Traditional Medicines & OTC Products: Brazil
A guide to the state-of-play regarding traditional medicines and over-the-counter (OTC) products in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for USD 99, here.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Resolution RDC No. 26/2014 provides for traditional and herbal drugs requirements. These drugs are subject to registration, simplified registration (those included on the list of the Normative Instruction No. 2/2014 or on the Community herbal monographs with well-established use) or notification (those with active ingredient contained in the Herbal Medicines National Formulary of Brazilian Pharmacopoeia and Pharmacopoeias recognized by ANVISA), depending on its formulation. In order to submit the product to ANVISA’s analysis is necessary to present proof of safety use (non-clinical and clinical toxicology) and of therapeutic effectiveness (non-clinical and clinical pharmacology) of the drug.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes, but only those that are classified as OTC.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Herbal and traditional drugs must comply with labeling and packaging limitations set forth in ANVISA Resolution No. 71/2009. Labels must only contain accurate, adequate and safe information, among other specific information depending on the type of product. Note however that all claims included on the products’ label must be based on the studies and/or on the pharmacopoeia.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The regulatory requirements will depend on the category of the drug.
Those that offer low risk to the consumers (and are included on the list of the ANVISA’s Resolution No. 107/2014) are exempted from registration and only need to comply with the procedure of notification, which required the submission of a reduced number of documents capable of attesting to the quality and safety of the drug.
As mentioned (on Question 6 of Regulatory, Pricing and Reimbursement), there is also the simplified procedure for the registration, which applies not only for generics, but also for similar, specific, dynamized, phytotherapeutic and biological drugs that have the same production line, same manufacturer, same technical and clinical reports, the same composition of another drug already registered by the regular procedure before ANVISA, but with a different name, labeling packaging and registration holder. The analysis/review by ANVISA of the documents is faster (when compared with the regular procedure) since the documents were already analyzed by ANVISA on a previous (regular) procedure.
Finally, there is also the OTCs drugs that are subject to the regular procedure (provided for in ANVISA’s Resolution No. 200/2017, which determined the minimum requirements for obtaining and renewing registration of drugs with synthetic and semi-synthetic active principles, classified as new, generic and similar), through this procedure the complete dossier will need to be submitted.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Only pharmacies and drugstores, with a technically responsible person present during all time of the operation, can dispense drugs. Note that remote means such as telephone and internet are also allowed, provided that the pharmacies and drugstores observe the restrictions set forth in the applicable rules.
6. What health, advertising, and marketing claims may be made for OTC products?
According to ANVISA’s Resolution RDC No. 96/2008 companies may only insert information that is scientifically evidenced. ANVISA also allows:
- the use of expressions such as “safe”, “effective” and “quality”, provided they are complemented by phrases that justify the veracity of the information, which must be extracted from studies published in scientific publications duly referenced;
- the use of expressions such as “absolute”, “excellent”, “maximum”, “optimum”, “perfect”, and “total” related to the efficacy and safety of the product, when faithfully reproduced from studies published in scientific publications and duly referenced;
- making reference to the number of countries where the product is marketed and/or manufactured, provided that the countries are identified in the advertisement.
7. Can OTC products be marketed or advertised directly to the public?
Yes. There are however some limitations concerning the advertisement
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
According to Resolution RDC No. 98/2016, the registration holder must submit a requirement to ANVISA.
9. What are the requirements for the importation of either traditional medicines or OTC products?
The most important ones are (i) be duly enrolled before the health authorities for the activity of importation; and (ii) obtain prior consent from ANVISA (request under Resolution No. 81/2008).