. /.WORLD TRADE
ORGANIZATIONG/TBT/N/BRA/75
13 January 2003
(03-0153)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   BRAZIL
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:  National Institute of Metrology, Standardization and Industrial
Quality-INMETRO
Telephone: +(55) 21 2563.2821
Telefax: +(55) 21 2502.6542
Email: barreirastecnicas@inmetro.gov.br
Web-site: www.inmetro.gov.br/barreirastecnicas
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:
Brazilian Sanitary Surveillance Agency - ANVISA
Telephone:  +(55) 61 448.1078Fax: +(55)61 448.1089
E-mail: rel@anvisa.gov.br
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):    Ganglioside-based
drugs (HS Chapter 30)
5. Title, number of pages and language(s) of the notified document:   Resolution
number 298, 6 November 2002 (Resolução RDC no. 298, de 6 de novembro de 2002)
issued by the Brazilian Sanitary Surveillance Agency on ganglioside-based drugs. (4 pages,
in Portuguese).
6. Description of content:  This technical regulation establishes that requirements concerning
raw material importation, ganglioside-based drugs manufacturing, distribution, trading and
prescription as well as drug usage will be subject to the control of the Brazilian SanitarySurveillance Agency. It also includes ganglioside-based drugs in the list C1 - Substances
Subject to Special Control, found in Annex I of Ministerial Act number 344, 12 May 1998
(Portaria SVS/MS no. 344 de 12 de maio de 1998).
In addition, the directions of the above mentioned drugs must contain the following
warnings in Portuguese:
- Medicamento a base de tecido nervoso que pode desencadear a Síndrome de
Guillan Barre (SGB).(  “Nervous tissue based drugs which can arouse Guillain-BarréG/TBT/N/BRA/75
Page 2
Syndrome (SGB)” and
- Medicamento a base de tecido nervoso bovino. Os tecidos bovinos estão associados à aparição da
Encefalite Espongiforme Bovi na, variável humana. ( “Bovine nervous tissue based drugs. The
nervous tissues are associated with the appearance of bovine spongiform encephalopathy,human variant”)
It also revokes the following Resolutions:1. Resolution number 527, 17 April 2001 (Resolução RE no. 527 de 17 de abril de 2001)
2. Resolution number 2, 5 March 2002 (Resolução RE no. 2 de 5 de março de 2002)
3. Resolution number 198, 12 July 2002 (Resolução RDC no. 198 de 12 de julho de 2002)
4. Resolution number 278, 24 October 2002 (Resolução RDC no. 278 de 24 de outubro de
2002)
Obs: Also notified under SPS Agreement
7. Objective and rationale, including the na ture of urgent problems where applicable:
Consumer’s  health and safety and directions requirements
8. Relevant documents:   Ministerial Act number 344, 12 May 1998 (Portaria SVS/MS no.
344 de 12 de maio de 1998)
9. Proposed date of adoption:
Proposed date of entry into force:  Not stated
10. Final date for comments:   Not stated
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body: National
Institute of Metrology, Standardization and Industrial Quality-INMETRO
Telephone: +(55) 21 2563.2821
Telefax: +(55) 21 2502.6542Email: barreirastecnicas@inmetro.gov.br
Brazilian Sanitary Surveillance Agency – ANVISATelephone: +(55) 61 448.1078
Telefax: +(55) 21 2502.6542
Email: rel@anvisa.gov.br
Or at the following link: http://www.anvisa.gov.br/legis/resol/2002/298 02rdc.htm