GENERIC MEDICINES REGULATION IN BRAZIL

  • Priscila Aburachid Cardoso Pharmascience Pharmaceutical Industry, Brazil.

Abstract

The regulation of medicines in Brazil has proven to be one of the major concerns of government policies in recent decades. In order to improve access to quality medicines for the population, the National Drug Policy was instituted, culminating in the creation of the National Health Surveillance Agency (ANVISA) and the implementation of generic medicines policy.
The generic medicines was effectively introduced in Brazil with the publication of the Law nº 9.787 in 1999, resulting from an objective of the Ministry of Health to significantly reduce the costs of pharmacological therapy, stimulate commercial competition and facilitate the population's access to drug treatment. In the same year the resolution no 391/1999 regarding the technical requirements for the registration of generics in Brazil was published. Since 1999, several legislation has been published in order to regulate the generic policy in Brazil.
The present article summarises the legal framework for the implementation of the generic medicines in Brazil. It also describes the current technical requirements and legislation for the registration and maintenance of the register of generics in Brazil, according to ANVISA.

Keywords: Generic drugs, Legislation, ANVISA, Registration, Technical requirements, Dossier.

Downloads

Download data is not yet available.

Author Biography

Priscila Aburachid Cardoso, Pharmascience Pharmaceutical Industry, Brazil.

Pharmascience Pharmaceutical Industry, Brazil.

