G/TBT/N/BRA/749  
 
10 October 2017  
(17-5437) 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   
Website: 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): Certification 
of Good Manufacturing Practices and Certification of Good Distribution Practices and/or 
Storage.  
5. Title, number of pages and language(s) of the notified document: Resolution – 
RDC n. 179, 27 September  2017. Portuguese.   
6. Description of content: This Resolution amends th e Resolution - RDC No. 39, of 
14 August 2013.  
Art. 4 of the Resolution - RDC No. 39 of 2013, which provides for administrative 
procedures to grant Certification of Good Manufacturing Practices and Certification of Good 
Distribution and/or Storage Practices, shall be in force with the following wording :  
"Art. 4 - .................................  
Anvisa may use confidential information on inspections received under Agreements or 
Agreements with health authorities of other countries to subsidize the granting of the 
certification referred to in the caput  of this article." (NR)  
It includes Art. 4 -A in the Resolution - RDC No. 39, of 2013, with the following wording:  
"Article 4 -A - For Health Products, the concession of the Certification of Good 
Manufacturing Practices referred to in the caput of article 4,  regarding establishments 
located outside the national territory and Mercosur, may occur, at the discretion of the 
Anvisa:  
I - from results of inspections carried out by Anvisa in loco;  
II - upon presentation of a valid audit report attesting to the effect ive compliance with the 
technical regulation of Good Manufacturing Practices for Medical Products and Products for 
Diagnosis of In Vitro use, as set forth in Resolution RDC No. 16 of 28/03/2013 and its G/TBT/N/BRA/749  
 
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  updates, issued by a third auditor, according to speci fic programs, both recognized by 
Anvisa;  
III - upon evaluation of technical documents requested by Anvisa related to the quality 
assurance system of the company and to the verification of compliance with Good 
Manufacturing Practices issued by the sanitary authority of the country of origin or by a 
third auditing body accredited by it, as will be established in Normative Instruction to be 
published by Anvisa. " 
Art. 5 of the Resolution - RDC No. 39, of 2013, shall become effective with the following 
wording:  
"Article 5 - .................................  
Anvisa may establish exceptions to the provisions of the caput of this article, in favour of 
the efficiency and optimization of resources related to international inspections, according 
to previously defined c riteria." (NR)  
This Resolution revokes the Resolution - RDC No. 15, dated 28 March  2014, published in 
the Official Gazette of the Union of 31 March 2014.  
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 189, 
2 October 2017, section 1, pages 55; (2) Law 9.782, 26 January 1999; Resolution RDC 61, 
3 February 2016 (3) Brazilian Official Journal; (4) Not applicable   
9. Proposed date of adoption:  2 September 2017  
Proposed date of entry into force:  2 September 2017  
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:   
http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?jornal=1&pagina=55&data=02 /
10/2017