G/TBT/N/BRA/532  
 
31 May 2013  
(13-2850)  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 :   
Institute of Metrology, Quality and Technology - INMETRO 
Telephone:  +(55) 21 2563.2821 
Telefax:  +(55) 21 2502.6542 Email:  barreirastecnicas@inmetro.gov.br  
Website:  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):  Traditional 
Chinese Medicine products (HS: 30.00). 
5. Title, number of pages and language(s) of the notified document:  Draft Ordinance 
No. 15, 14 May 2013 - Draft Technical Regula tion that establishes requirements to 
commercialize traditional Chinese medicine products in Brazil (3 pages, in Portuguese)     
6. Description of content:  This draft Technical Regulation has the objective to establish 
requirements to commercialize traditional Chinese medicine products in Brazil. 
It establishes a period of three years from the date of publication of this Resolution for 
the monitoring of the use of traditional Chinese medicine products in the country. 
For the purposes of this Resolution traditional Chinese medicine products are 
formulations obtained from vegetable and mineral raw materials in accordance with 
traditional Chinese medicine techniques and part of the Chinese Pharmacopoeia.  
It is forbidden for the use of animal origin raw material in the formulations to be 
commercialized in Brazil.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human Health.  G/TBT/N/BRA/532 
 
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  8. Relevant documents:    
1. Brazilian Official Journal (Diário Oficial da União), 15 May 2013; Section 1  Draft 
Resolution (Consulta Pública) number 15, 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.   
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:  19 August 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/61f704004fa210b897f0f79a71dcc661/Cons
ulta+P%C3%BAblica+n%C2%B0+15+SECOL.pdf?MOD=AJPERES"