G/TBT/N/BRA/692  
 
15 September 2016  
(16-4878) 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 Ag ency 
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 Metrolo gy, Quality and Technology  – INMETRO  
Telephone : + (55) 21 2563.2840  
Telefax : + (55) 21 2563.5637  
Email : barreirastecnicas@inmetro.gov.br   
Web-site: http://www.inmetro.gov.br/barreirastecnicas   
3. Notified under Article 2.9.2 [  ], 2.10.1 [ X], 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 additio n, where applicable) : Narcotic, psychotropic, 
precursor and other drugs under special contro l 
5. Title, number of pages  and language(s)  of the notified document : Technical 
Resolution RDC nº 103, 31 August 2016 (89 pages, in Portuguese)  
6. Description of content : Technical Resolution RDC nº 103, 31 August 2016, regarding the 
update of the Annex I of the Ordinance 344/1998 which concerns about the List of 
Narcotic, Psychotropic, Precursor and Other Drugs Under Special Control, by including, 
excluding, etc. some substances mentioned on the Ordinance 344/1998.  
It revokes some provisions applicable to List named "C4", about the substances and 
antiretroviral drugs, contained in:  
 Ordinance SVS/MS Nº. 344, 12 May 1998, (Portaria Anvisa SVS/MS Nº. 344, 
12 May 1998)  
 Ordinance Nº 6, 29 January 1999, (Portaria Anvisa Nº 6 , 29 January 1999)  
 Resolution  – RDC Nº 63, 9 September 2008  
 Resolution  – RDC Nº 81, 5 November 2008  
 Resolution  – RDC Nº 99, 30 December 2008  
 Resolution  – RDC Nº 11, 6 March 2013 and  
 Resolution  – RDC Nº  96, 29 July 2016  
7. Objective and rationale , including the nature of urgent problems where 
applicable : Protection of human health or safety  
8. Relevant documents : 1) Brazilian Official Journal (Diário Oficial da União), 
1 September  2016; Section 1, p. 3 9; 2) Not stated; 3) Brazilian Official Journal; 4) Not 
stated.  G/TBT/N/BRA/692  
 
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  9. Proposed date of adoption : On the date of publication  
Proposed date of entry into force : On the date of publication   
10. Final date for comments : On the date of publication  
11. Texts ava ilable from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:  
Agency Responsible  
Anvisa  – Brazilian Health Regulatory Agency  
SIA, Trecho 5, Área Especial 57  
Brasília  – DF / Brazi l 
CEP: 71.205 -050 
Phone. : +(55) 61 3462.5402  
Website : http://www.anvisa.gov.br   
http://portal.anvisa.gov.br/documents/10181/2965759/PRT_SVS_344_1998_COMP.pdf/219
44c32 -65ce-41a5-b6d1-6462026ada3a   
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