European Union (EU) Compliance Reporting
The European Medicines Verification System (EMVS) introduced a change in the contents of Commission Product Pack and Product Master Data reports. These changes are not backwards compatible. The original version of the reports (called "Legacy" reports within this documentation) are no longer accepted as of 24 Jul 2017. Any reports that generate after 24 Jul 2017 must comply with the new report content specification. Customers who implemented EU Compliance and were submitting reports prior to this date will have the legacy version and the new version of reports in the TraceLink Network. The "View Report Details" screens will display the appropriate content based on whether report is a legacy or new report.
EU Compliance Reporting Overview
How to Navigate to the Landing Page
- Select Compliance > European Union from the Modules menu.
or
- Select Compliance - European Union from the Modules menu.
What is TraceLink's EU Compliance Application?
The TraceLink EU Compliance application (app) helps Marketing Authorization Holders (MAHs) and Parallel Importers comply with the European Union government's serialization and reporting requirements.
Why Use EU Compliance?
- Search and view various EU Compliance reports.
- Search and view product alerts sent from the EU Hub.
- Verify serial numbers with the EU Hub.
- Request specific product information from the EU Hub.
What are the EU's Serialization Requirements?
The European Medicines Verification System (EMVS) introduced the Falsified Medicines Directive (FMD), which outlines serialization requirements for most EU countries. The law in its current state places compliance responsibility on MAHs, Dispensers, and Parallel Importers. The law addresses:
- Serialization
- Reporting
- Product Verification
Getting Started
Configuring Permissions/Access
Have a user with administrator access configure workflows for generating reports. See Configure Event Workflows for configuration details.
Go To Picker
- A picker navigates between the Search Compliance Reports and Search Information Requests screens.
- This drop-down is always in the top-right corner of the high-level screens.
- Select the previous screen name in the breadcrumb at the top of the screen if the drop-down is not visible.
Available Operations
Compliance Reports
- Search Compliance Reports - View/search EU Hub compliance reports. Change the reports displayed by altering any of the available search criteria.
- Active - Update Product Pack State - View information about products that have been previously reported as exported, supplied, free sample, sample, or locked and are now active.
- Batch Recall - View information about batch recalls submitted by the Owner's company.
- Checked Out - Update Product Pack State - View information about products that are decommissioned due to a repackage event.
- Update Product Pack Data - View information about lot numbers or expiration dates that have been modified and reported to the EU Hub.
- Destruction - Update Product Pack State - View information about products that have been previously reported to the EU Hub and are now decommissioned or destroyed.
- Export - Update Product Pack State - View information about products that have been previously reported to the EU Hub and are now shipped to a country outside of an EU FMD country.
- Free Sample - Update Product Pack State - View information about products that are shipped as a free sample.
- Locked - Update Product Pack State - View information about products that have been reported as locked for investigation.
- Master Data Report - View product, Target Market, and response information associated with the specific Master Data Report submitted to the EU Hub.
- Sample - Update Product Pack State - View information about products that are sampled by government authorities.
- Serial Number Verification - View requested verification information about salable returned products (e.g. returned products that do not need to be destroyed).
- Stolen - Update Product Pack State - View information about products that have been stolen.
- Supplied - Update Product Pack State - View information about products that are shipped with an Article 23 supply type.
Information Requests
Serial Number Verification
