G/TBT/N/BRA/1046  
23 July 2020  
(20-5074) 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):  
HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products)   
5. Title, number of pages and language(s) of the notified document:  Draft Normative 
Instruction no. 819, 01 June 2020. (46 page(s), in Portuguese)  
6. Description of content:  This draft normative instruction proposes the revision of 
Resolution – RDC no. 107, 5 September 2016, which approves, the "List of Low -risk 
medicinal produ cts subject to simplified notification".  
7. Objective and rationale, including the nature of urgent  problems where 
applicable:  RDC 199/2006 regulates the notification of low -risk drugs. The notification 
process aims to simplify the regularization of these drugs, which do not undergo analysis 
prior to their commercialization, thus optimizing the regulato ry process and facilitating 
access. Only those well -established drugs, with low probability of causing harm to humans 
and exempt from medical prescription are subject to notification. Considering the need to 
rationalize the work processes related to the re gularization of medicines, it is also 
necessary to update the list of low -risk drugs that can be communicated, which is the 
subject of RDC 107; Protection of human health or safety  G/TBT/N/BRA/1046  
 
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  8. Relevant documents:   
(1) Draft Normative Instruction no. 819, 01 June 2020, published in the Brazilian Official 
Gazette (Diário Oficial da União) no. 105, of 03 June 2020, section  1, page 502;  
(2) Resolution – RDC no. 107, 05 September 2016 , published in the Brazilian Official 
Gazette no. 172, of 06 September 2016, Section 1, page 31;  
(3) Resolution – RDC no.  199, 26 October 2016 , published in the Brazilian Official Gazette 
no.  208, of 30  October 2006, Section  1, page 167, full text available at:  
http://www.in.gov.br/materia/ -
/asset_publisher/Kujrw0 TZC2Mb/content/id/23527924/do1 -2016-09-06-resolucao -rdc-n-
107-de-5-de-setembro -de-2016-23527827  
http://portal.anvisa.gov.br/documents/10181/2971718/%282%29RDC_107_2016_COMP.
pdf/eee4a7f2 -edc3-4018-ab69-754bff7b95f4  
Resolu tion – RDC no. 199, 26 October 2006 : 
http://portal.anvisa.gov.br/documents/10181/2718376/RDC_199_2006_COMP.pdf/6d77eb
24-b247-4497-ab7e-c668795ef8cf   
9. Proposed date of adoption:  To be determined after the end of the consultation period  
Proposed date of entry into force:  To be determined after the end of the consultation 
period  
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:   
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+
819+GGMED.pdf/ 7ebfa646 -bb7c-4a03-bdde-00a3f0db9a7d