Romania

Regulation name

EU Falsified Medicines Directive

Serialization status

Active

Country population

19.8 million people

NMVS provider (EU Only): OSMR

Alert requirement: Yes - required

Aggregation requirement: Not mandatory

Track & Trace requirement: Not mandatory

Official governing body: The National Agency for Medicines and Medical Devices of Romania (NAMMD)

Market coding requirements:

GTIN

Serial Number

Batch Number

Expiry Date