Import Guide
Medications require COFEPRIS health registration and import license. Learn the complete regulatory requirements.
Register each medication with COFEPRIS. The process can take months.
Get import license as a pharmaceutical establishment.
Classify by active ingredient, pharmaceutical form, and dosage.
Comply with NOM-072-SSA1 with information in Spanish.
COFEPRIS verifies documentation and may sample products.
Complete import with approved health documentation.
Tariffs: 0-10% for most medications. Many active ingredients have 0% duty. Finished medications 0-5%.
COFEPRIS registration can take 6 to 18 months
Maintain cold chain for products requiring it
Narcotics require additional special permits
Verify GMP equivalency recognition