G/TBT/N/BRA/841  
 
17 September 2018  
(18-5705) Page: 1/3 
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 
Nº 551, 3 September 2018 (14 page(s), in Portuguese)    
6. Description of content: This Draft Resolution 551/2018 establishes the Good 
Pharmacovigilance Practices to be watched by all the registration holder of medicine for 
human use.  
The medicine registration holder:  
• is responsible for the actions of Pharmacovigilance related to their products and 
must preset the information requested by the health surveillance authority  
concerning Pharmacovigilance in the deadline established;  
• must assign 1 (one) Responsible Person for the Pharmacovigilance and offer the 
proper means for the development of the pharmacovigilance activities, including 
material and human resources, communi cations tools and access to all the 
necessary sources of information;  
• must implement mechanisms to inform the Responsible Person about all 
emergencies related to medicine safety under his responsibility and any 
information related to the evaluation of the risk-benefit relation;  
• must have a contingency plan for unforeseen events that includes software or 
hardware fails on the databases, to ensure the continuity of the Pharmacovigilance 
activities;  
• can transfer to a third part the execution of any Pharmacovig ilance activity 
regulated by this Resolution;  G/TBT/N/BRA/841  
 
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  • must implement a Pharmacovigilance System appropriated for its needs that 
allows, when necessary, the adoption of measures related to the products the 
registration holder is responsible for and have documentati on containing the 
detailed description of the Pharmacovigilance System, including information on 
structure, interfaces, work process, responsibilities and risk management 
activities;  
The Pharmacovigilance System:­  
• must be situated in Brazil, nevertheless S ystem elements and process can be 
developed in other countries as long as it does not compromise the operative 
capacity of monitoring and the problem identification of the products on national 
territory;­  
• must be developed in compliance with all safety req uirements related to the 
medicines including manufacturing aspects of quality assurance and quality 
control.  
The medicine registration holder must have a self -inspection program on 
pharmacovigilance and conduct at least one self -inspection per year.  
The G ood Pharmacovigilance Practices established in this Draft Resolution 551/2018 also 
addresses adverse event notification to Anvisa; relation benefit -risk evaluation and risk 
management plan.  
The Brazilian Health Regulatory System (SNVS) can conduct a pharm acovigilance 
inspection at the medicine registration holder at any time, announced or not.  
This Draft Resolution 551/2018 revokes:  
• Collegiate Board Resolution - RDC nº 4, from 10 February 2009;  
• Normative Instruction - IN nº 14, from 27 October 2009;  
• item V of Art. 18 of the Collegiate Board Resolution - RDC nº 31, from 
29 May 2014;  
• item III of Art. 47 of the Collegiate Board Resolution - RDC nº 200, from 
26 December 2014;  
• item II of Art. 119 of the Collegiate Board Resolution - RDC nº 49, from 
20 September  2011;  
• item IV and paragraph 3 of Art. 35 of the Collegiate Board Resolution - RDC nº 26, 
from 13 May 2014;  
• paragraph 2 of Art. 48 of the Collegiate Board Resolution - RDC nº 24, from 
14 June 2011;  
• item IX of Art. 37 of the Collegiate Board Resolution - RDC nº 64, from 
18 December 2009;  
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 91/92; (2) Not applicable;  (3) Brazilian Official 
Journal; (4) Not stated.   
9. Proposed date of adoption: On the date of its publication  
Proposed date of ent ry into force: 90 days after the date of its publication  
10. Final date for comments: 12 November 2018  G/TBT/N/BRA/841  
 
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  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://portal.anv isa.gov.br/english  
http://portal.anvisa.gov.br/documents/10181/4858873/CONSULTA+P%C3%9ABLICA+N%
C2%BA+551+GFARM.pdf/290926be -6495-4531-95d7-e986bcacf35c