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Registration in the serialization process

Drug serialization has been introduced to increase patient safety through verification of pharmaceutical products. Verification of drug authenticity is controlled in each country by a National Medicines Verification Organization, NMVO.

There is also a pan-European organization in the European Union coordinating the work of all organizations in the Member States, EMVO (European Medicines Verification Organization), and serialization regulations are described in the EU FMD directive.

The sales of serialized medicines require registration of the company and its products in NMVO (for EU also EMVO) in each country in which sales are planned. Registration and EMVO requirements are the same for the entire EU market, while registration in national organizations or NMVOs differs in each country.

Each country has its own local regulations, often several institutions requiring registration and access to IT systems.

Non-EU markets have other regulations and registration requirements for drug serialization and verification.

Our services related to registration

We offer the entire serialization process support for selected markets around the world.

We offer several different types of registrations support, as well as continuous support with reporting and verification of already serialized products.

What exactly do we do?

  • Registration of companies and products in NMVO and EMVO
  • Getting access and configuring NMVS and EMVS systems
  • Preparation of systems for drug verification and reporting
  • Serialization consulting for all markets, where serialization is required

Other services:

IT system implementation

IT system implementation

We offer a range of services related to the implementation of information systems for drug serialization; starting from the system selection support, through implementation at all levels (L1-5), as well as integration with external systems.

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System administration

System administration

We manage the administration of serialization systems, user access, Master Data (MD), as well as reports and verification alerts.

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System validations and re-validations

System validations and re-validations

We carry out validation of systems for serialization, as well as continuous revalidation necessary during system changes or updates. All in accordance with GMP practice. We support customers with client and institutional audits.

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Customer Support/ Helpdesk

Customer Support/ Helpdesk

We offer customer support in the form of Tier 1 helpdesk. We agree on hours, languages and scope of support directly with customers. We also offer this service to customers for whom we have not implemented the serialization systems.

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Serialization management in drug supply chains

Serialization management in drug supply chains

We can communicate on behalf of our customers with their contractors, trade partners, national organizations. We support our customers not only with deep industry expertise, but also language skills.

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