. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/350 
16 October 2009  
 (09-5085) 
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 governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Sanitary Surveillance Agency – ANVISA 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or auth ority designated to handle comments 
regarding the notification shall be indicated if different from above :   
National Institute of Metrology, Standa rdization and Industrial Quality-INMETRO 
Telephone: +(55) 21 2563.2821 Fax: +(55) 21 2502.6542 Email: barreirastecnicas@inmetro.gov.br Website:  http://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):  Herbal Active 
Pharmaceutical Ingredients. 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
number 63, 24 September 2009 – Herbal Acti ve Pharmaceutical Ingredients (API) 
(5 pages, Portuguese).     
6. Description of content:  This Resolution has the objec tive to settle Good Manufacturing 
Practices (GMP) for  Herbal Active pharmaceutical ingredients (API).  
The Resolution covers Good Manufacturing Practi ce at the production of Herbal API. The 
understanding of this Technica l Regulation should not be cons idered in isolation, but 
complementary to the prin ciples of GMP for interm ediate products and Active 
Pharmaceutical Ingredients, established by Resolution RDC number 249, 13 September 2005. 
The Resolution applies to all manufacturers of Herbal API,  not including fresh medicinal 
herbs and the ones used for isolation of pure subs tances, according to item 1.7 of Annex I of 
Resolution RDC 249, 13 September 2005.  
This Resolution does not contemplate the combination of raw plant materials with materials 
of animal and mineral origin , chemicals, among others.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  G/TBT/N/BRA/350 
Page 2  
 
  8. Relevant documents:   Brazilian Official Journal (Diário Oficial da União), 24 September 
2009; Section 1. Draft Resolution (Consulta Públ ica) number 63, 24 September 2009,  issued 
by Brazilian Sanitary Surveillan ce Agency – Anvisa; 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:  24 October 2009 
11. Text available from: National enquiry po int [ X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
Brazilian Sanitary Surveillance 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: http://www.anvisa.gov.br
 
http://www4.anvisa.gov.br/base /visadoc/CP/CP[27825-1-0].PDF