G/TBT/N/BRA/1086  
19 October 2020  
(20-7200) 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):  Dried 
glands and other organs for organo -therapeutic uses, whether or not powdered; extracts 
of glands or other organs or their secretions, for organo -therapeutic uses; heparin and 
its salts; other hu man or animal substances prepared for therapeutic or prophylactic uses, 
n.e.s (HS 3001); Human blood; animal blood prepared for therapeutic, prophylactic or 
diagnostic uses; antisera and other blood fractions and modified immunological products, 
whether or  not obtained by means of biotechnological processes; vaccines, toxins, 
cultures of micro -organisms (excl. yeasts) and similar products (HS 3002); Medicaments 
consisting of two or more constituents mixed together for therapeutic or prophylactic 
uses, not i n measured doses or put up for retail sale (excl. goods of heading 3002, 3005 
or 3006) (HS 3003); Medicaments consisting of mixed or unmixed products for 
therapeutic or prophylactic uses, in measured doses or put up for retail sale (excl. goods 
of heading 3002, 3005 or 3006) (HS 3004); Pharmaceutical preparations and products of 
subheading Nos 3006.10.10 to 3006.60.90 (HS 3006)  
5. Title, number of pages and language(s) of the notified document:  Normative 
Instruction number 68, 1 September 2020 (2 page(s), in Portuguese)  
6. Description of content:  This Normative Instruction establishes the inclusion of a 
declaration in the label of medical devices informing the existence of a new formula 
changing its composition.  
7. Objective and rationale, including the n ature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/BRA/1086  
 
- 2 - 
 
  8. Relevant documents:   
1) Brazilian Official Gazette 170 on 03 September 2020, section 1, page 74 2) Brazilian 
Official Gazette 170 on 03 September 2020, section 1, page 74 3) Resolution of the 
Collegiate Board - RDC No. 421 of 01 September 2020  
https://www.in.gov.br/web/dou/ -/instrucao -normativa -in-n-68-de-1-de-setembro-de-
2020-275656283  
https://www.in.gov.br/web/dou/ -/resolucao -de-diretoria -colegiada -rdc-n-421-de-1-de-
setembro -de-2020-2756565 06 
http://antigo.anvisa.gov.br/legislacao#/visualizar/432064  
9. Proposed date of adoption:  1 September 2021  
Proposed date of entry into force:  1 September 2021  
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  
https://www.in.gov.br/web/dou/ -/instrucao -normativa -in-n-68-de-1-de-setembro -de-
2020-275656283