G/TBT/N/BRA/742  
 
15 September 2017  
(17-4895) 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  
The comments to this Draft Regulation shall be sent to :  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=32938  
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 30 - 
Pharmaceutical products  
5. Title, number of pages and language(s) of the notified document: Draft 
Resolution  n. 393, September 13th, 2017. (16 page(s), in Portuguese)   
6. Description of content: This Draft Resolution provides for activities involving the 
substance lenalidomide and the medicine containing it.  
Substances listed in Schedule C3 listed in Annex I of Portaria SVS 344/98 and its updates, 
with the exception of thalidomide, shall comply with the requirements set forth in this 
Resolution after evaluation and express determination  of Anvisa.  
The market authorization holder of the lenalidomide medicine shall implement a supply, 
marketing, distribution and dispensation program to comply with the Pregnancy Prevention 
Plan (PPG) previously approved by Anvisa.  
The manipulation of the ac tive pharmaceutical ingredient (API) lenalidomide, the medicinal 
product containing it or of formulas containing lenalidomide in pharmacies is prohibited.  
In addition to complying with the standards that regulate Good Manufacturing Practices for 
the produc tion of API and medicines in the national territory, it is mandatory that 
companies provide individual and collective protection equipment that protects workers 
from exposure to the product and monitors their use in all stages of production the 
substance a nd the manufacture of the lenalidomide medicine.  
The presence of women on production and manufacturing lines is prohibited in any of the 
steps leading to product exposure.  
Distributors of the medicines must be previously qualified by the market authorizati on G/TBT/N/BRA/742  
 
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  holder of the lenalidomide medicine for their regularity of health and technical and safety 
capability for the distribution of this medicine.  
Any movement of the lenalidomide substance, as well as the medicine containing it, even 
when sent for analytica l or research purposes, must be carried out by issuing an Invoice or 
equivalent document.  
The importation and exportation of the substance lenalidomide or the medicine containing 
it shall comply with the requirements of Portaria SVS / MS no. 344/98, Portar ia nº 6/99, 
RDC no. 99/2008, RDC 11/2013 or those that replace it.  
This Resolution also contains informations on teaching and research; registration; 
prescription; dispensation; bookkeeping and balance sheets; package; free sample; 
pharmacovigilance; refun d; disposal; inspection.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  (1) Brazilian Official Journal (Diário Oficial da União) Nº 175, 
12 September 2017, section 1, page 28; (2) Resolution RDC 61, 3 February 2016; 
Law 9.782, 26 January 1999; Decree 3.029, 16 April 1999; (3) Brazilian Official Journal; 
(4) Not applicable   
9. Proposed date of adoption:  To be determined after the end of the consultation period.  
Proposed date of entry into force:  On the date of publication.  
10. Final date for comments: 30 September 2017  
11. Texts available from: National enquiry point [  ] 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/doc uments/10181/3351931/CONSULTA+PUBLICA+N+393+GG
MON.pdf/a509055f -53cd-434f-bdd9-b5ab6437587c