. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/380 
27 July 2010  
 (10-4020) 
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, Standard ization and Industrial Quality – INMETRO 
Tel.:  +(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 applicab le, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Active pharmaceutical 
ingredients.  
5. Title, number of pages and langu age(s) of the notified document:  Draft Resolution 
n° 59, 21 June 2010 – conduction of stability studies for active pharmaceutical ingredients 
(12 pages, Portuguese).     
6. Description of content:  This technical regulation establishes procedures to carry out 
stability testing of active pharmaceutical ingr edients derived from chemical synthesis, 
fermentation and isolated from natural sources in order to predict, determine or monitor its 
retest date or its expiry date.  All establishments that manufacture active pharmaceutical ingredients must attend the requirements estab lished in this Resolution.  For imported 
products, the stability studies may be conducted outside the country, according to the 
parameters defined in this Resolution.  The purpose of the stability study is to determine a 
retest period or an expiry date that is app licable to all batches of active pharmaceutical 
ingredients that will be produced under the sa me circumstances.  This Resolution is based 
on the World Health Organization (WHO) reco mmendations on Quality Certification of 
Pharmaceutical Products.  
7. Objective and rationale, including the natu re of urgent problems where applicable:  
Protection of human health and prevention of deceptive practices.  G/TBT/N/BRA/380 
Page 2  
 
  8. Relevant documents:   Brazilian Official Journal (Diári o Oficial da União), 21 June 2010; 
Section 1. Draft Resolution (Consulta Pública) number 59, 18 June 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:  21 August 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/conn ect/9299fa8042e67f1dac67be d90f4a3f31/CP+N%
C2%BA+59+GGIMP.pdf?MOD=AJPERES