WORLD TRADE  
ORGANIZATION   
G/TBT/N/BRA/465 
6 February 2012  
 (12-0714) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  BRAZIL  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Health Surveillance Agency – ANVISA 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
National Institute of Metrology, Standa rdization and Industrial Quality-INMETRO 
Telephone:  +(55) 21 2563.2821 Telefax:  +(55) 21 2502.6542 Email:  barreirastecnicas@inmetro.gov.br  
Web-site:  http://www.inmetro.gov.br/barreirastecnicas/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Brazilian Nonproprietary 
Names - DCB 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 4 
January 19th 2012 – Establishes rules used for classification of Braz ilian Non Proprietary 
Names - DCB. (7 pages, in  Portuguese)     G/TBT/N/BRA/465 
Page 2  
 
  6. Description of content:  This draft technical resolution esta blishes rules for classification of 
Brazilian Non-proprietary Name s - DCB. This resolution applies to generic nomenclature 
assigned to inactiv e and active pharmaceutical ingredient s, biological produ cts: heterologous 
hyper immune serum and vaccines, radiopharmace uticals, medicinal plants, homeopathic and 
biological substances used in th e registration process, importati on, marketing, advertising and 
promotional material, prescription, educational, technical and scientific material used in the 
country. The rules adopted for DCB must co mply with the World Health Organization 
(WHO) for International Non- proprietary Names - INN.  
It revokes resolution RESOLUTION RDC nº 276 21 October 2002, republished on 12 
November 2002, RESOLUTION RDC Nº 268 26 September 2003, RE SOLUTION RDC Nº 
96 20 April 2005, RESOLUTION RDC Nº 111 29 April  2005, RESOLUTION RDC Nº 235 
17 August 2005, RESOLUTION RDC Nº 281 22 Se ptember   2005, RESOLUTION RDC Nº 
346 16 December 2005, RESOLUTION RDC 16 31 January 2006, RESOLUTION RDC Nº 
50, 22 March 2006, RESOLUTI ON RDC 83, 16 May 2006, RESOLUTION RDC Nº 112 30 
June 2006, RESOLUTION RDC Nº 154 10 Augu st 2006 , RESOLUTION RDC Nº 210 17 
November 2006, RESOLUTION RDC Nº 211  17  November 2006, RE SOLUTION RDC Nº 
33 June 8th  2007, RESOLUTION RDC Nº 61 September 21st 2007,  RESOLUTION RDC 
Nº 64  October 2nd 2007, RESOLUTION RD C Nº 15 13 March 2008, RESOLUTION RDC 
53 29 July 2008, RESOLUTION RDC Nº 57 6 August 2008, RESOLUTION RDC Nº 61 25 
August 2008, RESOLUTION RDC Nº 10, 9 Ma rch 2009, RESOLUTION RDC Nº 38 7 July 
2009, RESOLUTION RDC Nº 11 9 March 2010, RESOLUTION RDC 30 August 11th 
2010, RESOLUTION RDC Nº 54 10 December 2010, and RESOLUTION RDC Nº 19 5 
May 2011. 
Entities, companies and users of Brazilian N on Proprietary Names (DCB) will be granted a 
period of 180, after the publication of the Reso lution to apply to the standards established on 
it.   
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  
8. Relevant documents:   Brazilian Official J ournal (Diário Oficial da  União), 19 January 2012; 
Section 1, page 36. Draft Reso lution (Consulta Pública) number 4 16 January 2012, issued by 
the Brazilian Health Regulatory Agency - A nvisa; When adopted, it will be published at 
Brazilian Official Journal. Available in Portuguese.   
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined after the end of the 
consultation period.  
10. Final date for comments:  19 February 2012.  G/TBT/N/BRA/465 
 Page 3 
 
 
  11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
National enquiry point 
Agency responsible Brazilian Health Regulatory Agency - ANVISA SIA, Trecho 5, Área Especial 57 
Brasília - DF / Brazil 
CEP:  71.205-050 Phone:  55 61 3462-5402 E-mail:  rel@anvisa.gov.br   
Website:  www.anvisa.gov.br 
"http://portal.anvisa.gov.b r/wps/wcm/connect/7e7f398 049d99b4cab87af6dcbd9c63c/Consulta
+P%C3%BAlblica+N+4+COFAR+ %282%29.pdf?MOD=AJPERES "