Tunisia

Regulation name

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

Tunisia

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