G/TBT/N/BRA/858  
 
4 January 2019  
(19-0026) 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 2563.2840  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br  
 Web-site: www.inmetro.gov.br/barreirastecnicas   
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 Regulatory Agency (Anvisa)  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=28757  
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): Plants, 
medical products containing controlled substances  
5. Title, number of pages and language(s) of the notified document: Draft 
Resolution  587, 27 December 2018, published by Brazilian Official Gazette (15 page(s), 
in Portuguese)   
6. Description of content: This draft resolution establishes the import and expor t controls, 
of plants and medical products containing controlled substances subject to special control 
for any purpose, among other measures.  
The lists of substances subject to special control and prohibited plants are included in 
Annex I of Portaria SVS/M S 344, 12 May 1998, and its updates.  
Any legal entity which imports or exports, for any purpose, controlled substances, plants 
and medicinal products, and Teaching and Research Institutions that realize any activity 
with this products are covered by this R esolution.  
Exceptions for the controls provided on this Resolution are:  
• The isotope and radioisotope patterns;  
• Isotopically labelled organic substances patterns;  
• Kits for in vitro diagnostics and for the detection of controlled substances in the 
environment;  
• Non-medicamental formulation containing substances in List D1 (does not 
apply to analytical standards on the list); and  G/TBT/N/BRA/858  
 
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  • Substances on list D2, which are subjected to the control and supervision of 
the Justice Ministry.  
This resolution establis hes the places for entry and exit of specific substances listed on 
the annex of Portaria SVS/MS 344.  
RDC 99, 30 September 2008, RDC No.11, 11 March 2013, RSC 201, 18 July 2002 and 
RDC 62, 11 February 2016 are hereby revoked.  
Also articles from Portaria SVS /MS 344, 12 May 1988 and Portaria SVS/MS 6, 29 January 
1999 are hereby revoked.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety  
8. Relevant documents:   
•  Ordinance (Portaria) SVS/MS  344 
•  Ordinance (Portaria) SVS/MS 6  
9. Proposed date of adoption:  On the date of its publication   
Proposed date of entry into force:  30 days from the date of its publication  
10. Final date for comments: 30 days from notification  
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/consultas -publicas#/visualizar/388482