. /.WORLD TRADE
ORGANIZATIONG/TBT/N/BRA/100
4 February 2003
(03-0723)
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):   Allergenic products
(HS: 30.03 , 30.04)
5. Title, number of pages and language(s) of the notified document:   Draft Resolution
number 99, December 16th, 2002 (Consulta Pública no. 99 de 16 de dezembro de 2002)
issued by the Brazilian Sanitary Surveillance Agency on registration, amendments, post
registration inclusion and validation of allergenic products.  (20 pages, in Portuguese).
6. Description of content:   This draft technical regulation aims at regulating registration and
post registration procedures of allergenic products. It also establishes the text to be included in
the directions and labelling as well as external packaging requirements.
Observation:  Also notified under SPS Agreement
7. Objective and rationale, including the na ture of urgent problems where applicable:
Labelling requirements and public health.G/TBT/N/BRA/100
Page 2
8. Relevant documents:   European Union Directive 2001/83/EC on drugs for human use;
European Union. Guiding note for allergenic products. 1996 Revision; United States.
CBER/FDA - Manual for the industry. Information on the chemistry, control and production
and descriptive information of an allergenic extract or  contact test with allergens. 1999;
Switzerland. Article with the Point of View  of the WHO. Allergens immunotherapy:
therapeutic vaccines for allergic diseases, Allergy 1998; 44(53): 5-42.; European Union.
European Pharmacopaea, 4th Edition, 2002. Monography of allergenic products; Italy.
Legislative Decree, December, 19th 1991, Allergens and radiopharmaceuticals; Spain. Royal
Decree 288/1991, March, 8th 1991, on the immunological drugs for human use; Germany.
Revision of Allergenic Products, 1992. Technical Guide; Brazil. National Standardization
Body. NBR ISO 9000 (BRASIL. Associação Brasileira de Normas Técnicas - ABNT - NBR
ISO 9000 –2: Normas de gestão da qualidade e garantia da qualidade - diretrizes gerais paraa aplicação das Normas ISO 9001, 9002 e 9003. (S.I.):(s.n.), 1994; Good Manufacturing
Practices of Pharmaceuticals: Authorized translation from the WHO, Brasília, p. 146; 1994;
Brazil. Resolution number 134, July 13
th 2001 and annex technical regulation on the good
fabrication practices of drugs (BRASIL Resolução - RDC nº 134, de 13 de julho de 2001.
Determinar a todos os estabelecimentos fabr icantes de medicamentos, o cumprimento das
diretrizes estabelecidas no Regulamento Técnico das Boas Práticas para a Fabricação de
Medicamentos, conforme ao Anexo I da presente Resolução); Brazil. