000155688-200000002322\"> </a></td><td>Referral under Article 5(3) Reg (EC) 726/2004</td></tr><tr><td style=\"white-space:nowrap\">200000002323<a name=\"100000155688-200000002323\"> </a></td><td>Repeat Use Procedure</td></tr><tr><td style=\"white-space:nowrap\">200000002324<a name=\"100000155688-200000002324\"> </a></td><td>Signal detection</td></tr><tr><td style=\"white-space:nowrap\">200000002325<a name=\"100000155688-200000002325\"> </a></td><td>no regulatory activity</td></tr><tr><td style=\"white-space:nowrap\">200000003166<a name=\"100000155688-200000003166\"> </a></td><td>Paediatric investigational plan partial deferral</td></tr><tr><td style=\"white-space:nowrap\">200000010406<a name=\"100000155688-200000010406\"> </a></td><td>Sunset Clause</td></tr><tr><td style=\"white-space:nowrap\">200000010407<a name=\"100000155688-200000010407\"> </a></td><td>Parallel Import</td></tr><tr><td style=\"white-space:nowrap\">200000018451<a name=\"100000155688-200000018451\"> </a></td><td>Variation not requiring assessment</td></tr><tr><td style=\"white-space:nowrap\">200000018452<a name=\"100000155688-200000018452\"> </a></td><td>Variation requiring assessment (reduced timetable)</td></tr><tr><td style=\"white-space:nowrap\">200000018453<a name=\"100000155688-200000018453\"> </a></td><td>Variation requiring assessment (standard timetable)</td></tr><tr><td style=\"white-space:nowrap\">200000018454<a name=\"100000155688-200000018454\"> </a></td><td>Variation requiring assessment (extended timetable)</td></tr><tr><td style=\"white-space:nowrap\">200000025603<a name=\"100000155688-200000025603\"> </a></td><td>Registration Application</td></tr><tr><td style=\"white-space:nowrap\">200000025605<a name=\"100000155688-200000025605\"> </a></td><td>Parallel Trade</td></tr><tr><td style=\"white-space:nowrap\">200000026016<a name=\"100000155688-200000026016\"> </a></td><td>Variation Type II Art. 29</td></tr><tr><td style=\"white-space:nowrap\">200000026017<a name=\"100000155688-200000026017\"> </a></td><td>Variation Type IB unforeseen</td></tr><tr><td style=\"white-space:nowrap\">220000000041<a name=\"100000155688-220000000041\"> </a></td><td>Article 45 Referral</td></tr><tr><td style=\"white-space:nowrap\">220000000042<a name=\"100000155688-220000000042\"> </a></td><td>Old Article 18</td></tr><tr><td style=\"white-space:nowrap\">220000000044<a name=\"100000155688-220000000044\"> </a></td><td>Workshare</td></tr><tr><td style=\"white-space:nowrap\">220000000045<a name=\"100000155688-220000000045\"> </a></td><td>Grouped Variation</td></tr><tr><td style=\"white-space:nowrap\">220000000046<a name=\"100000155688-220000000046\"> </a></td><td>IG Variation</td></tr><tr><td style=\"white-space:nowrap\">220000000047<a name=\"100000155688-220000000047\"> </a></td><td>Old Type I Variation</td></tr><tr><td style=\"white-space:nowrap\">220000000048<a name=\"100000155688-220000000048\"> </a></td><td>Switch Conditional to Full</td></tr><tr><td style=\"white-space:nowrap\">220000000049<a name=\"100000155688-220000000049\"> </a></td><td>Old Article 22</td></tr><tr><td style=\"white-space:nowrap\">220000000050<a name=\"100000155688-220000000050\"> </a></td><td>Flu Strain Update</td></tr><tr><td style=\"white-space:nowrap\">220000000051<a name=\"100000155688-220000000051\"> </a></td><td>Pandemic Update</td></tr><tr><td style=\"white-space:nowrap\">220000000052<a name=\"100000155688-220000000052\"> </a></td><td>Old