G/TBT/N/BRA/770  
 
5 January 2018  
(18-0091) 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 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetr o.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): 
Industrialized Allergen Products. Pharmaceutics (ICS 11.120).  
5. Title, number of pages and language(s) of the no tified document: Resolution - RDC 
n. 194, December 12th, 2017.  (22 page(s) in English)  
6. Description of content: This Resolution provides for registration and post -registration 
changes of Industrialized Allergen Products, and makes other arrangements. This 
Resolution applies to Industrialized Allergen Products to be submitted for analysis for 
marketing authorization (registration) and post -registration alterations, as well as 
regulates the products Allergenic Nominal Patient Vaccine, Allergen Vaccine for Use by 
Professional Enabled and Allergenic Product for use by Qualified Professional. Industrialized 
Allergen Produ ct: industrialized finished medicinal product, manufactured by authorized 
pharmaceutical industry, and can be an Industrialized Allergen Extract, an Industrialized 
Allergen Vaccine or an Industrialized Allergen Product for Diagnosis. Industrialized Allerge n 
Products may only be marketed and distributed in Brazil if registered in Anvisa and 
manufactured or imported by a company whose operation is authorized by this Agency, 
and duly licensed by the competent local health authority. All companies involved in t he 
manufacture of Industrialized Allergen Product, from the extraction stage, must comply 
with good manufacturing practices, and present the certificate of good manufacturing 
practices issued by Anvisa. Industrialized Allergen Products must be registered b y Anvisa 
as a biological product, according to specific petition procedures. The registration of 
Industrialized Allergen Products manufactured in other countries can only be granted by 
Anvisa if the product is registered and released for use in its country  of manufacture. In 
cases where the country of origin does not register Industrialized Allergen Products, the 
manufacturing authorization must be presented, in accordance with the local requirements, 
and the proof of commercialization. All therapeutic or d iagnostic allegations claimed in the 
registration application must be documented in the reports of the clinical studies in the 
product registration dossier. The studies mentioned in the caput of this article must have G/TBT/N/BRA/770  
 
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  been conducted with the Industrialized  Allergenic Product presented for registration. The 
clinical studies carried out must have been approved by the sanitary authority of the 
country where the clinical research was carried out. All clinical investigations conducted in 
Brazil with the Industri alized Allergen Product must have prior authorization from Anvisa, 
as provided for in the Resolution of the Collegiate Board of Directors - RDC No. 9 of 
February 20, 2015, and its updates. At the moment of applying for registration, the 
requesting company must present documentation regarding the validation of the transport 
chain, with the presentation of the operation qualification and performance qualification of 
the system to be used for the transport of the product. This Resolution establishes the 
necess ary or required documentation concerning the quality, safety and efficacy of the 
product to be registered. The absence of any document required by this Resolution shall be 
justified and scientifically based. This Resolution revokes the Resolution RDC nº 23 3, 17 
August 2005.   
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:   
Resolution RDC nº 55, December 16th, 2010; Resolution RDC nº 9, February 20th, 2015; 
Resolution RDC nº 68, March 28th, 2003; Resolution RDC nº 47, September 8th 2009; 
Resolution RDC nº 71, December 22th, 2009; Resolution RDC nº 166. July 24th, 2017; 
Resolution RDC nº 50, September 20th, 2011; Resolution RDC nº 49, September 20th, 
2011  
9. Proposed date of adoption:  On the date of its publication  
Proposed date of entry into force:  90 (ninety) days after the date of its publication  
10. Final date for comments: No final date for comments  
11. Texts available from: National enquiry point [X]  or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency Responsible  
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília – DF / Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 346 2.5402  
Website: www.anvisa.gov.br   
 
http://portal.anvisa.gov.br/documents/10181/ 3426936/RDC_194_2017_.pdf/bd1080ca -
1e76-432e-8601-47b687c148ba