MEXICO Trends and Developments Contributed by: Bernardo Martinez-Negrete, Lisandro Herrera Aguilar and Martha Contreras Secchi, Galicia Abogados, SC
cialisation in their country of origin and were aimed at public health institutions. These com- mercialisation authorisations came from regula- tory authorities – the US FDA, the Health Ministry of Canada and the Ministry of Health, Labor and Welfare of Japan – allowing the commercialisa- tion of medical devices within their respective territories, as well as from the Japan Pharma- ceuticals and Medical Devices Agency, the Euro- pean Commission, the Medicines and Health- care Products Regulatory Agency of the United Kingdom, the Ministry of Food and Drug Safety of Korea, the Therapeutic Goods Administration of Australia and the National Health Surveillance Agency of Brazil. Similar to drugs, once imported into Mexico, medical devices had to undergo the required application process to obtain marketing authori- sation from COFEPRIS. This process included a resolution period of 60 business days, which is shorter than the timeframes for ordinary appli- cations not covered by the 2020 Equivalence Agreement. Termination of the 2020 Equivalence Agreement for importation On 11 September 2024, an agreement was pub- lished in the Official Gazette revoking the 2020 Equivalence Agreement and its amendments, thereby terminating the provisions that allowed the importation of drugs and medical devices without a marketing authorisation issued by COFEPRIS (the “Termination Agreement” ). How- ever, it also established that any procedures ini- tiated before the Termination Agreement could continue based on the applicable provisions. At the time, this meant that it was no longer possi- ble for foreign products to participate in tenders without marketing authorisation.
The 2024 Equivalence Agreement for the importation of drugs and medical devices The current equivalence agreement, published in the Official Gazette on 4 December 2024, allows the importation of certain drugs and medical devices without a marketing authorisation issued by COFEPRIS, provided they have commerciali- sation authorisation from recognised regulatory agencies (the “2024 Equivalence Agreement” ). The provisions of the 2024 Equivalence Agree- ment regarding drugs will apply only to the fol- lowing types of drugs – ie, excluding those clas- sified as psychotropics or narcotics, as well as vaccines: • new molecules indicated in Article 2, Section XV of the RIS; • generics; • innovative biotechnology; • biocomparable biotechnology; and • biological products. Additionally, to obtain import permits for drugs under the terms of this agreement, applicants may submit commercialisation permits and mar- keting authorisations issued by the regulatory authorities of the following countries: Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Netherlands, Nor- way, Portugal, Japan, Singapore, Spain, Swe- den, Switzerland, the United States of America, Canada, Australia and the United Kingdom. In addition to the above, commercialisation permit and marketing authorisations issued by the EMA and obtained through a centralised process may be submitted. To obtain import permits for medical devices under the terms of this agreement, applicants may submit commercialisation permits and marketing authorisations issued by the regula-
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