Notification</td></tr><tr><td style=\"white-space:nowrap\">220000000053<a name=\"100000155688-220000000053\"> </a></td><td>Old Type I Following Type II</td></tr><tr><td style=\"white-space:nowrap\">220000000054<a name=\"100000155688-220000000054\"> </a></td><td>Old 2PMF</td></tr><tr><td style=\"white-space:nowrap\">220000000076<a name=\"100000155688-220000000076\"> </a></td><td>Orphan Designation Application</td></tr></table></div>"^^rdf:XMLLiteral ] ; # fhir:url [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000155688"^^xsd:anyURI] ; # fhir:version [ fhir:v "1.0.0"] ; # fhir:name [ fhir:v "ApplicationSubmissionTypeCs"] ; # fhir:title [ fhir:v "Application Submission Type"] ; # fhir:status [ fhir:v "active"] ; # fhir:experimental [ fhir:v false] ; # fhir:date [ fhir:v "2025-04-04T16:15:09+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 "Application Submission Type"] ; # fhir:caseSensitive [ fhir:v true] ; # fhir:content [ fhir:v "complete"] ; # fhir:count [ fhir:v "86"^^xsd:nonNegativeInteger] ; # fhir:concept ( [ fhir:code [ fhir:v "100000155689" ] ; fhir:display [ fhir:v "Initial Marketing Authorisation Application" ] ] [ fhir:code [ fhir:v "100000155690" ] ; fhir:display [ fhir:v "Variation Type IA" ] ] [ fhir:code [ fhir:v "100000155691" ] ; fhir:display [ fhir:v "Variation Type IAIN" ] ] [ fhir:code [ fhir:v "100000155692" ] ; fhir:display [ fhir:v "Variation Type IB" ] ] [ fhir:code [ fhir:v "100000155693" ] ; fhir:display [ fhir:v "Variation Type II" ] ] [ fhir:code [ fhir:v "100000155694" ] ; fhir:display [ fhir:v "National Variation" ] ] [ fhir:code [ fhir:v "100000155695" ] ; fhir:display [ fhir:v "Line Extension" ] ] [ fhir:code [ fhir:v "100000155696" ] ; fhir:display [ fhir:v "Periodic Safety Update Report" ] ] [ fhir:code [ fhir:v "100000155697" ] ; fhir:display [ fhir:v "Renewal" ] ] [ fhir:code [ fhir:v "100000155698" ] ; fhir:display [ fhir:v "Follow-up Measure" ] ] [ fhir:code [ fhir:v "100000155699" ] ; fhir:display [ fhir:v "Specific Obligation" ] ] [ fhir:code [ fhir:v "100000155700" ] ; fhir:display [ fhir:v "Active Substance Master File" ] ] [ fhir:code [ fhir:v "100000155701" ] ; fhir:display [ fhir:v "Plasma Master File" ] ] [ fhir:code [ fhir:v "100000155702" ] ; fhir:display [ fhir:v "Referral acc. Article 29, 30, 31, 35 or 107i" ] ] [ fhir:code [ fhir:v "100000155703" ] ; fhir:display [ fhir:v "Annual Reassessment" ] ] [ fhir:code [ fhir:v "100000155704" ] ; fhir:display [ fhir:v "Urgent Safety Restriction" ] ] [ fhir:code [ fhir:v "100000155705" ] ; fhir:display [ fhir:v "Paediatric Submission acc. Article 29" ] ] [ fhir:code [ fhir:v "100000155706" ] ; fhir:display [ fhir:v "Paediatric Submission acc. Article 46" ] ] [ fhir:code [ fhir:v "100000155707" ] ; fhir:display [ fhir:v "WHO Cooperation acc. Article 58" ] ] [ fhir:code [ fhir:v "100000155708" ] ; fhir:display [ fhir:v "Notification acc. Article 61(3)" ] ] [ fhir:code [ fhir:v "100000155709" ] ; fhir:display [ fhir:v "Transfer of a marketing authorisation" ] ] [ fhir:code [ fhir:v "100000155710" ] ; fhir:display [ fhir:v "Lifting of a Suspension" ] ] [ fhir:code [ fhir:v "100000155711" ] ; fhir:display [ fhir:v "Withdrawal" ] ] [ fhir:code [ fhir:v "100000155713" ] ; fhir:display [ fhir:v "Risk Management Plan" ] ] [ fhir:code [ fhir:v "100000155714" ] ; fhir:display [ fhir:v "Correction to the Published Annexes" ] ] [ fhir:code [ fhir:v "100000155718" ] ; fhir:display [ fhir:v "Periodic Safety Update Single Assessment" ] ] [ fhir:code [ fhir:v "200000002290" ] ; fhir:display [ fhir:v "Certificate of suitability application to EDQM" ] ] [ fhir:code [ fhir:v "200000002291" ] ; fhir:display [ fhir:v "Clinical data for publication – Final Version" ] ] [ fhir:code [ fhir:v "200000002292" ] ; fhir:display [ fhir:v "Clinical data for publication – Redacted Proposal" ] ] [ fhir:code [ fhir:v "200000002293" ] ; fhir:display [ fhir:v "Paediatric investigational plan according to article 7, 8 or 30 of the Reg (EC) 1901/2006" ] ] [ fhir:code [ fhir:v "200000002294" ] ; fhir:display [ fhir:v "Paediatric investigational plan compliance check" ] ] [ fhir:code [ fhir:v "200000002295" ] ; fhir:display [ fhir:v "Paediatric investigational plan deferral" ] ] [ fhir:code [ fhir:v "200000002296" ] ; fhir:display [ fhir:v "Paediatric investigational plan submission (Module 1.10)" ] ] [ fhir:code [ fhir:v "200000002297" ] ; fhir:display [ fhir:v "Paediatric investigational plan partial waiver" ] ] [ fhir:code [ fhir:v "200000002298" ] ; fhir:display [ fhir:v "Paediatric investigational plan waiver" ] ] [ fhir:code [ fhir:v "200000002299" ] ; fhir:display [ fhir:v "Annex II condition related to a post-authorisation measure" ] ] [ fhir:code [ fhir:v "200000002300" ] ; fhir:display [ fhir:v "Corrective Action/Preventive Action related to a post-authorisation measure" ] ] [ fhir:code [ fhir:v "200000002301" ] ; fhir:display [ fhir:v "Legally binding measure related to a post-authorisation measure" ] ] [ fhir:code [ fhir:v "200000002302" ] ; fhir:display [ fhir:v "Additional pharmacovigilance activity in the risk-management plan" ] ] [ fhir:code [ fhir:v "200000002303" ] ; fhir:display [ fhir:v "Submission of a post-authorisation efficacy study" ] ] [ fhir:code [ fhir:v "200000002305" ] ; fhir:display [ fhir:v "Recommendation related to a post-authorisation measure" ] ] [ fhir:code [ fhir:v "200000002306" ] ; fhir:display [ fhir:v "Cumulative review following a request related to a post-authorisation measure" ] ] [ fhir:code [ fhir:v "200000002307" ] ; fhir:display [ fhir:v "Specific obligation related to a post-authorisation measure" ] ] [ fhir:code [ fhir:v "200000002308" ] ; fhir:display [ fhir:v "Submission of a post-authorisation safety study protocol (according article 107n Dir. 2001/83/EC)." ] ] [ fhir:code [ fhir:v "200000002309" ] ; fhir:display [ fhir:v "Submission of a post-authorisation safety study report (according article 107o Dir. 2001/83/EC)" ] ] [ fhir:code [ fhir:v "200000002310" ] ; fhir:display [ fhir:v "Submission of a post-authorisation safety study report (according to article 107q Dir. 2001/83/EC)." ] ] [ fhir:code [ fhir:v "200000002311" ] ; fhir:display [ fhir:v "Referral under Article 107i Dir. 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000002312" ] ; fhir:display [ fhir:v "Referral under Article 16c (1c) Dir. 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000002313" ] ; fhir:display [ fhir:v "Referral under Article 16c(4) Dir. 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000002314" ] ; fhir:display [ fhir:v "Referral under Article 20 Reg (EC) 726/2004" ] ] [ fhir:code [ fhir:v "200000002315" ] ; fhir:display [ fhir:v "Referral under Article 29(4) Dir. 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000002316" ] ; fhir:display [ fhir:v "Referral under Article 29(1) Dir. 