MEXICO Trends and Developments Contributed by: Bernardo Martinez-Negrete, Lisandro Herrera Aguilar and Martha Contreras Secchi, Galicia Abogados, SC
cal devices into the country without the prior requirement for a marketing authorisation issued by COFEPRIS in the following circumstances (Article 132 of the RIS): • when a contingency arises; • when required by sanitary policy; • for purposes of scientific research, registra- tion or personal use; and • for laboratory tests. Equivalence agreement for drugs issued in 2020 Although the ability to import drugs and medi- cal devices without marketing authorisation has been in place for several years, it was not until recently (during the administration of for- mer President Andres Manuel Lopez Obrador) that Mexico’s government started to use this mechanism to import drugs and medical devic- es expeditiously, arguing that allowing a greater number of drug suppliers into Mexico would help reduce prices. As a result, an equivalence agree- ment was issued in the Official Gazette , permit- ting the importation of drugs for any disease or condition as long as they were aimed at public health institutions and authorised by the follow - ing regulatory authorities (the “2020 Equivalence Agreement” ) the Swiss Agency for Therapeutic Products (Swissmedic), the European Commis- sion, the US FDA, the Health Ministry of Can- ada, the Therapeutic Goods Administration of Australia and reference regulatory agencies of the Pan American Health Organization (PAHO)/ WHO, prequalified by the WHO’s pre-qualifica- tion programme for medicines and vaccines or regulatory agencies that are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). This agreement allowed the importation of for- eign drugs without a marketing authorisation
from COFEPRIS, as long as these products had the necessary authorisations for commercialisa- tion in their country of origin and were aimed at public health institutions. These commer- cialisation authorisations had to come from one of the regulatory authorities listed in the 2020 Equivalence Agreement. However, although drugs could be imported without a marketing authorisation issued by COFEPRIS, they still had to obtain their corresponding marketing authorisation in order to access the market. This process included a resolution period of 60 busi- ness days, which is shorter than the timelines for “ordinary” applications not covered by the 2020 Equivalence Agreement. At the time, one of the most common criti- cisms of the pharmaceutical industry was that the publication of the 2020 Equivalence Agree- ment sought to align Mexico’s regulatory stand- ards with those of certain agencies that have more lenient requirements. Critics argued that this could put the Mexican population at risk by allowing the importation of medicines that might not meet the safety, efficacy and quality standards set by Mexican law. However, under Article 222 of the General Health Law, market- ing authorisations in Mexico are granted only to drugs that demonstrate that they meet safety, efficacy and quality standards. This includes adherence to good manufacturing practices for both the drug and its active ingredients, among other requirements. Amendment to the 2020 Equivalence Agreement On 22 June 2021, an amendment to the 2020 Equivalence Agreement was published in the Official Gazette allowing importation of foreign medical devices without a marketing authorisa- tion from COFEPRIS, as long as these products had the necessary authorisations for commer-
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