G/TBT/N/BRA/1312  
15 March 2022  
(22-2291) 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 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Active 
Pharmaceutical Ingredients (HS 3006); Pharmaceutical preparations and products of 
subheadings 3006.10.10 to 3006.60.90 (HS 3006)  
5. Title, number of pages and language(s) of the notified docum ent: Resolution 
number 606, 23 February 2022 (6 page(s), in Portuguese)  
6. Description of content:  This resolution defines the extraordinary and temporary criteria 
and procedures for the certification of good manufacturing practices for the purpose of 
market authorization and post -market authorization changes of active pharmaceutical 
ingredient, medicine and health products due to the international public health emergency 
of the new Coronavirus.  
The Foreign Regulatory Authorities, for the purposes of the a ctions described in the caput, 
are those members of:  
I - PIC/S (Pharmaceutical Inspection Cooperation Scheme/Scheme for Cooperation in 
Pharmaceutical Inspection) for certifications related to medicines and pharmaceutical 
ingredients;  
II - MDSAP (Medical Device Single Audit Program) for certifications related to medical 
devices; or  
III - Programme to rationalize international GMP inspections of active pharmaceutical 
ingredients/active substance manufacturers for certifications related to pharmaceutical 
ingredients.   
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health; Protection of human health or safety  G/TBT/N/BRA/1312  
 
- 2 - 
 
  8. Relevant documents:   
- 
9. Proposed date of adoption:  2 March 2022 ; On the date of its publication  
Proposed date of entry into force:  2 March 2022 ; On the date of its publication  
10. Final date for comments:  Not applied  
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 at:  
http://antigo.anvisa.gov.br/documents/10181/5809525/RDC_606_2022_.pdf/c70745b0
-1f02-4cfa-ac9e-b418f93335c3  
http://antigo.anvisa.gov.br/d ocuments/10181/5809525/RDC_606_2022_.pdf/c70745b0
-1f02-4cfa-ac9e-b418f93335c3