. /.WORLD TRADE
ORGANIZATIONG/TBT/N/BRA/58
24 September 2002
(02-5117)
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 2502.6542Email: barreirastecnicas@inmetro.gov.br
Web-site: www.inmetro.gov.br/barreirastecnicas
Agency responsible: Brazilian Sanitary Surveillance Agency – ANVISA
Telephone: +(55) 61 448.1078
Fax: +(55)61 448.1089
E-mail: rel@anvisa.gov.br
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:           
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):   Similar, exempt,
phytotherapic and new drugs (HS Chapter 30)
5. Title, number of pages and language(s) of the notified document:   Draft Resolution
number 63, August 12th, 2002 (Consulta Pública no. 63 de 12 de agosto de 2002) issued by
the Brazilian Sanitary Surveillance Agency on technical procedures which apply to similar,
exempt, phytotherapic and new drugs. (6 pages, in Portuguese).
6. Description of content:   Draft Resolution proposing the establishment of a list of
guidelines that may be used to describe technical procedures related to products subject to
sanitary surveillance, namely similar, exempt, phytotherapic and new drugs.  It also lays
down marking, packaging and labelling requirements for the above mentioned products.
Similar drugs, as defined by the present draft resolution, are those drugs which contain thesame active principles, at the same concentration and pharmaceutical form, administration
route, posology and therapeutic indication, being thus equivalent to the drug registered at
the federal organism responsible for the sanitary surveillance, differing only on what
concerns those characteristics relative to the size and shape of the product, expiry date,
packaging, labelling, excipient and vehicle, requiring identification either by a trade nameor mark.G/TBT/N/BRA/58
Page 2
7. Objective and rationale, including the na ture of urgent problems where applicable:
Marking, packaging and labelling requirements and public health.
8. Relevant documents:   Draft Resolution number 62, August 12th, 2002 (Consulta Pública
no. 62 de 12 de agosto de 2002).
9. Proposed date of adoption:
Proposed date of entry into force: }Not stated
10. Final date for comments:   28 September 2002
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:
Brazilian Sanitary Surveillance Agency - ANVISA
SEPN 515 - Bloco "B", Edificio Omega
CEP 70770-502
Brasilia – DF/BrasilPhone.:  55 61 448 1078
E-mail:  rel@anvisa.gov.br
http://www.anvisa.gov.br/consulta/2002/63_2002.pdf
http://inmetro.gov.br/barreirastecnicas