. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/226 
3 November 2006 
 (06-5293) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   BRAZIL
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Brazilian Sanitary Surveillance Agency – ANVISA 
Name and address (including telephone and fax numbers, e-mail and web-site 
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: 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):   Generic Drugs 
5. Title, number of pages and language(s) of the notified document:   Draft Resolution 
nº 57, 13 September 2006 – Technical re gulation on generic drugs registration 
(11 pages, in Portuguese). 
6. Description of content:   This draft technical regulati on establishes new procedures for 
generic drugs registration.  It also allows the registration of oral contraceptives and oral 
endogenous hormones as generic drugs.  It requires the inclusion of a Relative Biodisponibility Study Protocol am ong procedures and documents for the registration. 
 
It revokes Resolution (RDC) n.º135, 29 May 2003. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health and Extens ion of Consumers’ Access to Drugs. 
8. Relevant documents:   Brazilian Official Journal (Diário Oficial da União), 
14 September 2006; Section 1, page 40. Dr aft Resolution number 57, 13 September 2006 
(Consulta Pública nº 57, de 13 de setembr o de 2006), issued by Brazilian Sanitary 
Surveillance Agency – Anvisa; to be published at Brazilian Official Journal. Available in 
Portuguese. G/TBT/N/BRA/226 
Page 2  
 
  9. Proposed date of adoption:   
Proposed date of entry into force:   }December 2006 
10. Final date for comments:   28 October 2006 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Enquiry Point 
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 Website: www.inmetro.gov.br/barreirastecnicas   
Agency responsible 
Brazilian Sanitary Surveillance Agency – ANVISA 
SEPN 515 - Bloco "B", Edificio Omega 
CEP 70770-502 Brasilia – DF/Brasil Telephone: 55 61 3448 1078 E-mail:  rel@anvisa.gov.br  Website: www.anvisa.gov.br 
 
The full text of the pr oposed technical regulation can be directly accessed th rough the link: 
http://www4.anvisa.gov.br/base/visadoc/CP/CP[16078-1-0].PDF