Questions about the verification of serial numbers and data storage

FAQs - Questions about the verification of serial numbers and data storage

The data contained in the individual platforms belong to the user who generates this data during his activity in the verification system.

The data generated by the issuing office (doctor's office, hospital or pharmacy) (e.g. the scanned GTIN, serial number) are used exclusively for the de-activation of the delivered package in the local system or in the EU hub. No personal data will be stored. Data owners can use the data for their purposes (e.g., for warehouse management).

The system is operated in accordance with these requirements and compliance with these requirements is ensured by means of appropriate safety precautions, a quality management system, as well as by appropriate controls by the national authorities and the EMVO.

First of all, the manufacturer loads the product data into the EU system (check-in).

The EU regulations clearly define when a product is to be deactivated (check-out). This happens at the end of the supply chain, when a drug is delivered to the patient. Then the product is checked for its authenticity by the service provider (pharmacy, hospital, doctor's office, etc.)  and the product will be deactivated in the database system.

The end-to-end verification process is supplemented by "risk-based verifications" e.g. at wholesalers. A risk-based verification can be performed in the case that a wholesaler has not received the product from the original manufacturer or from a pre-wholesaler. For example, when he receives the goods from another wholesaler, or as a return from a pharmacy.

If the product is affected by a callback, the code is deactivated and marked as «recalled».

One year after the expiry date, the code is automatically deactivated.

The following data is stored:

Basic data:

  • The master data (product code, form, dosage, target market), the MAHs, lot / batch number, expire date and serial number of the products are stored in the EMVS (EU hub).
  • In the National System (SMVS), registered user data of the service providers are registered for the check-out process.

Transactionional data:

  • The EU Hub is notified when a product has been disabled.
  • The national system stores when a product has been deactivated. Recognized counterfeits are also stored.

It is important that the data always belong to the one who created it and is not passed on, except for example. for official purposes in the event of a forged counterfeit. A third use of data is not possible.

No, the systems are verification systems for serialized drugs.

NTIN stands for National Trade Item Number. In Switzerland, NTINs (prefix 7680) are as unique as GTINs.Compared to a GTIN, the Swiss NTIN contains the 5-digit Swissmedic approval number. The difference to a GTIN is that its definition, lifecycle and allocation are determined by the refdata foundation.

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