ANVISA’s Notice invites public comments on the OTC pharmaceutical products draft Resolution by June 15, 2015
November 10, 2017

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).   If you have any questions or need additional information, please contact us at prevail@localhost/licks/site.

Go Back


See all events


This is some text inside of a div block.

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Go Back