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Table 1 Chronology of main laws, regulations, and decrees regarding branded generics, generics, and general product quality and bioequivalence, 1994–2011

From: The Brazilian private pharmaceutical market after the first ten years of the generics law

Year Branded generics Generics
Law/regulation/contenta Law/regulation/contenta
1994 Normative instruction n°1 - Requirements for the registration of similar medicines  
1996   Law 9279 - Regulates the rights and obligations regarding industrial property
1999   Law 9787 - Generics Law
Resolution RDC 391 - States that for a product to be registered as generic there is a need to prove bioequivalence.
Decree 3181 - Regulates Law 9787
2000 Resolution RDC 92 - Similar medicines can be marketed and identified by trade name or mark that distinguishes the products from those of other manufacturers Resolution RE 74 - Approval of the first registrations of generic medicines
2001 Resolution RES 36 - Similar medicines obligated to start presenting commercial names; a deadline of 180 days was given to industries to comply Resolution RDC 10 - Included a list of medicines that for safety reasons could not be registered as generic drugs; it is a revision of the RDC 391.
  Resolution RDC 47 - Regulating characteristics of the packaging of generics
Decree 3961
Updates the definitions of similar, reference and generic drugs
2002 Resolution RDC 157 - Established the requirements for pharmaceutical equivalence studies for similar drugs Resolution RDC 84 - Modifies the list of products identified in resolution RDC 10
2003 Resolution RDC 133 and RDC 134 - Regulations for the registration of similar medicines requiring products to undergo, by 2014, the same relative bioavailability and pharmaceutical equivalence testing, required from the beginning for generic medicines Resolution RDC 135 - Approves the Technical Regulation for Generic Drugs; repeals RDC 391 and RDC 84
2007 Resolution RDC 17 - Similar medicines were obligated to present the same documents for licensing as needed for generics Resolution RDC 16 - Approves the Technical Regulation for Generic Drugs; repeals RDC 135
2010 Resolution RES 16 - Amending and repealing legal texts related to the presentation prior to Anvisa protocol bioequivalence study; repeals RDC 17.  
  1. aLaws, regulations and contents are available at: http://portal.anvisa.gov.br/legislacao