. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/382 
3 August 2010  
 (10-4128) 
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 government 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 E-mail:  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 applicab le, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):  Biological products.  
5. Title, number of pages and langu age(s) of the notified document:  Draft Resolution 
N° 49, 25 May 2010 – registration of new biological products and biological products. 
(13 pages, Portuguese)     
6. Description of content:  This technical regulation estab lishes procedures and requirements 
for registration of new biological products and biological products.  This draft Resolution 
has the objective to ensure quality, safety and efficacy of these medicines.  This Resolution 
applies to new biological products and biolog ical products to be submitted to Anvisa´s 
analysis to obtain a registration.  
The following biological products are covered by this Resolution: I - Vaccines;  
II - Antibodies;  
III – Hemoderivatives;  IV - Biomedicines classified as: 
Medicines obtained from biological fluids or tissues of animal origin; and Medicines obtained by biotechnological procedures. 
V - Monoclonal antibodies; G/TBT/N/BRA/382 
Page 2  
 
  VI – Products containing live micr oorganisms, attenuated or dead; 
VII – Probiotics; VIII – Allergens. Only biological products registered at Anvisa, manufactured or imported by establishments 
authorized by the federal government and licensed by the state government, can be 
commercialized and distributed in Brazil. 
This resolution will revoke Reso lution RDC 315, 26 October 2005. 
7. Objective and rationale, including the natu re of urgent problems where applicable:  
Protection of Human Health and Prevention of Deceptive Practices  
8. Relevant documents:   Brazilian Official Journal (Diári o Oficial da União), 25 May 2010; 
Section 1. Draft Resolution (Consulta Pública) number 49, 24 May 2010, issued by Brazilian Sanitary Surveillance Agency – Anvi sa; 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:  25 July 2010 
11. Text available from: National enquiry po int [ 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 E-mail:  rel@anvisa.gov.br  Website:   http://www.anvisa.gov.br
 
http://portal.anvisa.gov.br/wps/wcm/c onnect/e2aadd80429bb147 83c6e32312e9dd30/CP+N
%C2%BA+49+GGMED.pdf?MOD=AJPERES