G/TBT/N/BRA/798  
 
8 March 2018  
(18-1437) 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):               
Chapter 30 - Pharmaceutical products  
5. Title, number of pages and language(s) of the notified document: Resolution – 
RDC N° 219, February 26th, 20 18. Post -registration of medicines. (8 page(s), in 
Portuguese)   
6. Description of content:  
This Resolution applies to requests for post -registration alteration of medicines and 
biological products filed with Anvisa before and after Law 13.411 of 28 Decem ber 2016.  
Art. 2. The maximum period for the final decision in the post -registration change processes 
of medicines and biological products will be, respectively:  
I - for the priority category, of sixty days, counted from the date of the respective 
prioritization protocol;  
II - for the ordinary category, one hundred and eighty days, counted from the date of the 
respective post -registration change protocol.  
Paragraph 1. The aforementioned period may be extended by up to one -third of the 
original term,  once, by means of a reasoned decision of Anvisa issued at least fifteen 
business days before the end of the original term.  
Paragraph 2. The aforementioned period will have their countdown suspended when they 
request information or requirements, until they  are attended to.  
Art. 6. Petitions for post -registration changes petitioned before the enactment of 
Law n° 13.411, of 2016, for which a safety and efficacy report is required, will have its 
analysis procedures maintained and can only be implemented after approval by Anvisa.  G/TBT/N/BRA/798  
 
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  Art. 8. The Anvisa areas responsible for medicine registration, inspection, monitoring and 
monitoring will establish a program to monitor post -registration changes implemented in 
accordance with the conditional approval set forth in thi s Resolution.  
Art. 9. During follow -up inspections or inspection actions, the company must provide all 
documentation related to the complete technical dossier, required by the health 
regulations in force at the time of the petition, which deals with post -registration changes.  
Art. 17. This 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:   
1) Brazilian Official Journal (Diário Oficial da União) N ° 39, 28 February 2018, section 1, 
page 79;  
2) Law No. 13.411 28 December  2016; Law 6.437, 20 August 1977;  
3) Brazilian Official Journal;  
4) Not applicable   
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.anvisa.gov.br   
http://portal.anvisa.gov.br/documents/10181/4106210/%281%29RDC_219_2018_.pdf/e2
a0ae4f -8998-4ebf-b37c-03dabb3ad87e