G/TBT/N/BRA/1412  
13 July 2022  
(22-5337) 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 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.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 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or 
more constituents which have been mixed together for thera peutic or prophylactic uses, 
not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); 
Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or 
unmixed products for therapeutic or prophylactic us es, put up in measured doses 
(including those in the form of transdermal administration systems) or in forms or 
packings for retail sale. (HS code(s): 3004)  
5. Title, number of pages and language(s) of the notified document:  Resolution - 
RDC number 721, 0 1 July 2022; (55 page(s), in Portuguese)  
6. Description of content:  This Resolution contains provisions on marketing authorization, 
renewal of marketing authorization, post -marketing authorization changes and 
notification of industrialized dynamized drugs .  
The current editions of the following pharmacopoeias and compendia should be used as 
a reference for production methods and quality control of drugs, excipients, active 
ingredients and industrialized dynamized drugs:  
I - Brazilian Homeopathic Pharmacopoeia;  
II - German Homeopathic Pharmacopoeia (GHP/HAB);  
III - American Homeopathic Pharmacopoeia (HPUS);  
IV - British Homeopathic Pharmacopoeia (BHP);  G/TBT/N/BRA/1412  
 
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  V - Mexican Homeopathic Pharmacopoeia;  
VI - Indian Homeopathic Pharmacopoeia;  
VII - European Phar macopoeia (Ph. EUR.);  
VIII - French Pharmacopoeia (PhFr); or  
IX - Anthroposophical Pharmaceutical Code (APC).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  This Resolution aims to establish minimum requirements for market 
registration, market registration renewal, post -market registration changes and 
notification of industrialized dynamized drugs.; Protection of human health or safety  
8. Relevant documents:   
- 
9. Proposed date of adoption:  1 August 2022  
Proposed date of entry into force:  1 August 2022  
10. Final date for comments:  Not Applicable  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
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  
The final text is available only in Portuguese and can be downloaded a t: 
http://antigo.anvisa.gov.br/documents/10181/2718376/RDC_721_2022_.pdf/e0a6da8f -
aeee-457e-9457-aca3be932e0d