G/TBT/N/BRA/526  
 
12 April 2013  
(13-1915)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member:  BRAZIL  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Health Regulatory Agency (ANVISA) 
Name and address (including telephon e 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, Quality and Technology (Inmetro) 
Telephone:  +(55) 21 2563.2821 
Telefax:  +(55) 21 2502.6542 Email:  barreirastecnicas@inmetro.gov.br  
Website:  http://www.inmetro.gov.br/barreirastecnicas  
The comments to this Draft Regulation shall also be sent to  
http://formsus.datasus.gov.br/admin/ aplicacao_campo.php?id_aplicacao=10937  
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 
(HS: 30.0000). 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
No. 10, 2 April 2013 - Anvisa proposal for the implementation of the Brazilian System of Medicines Control Mechanisms and Procedures for Traceability of Production, Commercialization, Dispensation and Prescription of Medicines (6 pages, in Portuguese)     
6. Description of content:  This draft Technical Regulation establishes the implementation 
of the Brazilian System of Medicines control mechanisms and procedures for traceability of 
production, commercialization, dispensation and prescription of medicines.  
It is established, within the Brazilian System of Medicines Control, mechanisms and 
procedures for traceability of drugs though capture technology, electronic storage and 
transmission of data through all the chain that involves production, commercialization, 
import, dispensation and prescription and other types of movement provided by health controls.  
The provisions contained in this draft Technical Regulation applies to all medicines that 
must be registered at Anvisa to be commercialized in Brazil.  
This draft Technical Regulation revokes Resolution RDC 59, 24 November 2009. According to article 23, it will be granted periods of 180 and 360 days from the date of 
entry into force of this Resolution for companies to promote the necessary adjustments to 
comply with this Technical Regulation.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human Health  G/TBT/N/BRA/526 
 
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  8. Relevant documents:    
1. Brazilian Official Journal (Diário Oficial da União), April  3rd   2013; Section 1  Draft 
Resolution (Consulta Pública) number 10, 2 April 2013, issued by Brazilian Health 
Regulatory Agency - Anvisa;  
2. Not Applicable; 3.  Brazilian Official Journal; 
4. Not Applicable 
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:  9 May 2013. 
11. Text available from:  National enquiry point [  ], or address, telephone and fax 
numbers, e-mail and web-site addresse s, 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:  www.anvisa.gov.br  
http://portal.anvisa.gov.br/wps/wcm/conne ct/6726b5804f204d97b0cfbcc88f4b6a31/Cons
ulta+P%C3%BAblica+n+10+G ADIP.pdf?MOD=AJPERES