ANVISA, the Brazilian medicines regulatory authority, has issued a resolution which sets new criteria for the classification of medicines, including non-prescription medicines. There are seven criteria that a medicine must meet in order to be sold without a prescription. Those criteria include (1) how long the product has been on the market, as a prescription medicine and also as a non-prescription medicine in countries where regulations are similar to the ANVISA regulations; (2) the safety profile of the medicine; (3) the duration of use; (4) whether symptoms can be easily identified by patients themselves; (5) whether patients can take the drug without the assistance of a healthcare professional; (6) whether the risk to the patient is low in the case of misuse or abuse; and (7) whether the medicine can lead to dependence.
ABIMIP, WSMI’s member association in Brazil, has worked with ANVISA for over 12 years to make more products conveniently available directly from pharmacists without a prescription. In 2003, medicines belonging to 18 therapeutic classes including anti-inflammatory, muscle relaxants, and smoking cessation aids were switched to non-prescription. With the new regulation, ABIMIP estimates that there are approximately 30 substances suitable for becoming OTC.
“It will be essential to educate and guide people so that they make the most of these new healthcare options”, said Marli Sileci, Executive Vice-President of ABIMIP. “We believe that non-prescription medicines are tools that help empower patients to practice self-care thus reducing the demands on the health system. This new regulation is a major step forward and aligns our country with the best global practices”.