. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/425 
10 March 2011  
 (11-1207) 
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 Health Surv eillance 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 Telefax:  +(55) 21 2563.5637 E-mail:  mailto: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):  Health products 
5. Title, number of pages and langu age(s) of the notified document:  Draft Resolution nº 5, 
15 February 2011.  It establishes compulsory notifications, corrective and preventive actions 
that must be carried out by hol ders of health products regist rations in Brazil (4 pages, 
Portuguese). 
6. Description of content:  This draft technical resolution establishes compulsory notifications, 
preventive and corrective actions that must be  carried out by holders of health products 
registrations at Anvisa.  
This draft Resolution sets out situations for mandatory execution and reporting of corrective 
and preventive actions by holders of health products registration in Brazil, establishing its 
minimum requirements.  
The holders of health products  registration, as well as a ll the actors involved on the 
commercialization of the products , from manufacturing to marke ting, are jointly responsible 
for maintaining the quality, safety and efficacy of  the health products until they reach the final 
consumer.  
The Resolution defines the actions that must be  carried out by holders of health products 
registrations aiming to reduce health risks and prevent the occurrence of adverse events related to the use of  health products.  
It will be granted a period of 360 days from the da te of entry into force of this Resolution for 
holders of health products regist rations to make the necessary adjustments to comply with this 
resolution.  G/TBT/N/BRA/425 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  
8. Relevant documents:   Brazilian Official Journal (Diári o Oficial da União), 16 February  
2011; Section 1 page 87. Draft Resolution (Consul ta Pública) number 5, 15 February 2011, 
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:  18 April 2011 
11. Text available from:  National enquiry point [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 Health Regulatory Agency – ANVISA SIA, Trecho 5, Área Especial 57 Brasília - DF / Brazil 
CEP: 71.205-050 
Tel.:  55 61 3462-5402 E-mail:  mailto:rel@anvisa.gov.br
  
Website:  http://www.anvisa.gov.br  
"http://websphere.anvisa.gov.br/wps/wcm /connect/86bed00045cd3253a743bfe99fa014e7/Co
nsulta+P%C3%BAblica+N% C2%BA+5.pdf?MOD=AJPERES "