The Brazilian Health Regulatory Agency (ANVISA) enacted new technical requirements for the notification of low-risk drugs (simplified scheme), as well as a new list of pharmaceutical products classified as low-risk drugs.
RDC Resolution n.º 576/2021 from the Brazilian Health Regulatory Agency (ANVISA) established new technical requirements for the notification of pharmaceutical products classified as low-risk drugs, which may be produced, imported, and commercialized under simplified procedures, exempt of specific product registration requirements at ANVISA. The new resolution stems from Public Consultation n.º 818/2020 and revoked four resolutions, including RDC Resolution n.º 199/2006 (Drugs subject to simplified notification).
Sections “II” and “III” of the resolution provided new technical requirements for the production, importation, and commercialization of low-risk drugs under the simplified notification scheme. Additionally, and as provided in the first article of the new resolution, Normative Instruction n.º 106/2021 revised the list of low-risk drugs, which now includes 118 products. According to ANVISA, 39 products were included in the list. Newly added products, as well as those excluded from the list, are provided a two-year adaptation period (articles 28 and 29 of the resolution).
