Argentina

Regulation name

Resolution 435/2011 - Argentina National Drug Traceability System

Serialization status

Active

Country population

47.1 million

Alert requirement: Yes

Aggregation requirement: No

Track & Trace requirement: Yes - full track and trace system from manufacturer/importer to patient

Official governing body: ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) - National Administration of Drugs, Food and Medical Technology, under the Ministry of Health

Serialization type / level: GTIN + SN + EXP + LOT

MAH / CMO responsibilities: Both manufacturers and importers must serialize products and report data to ANMAT at various stages (production, distribution, sales) / All imports of medical products must be carried out by an importer registered with ANMAT

Serialized product scope:
- RX
- All new drugs registered and unique in the market
- Imported Pharmaceutical Products: Any pharmaceutical product imported into Argentina that falls within the defined scope of "medicines"/ Cancer treatments (oncology drugs)
- HIV/AIDS medications
- Medicines for hemophilia and other coagulation disorders
- Narcotics and psychotropic substances
- Certain cardiovascular drugs
- Drugs for central nervous system conditions (e.g., antidepressants, antipsychotics, epilepsy, Parkinson's disease)
- Insulin
- Antibiotics

Penalties for non-compliance: Penalties include fines, closure of facilities, suspension or annulment of authorization to function, and regulatory actions

Repackaging rules:
Products must maintain traceability through any repackaging process and every physical movement of a serialized drug unit must be reported in real-time to ANMAT's central database. This includes:
- Production/Importation (commissioning)
- Shipping/Receiving events (from manufacturer to distributor, distributor to pharmacy/hospital)
- Dispensing to the patient (decommissioning)
- Returns, destructions, etc.