MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
fication. Each application to modify an MA must contain the technical and legal documentation supporting the relevant change. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations There are a limited number of cases where an unauthorised product can be imported into the country and supplied to patients, including low- prevalence diseases, donations (eg, in natural disasters), personal use, experimental products for clinical research and medical use. In addition, if the relevant product is included on the list of products that, due to their nature, characteristics and uses are not considered medical devices, it would not be considered as a medical device and consequently would not require an MA. The third wave of equivalency decrees intro- duced the import without registration route. This route was designed to secure the supply of medical products by requiring importers to apply for marketing authorisation within ten days after importing the first batch of the product. The import of medicines and medical devices that do not have an MA in Mexico is permitted provided they have an MA from certain recog- nised jurisdictions, that the medicine or medi- cal device is included in the national tender of medical products consolidated by Laboratorios y Reactivos Biologicos Mexicanos , S de R L de CV (BIRMEX) and that an MA application is filed after the first import of the product. This route allows some companies faster market access, bypassing costly and time-consuming regulatory requirements, but risks patent vio- lations, as the patent linkage system may be
overlooked. This could impact third-party pat- ent rights during COFEPRIS’s review of a mar- ket authorisation application under the official decree. Unequal market access and potential patent breaches could violate free trade agreements and enable counterfeit medical products. Like- wise, a company can access the market faster through the import without MA route, but if the application is denied, the company risks breach- ing its public contract and facing economic pen- alties. The importation of medicines and medical devices without an MA was previously author- ised during the pandemic, in the third wave of equivalency decrees published by the MOH on 28 January 2020 and 22 June 2021. To activate the importation without MA under these decrees, a prior declaration of necessity issued by multi- ple authorities was required. Both decrees have since been amended and their mechanisms sub- stituted by the current 4 December 2024 decree. 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations Holders of MAs must comply with good manu- facturing practices and stability, pharmacovigi- lance or technovigilance and labelling standards and regulations; they must also comply with the advertising regulations that apply to pharmaceu- ticals or medical devices. Product recall obliga- tions have also become relevant of late. In general, pharmaceuticals and medical devices are subject to post-approval vigilance. These obligations are developed in technical stand- ards, which generally specify the rights and obligations for holders of MAs, distributors, research sites, health institutions, physicians
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