Brazil regulates digital leaflet with QR Code on medicines; understand

Brazil approved, this Thursday (12), a new law that provides for the inclusion of the digital package insert on medication packaging. The virtual document can be accessed through a QR Code, printed on the medicine box by the responsible pharmacist. The measure aims to simplify access to formula details.

Published in the Federal Official Gazette (DOU), Law No. 14,338/22 causes an important transformation in terms of accessibility of medication package inserts. That’s because applications will be able to transform the text into audio, which will allow visually impaired and illiterate people to understand the package insert.

Medicines must also receive a virtual package insert with a QR Code in Brazil, according to the new law (Image: Rido81/Envato Elements)

In addition, the QR Code can direct the patient to links and other explanatory documents about the product, as a complement to the traditional package insert.

What should be included in the medicine’s digital package insert?

According to the text of the law, the digital leaflet must contain “complete and updated content, identical to the printed leaflet”. This means that, in the text, the composition, usefulness, dosages and contraindications of each medication must be included.

The text also provides that digital package inserts must be hosted on links authorized by the National Health Surveillance Agency (Anvisa). The measure aims to guarantee a degree of authenticity and greater reliability to the document.

Is the physical version over in Brazil?

It is important to explain that the new measure is a complementary strategy, that is, the digital package insert does not exclude the obligation of the printed version, which comes with the medicine, on the packaging. In this way, the decision does not affect people who do not have access to the internet or who have difficulties using technology.

“The inclusion of information in digital format by the competent federal health surveillance agency or by the holder of the product registration in a single format will not replace the need for its presentation also in printed leaflet format”, explains the law.

Source: Agência Brasil and DOU

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