The National Health Surveillance Agency (Anvisa) notified Mercado Livre after the company announced plans to create its own pharmacy to operate on its marketplace, aiming to sell medicines and other items subject to online health surveillance. This news was initially reported by Folha de S.Paulo and later confirmed by g1 this Tuesday, the 29th.
The agency's notification requires Mercado Livre to provide details on the company's compliance to carry out such an activity, covering adherence to all sanitary requirements pertinent to pharmacies and drugstores. Anvisa emphasized that, as of now, there is no established regulation allowing marketplaces to act as intermediaries in the sale of medicines.
Documentation and Procedures Requested
Among the requested documents are the identification and address of the company responsible for the pharmacy, the operating authorization issued by Anvisa itself, the sanitary permit, and the identification of the responsible technical pharmacist. Furthermore, the agency asked for detailed information on the methods used to verify medical prescriptions and the guidelines adopted for the storage and transport of pharmaceuticals.
Mercado Livre has a deadline of three business days, counted from receipt of the notification, to present all requested clarifications and documents, with the final deadline being this Thursday, the 1st.
Abrafarma's Intervention
The announcement also generated a statement from the Brazilian Association of Pharmacy and Drugstore Networks (Abrafarma), which contacted Anvisa. Through an official letter dated September 25th, the entity requested urgent clarification regarding the sanitary situation of the model proposed by Mercado Livre.
Anvisa informed that this action is part of its inspection activities, without linking the initiative to the document presented by Abrafarma. In the letter, the association mentioned having become aware of Mercado Livre's intention to integrate pharmacy networks into the marketplace under a format known as 3P, where third-party establishments sell their products on the platform.
Abrafarma argued that the announcement raised doubts, given that Anvisa had previously communicated that recent legislative changes do not imply automatic permission for digital platforms to commercialize pharmaceutical products. According to the document, in August, the agency had warned that the application of the new rule would depend on specific regulation, and that the practical effects of the legal authorization for the use of digital channels and e-commerce platforms would only occur after these norms were supplemented by Anvisa.
The entity also recalled that a regulatory process is underway to define the sanitary requirements for this type of operation, covering topics such as traceability, technical responsibility, and the limits of operation for digital platforms.
Abrafarma's Questions About the Business Model
Among the questions directed at the agency, Abrafarma inquired whether the sale of medicines by third-party pharmacies and drugstores integrated into a marketplace is already permitted before the completion of the regulation. The association also sought clarification on the possibility of a platform participating in phases such as product display, searching, selection, purchase intermediation, or execution of medicine transactions before the publication of the new rules.
Another issue raised was what measures would be taken if this model was not authorized at the time, and whether the participation of duly licensed pharmacies would be sufficient to change the understanding that the operation depends on specific regulation. Despite this, Abrafarma stated it does not oppose the use of technology or new logistics and delivery models in the pharmaceutical retail sector, advocating only that such changes be implemented respecting sanitary standards, ensuring legal certainty, and equality among companies in the sector.
Mercado Livre's Position
In an official note, Mercado Livre stated that it had not received any notification or information regarding the mentioned letter so far. The company assured that it complies with current regulations and prioritizes user safety. According to Mercado Livre, the foray into medicine sales will follow this same course of conduct. The company also highlighted that its products have full traceability, with control over origin and validity, and that it maintains contact with Anvisa and other entities to collaborate on regulatory adaptation.
The company had previously announced its intention to sell prescription medicines, including antibiotics and weight loss remedies, through its own pharmacy, and its plan includes the inclusion of pharmacy networks on the platform. Thus, the debate occurs while Anvisa finalizes the specific regulation for the operation of digital channels and e-commerce platforms in the logistics and delivery of medicines.