GLP-1 drugs and peptides in Brazil

Marketing authorisation. A medicine must hold an Anvisa registration before it is marketed; Anvisa publishes the register as open data and lists new medicines and new indications on its site. GLP-1 and related registrations found in the register on 2026-09-29: semaglutide (Ozempic 2018, Rybelsus 2020, Wegovy 2023, Extensior and Poviztra 2024, plus 2026 registrations for Ozivy and other Brazilian brands), tirzepatide (Mounjaro, registered September 2023; chronic weight management added June 2025; a multidose presentation registered March 2026), liraglutide (Victoza, Saxenda, Xultophy and Brazilian versions) and dulaglutide (Trulicity). Anvisa says the semaglutide patent expired on 2026-03-20 but registration is still mandatory. Ozivy (EMS, 2026-05-26) is classed as a new synthetic drug for type 2 diabetes, and the first semaglutide generics were registered in August 2026. Prescribing and dispensing. Prescription retention for GLP-1 agonists took effect on 2025-06-23 and is set out in RDC 973/2025 and IN 360/2025. It covers semaglutide, liraglutide, dulaglutide, tirzepatide and lixisenatide: prescriptions in two copies, valid 90 days, with sales logged in SNGPC. Compounding. Compounding is governed by RDC 67/2007 and needs an individual prescription. Despacho 97/2025 (published 2025-08-25) and Nota Técnica 200/2025 set criteria for importing and compounding GLP-1 ingredients. A biotechnology-derived ingredient such as semaglutide may be imported for compounding only if it comes from the same manufacturer as the medicine registered in Brazil. Anvisa said synthetic semaglutide could not be imported or compounded until a medicine with a synthetic ingredient was registered, and the first one (Ozivy) was registered on 2026-05-26. Anvisa did not ban tirzepatide compounding, but it is closely monitored. In June 2026 Anvisa suspended one compounder's tirzepatide production for selling standardised, non-individualised product. On 2026-04-06 Anvisa reported that more than 100 kg of ingredients were imported in the second half of 2025, 11 inspections and 8 interdictions in 2026, and said it is revising RDC 67/2007 and Nota Técnica 200/2025; on 2026-04-14 it said a draft revised technical note on GLP-1 ingredients would be presented that week. Import. Unregistered pens are the main enforcement target. Anvisa said it had published 10 prohibition actions against irregular GLP-1 products between January and early April 2026. Later examples include Resolution 2.238/2026 (June 2026), Resolution 3.480/2026 (September 2026, covering products sold by one website, including products claimed to contain retatrutide) and Resolution 3.626/2026 (September 2026, the T36 pen). These ban import, sale and advertising of the named products. In the first half of September 2026, Anvisa, the tax authority and the federal police seized 1,230 units of unregistered products at Rio's Galeão airport, as reported by Metrópoles. Personal import is also argued in court. On 2026-05-12 the TRF-5 federal appeals court ruled that customs acted unlawfully when it held Mounjaro that a person had brought in for her own and her mother's use, because a prescription, therapeutic use and no commercial purpose had been shown. Coverage and price. The price regulator CMED sets maximum prices; it placed Ozivy in its category for new presentations of drugs already sold in Brazil, so it was compared with Ozempic and Wegovy. The public health system (SUS) does not currently supply these drugs for obesity: Conitec rejected semaglutide and liraglutide in August 2025 on cost grounds, and on 2026-09-24 the Health Ministry asked Conitec to assess semaglutide and liraglutide for obesity.