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Health product may have the instruction manual online says Anvisa

06/15/2012

This article was translated by an automatic translation system, and was therefore not reviewed by people.

 

 




The Collegiate Directorate of ANVISA approved, on Thursday (14/6), a standard that allows manufacturers of health products the adoption of instructions for use in non-print format. The measure applies only to manufacturers of products for professional use and within the health services.

Thus, manufacturers of health products may offer users the option to access the instructions through the Internet, CD, DVD and other alternative formats that are not editable. Anyways, the producer must ensure the provision of printed instructions and free of charge when requested by the user.

Reference Drugs

During the meeting, the directors also approved the final text of the standard that defines the criteria for indication, inclusion and exclusion of drugs in the reference list. These medications are used as standard for studies of approval of generic drugs in Brazil and the like. The main innovation of this proposal is the requirement that manufacturers of these products provide the products for purchase. This will ensure that laboratories can test for bioequivalence are needed for the registration of generic and similar.

To prove that the generic drug has the same or similar effect as the reference medicine, laboratories need to perform studies comparing the product with the product ready to be registered. Therefore, it is necessary that the reference product is purchased on the market, which is not always easy to do. In the case of medicinal products for hospital or distributed only in specific programs, laboratories that are developing studies often have difficulty in acquiring the reference product, delaying the entry of new generics on the market.

The standards were approved during the 7th Open Meeting of the Public Board of ANVISA.
The texts of approved standards will be published in the Official Gazette the next day.



Carlos Augusto Moura - Press / Anvisa

Source: ANVISA

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