Brazil requires drug makers to add QR codes in package inserts and implement traceability systems

A new law was enacted in Brazil on May 12, 2022 (Law No. 14,338/2022) requiring that medicine package inserts will have to be provided in digital format, in addition to the existing written format. The law will require that a QR code be included in package inserts in all drugs for the purpose of allowing consumers to have access to the information in digital format. The purpose of the package insert (also known as “prescription drug product insert” or “professional labeling”) is to provide detailed drug information compiled and distributed by the drug manufacturer.

Under the new regulations in Brazil, a QR code will need to have the exact same and updated information as the written drug package insert that accompanies the drugs in question. Such information includes the composition (ingredients and quantities), use, dosage, contraindications, license information and expiration date. Other information can also be included in the digital package inserts, such as links and other informative documents about the drug. The digital format of the package insert should also facilitate a consumer’s ability to read and understand the information, and the digital format should also provide the option to convert the text into audio and/or video.

A digital package insert will be accessible through a database authorized by the Brazilian National Health Surveillance Agency (ANVISA), and the existence of a digital package insert does not eliminate the need to have a written package insert in each drug package.

The new law has also changed the rules related to the traceability of drugs. The law provides that the party responsible for registering the drug should have a system that allows for the tracking of the distribution of the drugs, identifying the amounts sold as well as the distribution of each lot, and the recipients of the drugs. The distribution map of the drugs, as well as the drug packaging, should provide the drug´s lot number, manufacturing date, and expiration date.

The new rules will be effective according to a schedule that will be defined by ANVISA. ANVISA may also provide exceptions to the rule, and permit some drug manufacturers to only include either digital or written drug package inserts.

Please do not hesitate to contact us to receive more information about this new law and any questions you may have with respect to conducting business in Brazil or across Latin America.

 

Authored by Mariana Vasques Soares de Campos Matos.

 

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