The Senate approved today (12) a bill (PL) that regulates the electronic drug leaflet. With this, laboratories must insert a QR Code on the packaging of medicines to access the digital version of the package insert, with information on its composition, usefulness, dosages and its contraindications. The project goes to presidential sanction.
The digital package inserts must be hosted on links authorized by the National Health Surveillance Agency (Anvisa) and the laboratory may insert other information, in addition to the complete and updated content, identical to the printed package insert. The format must be easy to read and understand and must allow converting the text into audio and/or video using an appropriate application.
The project does not provide for the end of the printed leaflet, which comes with the drug, in the packaging. If sanctioned by the President of the Republic, the law will enter into force immediately after its publication. “We agree with the author of the project, according to which a digital version of the leaflet can contain more details, being more explanatory, in addition to allowing the use of multimedia resources – which will bring accessibility to people with disabilities – and to enable paper savings” , argued the bill’s rapporteur in the Senate, Nelsinho Trad (PSD-MS).
*With information from the Senate Agency
