G/TBT/N/BRA/854  
 
3 January 2019  
(19-0007) 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:  
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2918  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br  
Web-site: www.inmetro.gov.br/barreirastecnicas  
The comments to this Draft Regulation shall be sent to : 
http://formsus.datasus.gov.br/site/formulario.php?id_aplicac ao=33294   
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:   
Brazilian Health Regula tory Agency (Anvisa)  
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): 11.120.10 
Medicaments and biological products  
5. Title, number of pages and language(s) of the notified document: Resolution - 
RDC 257, 20 December 2018 (1 page (s), in  Portuguese )  
6. Description of content: This present Resolution changes RDC 234 of 20 June  2018,  
regarding the outsourcing of production steps, quality control analysis, transportation and 
storage of medicaments and biological products, among other measures.  
Art.30 and art.31 of the RDC 234 (notified under the document G/TBT/N/BRA/700), 
20 June 2018 are suspended for two years from the date of publication of this Resolution.  
The art.33 of RDC 234, 20 June 2018, is now in force with the following text:  
"Art.33. Article 52 of the RDC 17. April 16th, 2010, and the RDC 25, March 29th, 2007, are 
hereby rev oked. " 
This Resolution also changes art. 8, art. 9 and the subsection VIII of art. 10 of the RDC  10, 
21 March  2011.  
This Resolution enter into force on the date of its publication.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  G/TBT/N/BRA/854  
 
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  8. Relevant documents:   
• Resolution of the Collegiate Board of Directors - RDC 234 of 20 June 2018  
• Resolutions of the Collegiate Board of Directors - RDC 10, 21 March 2011  
• Draft Technical Resolution 273, 10 November 2016  
9. Proposed date of adoption:  On the date of its publication.  
Proposed date of entry into force:  On the date of its publication.  
10. Final date for comments: Not applicable  
11. Texts available from: National enquiry point [  ] or address, telephone and fax 
numbers and email and website addresses, 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: www.anvisa.gov.br  
http://portal.anvisa.gov.br/documents/10181/5194604/RDC_257_2018_.pdf/dc743d7a
-98dd-44ba-b683-ae2c593c31d2