References

1. BRAZIL. Law nº 9782/1999 [Internet]. Official Diary of the Union; 1999 Jan 26 [Cited 2017 Jul 01]. Available from:
http://www.planalto.gov.br/ccivil_03/leis/l9782.htm
2. Kornis G.E.M., Braga M.H., Zaire C.E.F. Os marcos legais das políticas de medicamentos no Brasil contemporâneo (1990-2006), Revista de Atenção Primária em Saúde. 2008; 11(1): 85-99.
3. BRAZIL. Decree nº 793/1993 [Internet]. Official Diary of the Union; 1993 Apr 6 [Cited 2017 Jul 03]. Available from:
http://www.anvisa.gov.br/hotsite/genericos/legis/decretos/793.htm
4. BRAZIL. Decree nº 3.181/1999 [Internet]. Official Diary of the Union; 1999 Sept 24 [Cited 2017 Jul 01]. Available from:
http://www.anvisa.gov.br/hotsite/genericos/legis/decretos/3181.htm
5. BRAZIL. Law nº 9.787/1999 [Internet]. Official Diary of the Union; 1999 Feb 11 [Cited 2017 Jul 01]. Available from:
http://www.planalto.gov.br/ccivil_03/leis/l9787.htm
6. BRAZIL. Resolution of the collegiate board of ANVISA nº 391/1999 [Internet]. Official Diary of the Union; 1999 Aug 9 [Cited 2017 Jul 05]. Available from:
http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/1999/res0391_09_08_1999.html
7. Pinto C. M. D. Mercado brasileiro de medicamentos genéricos: análise do desempenho de uma subsidiária de laboratório estrangeiro, Dissertation (Master), Escola Brasileira de Administração Pública e de Empresas, Centro de Formação Acadêmica e Pesquisa-Fundação Getúlio Vargas; 2007.
8. Araújo L. U. Medicamentos genéricos no Brasil: um panorama histórico e legislação, Revista Panamericana de Salud Pública, 2010; 28(6): 480-92.
9. Storpiritis S., Bueno M. M., A vigilância sanitária e a política nacional de medicamentos no Brazil: medicamentos genéricos, similares e novos, Farmácia clinica e atenção farmacêutica, Guanabara Koogan, 2008; 25-36.
10. ANVISA [Internet]. ‘List of registered generic medicines’. Official website of Brazilian National Health Surveillance Agency; 2017 Mar [Cited 2017 Jul 17]. Available from:
http://portal.anvisa.gov.br/medicamentos-genericos-registrados
11. BRAZIL. Resolution of the collegiate board of ANVISA nº 60/2014 [Internet]. Official Diary of the Union; 2014 Oct 13 [Cited 2017 Jul 01]. Available from:
http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2014/rdc0060_10_10_2014.pdf
12. BRAZIL. Law nº 9.279/1996 [Internet]. Official Diary of the Union; 1996 May 15 [Cited 2017 Jul 19]. Available from:
http://www.planalto.gov.br/ccivil_03/Leis/L9279.htm
13. Thana C. C. The compulsory licensing of Medicine as Health policy of the State. Revista da Faculdade de Direito da Universidade de São Paulo. 2007; 102: 759-96.
14. Mastroianni P. C. Fundamentos de ética e legislação para o Uso Racional de Medicamentos, Artes Médicas, 1° ed, 2010; 204.
15. Fuchs F. D. Wannmacher L., Ferreira M. B. Farmacologia Clínica: fundamentos da terapêutica racional, Guanabara Koogan. 2006; (3) p. 46.
16. BRAZIL. Ordinance nº 3916/MS/GM/1988 [Internet]. Official Diary of the Union; 1988 Nov 10 [Cited 2017 Jul 19]. Available from:
http://www.planalto.gov.br/ccivil_03/Leis/L6360.htm
17. BRAZIL. Law nº 6360/1976 [Internet]. Official Diary of the Union; 1976 Sept 24 [Cited 2017 Jul 19]. Available from:
http://www.planalto.gov.br/ccivil_03/Leis/L6360.htm
18. BRAZIL. Resolution of the collegiate board of ANVISA nº 10/2001 [Internet]. Official Diary of the Union; 2001 Jan 9 [Cited 2017 Jul 29]. Available from:
http://portal.anvisa.gov.br/documents/10181/2718376/RDC_10_2001_COMP.pdf/11785bf7-ec50-426d-b84e-c8b4c2fbc1b2
19. BRAZIL. Resolution of the collegiate board of ANVISA nº 84/2002 [Internet]. Official Diary of the Union; 2002 Mar 20 [Cited 2017 Jul 17]. Available from:
http://portal.anvisa.gov.br/documents/10181/2718376/RDC_84_2002_COMP.pdf/afd3101a-3674-4e3b-8e3c-0bda637247ce
20. BRAZIL. Resolution of the collegiate board of ANVISA nº 135/2003 [Internet]. Official Diary of the Union. 2003 Aug 12 [Cited 2017 Jul 29]. Available from:
http://portal.anvisa.gov.br/documents/10181/2718376/RDC_135_2003_COMP.pdf/1f7d961b-265d-4034-96a3-efea215145ff
21. BRAZIL. Resolution of the collegiate board of ANVISA nº 16/2007 [Internet]. Official Diary of the Union; 2007 Mar 22 [Cited 2017 Jul 18]. Available from:
http://portal.anvisa.gov.br/documents/10181/2718376/RDC_16_2007_COMP.pdf/99bd7f71-7631-4361-a995-6bf27ce06b93
22. ANVISA. ‘Published resolution harmonizing criteria for registration of medicines’. Official website of Brazilian National Health Surveillance Agency; 2014 Jan [Cited 2017 Jul 21]. Available from:
http://portal.anvisa.gov.br/...
23. BRAZIL. Resolution of the collegiate board of ANVISA nº 35/2012 [Internet]. Official Diary of the Union; 2012 Jun 20 [Cited 2017 Jul 19]. Available from:
http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2012/rdc0035_15_01_2012.html
24. Storpirtis S. Bioequivalência de medicamentos genéricos, Revista Infecto Atual; 2002: 8-13.
25. Capucho H. C., Mastroianni P. C., Cuffini S. Farmacovigilância no Brasil: a relação entre polimorfismo de fármacos, efetividade e segurança dos medicamentos, Revista de Ciências Farmacêuticas Básica e Aplicada. 2008; 29(3): 277-83.
26. BRAZIL. Resolution of the collegiate board of ANVISA nº 57/2009 [Internet]. Official Diary of the Union; 2009 Nov 17 [Cited 2017 Jul 19].
Available from:
http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2009/rdc0057_17_11_2009.html
