Brazil: Food and Drugs Law

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Article
Anvisa abrirá processo para regulamentar venda de medicamentos em plataformas
Brazil's health regulatory agency Anvisa has approved the opening of an administrative process to regulate the sale and delivery of medicines through digital marketplaces, aiming to update sanitary rules to reflect the reality of online pharmaceutical retail that has evolved far beyond the outdated 2009 regulations. The decision comes after Law 15.357/2026 authorized pharmacies to contract digital platforms for logistics and delivery services, yet significant legal uncertainties remain about compliance requ
Brazil Healthcare
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Article
Reavaliação de agroquímicos e devido processo legal administrativo
A recent decision by Brazil's Federal Regional Court of the 1st Region confirms that the Ministry of Agriculture holds final authority over agrochemical use decisions following environmental assessments by Ibama. This ruling addresses regulatory inconsistencies in the re-evaluation process of active ingredients, particularly regarding imidacloprid, and establishes that uniform treatment must apply to both registered products and new registration requests.
Brazil Government
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Article
BRPTO Announces Collaborative Examination Program With INDECOPI
The Brazilian Patent and Trademark Office (BRPTO) and Peru's INDECOPI have launched a collaborative examination initiative for patent applications in pharmaceuticals, biotechnology, and natural products. This partnership, formalized through a 2025 Bilateral Cooperation Memorandum, will provide expedited technical examination for qualifying PCT applications that entered the national phase between October 2022 and July 2023.
Brazil IP
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Article
CMED Updates Rule On Drug Pricing
Brazil's Drug Market Regulation Chamber has introduced significant modifications to its drug pricing framework through Rule #7/2026, adjusting criteria for new drugs, biosimilars, and generic medications. The regulatory changes simplify documentation requirements for biosimilars while clarifying provisions for generic drug pricing, though several industry concerns regarding off-label treatment comparisons and retroactive application remain unresolved.
Brazil Healthcare
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Article
Lei do Chocolate: o que muda para a indústria alimentícia
O Senado Federal aprovou em abril de 2026 o Projeto de Lei 1.769/2019, conhecido como "Lei do Chocolate", que estabelece novos padrões para a indústria de chocolates no Brasil. A nova legislação eleva significativamente o teor mínimo de cacau necessário para que um produto seja denominado "chocolate", passando de 25% para 35% de sólidos totais de cacau, além de criar novas categorias de produtos e impor regras mais rigorosas de rotulagem frontal obrigatória.
Brazil Consumer
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