API for the Exchange of Medicinal Product Information (APIX), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions

Workflow Overview

Page standards status: Informative

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The Three Phases

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Workflow Diagram

The following diagram shows the complete lifecycle of a regulatory procedure through APIX.

sequenceDiagram
    participant C as Company
    participant R as Regulator
    
    Note over C,R: Phase 1: Submission & Validation
    C->>R: Register & Authenticate
    C->>R: Upload Documents (Binary / Bundles)
    C->>R: Create DocumentReferences
    C->>R: POST Task (Submission)
    R->>R: Validate Package
    
    alt Validation Passes
        R-->>C: Task.status → accepted
    else Validation Fails
        R->>C: Request Missing Documents
        C->>R: Submit Missing Documents
    end
    
    Note over C,R: Phase 2: Review Cycles
    
    par Technical Review
        R->>R: Assess Submission
    and Financial Review
        R->>C: Payment Task
        C-->>R: Proof of Payment
    end
    
    loop Q&A (if needed)
        R->>C: Question Task
        C-->>R: Response in Task.output
    end
    
    Note over C,R: Phase 3: Decision
    
    alt Approved
        R-->>C: Task.status → completed + Decision Letter
    else Rejected
        R-->>C: Task.status → rejected + Rejection Reasons
    end

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Key Concepts

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Example: Shelf-Life Update