Brazil: ANVISA's Ruling RDC # 59: Choosing A Name For Pharmaceutical Products

Last Updated: 23 October 2015
Article by Ana Montenegro and Isabella Bonisolo

In order to launch a new pharmaceutical product in the Brazilian market, companies must apply for registration of the "medicine name". In addition to registration as a trademark at the Brazilian Trademark and Patent Office, the "medicine name" must be registered at ANVISA.

ANVISA's ruling RDC nº 591 established criteria and limitations for the selection of names for medicines. The regulations are applicable to any products subject to registration or simplified notification before the Agency (subject to exemptions in respect of prescription and non-injectable medicines). The regulation excludes generics and immunotherapeutic drugs from its scope.

The purpose of the ANVISA regulation is to harmonize the market, assuring that medicine names (labels) will not exhibit confusing or misleading information. The key objectives of the regulation are as follows:

a) enhancing the graphical and phonetical distinctiveness among products and abandoning the rule requiring a minimum of three letters difference between existing marks (set out in article 3rd of the former RDC nº 333/2003);

b) preserving a clear reference to the active ingredient of medicines (drug identifier) or to the commonly used technical or scientific denomination;

c) promoting the differentiation of products of the same "medicine family" by inserting complementary names/words to distinguish individual features, used without exclusivity by all market players;

d) barring the use of words/expressions that are likely to lead consumers to drawing false conclusions regarding product's nature, features or effects;

ANVISA's RDC nº 59 final text results from the compilation of the claims and suggestions by several entities, which participated on the Public Consultation procedure prior to its introduction.

The new ruling established "safe harbors" for pharmaceutical companies, for instance, the guarantee that the names of medicines assigned with approved sanitary registrations would not be subject to revision. Similarly, it guaranteed that the restrictions for medicine families would not reach in-market products (to be seen as part of a medicine family the new products are required to have the same drug identifier and therapeutic indication).

In contrast to the above, the ruling is unclear on a number of points, obliging companies to rely on ANVISA's interpretation. Firstly, the wording of article 82 leaves considerable doubt if the names of prescription drugs are allowed to elicit their therapeutical indication. Secondly, the range of single paragraph of article 153 raises concerns about ANVISA's subjective reasoning for refusal of medicine names. Finally, we cannot overlook the lack of clear guidelines for an analysis in the event of a conflict between names.

The above described scenario requires that pharmaceutical companies are extra careful when selecting a new product brand, which will be subject to two adequacy analysis conducted by different agencies under their own regulations. It is also fair to say that a name refusal entails relevant costs and may even affect a product's market price.

In order to support our clients in their in-house choices for the naming of new products, we have created the explanatory chart below:

1. Definitions
(article 4th)
  • Medicine name: is the name of the pharmaceutical product technically designed, to distinguish it from others;
  • Drug Identifier: active pharmaceutical ingredient (or a set of these in association) responsible for the main therapeutic indication;
  • Name supplement: words used, on a non-exclusive basis, as complementary designation to the medicine's name, in connection with a medicine family;
  • Medicine family: set of pharmaceutical products from the same company with the same drug identifier, grouped by a common name and distinguished by individual supplements.
2 Medicine Names
(articles 7th to 14th)
  • Preferentially composed by a single word, with intended pronunciation in the Portuguese language according to spelling;
  • Shall hold sufficient graphic and phonetic distinctiveness when compared to other registered medicine names;
  • Vitamins, minerals and aminoacids may adopt synonyms commonly used in technical literature to designate them, as long as there is no controversy related to their identity;
  • Phytotherapeutic drugs may adopt their popular, technical or scientific name as medicine name, as long as there is no controversy related to their identity;
2.1 Supplements
(article 16th)
  • ANVISA will not consider, for registration purposes, exclusivity of use for supplements;
  • The use of the same supplement word with different meanings is prohibited;
  • Name supplements may be used to distinguish: administration methods, dosage form, target public, absorption or other situations, with company's reasoned justification;
  • Name supplements may be adopted in drugs from the same medicine family that have distinct kinetics release, separate dosage forms or different routes of administration;
2.2 Medicine "Family"
(articles 5th and 6th)
  • The exclusion or substitution of one or more drugs' identifiers entails the adoption of a distinguished medicine name;
  • For multivitamins, polyminerals and polyaminoacids it is allowed to change part of the composition, maintained the original therapeutic indication, aiming at adapting the drug to specific target consumers;
  • In the case of medicine's family formation, the company must adopt additional distinctive measures involving the labeling of such products, so as to promote greater distinction between them.

Footnotes

1 Published at the Official Journey in October 13, 2014.

2 Article 8: The name of medicines exempt from prescription may evoke their main approved therapeutic indication.

3 Single Paragraph of article 15: In the evaluation of other hypothesis not covered by this article, ANVISA will be allowed to refuse the medicine's name motivated by consumers' risk.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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