Bulls have bigger letters and will be specific to patients and health professionals
This article was translated by an automatic translation system, and was therefore not reviewed by people.
Brasilia - The resolution of the National Health Surveillance Agency (Anvisa) published today (9) in the Official Gazette determines that all drugs should be two versions of the leaflet, one for the patient and one for health professionals. The new standard also requires increasing the font size and requires laboratories to offer models of bull for the visually impaired.
"The label of the patient will have a more didactic language," said Tatiana Lowande, general manager of the Drug Anvisa. The leaflets will also be available on the Internet, in electronic lary Anvisa.
The deputy manager of a pharmacy in Brasilia, Leonardo da Costa Romualdo said that, eventually, receives complaints from consumers who do not understand the directions. "It happens, especially since the package comes in a technical language. Thereby also increasing the size, "he said.
A retired nurse, Maria das Graças Carvalho Pereira also welcomes aa Anvisa decision to increase the font size on the label. "I think the letters have to be larger, and simpler language," he said.
According to the resolution of the Anvisa, the package will be organized in the form of questions and answers, explaining the role of drug therapy, when it should not be used and what to do in case of super-strength, for example. It still should contain the warning to athletes about the potential to cause doping and expose more clearly the minimum age for their use. The resolution also determines the minimum size required by the letter of the inserts (Times New Roman with a minimum of 10 points).
Patients with visual impairments may request the service customer (SAC), the pharmaceutical company, the package in a special format, printed in Braille or in digital format, for example. Manufacturers will have ten days after the request to send them for free.
Manufacturers will have 180 days from today, to send new types of leaflet for Anvisa and after approval, a further 90 days to make medicines with new labels.
According to the CEO Anvisa, Dirceu Raposo, with the exception of the generic and the like, which should adopt the model of the reference product (which may differ in the specific information products, such as composition and duration, for example), all products must contain on its packaging the new model of literature.
Source: Agência Brazil
This article was translated by an automatic translation system, and was therefore not reviewed by people.
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