XPATH: Attribute codeSystem = OID for regulatory status value set XML Snippet Regulatory Authorization or Marketing Status SPL – Currently, this is not available in the message. Regulatory Authorization or Marketing Status ICSR – Currently, this is not available in the message. Regulatory Authorization or Marketing Status FHIR – Currently, this is not available in the message. Regulatory Authorization or Marketing Status N87 – Currently, this is not available in the message. Implementation Considerations The following conditions should be considered when incorporating the data exchange guidelines into the implementation guides: This requirement may need to be further developed in the standards.
XPATH: Attribute codeSystem = OID for regulatory status value set XML Snippet Regulatory Authorization or Marketing Status – SPL Currently, this is not available in the message. Regulatory Authorization or Marketing Status – ICSR Currently, this is not available in the message. Regulatory Authorization or Marketing Status – FHIR Currently, this is not available in the message. Regulatory Authorization or Marketing Status – N87 Currently, this is not available in the message. Implementation Considerations The following conditions should be considered when incorporating the data exchange guidelines into the implementation guides: This requirement may need to be further developed in the standards.
imdrf-proc-170316-data-exchange-guidelines.docx