Clipping of news on Brazilian Culture, Law and Citizenship
03/10/2016
This article was translated by an automatic translation system, and was therefore not reviewed by people.
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The list of OTC drugs, those who do not require a prescription, has been updated and is now available on the Anvisa site. The work is part of the Agency's review of the regulation of OTC drugs.
The list is organized by therapeutic groups, with their indications and exceptions that can not be exempt from prescription. These drugs may be purchased or used by people without the need for revenue, is the doctor or dentist. They are low-risk products that treat symptoms.
See the list of OTC drugs
The list is in line with Resolution RDC 98/2016 that recently updated the rules for classification of non-prescription medicines and reframing as prescription drugs.
Seven rules to be exempt from income
RDC Resolution 98/2016 defines seven rules so that the drug can be considered exempt from prescription:
time to market;
safety profile;
Indication for treatment of non-serious illnesses;
use indication for a short period;
Be manageable by the patient;
Low potential risk for misuse or abuse situations
Not present dependence potential.
Advice for businesses
With the new regulation, Anvisa has made available to companies in the sector an area on its website with specific information about the procedures related to the framework of OTC drugs.
Read also: Published standard on OTC drugs
Source: Anvisa
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This article was translated by an automatic translation system, and was therefore not reviewed by people.