G/TBT/N/BRA/758  
 
24 November 2017  
(17-6420) 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 2840 
Telefax: +(55) 21 2563 5637 
Email: barreirastecnicas@inmet ro.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): HS 3002 - 
Blood 
5. Title, number of pages and language(s) of the notified document: Resolution – 
RDC n. 187, Nove mber 8th, 2017. (13 page(s), in Portuguese)   
6. Description of content: This Resolution establishes the minimum requirements for the 
registration of Hyperimmune Serum in order to guarantee the quality, safety and efficacy 
of these products. It applies to Hyperimmune Serum submitted for analysis for registration 
purposes.  
Due to the biological origin of its Active Principles and the diversity of the technological 
processes used to obtain these products, all requests for the registration of Hyperimmune 
Serum  will be analyzed according to the requirements established in this Resolution.  
Only Hyperimmune Serum registered at the Brazilian Health Regulatory Agency - Anvisa, 
manufactured or imported by establishments authorized by the Federal Government and 
licens ed at a state level, may be marketed and distributed in Brazil.  
The Hyperimmune Serum manufactured in other countries may only be  Authorized 
(registered) by Anvisa if the product is registered and liberated for use in its country of 
manufacture. Hyperimmun e Serum not registered in their country of manufacture, but 
registered in another country due to epidemiological necessity, may be registered with 
Anvisa, after evaluation of the documentation presented, provided that the epidemiological 
impact of its use in Brazil is proven.  
Only those Hyperimmune Serum with their validated manufacturing process will be 
registered and have at least one method of inactivation and / or viral removal validated in 
their manufacturing process will be registered.  
For products ma nufactured in other countries, the latest periodic pharmacovigilance report 
shall be submitted, if available.  G/TBT/N/BRA/75 8 
 
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  Failure to submit any data requested in this Resolution relating to quality, safety and 
efficacy of the product to be registered shall be technica lly and scientifically justified.  
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), N° 215 
9 December 2017; Section 1 page 57. (2) Law nº 9. 782, de 26 January  1999; Law 
nº 13.097, de 19 January 2015  (3) Brazilian Official Journal;  (4) Not stated.   
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: Not applicable  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
http://portal.anvisa.gov.br/documents/10181/3233294/RDC_187_2017_.pdf/af6f9ea2 -
ff17-42ad-a147-0f3f14523250