The 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 (14-digit GTIN, NTIN, or 12-digit PPN).
Coding Scheme: Identifies the coding system used (GTIN or PPN).
Name: The product's (invented) name, including strength and pharmaceutical form.
Common Name: The non-invented name (mandatory as of EU Hub 1.16).
Pharmaceutical Form: The form in which the product is administered.
Strength: The potency or concentration.
Pack Type and Size: Type and size of packaging, including dose count.
List of ATC Codes: Consistent across submissions (not mandatory).
➡️ These elements are mandatory for every product uploaded to the EU Hub. Missing elements will trigger an A16 error, and the upload will be rejected.
Market-Specific Elements
Each market requires specific details in addition to the common elements:
Member State ISO ID: ISO code of the relevant market.
National Code: The national identification code.
MAH (Marketing Authorization Holder) Details: ID, name, and address (MAH and Manufacturer Address mandatory as of EU Hub 1.16).
List of Wholesalers: 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 intended market at the time of the initial upload.
⚠️ Important: The EU Hub no longer allows retrospective market additions. If a product will be placed in multiple markets, all markets must be included from the start.
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: Format YYMMDD.
Manufacturer Details: ID, name, and address of the manufacturer placing the safety features.
Pack Data:
Serial Number: Unique identifier for each pack.
Serial Number Status: Status of the serial number (e.g., active, inactive).
➡️ These elements are critical for tracking and verifying authenticity. Incomplete or incorrect submissions will be rejected.
Upload Procedure
OBPs must follow these procedures when uploading data:
Single-Market Products: Upload one set of common and market-specific data.
Multi-Market Products: Upload one set of common data and multiple sets of market-specific data — one for each market.
Adding a new market: A new Product Master Data (PMD) version must be created. Retrospective uploads are not permitted.
Conclusion
Accurate and timely uploads of both product master data and batch data are essential for compliance with the EMVS. OBPs must plan all intended markets before the first upload, as retrospective market additions are no longer supported by the EU Hub.
For full technical details, OBPs should consult the EMVS Master Data Guide and related regulatory documents.