G/TBT/N/BRA/602  
 
13 August 2014  
(14-4692)  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: ANVISA - Brazilian Health Surveillance Agency 
Name and address (including telephon e 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  
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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Clinical trials with 
medicines. 
5. Title, number of pages and langua ge(s) of the notified document: Draft Resolution nº 
65, 1 August 2014 that disposes about the clinical trials with medicines accomplished in Brazil. (20 pages, in Portuguese).     
6. Description of content: This draft technical resolution establishes the procedures and 
requirements to the accomplishment of clinical trials with medicines in Brazil, including the 
Dossier of a Medicine Clinical Development, which requires prior consent of ANVISA.  
This draft resolution is applicable to clinical trials with medicines, which will have all its 
clinical development, or part of it, in Brazil , in order to the registration by ANVISA. Post-
commercialization clinical trials (phase IV) are not subject to this regulation, except for 
those involving vaccines and those which purpose is to evaluate efficacy and safety, necessary to the registration or revalidation, and which are considered phase III. This draft resolution is also not applicable to bioequivalence and relative bioavailability studies, 
clinical trials with cosmetics, medical device s, foods, gene therapy and stem cells, which 
must follow specific regulations. 
The non-compliance with the terms of this regulation will be considered sanitary infraction, 
according to Federal Law 6.437/77. 
This draft resolution revokes the following technical Resolutions: RDC n. 39/2008; RDC n. 
36/2012; and items 1 and 1.1 of Section I of Chapter XXVI of RDC 81/2008. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of Human health or Safety 
8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União), August 04th 
2014; Section 1, p. 73, Draft Resolution (Consulta Pública) number 65, August 01th 2014, 
issued by Brazilian Health Surveillance Ag ency – Anvisa. When adopted, it will be 
published at the Brazilian Official Journal. Available in Portuguese. 
9. Proposed date of adoption: To be determined after the end of the consultation period.  G/TBT/N/BRA/602 
 
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  Proposed date of entry into force: To be determined after the end of the consultation 
period.   
10. Final date for comments: 11 September 2014 
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 Surveillance Agency - ANVISA 
SIA, Trecho 5, Área Especial 57 
Brasília – DF / Brazil 
CEP: 71.205-050 Phone.: 55 61 3462-5402 E-mail: rel@anvisa.gov.br   
Website: http://www.anvisa.gov.br 
 http://portal.anvisa.gov.br/wps/wcm/connect /b60b380044fb0348bc87bcc5b6e3ae4b/Consul
ta+P%C3%BAblica+n%C2%B0+65+C OPEM+GGMED.pdf?MOD=AJPERES