Labeling of medicines and herbal remedies
Establishes labeling requirements for domestic and imported medicines and herbal remedies for sale in Mexican territory.
Last updated: 2024-04-01
Identify all mandatory elements by medicine type (OTC, prescription, herbal).
Create the Spanish-language label with all elements required by the standard.
Add warning statements, contraindications, and precautions per medicine type.
Submit the label for review by a regulatory consultant or directly to COFEPRIS.
Apply the compliant label and maintain records as part of the regulatory file.
Product seizure, fines up to 200,000 UMA, sanitary registration suspension.
Camtom helps you identify and comply with all applicable regulations for your imports.