{"id":5038,"date":"2026-09-14T10:00:10","date_gmt":"2026-09-14T13:00:10","guid":{"rendered":"https:\/\/feadv.com.br\/?p=5038"},"modified":"2026-09-09T14:03:44","modified_gmt":"2026-09-09T17:03:44","slug":"pharmacies-marketplaces-and-medicines-anvisa-opens-process-to-regulate-digital-operations","status":"publish","type":"post","link":"https:\/\/feadv.com.br\/en\/farmacias-marketplaces-e-medicamentos-anvisa-abre-processo-para-regular-as-operacoes-digitais\/","title":{"rendered":"Pharmacies, marketplaces, and medicines: Anvisa opens process to regulate digital operations"},"content":{"rendered":"
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The sanction of Law No. 15,357\/2026 introduced a structural change in the sector: pharmacies and drugstores are now allowed to contract digital platforms for logistics and medication delivery purposes to the final consumer. The rule amended Law No. 5,991\/1973, adding paragraph 6 to its Article 6, and signaled that the e-commerce of medications has reached the center of the Brazilian regulatory agenda.<\/span><\/p>

The market moved quickly. In August 2026, Anvisa revoked the bans on the sale and advertising of medications on platforms such as iFood, Rappi, Mercado Livre, Submarino, Americanas, and Shopee\u00b9 <\/span>through Specific Resolutions REs Nos. 3,139\/2026 to 3,142\/2026 and RE No. 3,056\/2026. The agency, however, was explicit in clarifying that the revocations did not constitute automatic authorization for commercialization: the operation of these channels still depends on specific regulations that have not yet been issued.<\/span><\/p>

The regulatory vacuum, therefore, remains. And this is the scenario that Anvisa has committed to addressing.\u00a0<\/span><\/p>

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The opening of the regulatory process<\/b><\/h3>

On August 19, 2026, at the 15th Ordinary Public Meeting of the Collegiate Board of Directors, Anvisa decided to open an administrative proceeding to regulate the contracting by pharmacies and drugstores of digital channels and e-commerce platforms for the purpose of logistics and drug delivery.<\/span><\/p>

According to statements by Daniel Pereira, director of Anvisa, a public consultation for debate and contributions on the subject should soon be opened\u00b2<\/span>.<\/span><\/p>

For the pharmaceutical and e-commerce sectors, the initiative is welcome. The expectation is that the regulation will provide predictability to operations and, at the same time, establish safeguards for consumer protection.<\/span><\/p>

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Four challenges the standard will have to face<\/b><\/h3>

The architecture of this regulation is complex. Anvisa will need to arbitrate the interests of multiple stakeholders and regulate operational flows involving health, logistics, data, and advertising. The main outstanding points are:<\/span><\/p>


Logistics architecture and remote dispensing<\/b><\/p>

It is still uncertain how the sanitary operation between pharmacies and digital platforms will be structured. The regulation will need to define the boundaries of marketplace activities, review remote dispensing procedures (with special attention to specially controlled medications), define the pharmacist's role in digital care, and establish clear rules for the transport and storage of products.

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Distribution of responsibilities among the agents<\/b><\/p>

Many operational flows may be assigned simultaneously to pharmacies and platforms, such as product traceability, storage, and advertising. The precise definition of each party's responsibilities will be essential to ensure regulatory compliance and reduce litigation among those involved.

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Sensitive personal data protection<\/b><\/p>

The digital intermediation of sales implies the processing of health-related data: medical prescriptions, purchase history, and patient information. The regulation must outline data flows between pharmacies, platforms, and delivery providers in compliance with the General Personal Data Protection Law (LGPD), imposing clear obligations of data minimization and purpose limitation in processing.

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Combating illegal trade<\/b><\/p>

The expansion of digital channels demands effective control mechanisms to prevent the offering of medications by unauthorized establishments or products without a traceable origin. The regulation may establish criteria for the identification and qualification of participating pharmacies, in addition to procedures for tracking deliveries and swift removal of illicit advertisements.<\/span><\/p>

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The balance between innovation and health control<\/b><\/h3>

The regulation under construction will have a dual mandate: to stimulate the modernization of the sector and preserve the sanitary rigor that characterizes the commercialization of medicines.<\/span><\/p>

This balance is not trivial. The marketplace business model was designed for scale and speed, while medication dispensing requires traceability protocols, prescription verification, and quality control that do not fit, without adaptation, into the logic of generalist platforms.<\/span><\/p>

The public consultation that Anvisa will soon open will be the central opportunity for pharmacies, digital platforms, the pharmaceutical industry, and other stakeholders to actively contribute to the shaping of these rules. Qualified participation in this process can be decisive for the final regulation to reflect the operational reality of the sector.<\/span><\/p>

\u00a0<\/p>

Regulation of Medicines on Digital Platforms: Essential Points<\/b><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Does the revocation of sales bans on platforms already authorize the commercialization of medicines? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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No. Anvisa was explicit in stating that the 2026 revocations eliminated previous bans, but they do not constitute an operational authorization. The sale of medications on marketplaces remains conditioned upon the issuance of specific regulations still pending publication.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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What are the main legal risks for pharmacies and platforms operating without regulation? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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The absence of specific regulations creates uncertainty regarding the delimitation of responsibilities in issues such as traceability, remote dispensing, and the processing of consumers' sensitive data, exposing stakeholders to health, regulatory, and LGPD compliance risks.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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How can the industry influence the regulation being developed by Anvisa? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Anvisa must open a public consultation before issuing the regulation. This is the appropriate institutional channel for pharmacies, platforms, and the pharmaceutical industry to submit technical and operational contributions that inform the final regulatory design.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Life Sciences and Healthcare<\/b><\/h3>

The Life Sciences and Healthcare practice of <\/span>Fialdini Einsfeld Advogados (FEADV)<\/b> advises pharmacies, drugstores, digital platforms, and companies in the pharmaceutical sector on monitoring ongoing regulatory processes at Anvisa, analyzing contracts with digital channels, and structuring operational models that comply with health regulations and data protection standards. Follow the upcoming developments on the subject.<\/span><\/p>

\u00a0<\/p>

References<\/b><\/h4>

\u00b9 Resolutions No. 3,139\/2026, No. 3,140\/2026, No. 3,141\/2026, No. 3,142\/2026, and No. 3,056\/2026.\u00a0

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\u00b2 FUTURE OF HEALTH.<\/b> Anvisa approves opening of marketplace regulation. <\/span>Future of Health<\/span><\/i>, 2026. Available from: <\/span>https:\/\/futurodasaude.com.br\/anvisa-aprova-abertura-de-regulacao-de-marketplaces\/<\/span><\/a><\/span>. Accessed on: Aug. 28, 2026.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

The sale of medicines on digital platforms brings new opportunities, but Anvisa's regulation will still need to clarify the limits of operation and regulatory risks for pharmacies and marketplaces. <\/p>","protected":false},"author":13,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[32],"tags":[47,48,36,40],"ppma_author":[34],"class_list":["post-5038","post","type-post","status-publish","format-standard","hentry","category-life-sciences-e-healthcare","tag-anvisa","tag-comercio-eletronico","tag-direito-sanitario","tag-life-sciences"],"acf":[],"yoast_head":"\nFarm\u00e1cias, marketplaces e medicamentos: Anvisa abre processo para regular as opera\u00e7\u00f5es digitais - Fialdini Einsfeld Advogados<\/title>\n<meta name=\"description\" content=\"A Anvisa abriu processo para regulamentar a venda de medicamentos em marketplaces. 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