HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Brazil Prepares To Clear Backlog Of 25 Switch Applications

Executive Summary

Brazil's drug regulator Anvisa is seeking comments on its backlog of 25 Rx-to-OTC switch applications as it looks to make more prescription products available OTC.

Brazil’s national drug regulator Anvisa has revealed it has a significant backlog of switch applications relating to 25 different active ingredients.

The agency has a total of 45 applications from sponsors covering the 25 ingredients. The oldest applications were made in November 2016 with the most recent submitted in August 2019.

As the table below shows, a wide selection of categories are covered by the applications from erectile dysfunction (yohimbine hydrochloride) to seasonal allergic rhinitis (fluticasone propionate). Blockbuster prescription drugs such as Nexium are included on the switch list, as well as submissions for herbal treatments and vitamins and minerals.

Recognizing the need to clear the logjam and make progress with the applications, Anvisa is inviting interested parties to submit their opinions on the submissions.

The agency wants “medical associations, patients and the general public” to offer their opinion through an online consultation on the advantages and disadvantages of reclassifying one or more of the prescription drugs on the switch list as OTC.

Respondents are also requested to submit any relevant evidence in support of their opinion.

According to legislation governing prescription reclassifications – Resolução da Diretoria Colegiada (RDC) 98/2016 – drugs available OTC must:

  • Be indicated for the treatment of non-serious diseases

  • Have a low potential for toxicity and interactions with other drugs, as well a history of safe use

  • Have a short duration of use  

  • Be easy to handle by the patient, caregiver or upon the advice of the pharmacist

  • Present a low risk to the patient

  • Not have the potential to generate chemical or psychic dependence

Anvisa's list of received switch applications on which the agency is yet to make a decision:


Related Content





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts