ANVISA publishes Public Consultation on digital labels for medicines
On December 13, 2023, Anvisa opened the Public Consultation 1,224/2023, about the draft of new regulation for transitional guidelines for providing labels in digital format and dispensing printed labels on the packaging of certain medicines.
This proposal, approved during Anvisa’s Board of Directors Meeting # 20/2023, is part of the 2021-2023 Regulatory Agenda and will extend to 2024-2025 due to its complexity and the need for participation of society and the related economic sector.
In a nutshell, the measure proposes the creation of a pilot project aimed at providing an environment for experimentation and learning with subsequent phases, whose progressive approach will enable a gradual and in-depth analysis of the regulatory impacts as the project develops.
Background
In May 2022, Federal Law 14.338/2022 was published, amending the Federal Law 11.903/2009 to provide for digital labels for medicines.
This amendment delegated to Anvisa the possibility of defining which medicines will only have one label format, as well as the inclusion of a two-dimensional barcode (QR Code) for quick scanning. It also conditioned the use of the link for accessing the digital label on Anvisa’s prior approval.
The draft of the new regulation describes that, in addition to directing the user to the medicine’s digital label, the link will allow access to additional information, such as videos and instructions for use.
The project was characterized as a regulatory sandbox, which defines an experimental environment in a controlled manner and prior to final regulation, which will include debates, meetings, and broad social participation.
Anvisa’s Board of Directors (“DICOL”) highlighted that there is limited knowledge about the effects of removing the printed label and that evidence is scarce, reason why it is important to widely disseminate information and obtain data on the potential impact of the measure.
DICOL also recognized the importance of new initiatives to improve the label and information focused on the needs of patients and healthcare professionals, such as the “availability of comprehensive information on demand, interactive elements that lead to better patient education and the removal of the language barrier in the dissemination of scientific and medical information”.
Next steps
The Public Consultation will be open for contributions for a period of 90 days, from December 20, 2023, to March 19, 2024.
The submission file can be accessed at this link and the draft of the new regulation can be accessed here (Portuguese version).
After society’s contributions, the issue will return for final consideration by DICOL.
Our Life Sciences & Healthcare team is available if you have any questions about the topic and its possible developments via e-mail: lifesciences@soutocorrea.com.br.