Brazil ANVISA Updates COVID-19 Vaccine Strains, Low-Risk Medicines, and Ingredient Rules

Details of the Update

The update introduces flexibility in COVID-19 vaccine composition, allowing vaccines to include either the LP.8.1 or JN.1 viral strains, with final selection subject to the discretion of the Ministry of Health. 

In parallel, ANVISA has expanded the scope of low-risk medicines eligible for simplified notification prior to commercialization, now including povidone-iodine, paracetamol, simethicone, and bismuth subsalicylate, streamlining regulatory entry pathways for these products. 

The agency has also authorized new dietary supplement ingredients, including Baru nut oil, microalgae oil containing DHA (Schizochytrium sp.), lyophilized açaí concentrate, Bifidobacterium animalis subsp. lactis, and Streptococcus salivarius K12. These ingredients are subject to defined usage limits and labeling requirements, reinforcing compliance obligations. 

Additionally, ANVISA has reaffirmed the prohibition of nail products containing diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (TPO) and N,N-dimethyl-p-toluidine (DMPT). The restriction remains in force regardless of any pending appeals, confirming strict enforcement. 

Effective Date

The regulatory updates were announced on March 24, 2026. 

Why It Matters

These updates enhance regulatory clarity by defining permissible vaccine strains and authorized ingredients, while supporting digital and procedural efficiency through simplified notification pathways for low-risk medicines. At the same time, the continued enforcement of cosmetic restrictions ensures consistent compliance standards with minimal additional regulatory burden for compliant products.

Who This Affects

This update is relevant for regulatory affairs, quality assurance, R&D, and compliance teams, as well as IT and digital transformation teams responsible for managing regulatory workflows and product data across pharmaceutical, supplement, and cosmetic portfolios. 

Next Steps

Companies should evaluate current product portfolios against the updated requirements, including vaccine composition options, eligibility for low-risk medicine notification, authorized dietary supplement ingredients, and cosmetic substance restrictions. Stakeholders should coordinate cross-functional reviews to update regulatory filings, labeling practices, and supply chain controls to ensure continued compliance with ANVISA regulations. 

As regulatory updates become more frequent and complex across multiple product categories, organizations may benefit from centralized intelligence and automation to stay ahead of changes. 

RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors, including consumer products and life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely predictive actionable insights and end-to-end automation, streamlining compliance processes, mitigating risks, and accelerating market access across more than 160 countries. Learn more or book a demo now. 

FAQs

What COVID-19 strains are permitted under the updated ANVISA guidance? 

COVID-19 vaccines may include either the LP.8.1 or JN.1 viral strains, with final selection determined by the Ministry of Health. 

Which medicines qualify for simplified notification in Brazil? 

Povidone-iodine, paracetamol, simethicone, and bismuth subsalicylate are now eligible for simplified notification as low-risk medicines prior to commercialization. 

What new ingredients are authorized for dietary supplements? 

Authorized ingredients include Baru nut oil, microalgae oil with DHA (Schizochytrium sp.), lyophilized açaí concentrate, Bifidobacterium animalis subsp. lactis, and Streptococcus salivarius K12, subject to usage limits and labeling requirements. 

How can RegASK help with TITCK compliance updates? 

RegASK helps organizations track regulatory changes in real time, assess product impact, and streamline compliance workflows, enabling faster adaptation to updates such as vaccine composition changes, ingredient authorizations, and product restrictions in Brazil.