Brazilian Referral Medicines List (RML) is updated, according to Anvisa standards

Last Friday (March 6, 2026) Anvisa published Normative Instruction n. 428/2026, updating the Brazilian Referral Medicines List (RML). A referred medicine is an innovative product, wich has its efficacy, safety and quality scientifically proven before registration. After pre-established criteria, those products are registered according to Anvisa standards.

All the criteria for defining a medicinal product as a referred medicine, as well as the procedures for its inclusion or exclusion from the RML, are established in Resolution 957/2024.

Any medicinal products included in the RML are considered parameters of therapeutic efficacy, safety and quality. Those products may also be used as parameters for implementing comparative tests for the registration of generic and similar products.

The list can also be a source for healthcare professionals and the general population to seek information about medicines in Brazil.

Click here to access the Brazilian Referral Medicines List (RML).