  
  
G/TBT/N/BRA/1025  
26 June 2020  
(20-4456) 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:   
Nation al Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2145.3817  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
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):  Antibiotics 
(HS 2941); Medicaments consisting of two or more constituents mixed together for 
therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. 
goods of heading 3002, 3005 or 3006) (HS 3003); Medicam ents consisting of mixed or 
unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. 
those in the form of transdermal administration" or in forms or packings for retail sale 
(excl. goods of heading 3002, 3005 or 3006) (HS 3004 ); Wadding, gauze, bandages and 
the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with 
pharmaceutical substances or put up for retail sale for medical, surgical, dental or 
veterinary purposes (HS 3005)  
5. Title, number of page s and language(s) of the notified document:  Draft Resolution 
no. 818, 01 June 2020 (7 page(s), in Portuguese)  
6. Description of content:  This draft resolution proposes the revision of Resolution – 
RDC no. 199, 26 October 2006, which establishes the simpli fied notification of medicines 
through electronic submitting.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health.  ; Protection of human health or safety  
8. Relevant documents:   
• Resolution – RDC no. 199, 26 October 2006 .  
(http://portal.anvisa.gov.br/documents/10181/2718376/RDC_199_2006_COMP.pd
f/6d77eb24 -b247-4497-ab7e-c668795ef8cf ) G/TBT/N/BRA/1025  
 
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  9. Proposed date of adoption:  30 days after date of publication final text.  
Proposed date of entry into force:  30 days after date of publication final text.  
10. Final date for comments:  7 September 2020  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Draft: 
http://portal.anvisa.gov.br/documents/10181/5904481/CONSULTA+P%C3%9ABLICA+N+
818+GGMED.pdf/ae633641 -78d9-42d6-9bce-3c13ead743c1  
Comment form: : http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=56966  
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/10181/5904481/CONSULTA+P%C3%9ABLICA+N+
818+GGMED.pdf/ae633641 -78d9-42d6-9bce-3c13ead743c1  
 