G/TBT/N/BRA/707  
 
22 February 2017  
(17-1061) 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 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 Metr ology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br    
Web-site: http://www.inmetro.gov.br/barreirastecnicas  
The comments to this Draft Regulation shall be sent to:  
http://portal.anvisa.gov.br/documents/10181/2724161/CONSULTA+P%C3%9ABLICA+N+
311+DIGES.pdf/f7c69614 -fa3c-4be5-961d-9f9a850221df    
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 ap plicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Medicines . 
Pharmaceutical products (HS: 30) 
5. Title, number of pages  and language(s)  of the notified document:  Draft Resolution 
No. 311, 15 February 2017 (7 pages, in Portuguese)     
6. Description of content:  This Draft Resolution proposes the implantation of the National 
Medicine Control System (NMCS) and the mechanisms and procedures for medicine track 
and tracing, besides other measures.  
These me chanisms and procedures for medicine track and tracing is applicable throughout 
the national territory.   
The provisions of this proposal apply to all medicines registered at the Brazilian Health 
Regulatory Agency (ANVISA). It is not applicable to serum and  vaccines that are part of 
the National Immunization Program; radiopharmaceuticals; non -prescription medicaments; 
medicines included on the Programs of medicines for free distribution and individualized 
delivery control of the Ministry of Health; specific medicines and phytomedicines; free 
samples.  
Medicine track and tracing system establishes mechanisms and procedures that allow to 
recovery the medicine history, identify its current location and the last known destination.  
The bidimensional bar code is the  technology used to capture, store and comunicate 
events related to medicine track and tracing on the NMCS and the DATAMIX is the adopted 
standard as established  on ISO/IEC 16022:2006. The owner of the medicine marketing 
authorization is responsible for t he generation and inclusion of the Datamix on the 
comercial package, including data of  the Unique Medicine Identificiation (UMI) and other 
provisions established at RDC Nº 71 from 22 December 2009 (available at 
http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2009/res0071_22_12_2009.html ) and 
modified by the RDC Nº 26 from 16 June 2011 (available at 
http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2011/rdc0026_16_06_2011.pdf ). G/TBT/N/BRA/707  
 
- 2 - 
 
  Every transport package, from expedition at the marketing authorization owner, should 
have a unique identification code that allows identify the UMI insi de it. 
Imported medicines may have the Datamix and serial code printed by the manufacture on 
the country of origin or by the owner of the authorization in Brazil. The option adopted 
should be informed to Anvisa at the process for the Import Licence.  
Each member at the medicine supply chain should store and transmit electronically the 
data regarding the events of the medicine under its responsibility.  
The technological specifications related to the NMCS procedures will be published as 
Normative Instruction before the end of the fourth month after the date of publishing of 
this technical regulation.  
This proposal revokes the Resolution RDC Nº 54 from 10 December 2013 (available at 
http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2013/rdc0054_10_12_2013.pdf ) and 
the RDC Nº 114 from 29 September 2016 (available at 
http://portal.anvisa.gov.br/documents/10181/2718376/RDC_114_2016.pdf/823dbdb9 -
c11f-45fa-b313-220426e75fb0 ) 
7. Objective and rationale , including the nature of urgent problems where applicable: 
Protection of human health  
8. Relevant documents:  (1) Brazilian Official Journal (Diá rio Oficial da União) Nº 34, 
16 February 2017, section 1, page 39; (2) Ordinance RDC Nº 54/2013 ( Resolução da 
Diretoria Colegiada - RDC Nº, 54 de 10 de dezembro de 2013) ; (3) Brazilian Official 
Journal; (4) Not stated.  
9. Proposed date of adoption:   To be determined after the end of the consultation period  
Proposed date of entry into force:   On the date of publication   
10. Final date for comments:  17 March 2017  
11. Texts available from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if available , of 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  
Website: http://www.anvisa.gov.br  
http://portal.anvisa.gov.br/documents/1 0181/2724161/CONSULTA+P%C3%9ABLICA+N+31
1+DIGES.pdf/f7c69614 -fa3c-4be5-961d-9f9a850221df   
http://pesquisa.in.gov.br/imprensa/jsp/v isualiza/index.jsp?data=16/02/2017&jornal=1&pagi
na=39&totalArquivos=96