Client Alert

New Brazilian rules on OTC status

August 12, 2016

It took the Brazilian Food and Drug Administration (ANVISA) 13 years to update its rules on over-the-counter status requirements and proceduresIntroductionOn August 3, 2016, the ANVISA issued Rule #98 of 2016, containing the administration’s new guidelinesfor a drug to obtain the OTC status, which allows it to be sold without a medical prescription.This rule revokes the ANVISA Rule #138 of 2003, which listed the drugs that could be sold as OTC,according to their therapeutic indications. It has been 13 years since the ANVISA last updated saidlisting, and that translated into high anticipation.Despite revoking Rule #138, Rule #98 has not automatically changed the sales status of thedrugs currently having OTC status. Rule #98 establishes that the ANVISA can reassess their statusby requesting additional documents while seeking to evaluate compliance with the newrequirements, which are summarized below. However, a drug keeps its OTC status up until suchreassessment completion.Rule #98 was previously submitted to Public Inquiry #27 of 2015, on April 8, 2015. According to theANVISA’s report on the public inquiry, the general public’s feedback (companies, HCPs, associationsand consumers) was that the new rules will have a positive impact on the market, namely, thewidening of patient’s access to drugs and the recognition of the pharmacists’ role in healthcare. Onthe other hand, the main concern raised during the public consultation was the possible increase ofthe indiscriminate use of drugs, especially due to Brazilian’s self-medication culture.A new public list of OTC drugs remains pending. Nevertheless, the general expectation is thatRule #98 will increase the number of OTC drugs in the Brazilian market, therefore enhancing pricecompetition and marketing efforts towards consumers (instead of physicians).Summary of the new rulesBasically, to receive the OTC status, Rule #98 requires the drug to comply with seven criteria:(i) A minimum time of commercialization of the drug’s active pharmaceutical ingredient: tenyears, five of which being sold in Brazil as a prescription drug, or five years being sold as an OTCdrug in countries where regulations in this matter are similar to ANVISA’s;(ii) A high level of safety: the causes of the adverse reactions must be well known and easilyhandled, the drug must have a low level of toxicity and a safe therapeutic window and a lowlevel of drug and food interaction;(iii) The clinical condition treated by the drug cannot be one that potentially evolves rapidlyand its symptoms must be easily identifiable by the consumer;(iv) The drug must pose low risk when used off label or in overdose scenarios;(v) The drug cannot be indicated for continued use, it can only be indicated for a smallamount of time or a fixed period, which is pre-determined in the drug’s label, except for drugsaiming at prevention;(vi) The consumer must be capable of using the drug without any physical assistance fromhealthcare professionals;(vii) The drug cannot generate chemical dependency on consumers.A company can request the OTC status at any time, whether simultaneously with the Marketing ApprovalApplication, or after the drug has been approved. The OTC status request must be supported by thedocuments listed in Rule #98, proving the compliance with the seven criteria above. The company mustalso support its request with a risk reduction plan, informing the ANVISA how it will monitor occasionalrisks arising from the commercialization of its drug with the new status.Once the OTC status is approved, the ANVISA will publish its decision in the Official Gazette and includethe drug’s API in the list of OTC drugs, which will be made available in the administration’s website.Although the inclusion in said list does not automatically grant all drugs the same API the OTC status,it holds companies marketing them liable to file, within a 180-day term, a request to have its productsales status changed to OTC, as well as the appropriate amendments to the drug’s packaging and label.Finally, Rule #98 also sets out which products are not entitled to receiving the OTC status: (i) drugs withparenteral administration and (ii) the commercial packing, which can only be sold with a prescription,as it contains API in a quantity that exceeds the maximum limits fixed by ANVISA for each product.Rule #98 will enter into force 30 days after its publication on September 3, 2016.For more information, please contact

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