  
  
G/TBT/N/BRA/1062  
25 August 2020  
(20-5818) 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:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br  
Web-site: www.inmetro.gov.br/barreirastecnicas  
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):  Antibiotics 
(HS 2941); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting 
of two or more constituents which have been mixed together for therapeutic or 
prophylactic uses, not p ut up in measured doses or informs or packings for retail sale (HS 
3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of 
mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses 
or in forms or packings for retail sale (HS 3004); Wadding, gauze, bandages and similar 
articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with 
pharmaceutical substances or put up in forms or packings for retail sale for medical, 
surgical, dental or veterinary purposes (HS 3005); Pharmaceutical goods specified in Note 
3 to this Chapter (HS 3006)  
5. Title, number of pages and language(s) of the notified document:  Resolution – 
RDC number 389 number, May 26th, 2020. (2 page(s), in Portugu ese) 
6. Description of content:  This resolution establishes temporary requirements for the 
characterisation and risk verification of the decrease in the supply of medicines during 
the coronavirus pandemic.  
7. Objective and rationale, including the nature  of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
1) Brazilian Official Gazette 101, 28 May 2020, Section 1, Page, 62  
9. Proposed date of adoption:  In the date of its publication.  
Proposed date of entry into force:  In the date of its publication.  G/TBT/N/BRA/1062  
 
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  10. Final date for comments:  Not applied.  
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/10181/5893622/RDC_389_2020_.pdf/3f0bf9a2 -
af4c-4b82-9186-8ff729084881  
 