G/TBT/N/BRA/777  
 
11 January 2018  
(18-0274) 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): Specific 
medicines  
5. Title, number of pages and language(s) of the notified document: Draft Resolution 
Nº 460, D ecember 28th, 2017 (12 page(s), in Portuguese)    
6. Description of content: This Draft Resolution changes the Resolution RDC No. 24, dated 
14 June 2011, Resolution - RDC No. 107, dated 5 September 2016 and the Normative 
Instruction - IN No. 11, dated 29 September 2016, and regulates the registration of 
vitamins, minerals, amino acids and proteins for oral use, classified as specific medicines.  
Paragraph 3 of Article 3 of Resolution RDC No. 24 of 14 June 2011 shall become effective 
with the following wordi ng: “§3 This Resolution does not apply to food supplements, 
contemplated in the scope of RDC XXX of XXX, which can not be registered as specific 
medicines.”  
Section XII of Article 5 of Resolution RDC No. 24 of 14 June 2011 shall become effective 
with the f ollowing wording: “XII - medicines based on vitamins and / or minerals and / or 
amino acids and / or proteins isolated or associated with each other, for oral use, with 
well-established therapeutic indications and different from the claims authorized for f ood 
supplements in Resolution - RDC No. XX, XX of XXXXXX of 20XX”;  
Article 6 of Resolution No. RDC No. 24 of 14 June 2011 shall become effective with the 
following wording: “Art. 6 Isolated or associated vitamins, minerals and amino acids, 
registered as sp ecific medicinal products for oral or injectable use, are classified as 
medicines for sale under medical prescription.”  
Holders of specific medicine products based on vitamins and / or minerals and / or amino 
acids and / or proteins isolated or associated with each other for oral use shall have a G/TBT/N/BRA/777  
 
- 2 - 
 
  period of 24 (twenty four) months from the date of entry into force of this Resolution, for 
the adequacy of the registration as follows:  
I - In case they are classified as dietary supplements, registry holders must  comply with 
the procedures for registration and exemption from registration established in Resolution 
No. 23 of 15 March   2000 and Resolution No. RDC No. 27 of 6 August 2010;  
or II - If they remain classified as specific medicines, they must submit, by me ans of a 
specific petition, evidence of efficacy and safety for therapeutic indication as established at 
the Resolution RDC No. 24, dated 14 June 2011.  
Holders of specific medicines registration may request their revalidation as a specific drug 
in up to 24  (twenty four) months, as of the validity of this Resolution, but they can not fail 
to observe the final deadline established in the caput of this article for regularization of 
products as food supplements.  
Specific medicines that are classified as food su pplements and that are not regularized 
within 24 (twenty four) months from the entry into force of this Resolution will have their 
records canceled.  
This Resolution revokes:  
- I. subsection XIV of Article 4;  
- the sole paragraph of Article 6;  
- paragraphs  1 and 2 of Article 31;  
- paragraphs I and III of Article 33 of Resolution - RDC n ° 24 of 14 June 2011, which 
provides for registration of specific drugs;  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of  Human Health  
8. Relevant documents:  RDC nº 107/2016; RDC nº 24/2011;  RDC nº 27/2017; RDC nº 
23/2000; IN Nº 11/2016.   
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: 9 April 2018  
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/10181/3898888/CONSULTA+P%C3%9ABLICA+N+
460+GGMED.pdf/e6920b20 -9db9-4199-8f51-7cd1e80f9117