MEXICO Trends and Developments Contributed by: Bernardo Martinez-Negrete, Lisandro Herrera Aguilar and Martha Contreras Secchi, Galicia Abogados, SC
raw materials, or for drugs that are not or do not contain narcotics or psychotropic drugs, which have marketing authorisation, Modality C” ) must include: • proof of payment of governmental fees; • a valid sanitary licence for the manufacturing plant or laboratory of medicines or biological products intended for human use; • “sanitary responsible notice” ; • a commercialisation permit and marketing authorisation, which is in force, issued by any of the regulatory Authorities established in the 2024 Equivalence Agreement (apostilled or legalised by the country of origin, as applica- ble); • a public instrument proving the legal person- ality of the promoter, or a letter containing the procedure number and the legal representa- tive’s name, signature and scope of powers; • a letter in which the holder of the drug’s marketing authorisation abroad, along with their legal representative in Mexico, commits to complying with the provisions set forth in the agreement – the letter should also include the award number from the acquiring public institution; and • the original label, prescribing information and instructions, attached as applicable, along with a simple translation into Spanish and the electronic address where they can be accessed. Medical devices Applications for import permits for medical devices ( “COFEPRIS-01-014-A Sanitary permit for importation of medical devices with market- ing authorization that are not or do not contain narcotics or psychotropic drugs Modality A.- Importation of medical devices that have market- ing authorization (such as: medical equipment,
x-ray devices, heart valves, internal prostheses, pacemakers, prostheses, dental supplies, surgi- cal materials, healing and hygienic products with marketing authorization” ) must include: • proof of payment of governmental fees; • an operation notice with the relevant medical device classification; • a commercialisation permit and marketing authorisation, which is in force, issued by any of the regulatory authorities established in the 2024 Equivalence Agreement (apostilled or legalised by the country of origin, as applica- ble); • a public instrument proving the legal person- ality of the promoter, or a letter with the pro- cedure number and the legal representative’s name, signature and scope of powers; • a sworn letter in which the holder of the drug’s marketing authorisation abroad, along with their legal representative in Mexico, commits to complying with the provisions set forth in the agreement – the letter should also include the award number from the acquiring public institution; and • the original label and instructions for use, or the manual, as appropriate, with a simple translation into Spanish and the electronic address where they are available. It is important to note that, in accordance with the Federal Administrative Procedure Law, COFEPRIS is required to resolve the matter with- in a maximum of three months. If this time limit expires without a resolution, the outcome will be considered a rejection ( negativa ficta ). This principle is typically applied when the author- ity needs to conduct a thorough review before granting approval, ensuring that silence is not mistakenly interpreted as implicit approval.
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