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  3. /NOM-073-SSA1-2015
SSA1 (Health)PharmaceuticalActive

NOM-073-SSA1-2015

Stability of drugs and medicines

Establishes criteria and requirements for drug and medicine stability testing to determine shelf life and storage conditions. Fundamental for the health registry of any medication.

Last updated: 2023

Affected products

New drugsGeneric drugsBiological productsImported medicines

Compliance requirements

  • Conduct long-term stability studies
  • Accelerated stability studies
  • Determine storage conditions
  • Establish shelf life
  • Document results with COFEPRIS

Related tariff codes

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

3004.90.013003.90.01

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