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  3. /NOM-059-SSA1-2015
SSA1 (Health)PharmaceuticalActive

NOM-059-SSA1-2015

Good manufacturing practices for pharmaceuticals

Establishes minimum good manufacturing practice (GMP) requirements for establishments dedicated to manufacturing medicines for human use. It is the fundamental standard for the pharmaceutical industry in Mexico, including manufacturing, quality control, storage and distribution.

Last updated: 2024

Affected products

MedicinesPharmaceuticalsBiological productsVaccinesGeneric drugs

Compliance requirements

  • Implement pharmaceutical quality management system
  • Have qualified and trained personnel
  • Validated and qualified facilities and equipment
  • Complete manufacturing process documentation
  • Quality control with accredited laboratory
  • Product market recall system

Related tariff codes

These tariff codes may be subject to this NOM. Check the specific code to confirm.

3004.90.013003.90.013002.13.01

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