API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
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
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
These define constraints on FHIR resources for systems conforming to this implementation guide.
| APIX Endpoint for FHIR Subscription Notifications |
Endpoint requiring identifier, name, and connectionType of hl7-fhir-subscription-notify. |
| APIX Organization |
Organization profile for APIX regulatory workflows, derived from and compatible with ePI requirements. |
| APIX Regulatory DocumentReference |
DocumentReference profile used in APIX regulatory submissions. Supports both embedded base64 data and referenced binaries via URL (Index Pattern). Includes support for versioning, lifecycle status, and CTD section categorization. |
| APIX Regulatory Task |
Task profile for APIX regulatory submission workflows |
| APIX Task Assignment and Creation With Organization Filter |
SubscriptionTopic notifying an organization when a Task is created and assigned to them. |
| APIX Task Status Change With Identifier Filter |
Triggers when a Task.status value changes and allows filtering by Task.identifier. |
These define sets of codes used by systems conforming to this implementation guide.
| APIX CTD/eCTD Module Value Set |
Value set for CTD module codes used in APIX regulatory submissions |
| APIX CTD/eCTD Section Code System |
Value set for CTD section codes used in APIX regulatory submissions |
| APIX Regulatory Business Status |
Value set for regulatory business status in APIX submissions |
| APIX Submission Types |
Value set for submission types in APIX regulatory procedures |
| APIX Task Codes ValueSet |
Value set for task codes in APIX regulatory submissions |
| APIX Task Input Types |
Value set for task input types in APIX regulatory submissions |
These define new code systems used by systems conforming to this implementation guide.
| APIX CTD/eCTD Section Code System |
Code system defining all relevant CTD/eCTD section codes used in APIX regulatory submissions to EMA, FDA, PMDA and other agencies. Based on ICH M4 guidelines. |
| APIX Regulatory Business Status |
Code system for regulatory business status in APIX submissions |
| APIX Task Code System |
Code system for regulatory task types in APIX submissions |
| APIX Task Input Types Code System |
Code system for task input types in APIX regulatory submissions |
| APIX Task Output Types Code System |
Code system for task output types in APIX regulatory submissions |
These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.
| Example APIX interaction Endpoint with header |
Example APIX interaction Endpoint with header information; payload is very loosely defined, sufficient where payload considerations are handled internally and not exposed. Note identifier. n |
| Example Medicinal Product Definintion |
Example MedicinalProductDefinition |
| Example basic APIX interaction Endpoint |
Example basic APIX interaction Endpoint, payload is very loosely defined; payload considerations are handled internally and not exposed. Note identifier. |
| Invoice for Regulatiry Submission Review |
Example DocumentReference Invoice |
| Organization European Medicines Agency – Human Medicines Evaluation Division |
Example Organization European Medicines Agency – Human Medicines Evaluation Division |
| Organization SynthPharma AG |
Example Organization SynthPharma AG |
| Organization example with Endpoint |
Organization example with Endpoint. |
| Subscription for Task Status Change with Identifier Filter |
Subscription example to Task change status with an identifier filter, and sending full-resource. |
| SubscriptionNotification Task ID Only |
SubscriptionNotification Bundle example Task id only. |
| Task Assignment and Creation With Organization Filter |
SubscriptionTopic for a health authority to notify an organization when that organization has been assigned a new Task. |
| Task Status Change With Identifier Filter |
Triggers when a Task.status value changes. Allows subscriptions to filter by Task.identifier. |
| doc1 |
Example DocumentReference Cover Letter |
| doc10 |
Example DocumentReference |
| doc2 |
Example DocumentReference Application Form |
| doc3 |
Example DocumentReference Annotated Label |
| doc4 |
Example DocumentReference Clean Label |
| doc5 |
Example DocumentReference Pack Mockup |
| doc6 |
Example DocumentReference Stability Summary |
| doc7 |
Example DocumentReference Stability Data |
| doc8 |
Example DocumentReference Stability Commitment |
| doc9 |
Example DocumentReference |
| docref approval letter |
Example DocumentReference Cover Letter |
| docref assessment report |
Example DocumentReference Cover Letter |
| docref list of questions |
Example DocumentReference Cover Letter |
| docref payment proof |
Example DocumentReference Proof of Payment |
| docref responses qresponse |
Example DocumentReference Cover Letter / Response |
| docref stability data annex |
Example DocumentReference Stability Data |
| output ack |
Example DocumentReference Acknowledgement of Receipt |
| output validation |
Example DocumentReference Validation Report |
| scenario1 01 initial submission |
Example Task Type IB Variation |
| scenario1 02 validation |
Example Task Type IB Variation |
| scenario1 04 finance payment |
Example Task Request Payment |
| scenario1 05 technical question |
Example Task Information Request |
| scenario1 06 technical response |
Example Task Response to Information Request |
| scenario1 07 final decision |
Example Task Approval Letter / Positive Decision |