Senate committees approve bills on sanitary registrations and drug adulteration
30 septiembre 2021


On September 28 and 30, various committees of the Mexican Senate approved bills of interest. The first, approved in the Second Legislative Studies Committee, establishes the indefinite validity of drug registrations. The second, dealt with by the Second Legislative Studies and Health Committee, proposes penalties for the counterfeiting of medicines during a health emergency. Both texts are ready to be dealt with in the Senate Plenary.

Regarding the first bill, the approved text modifies article 376 of the General Health Law, establishing that the validity of a sanitary registration will be indefinite, when previously the registrations had to be renewed every 5 years. The initiative covers all drugs marketed in the country. The text also adds Article 376 TER, establishing that the holders of authorized health registrations with indefinite validity must provide the Federal Commission for the Protection of Health Risks (COFEPRIS in Spanish) with periodic pharmacovigilance reports on such products.

The second initiative seeks to deepen the penalties currently applied to different criminal activities related to medicines in pandemic contexts. Thus, for example, anyone who adulterates, falsifies, contaminates or allows the adulteration, falsification or contamination of medicines will be fined from USD 215,000 to 430,000. During its discussion, some modifications were introduced, such as including as an aggravating circumstance the adulteration of vaccines in the context of a sanitary emergency.