G/TBT/N/BRA/1024  
26 June 2020  
(20-4455) 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:   
Nation al 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 [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); Medicam ents consisting of mixed or 
unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. 
those in the form of transdermal administration" or in forms 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)  
5. Title, number of page s and language(s) of the notified document:  Draft 
Resolution  no. 815, 01 June 2020 (21 page(s), in Portuguese)  
6. Description of content:  This draft resolution establishes technical requirements for the 
labelling of medicines.  
7. Objective and rationale,  including the nature of urgent problems where 
applicable:  Protection of human health; Protection of human health or safety  
8. Relevant documents:   
• Brazilian Official Gazette (Diário Oficial da União) 105, 03 June 2020, section 1, 
page 501. 
9. Proposed date of adoption:  On the date of the publication of the final text.  
Proposed date of entry into force:  On the date of the publication of the final text.  G/TBT/N/BRA/1024  
 
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  10. Final date for comments:  7 September 2020  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Draft: 
http://portal.anvisa.gov.br/documents/10181/3426875/CONSULTA+P%C3%9ABLICA+N+
815+DIRE+2.pdf/70f4f3e3 -584d-4912-bdec-0a58c7632658  
Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=56967  
Brazilian Health Regulatory Age ncy (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/10181/3426875/CONSULTA+P%C3%9ABLICA+N+
815+DIRE+2.pdf/70f4f3e3 -584d-4912-bdec-0a58c7632658