Introduction
On August 19, 2026, the Board of Directors of the Brazilian Health Regulatory Agency (ANVISA) unanimously approved the opening of a regulatory process to establish the health rules applicable to the engagement of digital platforms and marketplaces by pharmacies and drugstores for the logistics and delivery of medicines to consumers. The decision marks the beginning of the regulation of §6 of Article 6 of Law No. 5,991/1973, as introduced by Law No. 15,357/2026, and will directly impact pharmacies, drugstores, e-commerce platforms, and logistics companies. The matter is going to be reported by Director Daniel Meirelles Fernandes Pereira.
Legislative Background
Law No. 15,357/2026 amended Law No. 5,991/1973 — which governs the health control of the trade of drugs, pharmaceutical inputs, and related products — to, among other innovations, add §6 to Article 6, which reads as follows:
“§ 6 Pharmacies and drugstores, duly licensed and registered with the competent authorities, may engage digital channels and e-commerce platforms for the logistics and delivery of medicines to consumers, provided that full compliance with the applicable health regulations is ensured.”
The legislative innovation originated from Bill No. 2,158/2023, initially aimed at regulating the sale of medicines in pharmacies located within supermarkets. The provision regarding digital platforms was introduced during the bill’s consideration by the Chamber of Deputies. Law No. 15,357/2026 also introduced other relevant changes, such as authorizing the installation of pharmacies within supermarket sales areas (§2) and requiring the presence of a pharmacist during all operating hours (§3).
What Was Decided
The Board of Directors resolved to:
- Open a regulatory administrative process to draft a regulation addressing the health aspects arising from the participation of digital platforms and e-commerce channels in the delivery of medicines;
- Waive the Regulatory Impact Analysis (RIA), pursuant to Article 19 of Ordinance No. 162/2021, on the grounds that the regulation is intended to implement rights and obligations already established by a hierarchically superior legal provision, leaving no meaningful room for alternative regulatory approaches; and
- Submit the future regulatory proposal to a public consultation, to ensure broad participation of stakeholders in the development of the regulation.
Key Rationale
- The Federal Attorney’s Office at ANVISA concluded (Note No. 4/2026) that §6 of Article 6 constitutes a provision of limited effectiveness, the full implementation of which depends on health regulation not yet enacted;
- ANVISA identified approximately 200,000 irregular advertisements for products subject to health surveillance in digital environments between 2022 and 2024;
- The absence of specific regulatory rules creates uncertainties regarding the allocation of responsibilities, the traceability of operations, and the maintenance of health standards during transportation and delivery.
Topics to Be Addressed by the Regulation
As indicated in the rapporteur’s vote and the statements of the other directors, the future regulation will need to address, among others, the following issues:
- Allocation of responsibilities among the agents involved (pharmacies, drugstores, digital platforms);
- Preservation of the pharmacy’s technical responsibility for dispensation;
- Electronic traceability of transactions;
- Health requirements applicable to the transportation and delivery of medicines;
- Provision of pharmaceutical care through digital means;
- Secure identification of the recipient;
- Protection of users’ health information;
- Rules applicable to controlled medicines; and
- Oversight mechanisms for the digital environment.
Next Steps
ANVISA is expected to prepare a draft regulation for submission to public consultation as soon as possible. The Board of Directors emphasized the need for swift processing, given the relevance of the matter and the legitimate expectations of the various stakeholders affected. No specific deadline has been set for the publication of the public consultation.
Additionally, the Reporting Director noted that ANVISA should assess, in due course, the need to regulate other provisions introduced by Law No. 15,357/2026, particularly those related to the installation of pharmacies within supermarket sales areas — a matter that falls outside the scope of the current proceeding.
Impacts on the Industry
The decision directly affects pharmacies and drugstores, digital platforms and marketplaces, logistics and delivery companies, and all players in the medicine commercialization and distribution chain.