SPL Mapping FHIR R5 Implementation Guide
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SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

Submit a Drug Label

Page standards status: Informative

Drug Label Use Cases

This page details the following use cases that all use profiles based on the Medicinal Product Definition resources:

  1. UC04 - Submit a Drug or Biologic Label
    • 53409-9 Bulk Ingredient
    • 60684-8 Cellular Therapy
    • 78744-0 Drug for Further Processing
    • 75031-5 Human Compounded Drug Label
    • 34390-5 Human OTC Drug Label
    • 34391-3 Human Prescription Drug Label
    • 53408-1 Licensed Minimally Manipulated Cells Label
    • 53406-5 Licensed Vaccine Bulk Intermediate Label
    • 53405-7 Non-Standardized Allergenic Label
    • 60683-0 Plasma Derivative
    • 60682-2 Standardized Allergenic
    • 53404-0 Vaccine Label
    • 86445-4 Blanket No Changes Certification of Product Listing

Here is a high level diagram that shows the generic use of the profiles for these use cases:

Product Submission High Level Profiles diagram
Figure 3.1 - Product Submission High Level Profiles

Here is a detailed diagram that shows the profiles used for drug label submission:

Product Submission Profiles diagram, Part 1
Figure 3.2 - Product Submission Profiles - Part 1
Product Submission Profiles diagram, Part 2
Figure 3.3 - Product Submission Profiles - Part 2