Active – pilot 2024, mandatory serialization from 2025
Country population
~70 million combined
Alert requirement: Planned via centralized regional portal
Aggregation requirement: Mandatory unit→case→pallet aggregation planned for 2026, not in effect yet—it’ll follow the 2025 serialization rollout
Track & Trace requirement:
Official governing body:
Implementation deadline / enforcement date: Serialization becomes mandatory in 2025; aggregation follows in 2026; full track & trace by 2027
Serialization type / level: Secondary packaging serialization mandatory from 2025; tertiary aggregation from 2026 Required: GTIN, Serial Number, Expiry, Batch on secondary; SSCC on tertiary
MAH / CMO responsibilities: MAH or their authorized 3PL/importer will transmit data to national or regional systems. CMO only generates codes at packaging stage
Serialized product scope: All Rx and OTC medicines — domestic and imported
Penalties for non-compliance: Not yet defined; expected regulatory actions starting with enforcement phases from 2025 onward
Repackaging rules: Not yet published; assumed that repackaged products will require re-serialization and aggregation as per GS1 norms
Serialization exemption rules: No formal exemptions defined; primary packaging may be exempted in practice, but not officially specified
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