Medicines on the Shelf and in the Palm of Your Hand: Anvisa to Regulate Dispensing in Supermarkets and Digital Platforms

On March 23, 2026, Law No. 15,357/2026 was enacted without any restrictions or vetoes, introducing significant changes to Article 6 of Law No. 5,991/1973, the legal framework governing the health surveillance control of drug commerce in Brazil.

The new law added paragraphs to that Article 6, with two main objectives: (i) authorizing the sale of medicines in supermarkets; and (ii) allowing pharmacies to contract digital channels and e-commerce platforms for logistics and delivery activities to the end consumer.

Sale of medicines in supermarkets

The sale of medicines in supermarkets is not a new topic in Brazil’s regulatory debate. Since the enactment of Law No. 5,991/1973, dispensing medicines has been an activity restricted to pharmacies and drugstores, subject to health licensing and the technical responsibility of a licensed pharmacist.

Attempts to relax this rule occurred throughout the 1990s. Provisional Measure No. 1,027/1995 went so far as to include supermarkets among the establishments authorized to dispense medicines, but the measure was later revoked, restoring the 1973 regime.

Law No. 15,357/2026 revisits the issue from a new perspective. The approved text authorizes the sale of medicines in supermarkets, including those subject to medical prescription and special control, provided the same health requirements already imposed on pharmacies are met — which makes sense from the standpoint of equal treatment between both activities and consumer safety.

The rule preserves the principle that medicines should not be indiscriminately mixed with other consumer goods. The pharmaceutical activity must be carried out in its own physical space within the supermarket — delimited, segregated, and exclusive — so as to operate with functional and health autonomy from the establishment’s other commercial activities.

From a regulatory standpoint, it is worth noting that Anvisa’s RDC No. 44/2009 already allowed pharmacies to be installed inside commercial establishments, including supermarkets, provided legal, tax, and operational independence between the activities was maintained.

The innovation brought by Law No. 15,357/2026 lies precisely in allowing the supermarket to operate the pharmaceutical dispensing under the same corporate taxpayer registration (CNPJ), without the need for an autonomous branch. Even so, the health requirements already applicable to independent pharmacies remain unchanged, meaning supermarkets will have to meet those requirements if they wish to offer medicines to their customers.

Digital channels and e-commerce platforms

Another relevant change lies in the new paragraph 6 of Article 6 of Law No. 5,991/1973, under which “pharmacies and drugstores may contract digital channels and e-commerce platforms for logistics and delivery purposes to the consumer, provided full compliance with applicable health regulations is ensured.”

This innovation is genuinely beneficial for consumers and pharmacies, which until now could only offer medicines through a website belonging exclusively to the pharmacy itself — a limitation for small pharmacists and an advantage for large chains. Seventeen years after the restriction established by Anvisa, reality has caught up, and the rule that provided for it deserves review.

Digital platforms have specialized in helping companies promote and deliver their products, providing payment methods, intermediation tools, and logistics services — elements of the supply chain that pharmacies, particularly those not part of large chains, cannot do without. This innovation benefits pharmacies themselves, which expand their service channels, and consumers, whether through greater competition or wider territorial reach.

The innovation brought by Law No. 15,357/2026, however, does not turn the digital platform into a pharmaceutical establishment, nor does it transfer to the platform the responsibilities inherent to dispensing, which remain tied to pharmacies.

Marketplace, logistics, and operating models

The wording adopted in paragraph 6, however, has been distorted by those who reject the innovation. The law expressly states that pharmacies may contract digital channels and e-commerce platforms “for logistics and delivery purposes to the consumer.” Some market players suggest that pharmacies could not advertise their products on the digital platform, arguing that this possibility is not provided for in the letter of the law.

However, this interpretation seems to us maliciously biased, not to say entirely mistaken. The legislator’s choice to expressly mention e-commerce platforms (marketplaces) requires recognizing that digital environments are fully permitted in remote dispensing. It would be conceptually contradictory to allow the contracting of an e-commerce platform solely for the logistics stage, emptying out its essential function of intermediation and facilitation of payments, promotion, and offering to meet demand.

The new rule, however, does not turn the marketplace into a pharmacy, nor does it authorize the platform to take on the role of dispenser or evaluator of prescriptions: the provision allows a licensed pharmacy to use third-party digital infrastructure to reach the consumer within a marketplace environment, but — to reiterate — the pharmacy remains fully responsible for dispensing.

Physical segregation and digital segregation

The new law explicitly reaffirms the need for physical segregation of the pharmaceutical activity within the supermarket. It seems to us that this regulatory logic tends to be replicated in the digital environment as well.

Just as medicines cannot be displayed indiscriminately alongside other products in the supermarket’s physical space, it seems to us that Anvisa will indicate that they should also not be presented indiscriminately in digital environments.

In practice, this means marketplaces will need to structure their interfaces to ensure (i) identification of the pharmacy responsible for dispensing; (ii) the link between the offer and a licensed establishment; (iii) the availability of information about the responsible pharmacist; and (iv) the availability of pharmaceutical assistance channels for the consumer.

Anvisa’s regulatory response

On August 10, 2026, the Agency published in the Federal Official Gazette acts revoking enforcement measures that had banned the sale and advertising of medicines on e-commerce platforms. As far as can be ascertained, those measures were taken in compliance with Law No. 15,357/2026, which no longer restricts the e-commerce sale of medicines through digital platforms.

This revocation, however, should be understood as part of a transition period, not a total liberalization. The law no longer allows banning digital platforms from participating in this market, but it does not eliminate the safeguards pharmacies have always adopted to ensure that digital dispensing takes place correctly and responsibly, which stem from another rule — Law No. 5,991/1973 — that remains fully in force.

Next steps: from legal authorization to health regulation

The scenario introduced by Law No. 15,357/2026 does not appear to be, and Anvisa warns that it will not be, one of unrestricted liberalization, but rather one of modernizing the model while preserving the health safeguards that have historically structured drug dispensing in the country, which are primarily aimed at promoting the rational use of medicines.

The next step will be precisely to align Anvisa’s regulations with this new legal regime, in order to delimit the responsibilities of the different parties involved and reconcile the new legal mandate with health rules.

At a meeting held yesterday, August 19, 2026, Anvisa’s Collegiate Board unanimously approved the Proposal to Open an Administrative Regulatory Process, including the topic in its biannual Regulatory Agenda (2026-2027).

The decision waived a prior Regulatory Impact Analysis (RIA) on the grounds that it “is a normative act intended to regulate rights or obligations defined in a higher-ranking rule that does not allow, technically or legally, for different regulatory alternatives.”

At this point, it seems to us that the Agency did not make the best judgment, on the premise that there are indeed regulatory nuances for which an impact study would certainly be quite instructive, bringing regulators the nuance the topic surely deserves.

It is hoped that the new regulation will be built to regulate the activity in an adequate and responsible manner, and not render the law’s intent a dead letter, however extensive the requirements that may end up being created. It is hoped that the guardrails will be developed to point out responsibilities, curb abuses, and ensure that dispensing is done correctly.

It is worth participating in the drafting of this rule, once it is opened for public consultation, to ensure that consumers benefit from the innovation, fostering healthy and fair competition.

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This material is provided for informational purposes only and should not be relied upon solely for decision-making. Specific legal advice may be provided by one of our attorneys. Copyright is reserved by KESTENER VIEIRA TORRONTEGUY SPEGIORIN ADVOGADOS.