This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Organizations

Details about each facility or legal entity involved in the manufacture of the medicinal product. This includes but is not limited to: name, identifier, and location address, for marketing authorization holders, sponsors, regulatory authorities, manufacturers, supplier, test site, packaging site.

Resources

Examples

eCTD section synthetic source data samples (PDF):

• 3.2.P.3 Manufacture
  • 3.2.P.3.1 Manufacturer(s)
• 3.2.S.2 Manufacture
  • 3.2.S.2.1 Manufacturer(s)

XML and JSON examples of synthetic CTD data:

• Organization example XML
• Organization example JSON

HTML presentation example of synthetic CTD data:

• Drug Substance or Product Organizations

Profiles

See Artifacts Index: Organizations