MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
without a legal basis therefor): emergency authorisa- tions. These expired once the health emergency was declared to be over, with regular market authorisations
• quality information; and • preclinical studies, including pharmacodynamics, pharmacokinetic and toxicology studies. For products manufactured abroad, it is also neces- sary to file a representation letter granted to the holder. Before the Amendment, COFEPRIS accepted cGMPs from regulatory agencies with which it had reliance agreements. COFEPRIS or an authorised third party could conduct inspection visits to confirm compliance with GMPs, but the Amendment now precludes third parties from performing inspections. The application to obtain an MA for medical devices • the technical and scientific information that proves the security and efficacy standards have been met; • draft labels; • instructions; • a general description of the manufacturing pro- cess; • a description of the structure, materials, parts and functions; • cGMPs for the finished product; • laboratory tests; and • bibliographic references, if required. For products manufactured abroad, it is also neces- sary to file the following: • a free sale certificate; • a representation letter issued by the manufacturer of the product; • a certification of analysis; • sanitary notification of the distribution warehouse; and • notification of the sanitary official of the distribution warehouse. Approval times are as follows: must be submitted with the following: • the payment for governmental fees; • for pharmaceuticals that include active and thera- peutic 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
subsequently being required instead. 3.3 Period of Validity of Marketing Authorisations
The period of validity of any MA for pharmaceuticals and medical devices is five years. After this period, MAs may be renewed every ten years. In contrast, a recognition letter for orphan drugs (the equivalent of an MA) lasts for two years only. If the MA is not renewed after the initial five-year period or subse- quent ten-year period, the MA shall be cancelled by COFEPRIS. Also, any authorisation may be revoked by COFEPRIS at any time – for instance, when a new risk to human health is found, if an infringer repeatedly disregards safety measures, or if false information is submitted. MAs may be cancelled if companies fail to submit renewal applications on time. A recent change to the RIS means that the second and subsequent renewals of MAs – both for medicines and for medical devices – will only be subject to a notifica- tion, not to an authorisation. The Amendment further grants the COFEPRIS powers to issue emergency use authorisations during public health emergencies. 3.4 Procedure for Obtaining a Marketing Authorisation In general, the procedure for obtaining an MA for phar- maceuticals includes filing the MA application form at COFEPRIS, along with evidence of the following: • the payment of governmental fees; • a manufacturing licence or equivalent; • notice of appointment of a qualified sanitary officer; • draft labels; • the information to prescribe; • certificates of good manufacturing practices (cGMPs) for the finished product, its active ingredi- ents and its additives; • the draft distinctive name; • the quantitative and qualitative formula;
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