G/TBT/N/BRA/783  
 
11 January 2018  
(18-0280) 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   
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): Medicinal 
product s 
5. Title, number of pages and language(s) of the notified document: RDC Nº 200, 
December 26th, 2017 (5 page(s), in Portuguese)    
6. Description of content: The purpose of this Resolution is to establish the criteria and 
minimum documentation required to grant and renew the registration of medicinal 
products with synthetic and semi -synthetic active principles, classified as new, generic and 
similar, in order to guarantee the quality, safety and efficacy of these drugs.  
This Regulation applies to all medici nes with synthetic and semi -synthetic active 
ingredient, classified as new, generic and similar, with the exception of those governed by 
specific legislation.  
Official documents in foreign languages used for registration purposes, issued by foreing 
health authorities, must be accompanied by a certified translation in accordance with the 
law. 
For the purposes of the provisions of these Resolutions, if there are specific legislation or 
guides, these should be fulfilled and the respective evidence must be pr esented.  
For the purpose of renewing the registration of the medicine in Anvisa, all companies must 
present the documents cited in this Resolution in the first half of the last year of the five -
year period of validity of the registration already granted.  
The company that holds the registration or manufactures the drug may be inspected for 
on-site verification of data and information regarding the grant application and renewal 
of  registration, at Anvisa's discretion.  G/TBT/N/BRA/783  
 
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  Anvisa may issue technical guidance on t he applicability of this Resolution to specific cases 
of drug registration, such as the submission of data to prove safety and efficacy for 
incremental innovations, whenever necessary  
This Resolution revokes:  
- Resolution - RDC nº. 136, of 29 May 2003;  
- Resolution - RDC no. 16, dated 2 March 2007, with the exception of items 1 and 2, VI, of 
Annex I;  
- Resolution - RDC no. 17, dated 2 March 2007, with the exception of items 1 and 2, VI, of 
the Annex, arts. 1 and 4 of the Resolution - RDC nº. 210, dated 2 September 2004, and 
Section I and II of Chapter XVIII of Resolution -RDC No. 48 of 6 October 2009.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  Resolution RDC nº 31/2010; Resolution RDC nº 39/2013; 
Resolution RDC nº 20/2015; Resolution RDC nº 71/2009; Resolution RDC nº 17/2010 and 
Resolution RDC nº 45/2012.   
9. Proposed date of adoption: On the date of its publication.  
Proposed date of entry into force: On the dat e 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/10181/2718376/RDC_200_2017.pdf/41a09070 -
4acd-4e34-8b0b-ba8e88295df0