  
  
G/TBT/N/BRA/1199  
23 June 2021  
(21-5108) 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):  
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 forms or packings for retail sale (excl. goods of heading 3002, 3005 
or 3006) (HS 3 004) 
5. Title, number of pages and language(s) of the notified document:  Resolution – 
RDC number 517, 10 June 2021. (4 page(s), in Portuguese)  
6. Description of content:  Due to the international public health emergency resulting from 
the new Coronavirus,  this resolution establishes exceptional and temporary criteria and 
requirements for exemption from package inserts and labe lling information for the 
presentation of medicines for use restricted to hospitals, clinics and services of home care, 
except pharm acies and drugstores.  
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 111 on 16 June 2021, section 1, page 243  
https://www.in.gov.br/web/dou/ -/resolucao -rdc-n-517-de-10-de-junho -de-2021-
326187747  G/TBT/N/BRA/1199  
 
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  9. Proposed date of adoption:  16 June 2021  
Proposed date of entry into force:  16 June 2021 ; This Resolution is valid for 180 days, 
and may be extended at the discretion of Anvisa.  
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/10181/6285580/RDC_517_2021_.pdf/21a88996
-5a12-4eb5-9979-fdf418745f5e  
 