G/TBT/N/BRA/531  
 
31 May 2013  
(13-2842)  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 Regulatory Agency 
Name and address (including telephon e 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/f ormulario.php?id.ap_aplicacao=11451  
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):  Herbal 
medicines (HS: 30.04). 
5. Title, number of pages and language(s) of the notified document:  Draft Ordinance 
No. 14, 14 May 2013 - Draft Normative Instruct ion that determines the publication of the 
List of herbal medicines that requires simplified registration and the List of herbal medicines of traditional use that requires simplified registration at Anvisa (13 pages, in 
Portuguese).    
6. Description of content:  This draft Normative Instruction determines the publication of 
the list of herbal medicines that requires simplified registration at Anvisa and the list of 
herbal medicines of traditional use that requires simplified registration at Anvisa to be commercialized in Brazil.  This Normative Instruction will enter into force on the date of 
its adoption. It will revoke Normative Instruction n. 5, 11 December 2008. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human Health . 
8. Relevant documents:    
1. Brazilian Official Journal (Diário Oficial da União), 15 May 2013; Section 1  Draft 
Resolution (Consulta Pública) number 14, 14 May 2013, issued by Brazilian Health 
Regulatory Agency - Anvisa;  
2. Not Applicable  
3. Brazilian Official Journal (Diário Oficial da União);  
4. Not Applicable; When adopted, it will be published at the  Brazilian Official Journal. 
Available in Portuguese.   G/TBT/N/BRA/531 
 
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  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:  22 July 2013. 
11. Text available from:  National enquiry point [  ], or address, telephone and fax 
numbers, e-mail and web-site addresse s, 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   
Website:  www.anvisa.gov.br 
"http://portal.anvisa.gov.br/wps/wcm/con nect/a5beee004fa126df932cf79a71dcc661/Cons
ulta+P%C3%BAblica+n+14+S ECOL.pdf?MOD=AJPERES"