New legislation affecting marketing approval of pharmaceutical products

by Raul Hey

November 01, 2001


The ANVISA has issued Resolution nº 36 of March 15, 2001, in effect as of March 16, 2001, containing provisions regarding the registration of products for commercialization, of the so-called "similar" medicines in Brazil.

The new regulation establishes that those "similar" medicines which were registered with the "generic designation" have their commercialization prohibited, under the penalties defined in the pertinent legislation.

A "similar" medicine is defined in the sanitary law, as "that which contains the same active ingridients, presents the same concentration, pharmaceutical formula, administration via, posology and prophylactic or diagnostic therapeutic indication, of the "reference" medicine registered at the Federal Agency responsible for the Sanitary Surveillance, being allowed to differ only in characteristics relative to the size and shape of the product, period of validity, packaging, labeling, excipients and carriers, and must be identified by commercial name or trademark."

A strict or literal interpretation of those new provisions allows one, in principle, to understand that similar medicines would cease to exist in Brazil, for the simple reason that all registrations granted until now fall into the prohibition contained in the new regulation, namely, they contain a generic designation (identical to that of the reference medicine). Since all those registrations have a validity term of 5 years, they could not be renewed using the said generic designation in view of the new regulation and would, therefore, cease to exist.

Since, however, this is a quite new regulation and no concrete case has yet been brought to discussion either before ANVISA or (much less) at the courts, close attention has to be paid to the developments in this issue and we will, obviously, keep our clients informed. 


Raul Hey

Advogado, Agente da Propriedade Industrial

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