If you are looking to expand your sales into Mexico, there’s no time like the present!
The Health Secretariat in Mexico has published a legal instrument allowing the importation of drugs with or without a Marketing Authorization.
This agreement, which is aimed at any drug with authorization by certain authorities abroad, was issued by the Mexican Secretariat of Health Jorge Alcocer Varela on January 28th, 2020 and came into effect the same day.
The Agreement is centered on establishing simplified rules for importation and future applications of a Marketing Authorization for drug manufacturers abroad that do not currently have a Marketing Authorization in Mexico. This fast-tracked importation and simplified Marketing Authorization process are only available to manufacturers that are approved and recognized by key jurisdictions abroad such as Swissmed, the EMA, the US FDA, Canadian MoH, and the Australian TGA. Alternatively, the agreement applies to products that have undergone WHO Prequalifications, or that have registrations granted by regulatory agencies that are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S).
For manufacturers importing drugs without having a Marketing Authorization, COFEPRIS, through the Sanitary Operation Commission, will take samples of the imported batches so that the Commission for Analytical Control and Expansion of Coverage can assess safety and quality.
Applications for Marketing Authorization must be submitted to COFEPRIS within a period not exceeding five business days after the first import. Drugs without Mexican Marketing Authorization that have been imported and for which the registration process has not been initiated cannot be considered for subsequent imports. We have derived from our analysis of the above-mentioned agreement that there are issues that are not entirely clear and must be addressed, such as:
– Who will be legally responsible for the import,
– The product release procedure at customs,
– The measures that the sanitary authority will take in case of adverse reactions or if the Marketing Authorization is not authorized in Mexico.