. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/BRA/431 
30 May 2011  
 (11-2710) 
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 Surve illance 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, Standard ization and Industrial Quality - INMETRO 
Telephone:  +(55) 21 2563.2821 Telefax:  +(55) 21 2502.6542 E-mail:  barreirastecnicas@inmetro.gov.br  
Website:  http://www.inmetro.gov.br/barreirastecnicas  
3. Notified under Article 2.9.2 [   ], 2.10.1 [   ], 5.6.2 [ X ], 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):  Dynamized medicines 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 13, 
March 16th  2011 - It establishes requirements to change, include, su spend, reactivate and 
cancel dynamized medicines already registered  at Anvisa (34 pages, in Portuguese). 
6. Description of content:  This draft technical re gulation establishes requ irements to change, 
include, suspend, reactivate and cancel dynamized medicines already registered at Anvisa.  
This draft resolution aims to classify post re gistration modifi cations of dynamized medicines 
and establishes the documentation and la boratorial tests required by Anvisa.  
It applies to all dynamized medicines th at are already registered at Anvisa.  
Anvisa's decisions about the pos t registration requests will be  published at the Brazilian 
Official Journal (Diári o Oficial da União), or in anothe r institutional publication, when 
applicable. 
Anvisa´s recommendations for post registration of dynamized medicines will be available at 
Anvisa´s website.  
This draft resolution will revoke annex III of Resolution RDC nº26, March 30th 2007. G/TBT/N/BRA/431 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  
8. Relevant documents:   Brazilian Official Journal (Diário Oficial da União), March 21st  
2011; Section 1 page 65. Draft Resolution (Cons ulta Pública) number 14, March 16th 2011, 
issued by Brazilian Sanitary  Surveillance Agency  - Anvisa; When adopted, it will be 
published in the Brazilian Official J ournal. Available in Portuguese   
9. Proposed date of adoption:   
 
Proposed date of entry into force:    To be determined after the end of the 
consultation period On the date of adoption 
10. Final date for comments:  21 April 2011 
11. Text available from: National enquiry point [X], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
Brazilian Health Regulatory Agency – ANVISA 
SIA, Trecho 5, Área Especial 57 
Brasília – DF / Brazil 
CEP:  71.205-050 Tel.:  55 61 3462-5402 E-mail:  rel@anvisa.gov.br   
Website:  http://www.anvisa.gov.br  
Text can be downloaded at: 
"http://portal.anvisa.gov.br/wps/wcm/conn ect/ec4242804637cfec85c5bf0ce2062da6/CP+N
%C2%BA+13+GGMED.pdf?MOD=AJPERES "