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Digital medication package inserts begin to be regulated by Anvisa.

Nowadays, it is the Resolution 47 of Anvisa’s Board of Directors (RDC), from September 8, 2009, that establishes the rules for the development, standardization, updating, publication and provision of medication package inserts. However, this year, the Act no. 14,338 from 2022 was passed, in May 11, 2022, where the contents of the standard will undergo a review. The new digital format must make the reading and understanding easier.

According to the Act no. 14,338, from 2022, digital medication package inserts musts be hosted on links authorized by Anvisa and must have contents like the printed package insert. However, with the possibility of making information more accessible, in a format that makes the reading and understanding easier, using a proper application. Also in accordance with the law, Anvisa will be authorized to define which medications may have package inserts in only one format.

With the purpose of making package inserts more accessible, Anvisa included the project that aims at the review of rules for the development, standardization, updating, publication and provision of package inserts in its Regulatory Agenda up to 2023, both for patients and health professionals.

The first stage of the review process was published by the office in November 7, 2022, with the Ordinance 1,063/2022, that created the Group of Work (GT) to  monitor, evaluate and propose regulation actions with the purpose of standardizing the digital package inserts of medication, as provided by the Act no. 14,338. Now, the review will follow the steps of Anvisa’s regulatory flowchart, including the conduction of the Regulatory Impact Analysis (AIR) and Public Consultation (CP).


Besides the digitalization of package inserts, the text of the law specifies that labs must have a system that develops a map of distribution of medications, identifying the amount of sold and distributed products of each batch, and also the shipment’s recipients.

The map of distribution, as well as the packages, must inform the batch number of the medication, the manufacture date and the expiration date. As established by the law, the companies will have a period of 12 months, after the system is regulated, to implement all the steps.

Also according to the text, the printed package insert continues to be mandatory and cannot be dismissed, except for cases to be defined by the Brazilian Health Regulatory Agency (Anvisa). The new law originated from the Draft Bill (PL) 3,846/2021, by the deputy André Fufuca (PP-MA). The text was approved in April by the Senate, reported by the senator Nelsinho Trad (PSD-MS).

Technologies are fundamental to educate the population on the damages caused by self-medication and make the work of diffusion of information for the whole population. For those that believe that the new digital package insert may potentialize self-medication, experts assure that it may not, since the patient will have to undergo the same procedures and processes of the medical consultation in order to obtain the prescription, and the package insert will keep the same information and structure of the original package insert, present on the medication package.

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