. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/414 
14 January 2011  
 (11-0243) 
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 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 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 116, 23 December 2010 - warning phrases fo r active ingredients and excipients in 
medicines labelling and leaflets (72 pages, Portuguese).     
6. Description of content:  This draft resolution establishes warning phrases in leaflets and 
labelling of medicines commercialized in Brazil, with the objective of ensuring access to safe 
and adequate information to support the rationa l use of medicines.  This draft resolution 
applies to all medicines registered or notifie d at Anvisa and to the compounded medicines 
commercialized in pharmacies.  
Companies must notify to Anvisa the text amendments of medicines leaflets and labelling, 
according to the provisions of this Resoluti on, and make available the new labelling and 
leaflets of medicines produced or imported into  the domestic market, within 180 (one hundred 
eighty) days from the date of entry into force of this Resolution.  
This resolution will revoke  Anvisa's Re solution RDC n. 137, 29 May 2003, Anvisa's 
Resolution RE n. 1548, 23 September 2003, Articl e 2, paragraph 1 and Ar ticle 3, paragraph 3 
of Anvisa's Resolution RE n. 1, 25 January 2002, and Articles 80, 81, 82, 83, 84 and 85 of 
Portaria n. 344,  12 May 1998. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health and Prevention of Deceptive Practices  G/TBT/N/BRA/414 
Page 2  
 
  8. Relevant documents:   (1) Brazilian Official Journal (Diário Oficial da União), 27 December  
2010; Section 1; (2) Draft Re solution (Consulta Pública) number 116, 23 December 2010,  
issued by Brazilian Sanitary  Surveillance Agency - Anvisa ; (3) When adopted, it will be 
published at Brazilian Official Journal; (4) Not stated.   
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:  27 April 2011 
11. Text available from: National enquiry point [X], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
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.b r/wps/wcm/connect/5dd0a880452992ceaf06ff2475bf1155/cp_116.p
df?MOD=AJPERES"