Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon 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 1.1.6 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

CodeSystem: Product Name Types Code Types

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types Version: 1.1.6
Draft as of 2024-09-22 Computable Name: CmcProductNameTypes
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.16.2

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)

This Code system is referenced in the content logical definition of the following value sets:

Generated Narrative: CodeSystem cmc-product-name-types

This case-sensitive code system http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types defines the following codes:

CodeDisplay
PROP Proprietary
NON Non-Proprietary