G/TBT/N/BRA/1143  
3 March 2021  
(21-1803) 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 3002, 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 fo rms or packings for retail sale (excl. goods 
of heading 3002, 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:  Resolution – 
RDC number 471, 23 Febr uary 2021 (7 page(s), in Portuguese)  
6. Description of content:  This resolution establishes criteria for prescription, exemption, 
control, packaging, and labelling of medicines based on substances categorized as 
antimicrobial for use under prescription, i solated or associated. They will be listed in a 
specific Normative Instruction.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/BRA/1143  
 
- 2 - 
 
  8. Relevant documents:   
1) Brazilian Official Gazette 36 on 24 February 2021, section 1, page 85 2) Normative 
Instruction No. 83, 23 February 2021.  
https://www.in.gov.br/en/web/dou/ -/resolucao -rdc-n-471-de-23-de-fevereiro -de-2021-
304923190  
http://antigo.anvisa.gov.br/documents/10181/6232328/IN_83_2021_.pdf/74dad76b -
30ce-43d3-8c54-c0e2a3403c05  
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/documents/10181/6232328/RDC_471_2021_.pdf/a678704e
-afb3-48bf-a33e-9b69c6270668