. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/BRA/470 
24 February 2012  
 (12-1067) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  BRAZIL  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Health Regulatory 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  
Web-site:  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):  Medicines. 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 11 
23 January 2012 - Establishes parameters for notif ication, identification and qualification of 
degradation products in medicines (6 pages, Portuguese). 
6. Description of content:  This draft technical regulati on establishes parameters for 
notification, identification a nd qualification of degradation products in medicines with 
synthetic and semi - synthetic active ingredie nts classified as new, generic or similar 
medicines.  
It regulates the notification, identification and qualificati on of degradation products in 
medicines. It establishes para meters to verify the degrada tion products in medicines, to 
elaborate the de gradation profile and to notify, iden tify and qualify the degradation products 
formed during the life time of the medicine. 
This draft resolution does not apply to  excipients, peptid es, oligonucleotides, 
radiopharmaceuticals, derived and fermentation products, herb al products, medicines based 
on vitamins and/or minerals associated with  each other or isolated poliaminoacids and 
products that have to submit si mplified notification to Anvisa.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  G/TBT/N/BRA/470 
Page 2  
 
  8. Relevant documents:   Brazilian Official J ournal (Diário Oficial da  União), 27 January 2012; 
Section 1, page 43. Draft Reso lution (Consulta Pública) number 11, 23 January 2012, issued 
by the Brazilian Health Regulat ory Agency - Anvisa; When a dopted, 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.  
10. Final date for comments:  27 February 2012 
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:    
Agency responsible 
Brazilian Health Regulatory 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/042a338 049f229df96d7bfaa19e2217c/Consulta
+P%C3%BAblica+n%C2%B0+11 +GGMED.pdf?MOD=AJPERES