Response to Regulatory Questions (RTQ)
0.1.0 - ci-build
Response to Regulatory Questions (RTQ), published by HL7 International. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/rtq-ig/ and changes regularly. See the Directory of published versions
| Active as of 2025-11-11 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="contact-purpose"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem contact-purpose</b></p><a name="contact-purpose"> </a><a name="hccontact-purpose"> </a><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/brr/CodeSystem/contact-purpose</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style="white-space:nowrap">SENDER<a name="contact-purpose-SENDER"> </a></td><td>Sender (Health Authority)</td><td>The contact represents the health authority issuing the regulatory questions (e.g., EMA, FDA).</td></tr><tr><td style="white-space:nowrap">RECIPIENT<a name="contact-purpose-RECIPIENT"> </a></td><td>Recipient (Marketing Authorization Holder)</td><td>The contact represents the sponsor or MAH responsible for responding to the questions.</td></tr><tr><td style="white-space:nowrap">CC<a name="contact-purpose-CC"> </a></td><td>Carbon Copy</td><td>The contact is copied on the correspondence for information purposes (optional).</td></tr><tr><td style="white-space:nowrap">REVIEWER<a name="contact-purpose-REVIEWER"> </a></td><td>Internal Reviewer</td><td>An internal stakeholder (e.g., project lead, legal) involved in review but not primary sender/recipient.</td></tr></table></div>
</text>
<url value="http://hl7.org/fhir/uv/brr/CodeSystem/contact-purpose"/>
<version value="0.1.0"/>
<name value="ContactPurpose"/>
<title value="Contact Purpose Code System"/>
<status value="active"/>
<date value="2025-11-11"/>
<publisher value="HL7 International"/>
<contact>
<name value="HL7 International"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org"/>
</telecom>
</contact>
<description
value="Defines the role of a contact in regulatory correspondence. Used to distinguish the sender (health authority) and recipient (marketing authorization holder) in structured Q&A."/>
<caseSensitive value="true"/>
<content value="complete"/>
<concept>
<code value="SENDER"/>
<display value="Sender (Health Authority)"/>
<definition
value="The contact represents the health authority issuing the regulatory questions (e.g., EMA, FDA)."/>
</concept>
<concept>
<code value="RECIPIENT"/>
<display value="Recipient (Marketing Authorization Holder)"/>
<definition
value="The contact represents the sponsor or MAH responsible for responding to the questions."/>
</concept>
<concept>
<code value="CC"/>
<display value="Carbon Copy"/>
<definition
value="The contact is copied on the correspondence for information purposes (optional)."/>
</concept>
<concept>
<code value="REVIEWER"/>
<display value="Internal Reviewer"/>
<definition
value="An internal stakeholder (e.g., project lead, legal) involved in review but not primary sender/recipient."/>
</concept>
</CodeSystem>