G/TBT/N/BRA/1144  
3 March 2021  
(21-1808) 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 [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):  Antibiotics 
(HS 2941); Medicaments consisting of two or more constituents mixed together for 
therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. 
goods of heading 3 002, 3005 or 3006) (HS 3003); Medicaments consisting of mixed or 
unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. 
those for transdermal administration" or in forms or packings for retail sale (excl. goods 
of heading 30 02, 3005 or 3006) (HS 3004); Wadding, gauze, bandages and the like, e.g. 
dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical 
substances or put up for retail sale for medical, surgical, dental or veterinary purposes 
(HS 3005) ; Pharmaceutical preparations and products of subheadings 3006.10.10 to 
3006.60.90 (HS 3006)  
5. Title, number of pages and language(s) of the notified document:  Normative 
Instruction number 83, 23 February 2021. (6 page(s), in Portuguese)  
6. Description of content:  This normative instruction defines the list of substances 
categorized as antimicrobial for use under prescription, isolated or associated.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Complement the req uirements of RDC No. 471 of 23 February 2021.; 
Protection of human health or safety  G/TBT/N/BRA/1144  
 
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  8. Relevant documents:   
1) Brazilian Official Gazette 36 on 24 February 2021, section 1, page 86 2) RDC No. 471, 
23 February 2021.  
https://www.in.gov.br/web/dou/ -/instrucao -normativa -in-n-83-de-23-de-fevereiro -de-
2021-304918127  
http://antigo.anvisa.gov.br/documents/10181/6232328/RDC_471_2 021_.pdf/a678704e
-afb3-48bf-a33e-9b69c6270668  
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://antigo.anvisa.gov.br/documen ts/10181/6232328/IN_83_2021_.pdf/74dad76b -
30ce-43d3-8c54-c0e2a3403c05