Pavo

Regulation name
Sistema de Seguimiento de Productos (ÜTS) / Sistema de Trazabilidad de Productos Farmacéuticos (ITS)
Serialization status
Began implementation process starting from 2005. Pilot launched in 2009; full serialization and traceability enforcement began in 2010 and became fully operational by 2012.
Country population
85 million

Alert requirement: Handled centrally via the ITS platform with automatic alerts for mismatches and counterfeiting.

Aggregation requirement: Not mandatory by law, but widely used operationally to streamline warehouse and logistics.

Track & Trace requirement: Mandatory end-to-end serialization and event reporting at every transaction level through ITS.

Official governing body: Turkish Medicines and Medical Devices Agency (TITCK) - Connected to Turkish Ministry of Health

Implementation deadline / enforcement date: Full compliance required as of 2012 following phased rollout from 2010.

Serialization type / level: Secondary packaging serialized with GTIN + SN + EXP + LOT in DataMatrix format.

MAH / CMO responsibilities: MAHs are legally responsible for serialization and ITS data uploads; CMOs may perform uploads if contractually delegated.

Serialized product scope: All Rx and OTC medicines and supplements in the Turkish market, including imports, are covered.

Penalties for non-compliance: Products cannot be dispensed or reimbursed by SGK; companies face supply blocks and enforcement by TITCK.

Repackaging rules: Repackaged products must be re-serialized and uploaded to ITS as new units with full traceability.

Serialization exemption rules: No exemptions—ITS applies to all human-use pharmaceuticals.

Market coding requirements:

GS1 DataMatrix on secondary packaging with GTIN, serial number, expiry date, and lot number.

Scroll al inicio
serialization maturity test square