The European Medicines Verification System (EMVS) requires On-Boarding Partners (OBPs) to upload both product master data and product pack data (collectively referred to as "EMVS master data") to the EU Hub. This article provides guidance on the procedures and data requirements for these uploads, ensuring compliance with regulatory standards.
Product Master Data
Common Elements
The product master data includes a set of common elements applicable to all markets. These elements are essential for identifying the product and include:
Product Code: The unique logistics code on the pack, which can be a 14-digit GTIN, NTIN, or a 12-digit PPN.
Coding Scheme: Identifies the coding system used, either GTIN or PPN.
Name: The product's (invented) name, including its strength and pharmaceutical form.
Common Name: The product's non-invented name (Mandatory as of EU HUB 1.16).
Pharmaceutical Form: The form in which the product is administered.
Strength: The product's potency or concentration.
Pack Type and Size: Describes the type and size of the packaging, including the dose count.
List of ATC Codes: These codes apply to all markets and should be consistent across submissions (Not mandatory).
These data elements are mandatory for every product uploaded to the EU Hub. Failure to include any of these elements will result in an A16 error, causing the upload to be rejected.
Market-Specific Elements
In addition to the common data, each market requires specific details:
Member State ISO ID: The ISO code for the relevant market.
National Code: The national identification code.
MAH (Marketing Authorization Holder) Details: Includes the MAH's ID, name, and address (Manufacturer Address and MAH Address mandatory as of EU HUB 1.16).
List of Wholesalers: Details about the designated wholesalers, including ID, name, and address (Wholesaler Address mandatory as of EU HUB 1.16).
For multi-market products, OBPs must submit a separate set of market-specific data for each market where the product is sold.
Batch and Pack Data
Batch and pack data are uploaded more frequently than master data and consist of two primary groups:
Batch Data:
Batch Number: As printed on the serialized pack.
Expiry Date: Represented in the format YYMMDD.
Manufacturer Details: Includes ID, name, and address of the manufacturer placing the safety features.
Pack Data:
Serial Number: The unique identifier for each pack.
Serial Number Status: The status of the serial number (e.g., active, inactive).
These elements are critical for tracking and verifying the authenticity of each product unit. OBPs must ensure that all mandatory fields are filled out correctly, as incomplete submissions will also lead to errors(EMVS Master Data Guide_…).
Upload Procedure
OBPs must follow specific procedures to upload data:
Single Market Products: Upload one set of data for each of the common and market-specific elements.
Multi-Market Products: Submit one set of common data and multiple sets of market-specific data, one for each market.
If a new market is added to an existing Product Master Data (PMD), a new PMD version must be created.
Conclusion
Ensuring the accurate and timely upload of both product master data and batch data to the EU Hub is crucial for compliance with the EMVS. OBPs must adhere to the outlined data requirements and procedures to avoid errors and ensure the smooth operation of their products within the European market. For detailed guidance, OBPs should consult the full EMVS Master Data Guide and related regulatory documents.