Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
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Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions

Example MedicinalProductDefinition: A DrugProductDescription for a multilayer product

Generated Narrative: MedicinalProductDefinition

Resource MedicinalProductDefinition "5772a6f2-cde1-4903-bfcf-1639340205cc"

Profile: Drug Product Description

description: A tablet consisting of two layers where one provides immediate release and of the two drugs (Figure in 3.2.P.1.3). Both immediate-release layers are composed of granules with a matrix layer for the modified release of the drug.

combinedPharmaceuticalDoseForm: TABLET, MULTILAYER (Dummy NCIT Codesystem#C42964)

route: ORAL (Dummy NCIT Codesystem#C38288)

name

productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg

type: Non-Proprietary (Product Name Types Code Types#NON)

part

part: ASPIRIN

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 200mg

type: strength name (EntityNamePartQualifierR2#STR)

part

part: ACETAMINOPHEN

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 300mg

type: strength name (EntityNamePartQualifierR2#STR)