G/TBT/N/BRA/723  
 
27 June 2017  
(17-3394) Page: 1/2 
Committee on Technic al 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 (A nvisa)  
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 Metr ology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2840  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
The comments t o this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=32378  
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):  Medicines  
5. Title, number of pages  and language(s)  of the notified document:  Draft Resolution n. 
355, June 19 2017. (6 page(s), in Portuguese)    
6. Description of content : This Draft Resolution applies to new medicines designated by 
ANVISA for rare diseases and establishes special procedures for clinical trials approval, 
certification of good manufacturing practices and registration of new drugs, designated for 
the treatme nt, diagnosis or prevention of rare diseases.  
The designation of rare disease drug is a prior stage on the approval of clinical trials 
performed in Brazil, registration of new medicines and certification of good manufacturing 
practices.  
ANVISA will publi sh, through Resolution (RE), a list of medicines designated for rare 
diseases, and their respective indications.  
The procedures related to the following topics should be performed in accordance with the 
specific legislation and complemented with the manife station of ANVISA regarding the 
medicine designation as for rare disease:  
- Submission of clinical drug development dossier (DDCM in Portuguese), specific clinical 
trial dossier, substantial modification by inclusion of protocol;  
- Certification of good ma nufacturing practices  
- Registration of the medicines  
Medicines registered through the criteria of this resolution will have a time period of three 
hundred and sixty -five days to be marketed, counting from the date of publication of the G/TBT/N/BRA/723  
 
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  registration. Medic ines not marketed within the established period will have the 
registration cancelled by ANVISA.  
7. Objective and rationale , including the nature of urgent problems where applicable: 
Protection of Human Health  
8. Relevant documents:  (1) Brazilian Official  Journal (Diário Oficial da União) Nº 116, 20 
June 2017, section 1, page 42, (2)Law 6437, 20 August 1977 (Lei nº 6.437, de 20 de 
agosto de 1977); (3) Brazilian Official Journal (Diário Oficial da União); (4) Not stated.   
9. Proposed date of adoption: To be determined after the end of the consultation period.  
Proposed date of entry into force: On the date of publication.  
10. Final date for comments:  26 July 2017  
11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and email and website address es, 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/10181/3113140/CONSULTA+PUBLICA+N+355+GG
MED.pdf/c7648e2f -4264-479c-95ca-4dd88 79a447a