On 31 May 2021, the Mexican President published on the Federal Official Gazette a major amendment to the Secondary Regulations for Health Supplies (Reglamento de Insumos para la Salud, “RIS”) (“Decree”). The Decree is effective as of 1 June 2021, affecting both medicines and medical devices. It improves the regulatory environment.
There is a clear increase of enforcement actions taken by health authorities, both at the Federal and State level, where authorities are verifying if both physician and dining rooms at manufacturing plants, from all industries, have been properly supported by the applicable Notices of Operation. At the same time, many local health authorities are unduly requesting companies to have a Notice of Operation for their manufacturing operations. Companies shall comply the former and be prepared to reject the latter in order to prevent disruptions of operations and future sanctions.