G/TBT/N/BRA/843  
 
17 September 2018  
(18-5707) 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 2563.2918  
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): Medicines  
5. Title, number of pages and language(s) of the notified document: Draft 
Resolution  552, 3 September 2018 (8 page(s), in Portuguese)    
6. Description of content: This Draft Resolution 552/2018 establishes the content of the 
Periodic Report of Evaluation of Risk-Benefit provided by the medicine registration holder.  
The Periodic Report of Evaluation of Risk -Benefit:  
• applies to all the registered medicines in national territory (Brazil);  
• is a technical document prepared by the medicine registration holder and m ust be 
presented to Anvisa on specific periods according to the active principal;  
• consists of the update of the national and international safety information and the 
analysis of the risk/benefit relation;  
• must provide information about indications, pharmac eutical formulation and 
posology by active principle;  
• shall be used by the holders to conduct systematical analysis in order to previously 
identify problems and propose interventions;  
The product registration holder is responsible for the Report elaborati on and submission to 
Anvisa.  
The medicine registration holder must have its own Reference Document on Medicine 
Security containing the consolidated information about medicine safety to provide a 
practical, efficient and consistent approach of the risk/bene fit evaluation.  G/TBT/N/BRA/843  
 
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  The compulsory utilization of the Medical Dictionary for Regulatory Activities (MedDRA) is 
established.  
The Reports submitted to Anvisa must follow the format and content  established on the 
updated version of the E2C Guide of the Internatio nal Conference on Harmonization (ICH).  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety  
8. Relevant documents:  (1) Brazilian Official Journal (Diário Oficial da União) 172, 
05 September 2018, section 1, pages 92; (2) Not applicable;  (3) Brazilian Official Journal; 
(4) Not stated.   
9. Proposed date of adoption: 90 days after the date of its publication  
Proposed da te of entry into force: 90 days after the date of its publication  
10. Final date for comments: 12 November 2018  
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: http://port al.anvisa.gov.br/english  
http://portal.anvisa.gov.br/documents/10181/4858873/CONSULTA+P%C3%9ABL ICA+N%
C2%BA+552+GFARM.pdf/3d89cd99 -243f-4afc-b13b-f6659ff4ee06