27. BRAZIL. Resolution of the collegiate board of ANVISA nº 45/2012 [Internet]. Official Diary of the Union; 2012 Aug 10 [Cited 2017 Jul 04]. Available from:
http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2012/rdc0045_09_08_2012.html
28. BRAZIL. Resolution of the collegiate board of ANVISA nº 166/2017 [Internet]. Official Diary of the Union; 2017 Jul 25 [Cited 2017 Jul 20]. Available from:
https://www20.anvisa.gov.br/coifa/pdf/rdc166.pdf
29. BRAZIL. Resolution of the collegiate board of ANVISA nº 305/2002 [Internet]. Official Diary of the Union; 2002 Nov 18 [Cited 2017 Jul 19]. Available from:
http://portal.anvisa.gov.br/documents/33880/2568070/RDC_305_2002.pdf/750b43f5-2f26-4d3a-8ed0-41d81285c850
30. BRAZIL. Resolution of the collegiate board of ANVISA nº 37/2009 [Internet]. Official Diary of the Union; 2009 Jul 08 [Cited 2017 Jul 20]. Available from:
http://portal.anvisa.gov.br/documents/33880/2568070/res0037_06_07_2009.pdf/bea487de-4eb5-413d-913b-4c71b3109ec6
31. BRAZIL. Resolution of the collegiate board of ANVISA nº 31/2010 [Internet]. Official Diary of the Union; 2010 Aug 11 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/33880/2568070/res0031_11_08_2010.pdf/5e157d15-d3d5-4bb9-98db-5667e4d9e0c8
32. BRAZIL. Resolution of the collegiate board of ANVISA nº 53/2015 [Internet]. Official Diary of the Union; 2015 Dec 7 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/10181/3295768/%281%29RDC_53_2015_COMP.pdf/d38f507d-745c-4f6b-a0a6-bd250f2e9892
33. BRAZIL. Normative Instruction nº 02/2009. [Internet]. Official Diary of the Union; 2009 Apr 1 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/10181/2718376/IN_02_2009_COMP.pdf/c48c0a7a-01cd-42be-ab4d-ff8c882f1062
34. BRAZIL. Resolution nº 01/2005 [Internet]. Official Diary of the Union; 2005 Aug 1 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/33880/2568070/RE_01_2005_SUP.pdf/02d99054-f436-4100-a1ed-7b0616d21ad0
35. BRAZIL. Resolution of the collegiate board of ANVISA nº 37/2011 [Internet]. Official Diary of the Union; 2011 Aug 4 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/33880/2568070/rdc0037_03_08_2011.pdf/13c41657-e93b-4d09-99eb-377f760f3aa0
36. BRASIL. Resolution nº 1170/2006 [Internet]. Official Diary of the Union; 2006 Apr 22 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/10181/2718376/%281%29RE_1170_2006_COMP.pdf/52326927-c379-45b4-9a7e-9c5ecabaa16b
37. BRAZIL. Resolution of the collegiate board of ANVISA nº 71/2009 [Internet]. Official Diary of the Union; 2009 Dec 23 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/10181/2718376/%281%29RDC_71_2009_COMP.pdf/192db064-dcc7-4816-829a-6b37a38f4b32,
38. BRAZIL. Resolution of the collegiate board of ANVISA nº 47/2009 [Internet]. Official Diary of the Union; 2010 Jan 19 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/10181/2718376/RDC_47_2009_COMP.pdf/00172aeb-caab-4016-bc11-d318a8b74170
39. BRAZIL. Resolution of the collegiate board of ANVISA nº 23/2015 [Internet]. Official Diary of the Union; 2015 Jun 08 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/10181/2867904/RDC_23_2015_.pdf/cd875afa-c9f1-4e7c-b745-271a9ceaaf3a
40. BRAZIL. Resolution of the collegiate board of ANVISA nº 25/2008 [Internet]. Official Diary of the Union; 2008 Apr 7 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/10181/2718376/RDC_25_2008_COMP.pdf/e80b3fd4-d7a5-4bf8-b935-9e687fe9464c
41. BRAZIL. Resolution of the collegiate board of ANVISA nº 204/2005 [Internet]. Official Diary of the Union; 2005 Jul 7 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/10181/2718376/RDC_204_2005_COMP.pdf/786581c5-18f9-45c2-9644-ed1d535d5ad0
42. BRAZIL. Resolution of the collegiate board of ANVISA nº 73/2016 [Internet]. Official Diary of the Union; 2016 Nov 7 [Cited 2017 Aug 20]. Available from:
http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2016/rdc0073_07_04_2016.pdf
43. BRAZIL. Law nº 10.742/2003 [Internet]. Official Diary of the Union; 2003 Oct 7 [Cited 2017 Aug 20]. Available from:
http://www.planalto.gov.br/ccivil_03/leis/2003/L10.742.htm
44. BRASIL. Resolution of the collegiate board of ANVISA nº 25/2007 [Internet]. Official Diary of the Union; 2007 Mar 30 [Cited 2017 Aug 20]. Available from:
http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=30/03/2007&jornal=1&pagina=113&totalArquivos=168
45. BRASIL. Resolution of the collegiate board of ANVISA nº 4/2009 [Internet]. Official Diary of the Union; 2009 Feb 11 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/33880/2568070/res0004_10_02_2009.pdf/05f05642-1cae-4a60-9485-5ff63cfb22af
46. BRASIL. Resolution of the collegiate board of ANVISA nº 55/2005 [Internet]. Official Diary of the Union; 2005 Mar 21 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/33880/2568070/RDC_55_2005.pdf/958b1146-2e2c-498f-8f15-32c8a76f3a8b
47. BRASIL. Resolution of the collegiate board of ANVISA nº 96/2008. Official Diary of the Union; 2008 Dec 18 [Cited 2017 Aug 20]. Available from:
http://portal.anvisa.gov.br/documents/10181/2718376/RDC_96_2008_COMP.pdf/e1064ff1-781d-402e-b74f-9521655c663d.
Statistics
590 Views | 1274 Downloads
How to Cite
Cardoso, P. A. “GENERIC MEDICINES REGULATION IN BRAZIL”. International Journal of Drug Regulatory Affairs, Vol. 5, no. 3, Sept. 2017, pp. 1-9, doi:10.22270/ijdra.v5i3.201.