By Lívia Honório de Figueiredo

Our specialists Lívia Figueiredo and Jansen Viana are set to attend the BIO International Convention, which will take place from June 5-8, 2023, … Kasznar Leonardos attends the BIO International Convention

Patents to new medicines usually protect the active ingredient (compound), provided that it is new and inventive. It is also a common … “Brazil: The patent combination conundrum” for LSIPR Magazine

The Brazilian Patent and Trademark Office (BPTO) published, by means of Ordinance n° 78, dated December 16th 2022, phase IV of the Patent … BPTO publishes phase IV of the Patent Prosecution Highway (PPH) Program

Patents are critical to the life sciences industry and often spark intense and heated debate. To be successful, one key strategy that … Life sciences patent eligibility in Latin America: a guide

The Brazilian Patent and Trademark Office (BPTO) published, by means of Ordinance n° 55, dated December 15, 2021, phase III of the … BPTO publishes phase III of the Patent Prosecution Highway (PPH) Program

The Brazilian FDA (ANVISA) published on November 19, 2020, four manuals regarding the analysis of prior consent of patent applications related to … ANVISA published manuals related to prior consent of patent applications

As informed in our Newsletter No. 01/2018, the Brazilian Patent Office (BPTO) recently published Resolution No. 208, which entered into force on … Complementary information referred to the Guidelines for Examination of Patent Applications in the field of Chemistry

Following our Notice sent on March 2017, regarding the public consultation on the Guidelines for Examination of Patent Applications in the field … Guidelines for Examination of Patent Applications in the Field of Chemistry

On August 8 2017 ANVISA officially published the new Rule RDC Nº 168, related to the prior consent of the Agency on patent applications for pharmaceutical products and processes, regulated by Joint Ordinance ANVISA-INPI No. 1, dated April 12, 2017, aiming to a more efficient way to analyze patent applications.

1. What are the legal pre-conditions for a drug to be distributed within the jurisdiction?

Authorisation

The distribution of medicinal products is regulated by the National Sanitary Surveillance Agency (ANVISA)

Pharmaceutical can be marketed and distributed if the following requirements are met:

In Official Gazette of February 11, 2015, ANVISA published RDC #7/2015, an update of the technical requirements for the regulation of personal hygiene products, cosmetics and perfumes, in order to simplify and expedite the treatment of this category of products in the country. The resolution came into force on February 25, 2015.

In Brazil, cosmetics are classified by ANVISA as products grade 1 or 2. Grade 1 products are characterized by having basic properties, which do not require further characterization or detailed information regarding their use and restrictions. On the other hand, grade 2 products have specific indications, which characteristics demand attesting safety and/or efficacy, as well as information regarding care, use and restrictions.

As of publication of RDC #4/2014, the procedures regarding the regulation of cosmetics had already been defined in order to stablish the Electronic Automation System of ANVISA as the basis for all activities comprehending notification, registration and corresponding alterations regarding this product’s category.

The main law regulating the health system in Brazil – Law #6,360 dated 1976 – establishes that each and every drug available in the pharmaceutical market must be approved by the Ministry of Health. Since the creation of the Brazilian FDA (called ANVISA), this autonomous autarchy subordinated to the Ministry of Health is in charge of issuing marketing authorization for drugs for human use and of establishing specific resolutions in order to regulate each of the existing categories of medicaments, such as the new drugs, generics, similars, biologicals.

According to ANVISA’s requirements, the documentation submitted by the manufacturers of both generic and similar drugs, upon applying for marketing approval, is significantly simplified compared to the reference product (the so-called “abridged process”), as only pharmaceutical equivalence and relative bioavailability/ bioequivalence assays are required to obtain approval for products pertaining to these categories.

It should be noted that, since the publication of Resolutions RDC #133 (new applications for marketing approval) and RDC #134 (similars, already approved), both dated May 29, 2003, ANVISA has begun to require proof of therapeutic equivalence also for similar drugs; therefore, it is estimated that all manufacturers of these products will have complied with such requirement by the end of 2014.

Accordingly, studies of pharmaceutical equivalence and bioavailability/bioequivalence became necessary in order to obtain marketing authorization for both generic and similar drugs, although the latter were not then yet considered to be interchangeable with the reference product.