G/TBT/N/BRA/1048  
27 July 2020  
(20-5166) 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:  National Institute of Metrology, Quality and Technology (INMETRO)  
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 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 30 06) (HS 3003); Medicaments 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); Ph armaceutical preparations and products of subheading 
Nos 3006.10.10 to 3006.60.90 (HS 3006)  
5. Title, number of pages and language(s) of the notified document:  Resolution – 
RDC no. 400 on 21 July 2020 (3 page(s), in Portuguese)  
6. Description of content:  RDC 400 Defines the extraordinary and temporary criteria and 
procedures for the application of exceptionalities to specific labelling requirements and 
drug leaflets due to the international public health emergency resulting from the new 
Coronavirus.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Exceptionalities refer to the temporary non -compliance with technical 
requirements of labeling and package leaflet of medicines, provided that they arise from 
reasons proven related to Covid -19 and that may, through documented risk management, 
have the effects of their non -compliance controlled; Protection of human health or safety  G/TBT/N/BRA/1048  
 
- 2 - 
 
  8. Relevant documents:  (01) Published in the Brazilian Official Gazette no. 140, on 23 July 
2020, section 1, page 87.  
9. Proposed date of adoption:  On the date of publication  
Proposed date of entry into force:  On the date of publication  
10. Final date for comments:  Not Applicable  
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://www.in.gov.br/en/web/dou/ -/resolucao -de-diretoria -colegiada -rdc-n-400-de-21-de-
julho-de-2020-268192338