• Abbreviations, isolated letters, random sequence of letters, Arabic or Roman numbers, without clear meaning to the consumer or that do not have any relation to the features of the product – this rule is self-explanatory and can be used to prevent the use of terms and abbreviations that do not have a clear meaning to the Brazilian consumer; and can be used to prevent the use of terms and abbreviations that do not have a clear meaning to the Brazilian consumer; ingredient, when it is not part of the drug product composition – the aim of this rule is to guarantee that the parcel of the nonproprietary name associated with a particular active ingredient is only used when the active ingredient is present in the medication. The term TAMOL therefore, can only be used in connection with medications which have paracetamol as an active ingredient; Finally, the Resolution provides that, when evaluating other cases not included in the prohibitions, ANVISA may still reject the proposed name when it detects any sanitary risk to the consumer. • Name of drug product that has been rejected due to efficacy or safety reasons. connection to variations of an existing medication, unless the manufacturer is able to prove that the variation is indeed superior to the prior one; • ANVISA will not consider, for purposes of registration, the existence of exclusive rights over the name complement – this means that, in principle, the agency will presume that the name complement cannot be appropriated. Thus, if the company believes that the complement is distinctive and able to function as a mark, it should take judicial measures to avoid the inclusion of the complement in subsequent third party registrations; • Using the same name complement with different meanings is prohibited; Families of drug products • Names that do not correspond to the way the drug product is given – the goal of this rule is to prevent confusion as to the pharmaceutical form of the drug or as to how the medication is administered. Thus, for instance, the terms spray or lotion cannot be used in connection with a liquid preparation administered orally; Resolution RDC nº 59/2014 fortunately embraces the concept of families of drug products. It provides that drug products of the same company, whose formulation contains the same active ingredient, may be grouped in families sharing the same mark and adopting complements that distinguish the drug products. • Pharmaceutical companies can, upon substantiated justification, use name complements to distinguish routes of administration, pharmaceutical forms, target groups and absorption details of the drug products; • Drug products presenting kinetics of different release, different pharmaceutical forms or different routes of administration within the same family must adopt name complements. • Words or expressions that may lead to the understanding that the drug product is innocuous, natural, exempt from or with reduced side effects, or that the drug product has superior potency and quality or unproven special properties – this rule prohibits the use of expressions such as NATURAL, SOFT and LIGHT or any other term that may lead the consumer into doubt or error as to the features of the medication; The Resolution also mandates that the exclusion or replacement of the active ingredient demands the adoption of another mark for the medication. Thus, consider a family of analgesics whose active ingredient is ibuprofen. If the manufacturer replaces the ibuprofen by dipyrone in one of the products, the mark of that product would have to be changed, in a manner to adopt a different mark as opposed to the family. The exceptions are the multivitamin, multimineral and multi amino acid products. In these cases, the mark of the family can be maintained, but the manufacturer should use complements indicating the target public of the product. Conclusion ANVISA’s new Resolution regulates several aspects relating to the names of pharmaceutical products. Some changes are quite positive, such as the abolition of the 3-letters rule, a test which was severely criticized by the pharmaceutical industry and the entire trade mark community. On the other hand, the Resolution brings some specific provisions to the current regulatory scenario. This is extremely relevant because the rejection of the application can obstruct the launching and sale of the drug product in the market. Criteria for complements of names of drug products • Words or expressions that emphasize a therapeutic action, without evidence from clinical studies, and that may lead the consumer to believe that such drug product has superior therapeutic effect as opposed to another drug product of equal composition – this rule forbids the use of terms such as MAX, PLUS, SUPER in Finally, Resolution RDC nº 59/2014 regulates the use of complements in pharmaceutical trade marks, pointing out that the complements must be used to distinguish certain medication from other medication registered by the same company, within the same family of products. In respect to these complements, the Resolution provides that: 12 Pharmaceutical companies operating in Brazil therefore, should be attentive to these rules and create an efficient interaction between their regulatory and intellectual property departments.