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000002317" ] ; fhir:display [ fhir:v "Referral under Article 13 Commission Reg (EC) 1234/2008" ] ] [ fhir:code [ fhir:v "200000002318" ] ; fhir:display [ fhir:v "Referral under Article 29 paediatric Reg (EC) 1901/2006" ] ] [ fhir:code [ fhir:v "200000002319" ] ; fhir:display [ fhir:v "Referral under Article 30 Dir. 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000002320" ] ; fhir:display [ fhir:v "Referral under Article 31 Dir. 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000002321" ] ; fhir:display [ fhir:v "Referral under Article 35 Dir. 2001/83/EC" ] ] [ fhir:code [ fhir:v "200000002322" ] ; fhir:display [ fhir:v "Referral under Article 5(3) Reg (EC) 726/2004" ] ] [ fhir:code [ fhir:v "200000002323" ] ; fhir:display [ fhir:v "Repeat Use Procedure" ] ] [ fhir:code [ fhir:v "200000002324" ] ; fhir:display [ fhir:v "Signal detection" ] ] [ fhir:code [ fhir:v "200000002325" ] ; fhir:display [ fhir:v "no regulatory activity" ] ] [ fhir:code [ fhir:v "200000003166" ] ; fhir:display [ fhir:v "Paediatric investigational plan partial deferral" ] ] [ fhir:code [ fhir:v "200000010406" ] ; fhir:display [ fhir:v "Sunset Clause" ] ] [ fhir:code [ fhir:v "200000010407" ] ; fhir:display [ fhir:v "Parallel Import" ] ] [ fhir:code [ fhir:v "200000018451" ] ; fhir:display [ fhir:v "Variation not requiring assessment" ] ] [ fhir:code [ fhir:v "200000018452" ] ; fhir:display [ fhir:v "Variation requiring assessment (reduced timetable)" ] ] [ fhir:code [ fhir:v "200000018453" ] ; fhir:display [ fhir:v "Variation requiring assessment (standard timetable)" ] ] [ fhir:code [ fhir:v "200000018454" ] ; fhir:display [ fhir:v "Variation requiring assessment (extended timetable)" ] ] [ fhir:code [ fhir:v "200000025603" ] ; fhir:display [ fhir:v "Registration Application" ] ] [ fhir:code [ fhir:v "200000025605" ] ; fhir:display [ fhir:v "Parallel Trade" ] ] [ fhir:code [ fhir:v "200000026016" ] ; fhir:display [ fhir:v "Variation Type II Art. 29" ] ] [ fhir:code [ fhir:v "200000026017" ] ; fhir:display [ fhir:v "Variation Type IB unforeseen" ] ] [ fhir:code [ fhir:v "220000000041" ] ; fhir:display [ fhir:v "Article 45 Referral" ] ] [ fhir:code [ fhir:v "220000000042" ] ; fhir:display [ fhir:v "Old Article 18" ] ] [ fhir:code [ fhir:v "220000000044" ] ; fhir:display [ fhir:v "Workshare" ] ] [ fhir:code [ fhir:v "220000000045" ] ; fhir:display [ fhir:v "Grouped Variation" ] ] [ fhir:code [ fhir:v "220000000046" ] ; fhir:display [ fhir:v "IG Variation" ] ] [ fhir:code [ fhir:v "220000000047" ] ; fhir:display [ fhir:v "Old Type I Variation" ] ] [ fhir:code [ fhir:v "220000000048" ] ; fhir:display [ fhir:v "Switch Conditional to Full" ] ] [ fhir:code [ fhir:v "220000000049" ] ; fhir:display [ fhir:v "Old Article 22" ] ] [ fhir:code [ fhir:v "220000000050" ] ; fhir:display [ fhir:v "Flu Strain Update" ] ] [ fhir:code [ fhir:v "220000000051" ] ; fhir:display [ fhir:v "Pandemic Update" ] ] [ fhir:code [ fhir:v "220000000052" ] ; fhir:display [ fhir:v "Old Notification" ] ] [ fhir:code [ fhir:v "220000000053" ] ; fhir:display [ fhir:v "Old Type I Following Type II" ] ] [ fhir:code [ fhir:v "220000000054" ] ; fhir:display [ fhir:v "Old 2PMF" ] ] [ fhir:code [ fhir:v "220000000076" ] ; fhir:display [ fhir:v "Orphan Designation Application" ] ] ) . #
IG © 2025 EMA. Package emavar#1.0.0 based on FHIR 5.0.0. Generated 2025-04-04
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