. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/387 
22 September 2010  
 (10-4782) 
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 authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
National Institute of Metrology, Standa rdization and Industrial Quality-INMETRO 
Tel.: +(55) 21 2563 2821 
Fax: +(55) 21 2563 5637 Email:  barreirastecnicas@inmetro.gov.br
 
Website:  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):  Active pharmaceutical 
ingredients 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 84, 
10 August 2010 – Good Manufacturi ng Practices of Active Phar maceutical Ingredients, 
(39 pages, in Portuguese). 
6. Description of content:  This technical regulat ion establishes Good Manufacturing Practices 
for active pharmaceutical ingredients (API).  
All establishments that manufacture active pharmaceutical ingredients must attend the 
requirements established in this Resolution. 
This resolution outlines procedures and practice s that manufacturers mu st comply to ensure 
that the facilities, methods, processes, syst ems and controls used to manufacture active 
pharmaceutical ingredients are adequate to ensure the quality of the API, allowing  its  use on 
the development of pharmaceutical products.  
The manufacturer of active pharmaceutical ingredients must ensure that they are adequate for 
the pretended use and in accordance with identity, purity and sa fety requirements. 
The manufacturer that produces active pharmace utical ingredients is  responsible for its 
products quality.  
The manufacturers shall present evidences that they fulfil the GMP Practices, as defined on  
Annex 1 of the Resolution. 
This resolution will revoke Anvisa's reso lution - RDC n°. 249,  13 September 2005.  G/TBT/N/BRA/387 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health and Prevention of Deceptive Practices  
8. Relevant documents:   Brazilian Offici al Journal (Diári o Oficial da União), 12 August 2010; 
Section 1. Draft Resolution (Consulta Públic a) number 84, 10 August 2010, issued by 
Brazilian Sanitary Surveillance Agency – A nvisa; When adopted, it will be published at 
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:  13 October 2010 
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:    
National enquiry point 
Agency responsible Brazilian Sanitary Surveillance Agency – ANVISA SIA, Trecho 5, Área Especial 57 Brasília – DF / Brazil 
CEP: 71.205-050 
Tel.:  +55 61 3462-5402 Email:  rel@anvisa.gov.br  Website:  http://www.anvisa.gov.br
 
 
http://portal.anvisa.gov. br/wps/wcm/connect/71728 c00438e912bbeeabe07ebd78d7a/CP+N%
C2%BA+84+GGIMP.pdf?MOD=AJPERES