Colombia

Regulation name

Voluntary pilot initiatives (GS1 traceability system under INVIMA); Law 1122/2007 mandates traceability framework but no mandatory serialization yet

Serialization status

No binding unit-level serialization requirement currently. INVIMA’s traceability framework exists since Law 1122 (2007), and GS1-based pilots started with manufacturers and wholesalers (e.g., Pfizer, Dromayor) since ~2011–2013

Country population

51 million

Alert requirement: N/A

Aggregation requirement: Not mandated; pilot implementations likely include case-level aggregation internally

Track & Trace requirement: N/A

Official governing body: INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), under the Ministry of Health

Implementation deadline: No enforcement date

Serialization type / level:
S1 DataMatrix on primary/secondary packaging with GTIN, serial number, batch, expiry date

MAH / CMO responsibilities: Sponsors of pilot programs should report to governing bodies

Serialized product scope: Prescription and OTC medicines

Penalties for non-compliance: N/A

Colombia

Alert requirement: N/A

Aggregation requirement: Not mandated; pilot implementations likely include case-level aggregation internally

Track & Trace requirement: N/A

Official governing body: INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), under the Ministry of Health

Implementation deadline: No enforcement date

Serialization type / level:
S1 DataMatrix on primary/secondary packaging with GTIN, serial number, batch, expiry date

MAH / CMO responsibilities: Sponsors of pilot programs should report to governing bodies

Repackaging rules: N/A

Market coding requirements:

GTIN + SN + LOT + EXP encoded in GS1 DataMatrix.
Not enforced legally

Colombia

Alert requirement: N/A

Aggregation requirement: Not mandated; pilot implementations likely include case-level aggregation internally

Track & Trace requirement: N/A

Official governing body: INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), under the Ministry of Health

Implementation deadline: No enforcement date

Serialization type / level: S1 DataMatrix on primary/secondary packaging with GTIN, serial number, batch, expiry date

MAH / CMO responsibilities: Sponsors of pilot programs should report to governing bodies

Repackaging rules: N/A

Market coding requirements:

GTIN + SN + LOT + EXP encoded in GS1 DataMatrix. Not enforced legally

Serialization type / level:
S1 DataMatrix on primary/secondary packaging with GTIN, serial number, batch, expiry date

GTIN + SN + LOT + EXP encoded in GS1 DataMatrix.
Not enforced legally