G/TBT/N/BRA/808  
 
12 April 2018  
(18-2216) 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 2563.2840  
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): Nasal and 
oral inhalants medicines  
5. Title, number of pages and language(s) of the notified document: Draft 
Resolution  490, 26 March 2018 - criteria for acceptance of the in vitro and in vivo tests 
necessary to prove therapeutic equivalence for nasal and oral inhalants medicines. (10 
page(s),  in Portuguese)   
6. Description of content: Article 1 This Draft Resolution establishes the criteria for 
acceptance of the in vitro and in vivo tests necessary to prove therapeutic equivalence for 
the granting and renewal of registration and post -registra tion changes in nasal and oral 
inhalants medicines with synthetic active principles classified as new, generic and similar.  
Article 2 Single paragraph. In the case of new medicine products, the scope of this 
resolution is limited to medicine products conta ining active principles within the approved 
therapeutic range where therapeutic equivalence studies may replace clinical studies of 
Phase II and III, as defined by Resolution - RDC 60, 10 October 2014 and its updates.  
Article 4 All requirements for conduct ing the pharmaceutical equivalence study of nasal 
and oral inhalation medicines and for the preparation of reports shall meet the criteria 
established in this resolution, as well as in Resolution RDC  31, 11 August  2010, and its 
updates, which provides the Guide for Study Execution and Elaboration of the 
Pharmaceutical Equivalence Report and Dissolution Profile.  
Article 14 In addition to the requirements presented in this Resolution, pharmacokinetic 
studies for the purpose of proving the relative bioavailability/bioequivalence of nasal 
medicines products and oral inhalers should meet the criteria established in other 
regulations on the subject.  G/TBT/N/BRA/808  
 
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  Art 45 The relative bioequivalence/bioavailability study may be dispensed for other generic 
and new gener ic drug dosages, provided that the criteria for pharmacokinetic linearity and 
proportionality of the formulations are met, as deter mined by Resolution - RDC 37, 
3 August 2011, which provides the Guide for Exemption and Substitution of Relative 
Bioavailabil ity Studies/Bioequivalence  
Paragraph 1 The other dosages should use the same device as the dosage under study in 
vivo. 
Paragraph 2 The comparative performance tests between test drug and reference of the 
same dosage, as described in Section I of Chapter II  of this Resolution, shall also be 
presented in the above exemption cases  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety  
8. Relevant documents:  1) Brazilian Official Journal (Diá rio Oficial da União), 2 April 2018; 
Section 1, p. 94; 2) Resolution – RDC 60/2014; Resolution – RDC 31/2010; Resolution – 
RDC 37/2011;Resolution – RE 1170/06 and Resolution – RDC 27/12;  3) Brazilian Official 
Journal; 4) Not stated.   
9. Proposed date of adoption:  On the date of its publication  
Proposed date of entry into force:  On the date of its publication, after the end of the 
consultation period.  
10. Final date for comments: 7 June 2018  
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.anv isa.gov.br/documents/10181/3178137/CONSULTA+P%C3%9ABLICA+N%
C2%BA+490+GGMED.pdf/383ff9a9 -1289-415e-9802-be4d411796ce