SERVICE GUIDELINE FOR THE DRUG NAMES
The Brazilian National Health Surveillance Agency (ANVISA) published the guideline No. 43 stablishing further criteria for the analysis of drug names and their changes after registration
This guide states that the analysis of drug names comprises: Search at an internal system of phonetic and orthographic computer analysis, search at an internal medicine database, search at the Brazilian Patent and Trademark Office (BPTO) database in order to check trademark applications/ registrations, evaluation of graphic and phonetical resemblance, evaluation of potential mistakes and evaluation of the names’ safety, in order to avoid risks on prescription, dispensing and administration or use of a medicine. Consequently, there is connection between the drug trademark registration at the BPTO and the registration of a drug name at ANVISA.
Furthermore, ANVISA will be able to issue office actions in case of graphical and phonetical resemblance between the proposed drug name and a previous registered drug name and/or trademark in order to allow the company to evaluate: The purpose of use of the drug, how the drug must be used, how the drug works, the benefits of the drug, the risks related to the use of the drug, the measures that can be taken in order to guarantee the safe use of the drug and the intrinsic characteristics of the drug (name, active pharmaceutical ingredient, therapeutic class, etc.).
If the ANVISA identifies graphical and phonetic resemblance between the medicine name to be registered and a previous registered medicine name or trademark, said agency will only reject the registration if it represents risk of mistake or confusion on prescription, dispensing or on the administration and/ or use of the medicine.