G/TBT/N/BRA/535  
 
10 July 2 013  
(13-3654) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member :  BRAZIL   
If applicable, name of local government involved  (Article 3.2 and 7.2) :    
2. Agency responsible:  ANVISA - Brazilian Health Regulat ory Agency  
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, Quality and Technology - INMETRO  
Telephone:  +(55) 21 2563.2821  
Telefax:  +(55) 21 2502.6542  
Email:  barreirastecnicas@inmetro.gov.br  
Web-site:  http:// www.inmetro.gov.br/barreirastecnicas  
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id _aplicacao=11452  
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):  Active 
Pharmaceutical Ingredients.  
5. Title, number of pages  and language(s)  of the notified document:  Draft Resolution 
nº 22, 25 June  2013 - Draft Technical Regulation that establishes requirements to post -
registration modifications of active ph armaceutical  ingredients (API)  (10 pages , in 
Portuguese).     
6. Description of content:  This draft Technical Regulation has the objective to establish 
requirements to post -registration modifications of active pharmaceutical ingredients 
(API) registered in Brazil us ed in the production and/or commercializati on of medicines 
in the country   
7. Objective and rationale , including the nature of urgent problems where 
applicable:   Protection of human health and safety  
8. Relevant documents:    
1. Brazilian Official Journa l (Diário Oficial da União), 26 June  2013; Section 1   Draft 
Resolution (Consulta Pública) number 22, 25 June  2013, issued by Brazilian Health 
Regulatory Agenc y - Anvisa;  
2. Not Applicable;  
3. Brazilian Official Jou rnal (Diário Oficial da União);  
4. Not App licable . G/TBT/N/BRA/535  
 
- 2 - 
 
  9. Proposed date of adoption:   
 
Proposed date of entry into force:    To be determined after the end of the 
consultation period  
This Resolution will enter into force 90 days 
after its adoption  
10. Final date for comments:  2 September  2013  
11. Text available from :  National enquiry point  [  ], or address, telephone and fax 
number s, e-mail and web -site address es, if available of the other body:    
Agency responsible  
Brazilian Health Regulatory Agency - ANVISA  
SIA, Trecho 5, Área Especial 57  
Brasília - DF / Brazil  
CEP: 71.205 -050 
Phone.:  55 61 3462 -5402 
E-mail:  rel@anvisa.gov.br   
Websit e: 
"http://portal.anvisa.gov.br/wps/wcm/connect/e692a480402220199ec7dedc5a12ff52/Con
sulta+P%C3%BAblica+n%C2%B0+22+GGMED.pdf?MOD=AJPERES " 
"http://portal.anvisa.gov.br/wps/wcm/connect/e692a480402220199ec7dedc5a12ff52/Con
sulta+P%C3%BAblica+n%C2%B0+22+GGMED.pdf?MOD=AJPERES "