Laws on packaging, substitution and prescription of generics in Brazil

Generics/Research | Posted 09/07/2021 post-comment0 Post your comment

According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.

Labelling V14I26

The creation of the legal system for generic medicines began with the introduction of Law Number 9787 in February 1999 (Brazil 1999).

There are differences in the presentation of the packaging of generic medicines in Brazil. In order to differentiate them from similars and reference (trade name) medicines, ANVISA establishes rules to identify them. The logo, consisting of a stylised 'G' and the words 'Medicament' and 'Generic' written in blue and enclosed in a yellow rectangle, must be displayed on the packaging, according to the 2001 ANVISA regulation [1].

One of the measures that have been introduced to promote the use of generic medicines in Brazil is the possibility of substitution of the brand-name medicine for its generic equivalent by pharmacists – interchangeability can occur at the time of purchase and at the request of the patient, except in cases where the prescriber requests, in writing, that the brand-name medicine is not to be replaced.

Another measure is the obligation for doctors in the public health system to prescribe medicines by their Brazilian Common Denomination (BCD) or, in its absence, by their international non-proprietary name. Mandatory reductions in the price of generic medicines compared to reference medicines have been seen as a way to boost their use – they must be registered at least 35% cheaper than their trade name equivalent, as established by ANVISA in its 2003 and 2007 regulations [1].

Since then, further rules on technical requirements for generic medicines have been published, see Table 1.

Table 1: Main laws, regulations and decrees on generic medicines in Brazil 1999–2019
Year Law/Regulation Content of the Law/Regulation
1996 Law No. 9279 of 14 May 1996 Intellectual Property Rights Act
1998 Ordinance No. 3916 of October 1998 Guiding instrument for all medicines-related actions in the country
1999 Law No. 9787 of February 1999 Law on generics - generic medicines legally established in Brazil
1999 Decree No. 3181 of 1999 Regulation of Law 9787
2001 Resolution RDC No. 47 of 2001 Identification/packaging of generic medicines
2007 Resolution RDC No. 53 of 2007 Dispensing medicines
2015 Law No.13235 of 2015 Quality of similar medicines
Source: ANVISA.

Editor’s comment
Readers interested to learn more about pricing of generics are invited to visit to view the following manuscript published in GaBI Journal:

Strategies for pricing of pharmaceuticals and generics in developing countries

GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.

Readers interested in contributing a research or perspective paper in Spanish and/or English on substitution and prescription to GaBI Journal – an independent, peer reviewed academic journal – please submit your manuscript here.

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1. Nardi EP, Silva ARA. A closer look at generic drugs: the Brazilian case. In: Lowell T. Duncan (Ed). Advances in Health and Disease. Volume 21. Nova Science Publishers; 2020. Chapter 2. ISBN: 978-1-53617-783-1.

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