MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
3.6 Ongoing Obligations Imposed by Marketing Authorisations
COFEPRIS has now begun to populate a public data- base on its website that displays key data contained in the MAs for pharmaceuticals. Confidential information is protected by several spe- cial laws, including those related to privacy, IP and administrative procedures, and labour and criminal law. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes Mexico’s regulatory framework for medicines and medical devices includes fast-track registration through agreements with 42 global regulatory agen- cies via the equivalencies registration route. Mexico signed its first equivalency agreements with Australia, Canada, Switzerland, the EU and the United States on 10 March 2012. On 29 March 2019, the agreements were expanded to include medicines and vaccines prequalified by the World Health Organiza- tion (WHO), covering Argentina, Brazil, Canada, Chile, Colombia, Cuba and the United States. During the COVID-19 pandemic in 2020 and 2021, the equivalencies registration route was expanded to ensure a stable local supply of medical products. This third expansion acknowledged members of the Phar- maceutical Inspection Cooperation Scheme (PIC/S) and countries with products prequalified by the WHO. Thus, the equivalencies registration route established a 60-business day (three-month) fast-track period, as opposed to the traditional registration route applicable to local medical products and subject to a 240-calen- dar day (eight months) period for COFEPRIS to issue a resolution on MA applications. The three waves of equivalency decrees are largely similar, with only minor differences. The inclusion of WHO-prequalified medicines and vaccines was logical both scientifically and economically, but the reasoning for extending equivalence to members of PIC/S (the third group) is unclear.
Holders of MAs must comply with good manufac- turing practices and stability, pharmacovigilance or technovigilance and labelling standards, and regu- lations; they must also comply with the advertising regulations that apply to pharmaceuticals or medical devices. Product recall obligations have also become relevant of late. In general, pharmaceuticals and medical devices are subject to post-approval vigilance. The Amendment introduced pharmacovigilance and technovigilance obligations. These obligations are developed in tech- nical standards, which generally specify the rights and obligations for holders of MAs, distributors, research sites, health institutions, physicians and patients to monitor adverse events or incidents, and to investi- gate and report them. It is also necessary to have a pharmacovigilance or technovigilance unit, some- one responsible for pharmacovigilance and someone responsible for technovigilance, and a pharmacovigi- lance or technovigilance manual. However, Phase IV data is only required for more complex products (eg, complex biologics or biotech drugs), as decided by the New Molecules Committee. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations COFEPRIS has periodically published lists of applica- tions and lists of granted or rejected MAs. However, these lists are not updated regularly, and frequently contain limited information that excludes confiden- tial information. Full access to individual files is only granted to the applicant. Although third parties have long been able to file pub- lic information requests in relation to any file held by COFEPRIS under the mechanisms overseen by the National Institute for Access to Public Information and Data Protection ( Instituto Nacional de Transparencia, Acceso a la Información y Protección de Datos Per- sonales INAI), COFEPRIS historically resisted provid- ing access to most of the files of MAs, which it regard- ed as being confidential in their entirety. Nevertheless, through several INAI decisions, an increasing number of data elements can now be accessed. Fortunately,
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