. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/353 
1 December 2009 
 (09-6068) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  BRAZIL
  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Sanitary Surveillance 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, Standa rdization and Industrial Quality-INMETRO 
Telephone: +(55) 21 2563 2821 Telefax: +(55) 21 2502 6542 Email: barreirastecnicas@inmetro.gov.br Website: http://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 applicab le, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Active Pharmaceutical 
Ingredients. 
5. Title, number of pages and langu age(s) of the notified document:  Draft Resolution 
number 70, 3 November 2009 – Active Pharmaceutical Ingredients (API) obtained by cell 
culture/fermentation (6 pages, Portuguese)     
6. Description of content:  This Resolution has the objective of settling Good Manufacturing 
Practices (GMP) for  Active pharmaceutical ingredients (API) obtained by cell 
culture/fermentation.  
The Resolution covers Good Manufacturing Prac tice at the production of API obtained by 
cell culture/fermentation. This Technical Regula tion should not be considered in isolation, 
but in addition to the principles of GM P for intermediate products and Active 
Pharmaceutical Ingredients, established by  Resolution RDC number 249, dated September 
13th 2005. 
Thus, Resolution RDC number 249/2005 has an amendment of Article 1B and Annex III, 
relating to Good Manufacturing Practices of AP I obtained by cell culture/fermentation.  
Article 1-B determines that a ll production sites of API obtained by cell culture/fermentation 
have to comply with the guidelines set forth in Annex I and III.  
The Resolution applies to all manufacturers of API obtained by cell culture/fermentation,  G/TBT/N/BRA/353 
Page 2  
 
  according to item 1.7 of Annex I of RDC number 249/2005. 
Article 5 grants a period of 360 (three hundred and sixty days) from the day of entry into 
force of the Resolution for producers to adequate to the new legislation.  
The resolution is based on the recommendati ons of the World Health Organization on 
Certification Scheme on the Quality  of Pharmaceutical Products.  
7. Objective and rationale, including the natu re of urgent problems where applicable:  
Protection of Human Health  
8. Relevant documents:   Brazilian Official Journal (Diári o Oficial da União), November  
10th      2009; Section 1. Draft Resolution (Consulta Pública) number 70, November 3rd  
2009,  issued by Brazilian Sanitary Surveillan ce Agency – Anvisa; When adopted, it will be 
published at  the  Brazilian Official Journal. Available in Portuguese.   
9. Proposed date of adoption:   
 Proposed date of entry into force:    To be determined after the end of the 
consultation period.  360 days after the date of adoption. 
10. Final date for comments:  10 December 2009 
11. Text available from: National enquiry point [ X], or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:    
Agency responsible: 
Brazilian Sanitary Surveillance Agency – ANVISA 
SIA, Trecho 5, Área Especial 57 
Brasília – DF / Brazil CEP: 71.205-050 Phone.: 55 61 3462-5406 E-mail: rel@anvisa.gov.br  
Website: http://www.anvisa.gov.br
 
http://www4.anvisa.gov.br/base/visadoc/CP/CP[28348-1-0].PDF