June 30, 2021
A Decree was published on June 22, 2021. Said decree amended the so-called Equivalence Decree published back on January 28, 2020 in the Federal Official Gazette by the Ministry of Health (For further reference please see our newsletter No. 91/FEB 2020).
The Decree of January 2020 established the equivalent requirements to recognize the approval process of certain foreign regulatory agencies to allow the importation of drugs with or without marketing authorization in México in case of “necessity” with the aim to expedite the granting of marketing authorizations of health supplies (i.e. drugs, vaccines) in Mexico, by establishing an authorization equivalence mechanism for products that had met the corresponding requirements and procedures before a foreign regulatory agency recognized in the Decree.
The Decree includes the following amendments:
At OLIVARES, we will continue monitoring and studying the impact of this decree to guide our clients and the industry with best practice strategies.