  
  
G/TBT/N/BRA/990  
26 March 2020  
(20-2458) 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:   
 The Brazilian Health Regulatory Agency  
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 addition, where applicable):  HS 
Code(s): 2941; 3002300; 3003; 3004; 3005; (pharmaceutical products, in vitro diagnosis 
products, biological products  
5. Title, number of pages and language(s) of the notified document:  Resolution – 
RDC number 348, 17 March 2020 (7 page(s), in Portuguese)  
6. Description of content:  This resolution establishes exceptional and temporary criteria 
and procedure for the processing of petitions for the market authorization of medicines, 
biological products, and  in vitro diagnosis products; and for  the post -market authorization 
of medicines and biological products  due to the international public health emergency of 
the new coronavirus (Covid -19). 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health  
8. Relevant documents:  (1) Brazilian Official Journal (Diário Oficial da União) 53, 18 March 
2020, section 1, page 59; (2) Not informed. (3) Brazilian Official Journal (Diário Oficial da 
União); (4) Not informed.  
9. Proposed date of adoption:  In the date of its publication.  
Proposed date of entry into force:  In the date of its publication.  
10. Final date for comments:  Not applied.  G/TBT/N/BRA/990  
 
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  11. Texts available from:  National enquiry point [X] 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/10181/5815062/RDC_348_2020_.pdf/ea3791b 2-
ca73-4ae9-83b8-1882f1e80662  
 