G/TBT/N/BRA/1061  
12 August 2020  
(20-5538) 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  
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 put 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 (H S 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 p urposes (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 405, July 22nd, 2020 (5 page(s), in Portuguese)  
6. Description of content:  This resolution establishes control measures for medicines that 
contain substances mentioned by the Annex I of this resolution, isolated or in association 
with other drugs, due to the international public health emergency of the new coronavirus 
(SARS -CoV-2). 
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 140 on 23 July 2020, Section 1 Page 88 2) Not stated 3) 
Brazilian Official Gazette 4) Not stated  G/TBT/N/BRA/1061  
 
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  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.  
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/10181/5956497/RDC_405_2020_.pd f/5ea72f28 -
c9dd-47c2-b7da-1b1ed2f1749e