Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot United States of America flag

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

: Product Name Types Code Types - JSON Representation

Active as of 2024-04-04

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{
  "resourceType" : "CodeSystem",
  "id" : "cmc-product-name-types",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This case-sensitive code system <code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types</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\">PROP<a name=\"cmc-product-name-types-PROP\"> </a></td><td>Proprietary</td></tr><tr><td style=\"white-space:nowrap\">NON<a name=\"cmc-product-name-types-NON\"> </a></td><td>Non-Proprietary</td></tr></table></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "brr"
    }
  ],
  "url" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types",
  "identifier" : [
    {
      "system" : "urn:ietf:rfc:3986",
      "value" : "urn:oid:2.16.840.1.113883.4.642.40.36.16.2"
    }
  ],
  "version" : "1.0.0-ballot",
  "name" : "CmcProductNameTypes",
  "title" : "Product Name Types Code Types",
  "status" : "active",
  "experimental" : false,
  "date" : "2024-04-04T12:53:15+00:00",
  "publisher" : "HL7 International / Biomedical Research and Regulation",
  "contact" : [
    {
      "name" : "HL7 International / Biomedical Research and Regulation",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/rcrim"
        },
        {
          "system" : "email",
          "value" : "brr@lists.HL7.org"
        }
      ]
    }
  ],
  "description" : "Indicates patent or trademark status. Codes temporarily defined as part of the PQ-CMC-FDA implementation guide.  These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "urn:iso:std:iso:3166",
          "code" : "US",
          "display" : "United States of America"
        }
      ]
    }
  ],
  "caseSensitive" : true,
  "content" : "complete",
  "count" : 2,
  "concept" : [
    {
      "code" : "PROP",
      "display" : "Proprietary"
    },
    {
      "code" : "NON",
      "display" : "Non-Proprietary"
    }
  ]
}