No national serialization law; companies voluntarily exploring GS1 serialization (e.g., UNIMED & Laboratoires MédiS) for export compliance
Serialization status
In progress — individual companies piloting serialization systems (e.g., blister and aggregation-capable equipment installed in 2023), but no mandatory regime yet
Country population
~12 million
Alert requirement: Not defined in Tunisia—no regulatory traceability system active
Aggregation requirement: Pilot systems support tertiary aggregation for export compliance (cases/pallets aggregation)
Track & Trace requirement: Voluntary for export-oriented manufacturers only; no national track‑and‑trace system
Official governing body: Directorate of Medicines & Pharmacy (Ministry of Health) likely authority; no official traceability program
Implementation deadline / enforcement date: Not applicable—no enforcement date set
Serialization type / level: Voluntary secondary-level serialization; tertiary aggregation where needed for export. Pilot lines encode GTIN, serial number, batch, expiry on blister/carton; SSCC for cases
MAH / CMO responsibilities: No central system in place—serialization data handled internally for export markets
Serialized product scope: Export-destined products only (e.g., EU, US); domestic market not serialized
Penalties for non-compliance: None domestically; export compliance enforced by foreign authorities
Repackaging rules: Pilot systems include aggregation-ready lines; no national requirement
Serialization exemption rules: Domestic products exempt by default—no regulation in place
Market coding requirements:
Pilot implementations follow GS1 DataMatrix (GTIN + Serial, Batch, Expiry) per export rules, not domestic mandate
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