MEXICO: Exemption of the regulatory approval for imported drugs


Exemption of the regulatory approval for imported drugs

This past 28 January 2020, the Mexican Federal Health Secretariat published a decision whereby the importation of medicines from other countries without a prior sanitary registration granted by the Federal Commission for Protection against Sanitary Risks (Comisión Federal para la protección Contra Riesgos Sanitarios- COFEPRIS) shall be permitted.

The fundamental arguments for the issuance of said decision are the following:

  • To guarantee the correct provision of services by means of establishing a system to control the supply of medicines and their raw materials for health.
  • To allow the purchase of medicines in any country around the world to prevent the shortage of supplies as occurs, for example, in the case of cancer medicines in other countries.
  • To increase the stocks of medicines, which helps to reduce monopolies.

This decision allows foreign companies to import medicines that have not been granted a sanitary registration issued by the Mexican authorities.

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