G/TBT/N/BRA/787  
 
26 January 2018  
(18-0625) 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): Product 
registration  
5. Title, number of pages and language(s) of the notified document: Resolution - RDC 
n. 212,  22 January  2018. Procedures related to the revalidation of product registration and 
provides other measures. (1 page(s), in Portuguese)   
6. Description of content: This Resolution changes the  Resolution - RDC No. 250 of 
20 October 2004, which provides for procedures related to the revalidation of product 
registration and provides other measures.  
The caput of art. 1 and of art. 4 of the Resolution - RDC No. 250, dated 20 October 2004, 
shall become effective with the followin g wording:  
"Article 1. The revalidation of the registration must be requested in advance of a maximum 
of twelve months and a minimum of six months of the date of maturity of the registration, 
being considered automatically revalidated, regardless of the de cision, if it has not been 
rendered until the day of termination of that."  
"Art. 4 In the counting of the term to request the revalidation of the record, the final day 
of validity will be considered as the day of the beginning to count down the maximum 
advance of twelve months and minimum of six months of the day of registration, under the 
terms of the previous article."  
It is revoked the paragraph 3 of art. 2 of the Resolution - RDC No. 250, 2004.  
7. Objective and rationale, including the nature of urgent  problems where 
applicable: Protection of Human Health  
8. Relevant documents:  Resolution – RDC nº 250 of October 20th, 2004.   G/TBT/N/BRA/787  
 
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  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 [  ] 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.anvisa.gov.br  
http://portal.anvisa.gov.br/documents/10181/3426501/RDC_212_2018_.pdf/09992788 -
8fa5-435b-8424-5f2214964ed4