ANVISA has declared the commencement of a 60-day term (from April 15 onwards) in which it will accept public comments relating to its draft Resolution on OTC products. The draft Resolution covers the criteria and required steps in order for pharmaceutical products to be classified as over the counter (OTC) products (those sold without a prescription).
According to ANVISA, the draft Regulation has the purpose of establishing a fast and efficient mechanism for the evaluation of category changes, switching from the prescription Rx into the OTC category. Under the draft Regulation, products would be individually classified, resulting in a more efficient procedure for switching between the categories. Currently, Resolution RDC 138/2003 provides a list of groups and therapeutic indications eligible to be sold without prescription. The Agency has admitted that this list has not been updated over the last 12 years.
The draft also allows for medicines developed in Brazil to be classified as OTC. Currently, a condition of this classification is the commercialization of the product in the American or European market.
Another new provision in the draft Resolution provides ANVISA with the option of demanding additional evidence related to the reclassification conditions for products already classified as OTC. In situations where there is doubt regarding the reclassification conditions or where circumstances lead to further evaluations, ANVISA can start administrative proceedings for the re-evaluation of the product classification.
The draft Resolution will be available in full on the ANVISA’s website and can be downloaded using the following link: Public Consultation 27, of April 06, 2015 (original version in Portuguese).
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