To guarantee the supply of drugs of foreign origin in the national territory, an Emergency Amendment to the NOM-177-SSA1-2013 (“Amendment”) was published in the Official Gazette of the Federation in May, providing the procedures and requirements for drug interchangeability. The purpose of the Amendment, which would be in force for six months, was to expedite the administrative formalities regarding sanitary registrations of foreign products.

Since the circumstances that motivated the issuance of the Amendment still exist in Mexico, on October 26, the Ministry of Health published a Notice by which its validity is extended for six more months, from November 5, 2021.

The most important aspects of the Amendment were:

  1. Interchangeability tests may be carried out in Mexico.
  2. Tests must be carried out by authorized third parties.
  3. For drugs manufactured abroad, interchangeability tests carried out in the country of origin will be accepted provided that:
    • a. The tests are carried out by authorized establishments in the country of origin.
    • b. The technical criteria for conducting tests refer to the guidelines and standards issued by the following organizations and agencies:
      • Agencia Nacional de Vigilancia Sanitaria (ANVISA)
      • European Medicines Agency
      • Food and Drug Administration (FDA)
      • Health Canada
      • The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
      • World Health Organization (WHO)
  4. If during the manufacturing process, the properties of drugs are modified, tests should be carried out as determined by the Ministry of Health.
  5. The Ministry of Health shall evaluate the preclinical protocols and, where appropriate, request the extension of tests.

 

Regulatory

Juan Carlos Partida
juan.partida@ecrubio.com

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