Anvisa Clarifies Limits on the Use of Retail Pharmacy Brands in Medicines
On October 29, 2026, the Brazilian Health Regulatory Agency (Anvisa) published Technical Note No. 42/2026/SEI/CBRES/GGMED/DIRE2/ANVISA, clarifying the scope of the prohibition on the use of brands associated with pharmacy and drugstore chains on medicine packaging and package inserts.
The document was issued in response to questions raised by the Ministry of Health’s Secretariat of Science, Technology, and Innovation regarding the participation of retail pharmacy chains in companies authorized to engage in pharmaceutical manufacturing activities. The consultation sought clarification on the limits of such arrangements in which medicines are marketed under brands linked to retail chains. The main conclusions are summarized below.
Prohibition Extends to Private-Label and Exclusive Brands
The discussion centers on Article 8 of RDC No. 768/2022, which provides that a medicine’s identification on packaging and package inserts may not incorporate distinctive signs of establishments engaged solely in the sale or dispensing of medicines. The restriction covers corporate names, trademarks, logos, and visual identity elements, including those of pharmacies and drugstores.
In interpreting this provision, Anvisa distinguishes between two business models: (i) private-label brands, which are owned by or otherwise associated with a pharmacy or drugstore chain, and (ii) exclusive brands, which belong to the marketing authorization holder but are contractually designated for sale through a specific retail chain. According to the Agency, both models fall within the scope of the prohibition where the product’s presentation leads consumers to associate the brand with the retail chain.
The analysis therefore goes beyond determining trademark ownership. The key consideration is whether the product presentation creates an association between the medicine and the retail chain. Accordingly, the use of a separate legal entity or an exclusivity arrangement does not, in itself, remove the application of the prohibition.
Anvisa bases this interpretation on the need to make clear who is responsible for the medicine and to prevent consumer confidence in the retail chain from being transferred to the product or influencing purchasing decisions at the point of dispensing. In support of this position, the Agency cites the sole paragraph of Article 3 of Law No. 15,279/2025, which prohibits the sale or dispensing of medicines bearing trademarks or signs linked to companies that are not authorized to operate as pharmaceutical manufacturers.
Registration of Clone Medicines Cannot Be Used to Circumvent Private-Label Restrictions
Anvisa also examined the simplified registration pathway for medicines commonly known as “clones.” The Agency emphasized that this mechanism serves a specific regulatory purpose and is not intended as a means of circumventing restrictions applicable to retail-linked brands.
Under this pathway, registration is based on a reference product and permits changes only to certain defined elements, namely the product name, labeling, sales designation, and legal statements contained in the package insert. RDC No. 954/2024 limited access to this pathway, as a general rule, to companies belonging to the same economic group as the holder of the reference product registration. Specific exceptions remain available for Productive Development Partnerships, the Local Development and Innovation Program, and technology transfer arrangements between public and private partners. According to the Technical Note, these restrictions are intended to strengthen quality control, pharmacovigilance, and traceability.
Why Does This Matter? Industry Impacts and Risk Assessment
For pharmaceutical manufacturers, marketing authorization holders, and retail pharmacy chains, the main practical takeaway is that the assessment of a commercial model must extend beyond corporate documentation and trademark ownership.
Contracts, marketing authorizations, product labeling, and commercial practices should be reviewed together to identify any elements that could lead consumers to perceive the medicine as a product of the retail chain.
Attention should be paid to exclusivity and licensing arrangements, corporate links between the parties, and the visual presentation of the products. The formal validity of these arrangements does not eliminate the risk of regulatory scrutiny if the presentation of the medicine creates, in the eyes of consumers, a connection with the pharmacy or drugstore chain. Commercial exclusivity should therefore be assessed in the broader context of brand presentation rather than as an isolated factor.
The Life Sciences & Healthcare Team at Souto Correa Advogados remains available to clarify any questions regarding this matter.olado.