. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/225 
2 October 2006 
 (06-4674) 
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):   Similar Drugs 
5. Title, number of pages and language(s) of the notified document:   Draft Resolution 
nº 56, 13 September 2006 – Technical regulatio n on similar drugs registration (8 pages, 
Portuguese). 
6. Description of content:   This draft technical regulati on establishes new procedures for 
similar drugs registration.  It requires the inclusion of a Relative Biodisponibility Study 
Protocol for contraceptive drugs, endogenous hormones, cyclosporine and myc ophenolate 
mofetil, as well as changes the documentation that manufacturer shall present to have the 
similar drug regi strated.   
It revokes Resolution (RDC) n.º133, 29 May 2003. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health and Improvement of Drugs Quality. 
8. Relevant documents:   Brazilian Official Journal (Diário Oficial da União), 
14 September 2006; Section 1, page 40. Dr aft Resolution number 56, 13 September 2006 
(Consulta Pública nº 56, 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/225 
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:   
National Institute of Metrology, Standard ization 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 
 Agency responsible  
Brazilian Sanitary Surveillance Agency – ANVISA 
SEPN 515 - Bloco "B", Edificio Omega CEP 70770-502 
Brasilia – DF/Brasil 
Phone.:  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[16077-1-0].PDF