Dear Clients and Friends:
On January 28, the Official Journal of the Federation published an agreement of the Ministry of Health that allows the importation of medicines with or without sanitary registration into Mexico (“Agreement”), in order to prevent drug shortages and ensure the adequate provision of health services.
According to the Agreement, which entered into force on the same day of its publication, drugs without a sanitary registry in Mexico must, nevertheless, be authorized by any of the following regulatory agencies:
- Swiss Agency for Therapeutic Products (Swissmedic)
- European Medicines Agency (EMA)
- U.S. Food and Drug Administration (FDA)
- Health Canada
- Therapeutic Goods Administration of Australia (TGA)
- National Reference Regulatory Agencies / Pan American Health Organization / World Health Organization (PAHO/WHO)
- Regulatory Agencies Members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Likewise, drugs prequalified by the WHO Prequalification of Medicines Programme (PQP) are considered eligible for importation.
Under the Agreement, in case of unregistered medicines imported to Mexico, a sanitary authorization must be submitted to the Federal Commission for the Protection against Health Risks (COFEPRIS) within 5 business days of import. COFEPRIS will have a maximum of 60 business days to issue its decision.
The Agreement also provides that unregistered medicines that are imported into Mexico, but whose health registration is not processed before COFEPRIS, will not be considered for subsequent imports.
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