National verification system
SPECIFIED SAFETY FEATURES
The safety features consist of two elements placed on the packaging of a medicinal product:
1. UNIQUE IDENTIFIER
Unique identifier is an unique sequence carried by a two-dimensional barcode allowing the identification and authentication of the individual pack on which it is printed. Two-dimensional barcode allows large amounts of data in a relatively small area.
GTIN – Global Trade Item Number indicates sales unit;
The expiry date – 6 numbers (YYMMDD)
The Batch Number – up to 20 alpha-numeric characters
Unique Serial Number (randomized) – up to 20 alphanumeric characters
2. ANTI TEMPERING DEVICE
A device allowing the verification of whether the packaging of the medicinal product has been tampered with.
Serialization
Serialization is the allocation and identification of the unique number or identifier on the individual packaging unit of the same product, which enables tracking of the product throughout the entire supply chain.
EU HUB
Each national or supranational repository composing the repositories system shall exchange data with the hub using the data format and data exchange modalities defined by the hub.
Where notified by a national or supranational repository of the change of status of a unique identifier, the hub shall ensure the synchronization of that status between those national or supranational repositories serving the territory of the Member State or Member States where the medicinal product bearing the unique identifier was intended to be placed on the market.
Role of MVI
The national medicinal product verification organisation or the Medicines Verification Institute (MVI)
Each member country of the European Union must establish a National Medicines Verification System – NMVS. The system is established and operated by the competent National Medicines Verification Organization – NMVO.
The role of NMVO in Slovenia is performed by the Medicines Verification Institute – MVI.
The organisation is tasked with:
- establishment and maintenance of an information system for the verification of medicines;
- providing information and support for local IT system providers (pharmacy systems, wholesalers);
- exchanging data with a wider European network of archives and systems in the European Union central hub.