G/TBT/N/BRA/797  
 
8 March 2018  
(18-1432) 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   
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): Good 
Distribution and/or Warehousing Practices  
5. Title, number of pages and language(s) of the notified document : Resolution – 
RDC N° 217, February 20th, 2018. Certification of Good Manufacturing Practices and 
Certification of Good Distribution and/or Warehousing Practices. (1 page(s), in Portuguese)    
6. Description of content:  
Changes the Resolution - RDC N ° 39, 14 August 2013, which provides for administrative 
procedures to grant Certification of Good Manufacturing Practices and Certification of Good 
Distribution and / or Warehousing Practices.  
Art. 1 ° The article 4 of the Resolution - RDC N ° 39, 14 August 2013, which provides for 
administrative procedures to grant Certification of Good Manufacturing Practices and 
Certification of Good Distribution and/or Warehousing Practices, becomes effective with the 
following wording:  
"Art. 4 …  
Paragraph  1. In order to subsidize the granting of the certification referred to in the caput 
of this article, Anvisa may use confidential information on inspections received under 
Agreements or Accords with health authorities of other countries.  
Paragraph 2. The g ranting of the certification referred to in the caput of this article may 
occur upon presentation of a valid audit report issued by a third auditor recognized by 
Anvisa, according to specific regulations, and applicable to companies located in the 
national  territory, Mercosur and other countries." (NR)  
Art. 2. Paragraph 3 of art. 5 of the Resolution - RDC N ° 39, of 2013, shall become effective 
with the following wording:  G/TBT/N/BRA/797  
 
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  "Art. 5 …  
Paragraph 3. Anvisa may establish exceptions to the provisions of the caput o f this article, 
which aim to favor the efficiency and optimization of resources related to international 
inspections, according to previously defined criteria." (NR)  
Art. 3. This Resolution revokes the Resolution - RDC N° 179, 27 September 2017.  
Art. 4. Th is Resolution comes into force on the date of its publication.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human Health  
8. Relevant documents:  G/TBT/N/BRA/749   
9. Proposed date of adoption: On the date of its publication  
Proposed date of entry into force: On 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.an visa.gov.br   
http://portal.anvisa.gov.br/documents/10181/3612364/RDC_217_2018_.pdf/c510c05b -
5693-469e-81b4-36bbd21324e5