  
  
G/TBT/N/BRA/1019  
11 June 2020  
(20-4143) 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 2145.3817  
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)  
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 Resolution  
number 812, 12 May 2020 (5 page(s), in Portuguese)  
Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=56188   
6. Description of content:  This draft resolution changes the Resolution – RDC number 73, 
7 April 2016, which establ ishes technical requirements for post -registration changes and 
cancellation procedures for registering medicines.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
• Resolution – RDC number 73, 7 April 2016 , published in the Brazilian Official 
Gazete  67, of 8 April 2016, section 1, page 32;  Draft Resolution number 812, of 
12 May 2020, published in the  Brazilian Official Gazete 95, of 20 May 2020, 
section  1, page  77. 
9. Proposed date of adoption:  On the date of publication of the final text  
Proposed date of entry into force:  On the date of publication of the final text  
10. Final date for comments:  10 July 2020  G/TBT/N/BRA/1019  
 
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  11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
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/10181/5 885665/CONSULTA+P%C3%9ABLICA+N+
812+GQMED.pdf/d9e509d6 -7524-40c0-9250-355ff3010c95  
 