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)

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