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Home > Brazil approves pilot project for digital package leaflets
July 20, 2024
The National Health Surveillance Agency (Anvisa) has approved the implementation of a pilot project for digital package leaflets in Brazil. The proposal is to include a two-dimensional barcode (QR Code) for quick reading on the packaging of certain medicines.
As well as directing you to the medicine’s digital package leaflet, the QR Code printed on the packaging will also give you access to other information, such as videos and instructions to help you use the medicine properly.
During the project, which will last until December 31, 2026, information will be collected and monitored which should serve as a basis for future definitive regulation of the digital package leaflet, according to Anvisa.
According to Anvisa director Daniel Pereira, the proposal to implement the digital package leaflet in Brazil is in line with the modernization and digital transformation actions in the health sector and also with the global trend. “This is the first step in the transition from paper to electronic information on medicines and an opportunity to improve the accessibility and personalization of health information,” says Pereira.
Initially, digital package leaflets will be allowed for the following types of medicines:
In a statement, Anvisa reinforced that even in cases where digital package leaflets are allowed, printed versions must be offered if requested by patients or health professionals. The regulation also stipulates that establishments that sell medicines must inform people, by means of visual communication, of the possibility of requesting the printed package leaflet.
The digital package leaflet proposal approved by Anvisa underwent a public consultation (CP 1.224/2023) between December 2023 and March 2024. The initiative is provided for in Law 14.338 sanctioned on May 12, 2022, which provides for the creation of the federal government’s National Medicines Control System, whose purpose is to monitor medicines throughout the production chain, from manufacture to consumption by the population.
The digital package leaflets must be hosted on websites authorized by the competent federal health surveillance authority, and the respective laboratories will be able to insert information in addition to the complete and up-to-date content identical to that of the printed package leaflet. The format must be easy to read and understand and allow the text to be converted into audio and/or video using an appropriate application. Laboratories will also have to maintain a system for drawing up drug distribution maps to identify batches and recipients of drug shipments.
The European Commission is leaving it up to each country to decide whether the package leaflet will have an electronic format, a paper format or both. A reformulation of the regulatory framework presented by the European Commission on April 26, 2023 for pharmaceutical products gives the option of maintaining, in principle, the electronic format of the package leaflet. However, a paper version of the package leaflet will have to be guaranteed on request and at no extra cost to those interested.
According to the Wall Street Journal, a bill going through the US Congress could reverse the rules that require paper package leaflets. Proponents of the bill argue that medical professionals only consult package leaflets and do so using the most up-to-date electronic versions. Proponents of paper package leaflets, on the other hand, say that they are consulted often enough and help to ensure that medicines are used properly.
The newspaper points out that if the United States were to follow Japan and other countries that have already adopted the digital package leaflet, around 90 billion sheets of paper could be saved every year, according to estimates by the Environmental Paper Network. This is equivalent to more than 3.8 million metric tons of emissions from the production and disposal of paper, or around 10.9 million trees.
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