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 team also specializes in MDLP registration in Russia.