The Mexican President, in an effort to increase the supply of generic medicines and medicines from abroad, ordered the health authorities to take the necessary measures to expedite the granting of marketing authorizations based on the so-called Equivalence Decrees. (See Newsletter November 2020 https://bit.ly/36YJVD9).
As a follow-up to the President's order, the Ministry of Health issued a Decree, published on November 18, 2020, in the Official Federal Gazette, ordering the following:
- COFEPRIS must resolve the applications of marketing authorization of medicines and health supplies coming from abroad within 5 working days.
- If an application is not resolved within the above-mentioned period, it will automatically be understood to have been granted (afirmativa ficta).
- The period of 5 days will be suspended if COFEPRIS requires documents, clarification or additional information from the applicant, with the 5-day period being reactivated immediately following the presentation of the information.
- COFEPRIS must carry out the necessary actions to guarantee the safety, quality and efficacy of the medicines.
- The applicants, importers and marketers are not exempted from complying with the applicable provisions to maintain the marketing authorization.
The Decree has been highly criticized, because in addition to not going through a legislative process, as the nature of the matter requires, a period of 5 working days does not seem reasonable for COFEPRIS to ensure that the medicines and material acquired from abroad comply with regulatory standards that guarantee safety and efficacy for products of various kinds, such as biotechnological medicines, or that patent rights are observed within the framework of the Linkage System in force in Mexico, as well as protection of clinical data.
The Decree has also been criticized for granting facilities to companies and products coming from abroad, specifically, obtaining a marketing authorization within 5 working days, when the procedure for the pharmaceutical industry established in Mexico, according to the applicable regulatory framework, takes approximately between 180 and 240 working days (6 to 8 months). Additionally, for various reasons, including the COVID-19 pandemic, the procedures of such national or international companies established in Mexico have been considerably delayed.
OLIVARES will continue to analyze the possible actions to be taken by the companies and individuals affected by this Decree, due to its enactment or when applied in prejudice of the rights established in the Constitution, international treaties and other laws.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.