  
  
G/TBT/N/BRA/1162  
22 April 2021  
(21-3445) 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:  Public 
Consultation No. 1031, 7 Apri l 2021. Comment form: 
https://pesquisa.anvisa.gov.br/index.php/512992?lang=pt -BR (3 page(s), in 
Portuguese)  
6. Description of content:  Public Consultation No. 1031 proposes the upd ating of the 
Resolution – RDC number 367, 6 April 2020, which provides the control of import and 
export of substances, plants and medicines subject to special control  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  In order to work with substances subject to special control, it is necessary 
to comply with a series of requirements established in Ordinances SVS/MS n. 344/98 and 
n. 6/99 and other relevant regulations, including a special authorization. Ordinance 
SVS/MS n.  344/98 is the Technical Regulation on substances and medicines subject to 
special control, while Ordinance SVS/MS n. 6/99 is the Normative Instruction of this 
regulation. RDC 367/2020 updates and establishes requirements for international trade 
for these substances. In this sense, companies, including those that carry out research G/TBT/N/BRA/1162  
 
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  activities for commercial purposes, must apply for Special Authorization (EA), in 
accordance with the provisions of RDC 16/2014. On the other hand, educational and 
research insti tutions that want to use medicines subject to special control should apply 
for the Simplified Special Authorization for an Educational and Research Institution - AEP, 
which authorizes educational and research institutions to acquire and use plants, 
analyti cal standards, substances and medicines subject to special control, to develop 
teaching and research activity, in accordance with the provisions of the RDC  367/2020. 
It turns out that this Management of Controlled Products has received requests for 
Simpli fied Special Authorization for Educational and Research Institution - AEP requested 
by companies that carry out research activities for commercial purposes, which must 
request Special Authorization (AE), as provided by RDC 16/2014. In the face of these 
requests for AEP, which were refused, the need to have the standard was verified, in 
order to clarify in which situations the AE applies.; Protection of human health or safety  
8. Relevant documents:   
01) Brazilian Official Gazette 65 -A on 08 April 2021, section 1, page 1 02) RDC 367, 6 
April 2020 03) Justification for the draft resolution  
https://ww w.in.gov.br/web/dou/ -/consulta -publica -n-1.031 -de-7-de-abril-de-2021-
312833842  
http://antigo.anvisa.gov.br/documents/10181 /5210712/%281%29RDC_367_2020_CO
MP.pdf/a17c82d2 -fc9d-4efb-9c46-1d4ba8b10b44  
http://antigo.anvisa.gov.br/documents/10181/5210712/Parecer+com+as+motiva%C3
%A7%C3%B5es+e+justicativas+para+a+dispensa+de+AIR.pdf/431607e5 -9df1-494d-
a4f7-878b3ce2d570  
9. Proposed date of adoption:  Not applicable  
Proposed date of entry into force:  Not applicable  
10. Final date for comments:  31 May 2021  
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/10181/5210712/%281%29Minuta+1031.pdf/78
1727b7 -87df-4e22-b9d5-fd80ad42fb7a  
 