. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/379 
27 July 2010  
 (10-4019) 
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):  Medicines based on 
substances classified as antimicrobial use.  
5. Title, number of pages and langu age(s) of the notified document:  Draft Resolution 
n° 58, 18 June 2010 – packaging, labelling, di spensing and control of medicines based on 
substances classified as antimicrobial (5 pages, Portuguese).     
6. Description of content:  This technical regulation estab lishes procedures and requirements 
for packaging,  labelling, disp ensing and control of drugs based  on substances classified as 
antimicrobial, that can be used only by medical  prescription, isolated or in associations.  
This draft resolution has the objective to en sure quality, safety and efficacy of these 
medicines.  Anvisa will grant a period of 180 days for all detainers of this type of medicines 
registration to produce medicines according to this Resolution, after its entry into force.  
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), 18 June 2010; 
Section 1. Draft Resolution (Consulta Pública) number 58, 17 June 2010, issued by 
Brazilian Sanitary Surveillance Agency – A nvisa; When adopted, it will be published at 
Brazilian Official Journal. Available in Portuguese.   G/TBT/N/BRA/379 
Page 2  
 
  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 July 2010 
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:    
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/84a5128042e59c46a3 1fb7d90f4a3f31/CP+N
%C2%BA+58+DIDBB.pdf?MOD=AJPERES