[author: Mariana Vasques Soares de Campos Matos]
A brand new legislation was enacted in Brazil on May 12, 2022 (Law No. 14,338/2022) requiring that drugs package inserts could have to be supplied in digital format, in addition to the prevailing written format. The legislation would require {that a} QR code be included in package inserts in all medicine for the aim of permitting customers to have entry to the data in digital format. The objective of the package insert (also referred to as “prescription drug product insert” or “professional labeling”) is to present detailed drug info compiled and distributed by the drug producer.
Under the brand new laws in Brazil, a QR code will want to have the very same and up to date info because the written drug package insert that accompanies the medicine in query. Such info contains the composition (components and portions), use, dosage, contraindications, license info and expiration date. Other info may also be included in the digital package inserts, resembling hyperlinks and different informative paperwork in regards to the drug. The digital format of the package insert also needs to facilitate a client’s skill to learn and perceive the data, and the digital format also needs to present the choice to convert the textual content into audio and/or video.
A digital package insert will probably be accessible by way of a database licensed by the Brazilian National Health Surveillance Agency (ANVISA), and the existence of a digital package insert doesn’t remove the necessity to have a written package insert in every drug package.
The new legislation has additionally modified the foundations associated to the traceability of medicine. The legislation gives that the social gathering chargeable for registering the drug ought to have a system that permits for the monitoring of the distribution of the medicine, figuring out the quantities offered in addition to the distribution of every lot, and the recipients of the medicine. The distribution map of the medicine, in addition to the drug packaging, ought to present the drug´s lot quantity, manufacturing date, and expiration date.
The new guidelines will probably be efficient in accordance to a schedule that will probably be outlined by ANVISA. ANVISA may present exceptions to the rule, and allow some drug producers to solely embrace both digital or written drug package inserts.
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Brazil requires drug makers to add QR codes in package inserts and implement traceability systems | Hogan Lovells & More Latest News Update
Brazil requires drug makers to add QR codes in package inserts and implement traceability systems | Hogan Lovells & More Live News
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Brazil requires drug makers to add QR codes in package inserts and implement traceability systems | Hogan Lovells & More News Today
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