Approval of Disruptive Provisions for the Importation of Pharmaceutical Products in Mexico

February 19, 2020

At the end of January 2020, the Ministry of Health published an official administrative
decree, establishing new relevant provisions on the applications for marketing
authorization and importation of medicines into Mexico, consisting of the following:

a) The Ministry of Health confirms the recognition that the requirements and
evaluation procedures requested by various foreign regulatory health authorities to allow
in their respective countries, the sale, distribution and use of allopathic and biological
medicines, are equivalent to those that the General Health Law, the Health Supplies
Regulation and other applicable provisions require to guarantee the quality, safety and
efficacy standards that these products must demonstrate to the Federal Commission for
Protection Against Sanitary Risks (COFEPRIS) to be eventually granted with a marketing
authorization in Mexico.

b) Regardless of the country of origin of the medicine, COFEPRIS must resolve
marketing authorization applications submitted in accordance with said decree within a
maximum period of 60 working days. If COFEPRIS fails to provide a response before the
aforementioned period expires, it will be understood that the application has been denied.
Presently, the deadline for resolving marketing authorization applications for allopathic
and biologic medicines, not considered in this decree, ranges from 180 to 240 calendar
days, depending on the case, and for allopathic medicines, there is the possibility of
reducing these deadlines by half when the applicant submits a favorable technical report
issued by an Institution recognized as a Third Party Authorized by the Ministry of Health.

c) The Mexican authorities are being authorized to import medicines that do not have a
marketing authorization in Mexico, provided said import is carried out by necessity in
order to guarantee the supply of medicines for the correct and timely provision of health
services to the population. In this case, the holder or legal representative of the marketing
authorization of the drug in the country of origin is the one who must initiate the process
of sanitary authorization with COFEPRIS within a term of 5 working days after the
importation of the product, which COFEPRIS must then resolve within a maximum period
of 60 working days.

In general terms, the decree is welcome with exception to point c) which may be
considered unconstitutional, as it violates the provisions of the Mexican Constitution,
General Health Law and the international treaties of which Mexico is part, by not taking
into consideration the entire regulatory landscape and exclusive rights, by the absolute
disregard of data exclusivity protection currently applicable in our country by the
international treaties and it seems that the patent linkage regulation during the
importation process in case of “necessity”.

OLIVARES is currently reviewing the regulatory and legal repercussions of this decree to
develop a strategy that allows us to avoid the application of these provisions to the
detriment of our clients, decree that we consider is unconstitutional, either for its sole
entry into force or due to the first act of application of the decree in detriment of a party. A
favorable ruling declaring the unconstitutionality of the decree could prevent its
application in prejudice of the claimant.