MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
sold freely in their country of origin, a decision shall be taken within 240 days; • for new molecules, after a prior technical meeting between applicants and the New Molecules Com- mittee of COFEPRIS, the decision shall be taken within 180 days; • for homeopathic, herbal and vitamin pharmaceuti- cals, decisions shall be taken within 45 days; and • for biotechnological drugs, applications must be resolved within 180 days. These approval times can be extended if COFEPRIS requires additional information. For class I medical devices, the decision must be granted within 30 days; for class II, the decision shall be taken within 35 days; and for class III, the decision shall be taken within 60 days. As with pharmaceuticals, these approval times can be extended if COFEPRIS requires additional infor- mation. There is no mandatory requirement to conduct clinical trials in a paediatric population, nor to obtain a waiver from this requirement in relation to individual pharma- ceuticals; this is completely optional and subject to stricter requirements. The modification of MAs can be classified as adminis- trative or technical. Technical modifications are those relating to changes in the formulation, indication or manufacturing process. Administrative modifications include changes to the corporate name or address of the holder, or to the information to prescribe. The assignment of an MA is regarded as an administrative modification. Each application to modify an MA must contain the technical and legal documentation sup- porting the relevant change. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations There are a limited number of cases where an unau- thorised 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, character- istics 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 introduced the import without registration route. This route was designed to secure the supply of medical products by requiring importers to apply for marketing authorisa- tion 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 recognised jurisdictions, that the medicine or medical 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 regu- latory requirements, but risks patent violations, as the patent linkage system may be overlooked. This could impact third-party patent rights during COFEPRIS’s review of a market authorisation application under the official decree. Unequal market access and potential patent breaches could violate free trade agreements and enable coun- terfeit medical products. Likewise, a company can access the market faster through the import-without- MA route, but if the application is denied, the com- pany risks breaching its public contract and facing economic penalties. The importation of medicines and medical devices without an MA was previously authorised 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 neces- sity issued by multiple authorities was required. Both decrees have since been amended and their mecha- nisms substituted by the current 4 December 2024 decree.
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