G/TBT/N/BRA/536  
 
10 July 2013  
(13-3655)  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:   ANVISA - Brazilian Health Regulatory Agency 
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  
Web-site: http://www.inmetro.gov.br/barreirastecnicas  
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=11885  
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 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
nº 24, 27 June 2013 - Draft Technical Regu lation that establishes the obligation to 
communicate Anvisa in cases of discontinuation or temporary suspension of manufacturing, importation of medicines, reactivation of manufacturing or importation of medicines (3 pages, in Portuguese).     
6. Description of content:  This draft Technical Regulation has the objective to establish 
the obligation to communicate Anvisa in cases of discontinuation or temporary 
suspension of manufacturing, importation of medicines, reactivation of manufacturing or 
importation of medicines. 
The communication to Anvisa by the medicines registration holder must be made with, 
at least, 180 (one hundred and eighty) days pr ior to the date of the implementation of 
the measure. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health and safety. 
8. Relevant documents:    
1. Brazilian Official Journal (Diário Oficial da União), 28 June 2013; Section 1 Draft 
Resolution (Consulta Pública) number 24, 27 June 2013, issued by Brazilian Health Regulatory Agency - Anvisa;  
2. Not Applicable;  
3. Brazilian Official Journal (Diário Oficial da União);  4. Not Applicable   G/TBT/N/BRA/536 
 
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  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:  5 August 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 
http://portal.anvisa.gov.b r/wps/wcm/connect/09d9050040283d9da5bcf5dc5a12ff52/Cons
ulta+P%C3%BAblica+n%C2%B0+ 24+DIREG.pdf?MOD=AJPERES