. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/BRA/473 
24 February 2012  
 (12-1070) 
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, Standard ization and Industrial Quality - INMETRO 
Telephone:  +(55) 21 2563.2821 Telefax:  +(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 applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Parenteral Solutions 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 13 
30 January 2012 - Establishes primary packagi ng requirements for pare nteral solutions of 
small volume (5 pages, Portuguese) 
6. Description of content:  This draft regulation establishes pr imary packaging requirements for 
parenteral solutions of small volume. The sm all volume parenteral solutions (SPPV), with 
active ingredients used in anaest hesia, intensive care or hospita l emergency must adopt colour 
standardization, according to the Pantone system, when printing text, identification bands on 
the stem or in the breaking ring in their prim ary packaging as specif ied in this normative 
instruction. The glass ampoules must presen t two identification bands printed on the stem 
above the rupture ring, with a minimum widt h of 0.6 (six tenths) mm, in the colours 
established in this normative instruction for each  therapeutic class. It will be granted a period 
of 180 (one hundred and eighty) days for compan ies to adequate their primary packing to the 
therapeutic categories specified in this normative instruction.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  G/TBT/N/BRA/473 
Page 2  
 
  8. Relevant documents:   Brazilian Official J ournal (Diário Oficial da  União), 31 January 2012; 
Section 1 page 56. Draft Resolution (Consulta Pública) number 13, 30 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:  31 March 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:    
National enquiry point 
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/128fb50049f e83b39bc1bbaa19e2217c/Consulta
+P%C3%BAblica+n%C2%B0+13+ GGMED.pdf?MOD=AJPERES