MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
• preclinical studies, including pharmacody- namics, pharmacokinetic and toxicology studies. For products manufactured abroad, it is also necessary to file a representation letter granted to the holder. The application to obtain an MA for medical devices must be submitted with the following: • the payment of governmental fees; • the technical and scientific information that proves the security and efficacy standards; • draft labels; • instructions; • a general description of the manufacturing process; • a description of the structure, materials, parts and functions; • certificates of good manufacturing practices for the finished product; • laboratory tests; and • bibliographic references, if such are required. For products manufactured abroad, it is also necessary to file the following: • a free sale certificate; • a representation letter issued by the manufac- turer of the product; • a certification of analysis; • sanitary notification of the distribution ware- house; and • notification of the sanitary official of the distri- bution warehouse. Approval times are as follows: • for pharmaceuticals that include active and therapeutic indications already registered in
Mexico, the decision must be granted within 180 days; • for pharmaceuticals whose active ingredients are not registered in Mexico but are registered and 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 Committee of COFEPRIS, the decision shall be taken within 180 days; • for homeopathic, herbal and vitamin pharma- ceuticals, 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 COFE- PRIS requires additional information. For class I medical devices, the decision must be granted within 30 days; for class II, the deci- sion 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 addi- tional information. 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 pharmaceuticals; this is completely optional and subject to stricter requirements. The modification of MAs can be classified as administrative or technical. Technical modifica- tions are those relating to changes in the for- mulation, 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 modi-
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