G/TBT/N/BRA/784  
 
12 January 2018  
(18-0381) 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 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmet ro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=33294  
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 (HS 3003, 3004)  
5. Title, number of pages and language(s) of the notified document: RDC Nº 205, 
28 December 2017. (8 page(s), in Portuguese)   
6. Description of content: This Resolution establishes special procedure for approval of 
clinical trials, good manufacturing practic es certification and registration of new medicines 
for treatment, diagnosis or prevention of rare diseases.  
This resolution applies to new medicines for rare diseases.  
The special procedure applies to:  
I – clinical trials authorization to be performed in Brazil for the evaluation of medicines for 
rare diseases;  
II - certification of good manufacturing practices of medicines for rare diseases;  
III – market authorization of new medicines for rare disease s. 
A medicine for a rare disease shall be considered a medicine intended to treat, diagnose or 
prevent a rare disease and:  
I - is used in a serious debilitating condition;  
II - proposes to change in a clinically significant way the disease evolution or t o make 
possible the remission of the disease.  
The request of approval for clinical trials and registration of a new medicine for rare G/TBT/N/BRA/784  
 
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  diseases is established in this Resolution.  
If it is not confirmed during the technical analysis that the petitions for ap proval of clinical 
trials and registration of new medicine refers to rare disease, the petition will be rejected.  
Submission of clinical medicine development dossier, specific clinical trial dossier, 
substantial modification by inclusion of protocol should  be performed according to specific 
legislation regarding clinical trials in Brazil, added by the documentation established in this 
Resolution.  
The request for registration of a new rare disease medicine must be carried out according 
to specific legislatio n for each regulatory category, added by the documentation described 
in this Resolution.  
Supplemental data and additional evidence may be allowed after the registration has been 
granted, by means of a signature of an agreement between Anvisa and the compan y 
requesting registration. Failure to comply with the agreement may lead to cancellation of 
the registration.  
Anvisa may permit the use of an international comparator medicine registered with 
another regulatory authority, under the terms set forth in this Resolution in the event of a 
request for registration of a rare disease medicine with the same registered medicine IFAs.  
Companies that submit a request for registration of new medicine in accordance with this 
resolution must present a maximum price defini tion dossier concomitantly with the 
registration request  
For applications for registration of new medicines for rare diseases, it does not apply the 
provisions of art. 2 of the Resolution of the Collegiate Board of Directors - RDC nº 20, of 
10 April  2013.  
This resolution changes the text of §2 of art. 47 of the Resolution of the Collegiate Board 
of Directors - RDC nº 9 of 20 February 2015.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  Resolution of the Collegiate Board of Directors - RDC nº 9 of 
February 20, 2015.   
9. Proposed date of adoption:  On the date of its publication.  
Proposed date of entry into force:  60 (sixty) days after the date of its publication.  
10. Final date for comments: Not applicable  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency Responsible  
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://portal.anvisa.gov.br/documents/10181/2718376/RDC_205_2017_.pdf/996fc46e -
216b-44ab-b8c8-2778151b786e