Romania

Regulation name: EU Falsified Medicines Directive

Serialization status: Active
Country population: 19,8 mln people
Market coding requirements: GTIN, Expiry Date, Batch Number, Serial Number
NMVS provider (EU Only): OSMR
Alert management: Yes – required
Aggregation requirement: Not mandatory
Track & Trace requirement: Not mandatory
Official governing body: the National Agency for Medicines and Medical Devices (NAMMD) (https://www.anm.ro/en/)
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