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Anvisa approves pilot project for digital drug leaflets

The collegiate board of the National Health Surveillance Agency (Anvisa) approved this Wednesday (10) the pilot project for the implementation of the digital medicine package insert in Brazil.

A The proposal is that a two-dimensional barcode (QR Code) for quick reading be included on the packaging of specific medicines.

The project will be valid until December 31, 2026. The information collected and monitored during the period, according to Anvisa, should serve as a subsidy for future definitive regulation of the digital package insert.

In his vote, the rapporteur director Daniel Pereira assessed that the proposal to implement the digital package insert in Brazil moves in the direction of modernization and digital transformation in the health sector and is in line with the global trend.

“It is the first step towards beginning the transition from paper-based to electronic information about medicines, and it creates an opportunity to improve the accessibility and personalization of health information,” he said.


In addition to directing the user to the medication’s digital leaflet, the QR Code available on medication packaging will also allow access to additional information, such as videos and other instructions that help with the proper use of the medication.

At this first stage, digital leaflets will be permitted for the following types of medications:

  • free medicine sample packaging: free samples can only be delivered by the healthcare professional to the patient during a consultation, with the appropriate prescription for use and instructions relevant to each treatment;
  • medicines intended for health establishments, except pharmacies and drugstores: permitted for sale in hospitals, clinics, outpatient clinics and home care services, for example, were selected because they are used under the supervision of health professionals;
  • Over-the-counter medication (OTC), sold in multiple packages: these are low-risk products that currently have the right to be sold on pharmacy shelves in primary packaging (e.g. blister packs) without accompanying leaflets. If the consumer wants the physical leaflet, they can request it from the establishment;
  • medicines intended for government use, packaged in packaging bearing the Ministry of Health’s own government brands: current legislation already largely exempts the requirement for printed leaflets on packaging. As with OTCs, there has already been a considerable reduction in the availability of physical leaflets.

Printed leaflet

In a note, Anvisa reinforced that, even in cases where the implementation of the digital package insert is permitted, printed package inserts must be offered if requested by patients or healthcare professionals.

The approved standard also requires establishments that sell medicines to inform consumers, through visual communication, about the possibility of requesting a printed leaflet, with the following sentence: “Attention: This establishment dispenses medicines with a digital leaflet! You can access it online. If you prefer, request the printed leaflet from one of our attendants.”

Public consultation

The discussion about digital leaflets arose after the publication of the Law 14.338/22which determines that the health authority can define which medicines will have only one package insert format.

The proposal approved this Wednesday by Anvisa went through public consultation between December 2023 and March 2024.

Information from Agência Brasil

Source: CNN Brasil

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