G/TBT/N/BRA/774  
 
8 January 2018  
(18-0138) 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@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): Medicines  
5. Title, number of pages and language(s) of the notified document: Resolution – 
RDC n. 191, December 11th, 2017 (20 page(s), in Portuguese)    
6. Description of content: This Resolution establishes mechanisms of control for the 
substance lenalidomide and lenalidomide -based medicine, and gives other measures.  
The supply, marketing, distribution and dispen sation of lenalidomide -based medicine 
products is prohibited until the proper implementation by the holder of the registration of 
the respective PPP (Pregnancy Prevention Program) previously approved by Anvisa.  
The handling of the Active Pharmaceutical Int ake (IFA) lenalidomide, as well lenalidomide -
based medicine  or formulas  containing it is forbidden for pharmacies.  
Distributors of medicines products must be previously qualified by the holder of the 
lenalidomide medicine product registration  for their regularity of health and technical and 
safety capability for the distribution of this medicine product, according to the 
particularities and needs of the PPP (Pregnancy Prevention Program) previously approved 
by Anvisa.  
The importation and exportation of t he substance lenalidomide or medicine containing it 
should follow the provisions of Ministerial Ordinance SVS 344 of 12 May 1998; Ministerial 
Ordinance no. 6, dated 1 February 1999; Resolution - RDC No. 99, of 24 December 2008; 
Resolution - RDC No. 11, of 6 March 2013; Resolution - RDC No. 62, of 11 February 2016; 
Resolution - RDC No. 172, of 8 September 2017, or any that may replace them.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  G/TBT/N/BRA/774  
 
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  8. Relevant documents:  Draft Resolution nº 393 of 12 September 2017, notified as 
G/TBT/N/BRA/742; Ministerial Ordinance SVS 344 of 12 May 1998; Ministerial Ordinance 
no. 6, dated 1 February 1999; Resolution - RDC No. 99, of 24 December 2008; Resolution 
- RDC No. 11, of 6 March 2013; Resolution - RDC No. 62, of 11 February 2016; Resolution 
- RDC No. 172, of 8 September 2017; Resolution RDC nº 71, 22 December 2009; 
Resolution RDC nº 47 8 September 2009; Resolution RDC nº 99, 24 December 2008;   
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: 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 3462.5402  
Website: www.anvisa.gov.br    
http://portal.anvisa.gov.br/documents/10181/3351931/RDC_191_2017_.pdf/a08ff846 -
09d0-4ee2-bc8f-1489f6f384da