G/TBT/N/BRA/732  
 
8 August 2017  
(17-4288) 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 (A nvisa)  
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 Metr ology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.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=33059  
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):  Medicines  
5. Title, number of pages  and language(s)  of the notified document:  Draft Technical 
Resolution n. 373, 2 August 2017 (54 page(s), in Portuguese)   
6. Description of content:  This Draft Resolution provides for registration, renewal of 
registration, post -registration changes and notification of industrialized dynamized drugs.  
The technical regulation that esta blishes the minimum requirements for registration, 
renewal of registration, post -registration changes and notification of industrialized 
dynamized drugs, in accordance with this Resolution, is hereby approved.  
This resolution applies to industrialized dyna mized drugs. Homeopathic, anthroposophic 
and antihomotoxic medicines are considered as dynamized drugs, framed in specific 
categories according to the criteria set forth in art. 5 of this Resolution.  
For the purpose of framing the different categories of d ynamized drugs, the following 
classification should be observed:  
I - are classified as homeopathic dynamized medicinal products those whose claim to use 
is defined based on the fundamentals of Homeopathy and that are elaborated according to 
homeopathic pha rmacotechnical.  
II - are classified as anthroposophic dynamized drugs those prepared according to 
anthroposophic pharmacotechnics or those whose claim and use is defined based on the 
foundations of Anthroposophic Medicine, even if prepared according to hom eopathic 
pharmacotechnics.  
III - anti-homotoxic drugs are defined as those that have their therapeutic indications 
defined according to the concepts of Homotoxicology and are elaborated in accordance G/TBT/N/BRA/732  
 
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  with the homoeopathic or antihomotoxic pharmacotechnics.  
The addition of colorings, sweeteners, flavorings and essences to the formulation of 
energized medicinal products shall not be permitted.  
The claim of use of compounded dynamized medicinal products may be given considering 
the individual indication of eac h of the components of the drug and the rationale of the 
association must be proven.  
This notification also establishes provisions regarding the restriction on the sale of 
industrialized dynamized drugs; notification of medicinal products; drug registratio n; 
registration and notification; renewal of registration; labelling; medication package; post -
registration changes; and final and transitional provisions.  
This resolution revokes the RDC nº 26, of 30 March  2007.  
7. Objective and rationale , including the nature of urgent problems where applicable: 
Protection of Human Health  
8. Relevant documents:  (1) Brazilian Official Journal (Diá rio Oficial da União) Nº 148, 
3 August 2017, section 1, page 112; (2) Law 9.782, 26 Ja nuary 1999 (Lei nº 9.782, 
de 26 de janei ro de 1999); (3) Brazilian Official Journal; (4) Not stated.   
9. Proposed date of adoption:   To be determined after the end of the consultation period.  
Proposed date of entry into force:  On the date of its publication.    
10. Final date for comments:  8 October 2017  
11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:   
Agency Responsible  
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especia l 57 
Brasília – DF/Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
http://portal.anvisa.gov.br/documents/10181/2959207/CONSULTA+PUBLICA+N+373+GG
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