Spain

Regulation name

EU Falsified Medicines Directive

Serialization status

Active

Country population

47.5 million people

NMVS provider (EU Only): SEVeM

Alert requirement: Yes - required

Aggregation requirement: Not mandatory

Track & Trace requirement: Not mandatory

Official governing body: The Spanish Agency of Medicines and Medical Devices (AEMPS)

Market coding requirements:

GTIN / NTIN (with Codingo National embedded)

Serial Number

Batch Number

Expiry Date

Codingo National (if GTIN is used)