. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/230 
13 December 2006 
 (06-5983) 
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 WTO/TBT 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 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):   Intra-uterine 
Contraceptive 
5. Title, number of pages and language(s) of the notified document:   Draft Resolution 
nº 78, 13 November 2006 – Technical regula tion on registration, manufacture, quality 
control and information for c onsumers of copper intra-uterine contraceptive (5 pages, in 
Portuguese). 
6. Description of content:   This draft technical regulat ion establishes procedures for 
registration, manufacture and qual ity control of copper intra-uterine contraceptive. It also 
establishes the information that has to be given to consumers of copper intra-uterine 
contraceptive. 
It revokes Administrative Act (Por taria DIMED) nº. 6, 6 July 1984. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health.  
8. Relevant documents:   Brazilian Official Journal (Diári o Oficial da União), 17 November 
2006; Section 1, page 66. Draft Resolution (Consulta Pública) number 78, 13 November 
2006, issued by Brazilian Sanitary Surveilla nce Agency – Anvisa; to be published at 
Brazilian Official Journal. Available in Portuguese. G/TBT/N/BRA/230 
Page 2  
 
  9. Proposed date of adoption:   
Proposed date of entry into force:    January 2007  
January 2007 
10. Final date for comments:   31 December 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 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 
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[16642-1-0].PDF