[author: Mariana Vasques Soares de Campos Matos]
A new law was enacted in Brazil on May 12, 2022 (Law No. 14,338/2022) requiring drug package inserts to be provided in digital format, in addition to the existing written format. The law will require that a QR code be included in the leaflets of all medicines in order to allow consumers to have access to the information in digital form. The purpose of the Package Insert (also known as a “Prescription Drug Product Leaflet” or “Professional Labeling”) is to provide detailed information about the drug compiled and distributed by the drug manufacturer.
Under the new regulations in Brazil, a QR code will have to contain exactly the same information and updates as the written medicine leaflet that accompanies the medicines in question. Such information understand composition (ingredients and quantities), use, dosage, contraindications, license information and expiration date. Other information may also be included in the digital leaflets, such as links and other informational materials about the medicine. The digital format of the leaflet should also facilitate the consumer’s ability to read and understand the information, and the digital format should also provide the ability to convert text to audio and/or video.
A digital leaflet will be accessible through a database authorized by the Brazilian National Health Surveillance Agency (ANVISA), and the existence of a digital leaflet does not eliminate the need to have a written leaflet in each package. of medicine.
The new law also modified the rules relating to the traceability of medicines. The law provides that the party responsible for drug registration must have a system in place to track the distribution of drugs, identify the quantities sold as well as the distribution of each batch and the recipients of the drugs. The drug distribution card, as well as the drug packaging, must indicate the drug’s batch number, its date of manufacture and its expiry date.
The new rules will come into effect according to a timetable to be defined by ANVISA. ANVISA may also provide exceptions to the rule and allow certain drug manufacturers to include only digital or written drug inserts.