New criteria for registering medication brands with ANVISA

by Mauro Ivan C. R. dos Santos

December 16, 2006


In July 2010, through Public Consultation Nº 72, Brazil’s Sanitary Surveillance Agency (locally, ANVISA) issued a draft resolution for the purpose of setting new acceptability criteria for brand or trade names and differential medication complements.

The objective is to regulate trading names and their complements and thus avoid health risk arising from any confusion that might be caused by using similar names for different medications. These criteria do not apply to generic or immunotherapy medications, which are still required to use the common name of their active principle.

The document defines “trade name” of a medication as the designation used to differentiate it from other medications of the same company or different companies. Broadly speaking, "trade name" as defined in the draft resolution, means what the market and the Industrial Property Law define as "brand".

The resolution states that there is a case of "graphic similarity" if two products, from the same company or otherwise, have trade names that appear to be very similar and capable of causing a mistake in medication by one being taken for the other. This criterion may affect companies that have families of brands (trade names marks or brands with a common or shared element). In addition, the criterion appears to cover not only a brand name attaching to a product’s packaging but also the form it is written on paper or other printed matter by doctors, pharmacists and other health professionals, which involves a great deal of subjectivity.

There is "phonetic similarity", according to the resolution, if two products have very similar trade names when pronounced, which may lead to mistakes.

§ 2 of Article 5 stipulates that products have the appropriate identity of formulation may comprise a family of products and use the same trade name. The main body of Article 5 stipulates that there is "identity of formulation" if medications have the same identifying components in their formulation and have the same therapeutic indications. The interpretation of this article suggests there may be difficulties when registering brand names for pre-used medications.

It also prohibits the use of trade names using, in whole or in part, the generic name of the active substance as per DCB, DCI, CAS or their synonyms used for these compounds. It is a known fact that there are different brand names for medications registered with Brazil’s Institute of Industrial Property (locally, INPI) that include roots in these conditions (e.g. ACETILDOR, DESFENIL etc).

Similarly, we believe it is excessive to not allow trade names to use Roman or Arabic numerals, even if spelled out (e.g. COXDOIS), abbreviations, or random sequences of letters and words (e.g. XYZAL) foreign language expressions (e.g. NEW LS MASS I).

The draft resolution contains other points that should be clarified, including the division of spheres of competence of the INPI and ANVISA and harmonization of criteria for analysis of marks and acceptability of trade names determined by these bodies.

The deadline for submitting comments and suggestions on ANVISA’s proposal was in August. According to ANVISA information, more than 180 contributions were forwarded, including those from the Brazilian Intellectual Property Association (locally, ABPI) and are being examined, and no date has been set for publishing the final resolution to regulate this matter.


Mauro Ivan C. R. dos Santos

Advogado, Agente da Propriedade Industrial

read +

related posts