. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/227 
3 November 2006 
 (06-5319) 
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 Website: 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):   Dinamized Drugs 
(Homeopathic, Anthroposophic and Antihomotoxic Drugs) 
5. Title, number of pages and language(s) of the notified document:   Draft Resolution nº 
52, 1 September 2006 – Technical regulation on i ndustrialized dinamized drugs registration 
(30 pages, in Portuguese). 
6. Description of content:   This draft technical regulation establishes the procedures for the 
registration and the notification of trade of industrialized dinamized drugs (homeopathic, 
anthroposophic and antihomotoxic drugs).  It also establishes the procedures for dinamized 
drugs post-registering and the parameters for dina mized drugs leaflet packaging and labelling.   
It revokes Resolution (RDC) 139/2003 and articles  12, 16, 18, 19 and 20 from Administrative 
Act (Portaria) 17/1966. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health and sanitary control. 
8. Relevant documents:   Brazilian Official Journal (Diário Oficial da União), 
4 September 2006; Section 1, page 103. Draf t Resolution (Consulta Pública) number 52, 
1 September 2006, issued by Brazilian Sanita ry Surveillance Agency – Anvisa; to be 
published at Brazilian Official Journal. Available in Portuguese. G/TBT/N/BRA/227 
Page 2  
 
  9. Proposed date of adoption:   
Proposed date of entry into force:    November 2006 
May 2007 
10. Final date for comments:   60 days after publication on WTO website 
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 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 
Website: www.inmetro.gov.br/barreirastecnicas 
 
Regulatory authority 
 
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[15943-1-0].PDF