. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/361 
4 February 2010  
 (10-0598) 
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 
Telephone: +(55) 21 2563.2821 
Telefax: +(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):  Drugs.  
5. Title, number of pages and langu age(s) of the notified document:  Draft Resolution nº 1, 
18 January 2009 – Drugs (3 pages, Portuguese)     
6. Description of content:  This technical regulat ion settles operation rules for drug importing 
companies.  
The import of medicines can only be made by a company that holds the operating  permit  to 
import activities issued by ANVISA, call ed in this Resolution as importers.  
Companies legally authorized to develop im port activities, except for manufacturing 
companies, can only import finished products and in its final packaging.  
The importer is responsible for the quality, effi cacy and safety of the products they import. 
All importers must have quality control laborat ory and storage location themselves, including 
specific location for storage of retention samples. The company also must have adequate 
technical capacity to complete the necessary activities. 
All imported drugs must be tested for complete quality control in accordance with the product 
registration, batch to batch, in its own la boratory located in the importing country.  
Biomedicines are disciplined by a specific Regulation and they are an exception for this  
Resolution.  G/TBT/N/BRA/361 
Page 2  
 
  The Resolution revokes Resolution "Portaria nº 185/1999".   
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 Official J ournal (Diário Oficial da  União), 20 January 2010; 
Section 1. Draft Resolution (Consulta Públic a) number 1, 18 January 2009, 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:  20 February 2010 
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:    
National enquiry point 
Agency responsible 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://portal.anvisa.gov.br/wps/wcm /connect/90764b00411cf 905954695ad4d689a3d/CP+N%
C2%BA+1+GGIMP.pdf?MOD=AJPERES