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09 December 2020
On 18 November 2020 the Ministry of Health published the Accord Establishing Administrative Measures to expedite the Marketing Authorisation Process for Foreign Medicines and Other Health Supplies (the accord) in the Federal Official Gazette. The accord derived from the publication on 11 November 2020 of the Accord Wherein the Constitutional President of the United Mexican States Instructs the Ministry of Health and the Federal Commission for the Protection against Health Risks (COFEPRIS) to Conduct the Granting of the Marketing Authorisations for Health Products in a Period Less than that Established in the Equivalence Agreements Executed by that Date, and to Establish Shorter Periods for Future Ones (accord two), which aims to provide a larger number of Mexicans with access to more and better medicines and other health supplies.
The accord establishes that COFEPRIS must make a decision on applications for marketing authorisations of foreign medicines and health supplies within five working days of the applicant's filing of the corresponding documentation. If COFEPRIS does not respond to an application within this period, the application will be deemed to have been authorised (deemed affirmation). If the applicant must provide documents, clarifications or missing information, the abovementioned period will be suspended and resume on the working day following that on which the applicant provides said information or documents or makes the corresponding clarifications. If the applicant does not respond to this request, the application will be deemed as not having been submitted.
For the purposes of the abovementioned procedure, the health authority will have a period equal to one-third of the period granted to decide on an application (ie, two days) to require additional information or documentation from the applicant regarding administrative matters and two-thirds of that same period (four days) for matters of a technical nature.
The accord does not exempt importers, distributors or retailers of products that must obtain said marketing authorisation from complying with the requirements established in Article 131 of the Health Supplies Regulations or any other requirement or specification necessary to keep such marketing authorisation or from any other additional requirement to the marketing authorisation procedure that must be met to market medicines or health supplies in Mexican territory. The accord entered into force on 18 November 2020.
For further information on this topic please contact José Alberto Campos Vargas, Maria Luisa Mendoza, Laura Sánchez Barrón or Ernesto Vega Saldivar at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email (email@example.com, firstname.lastname@example.org, email@example.com or firstname.lastname@example.org). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.
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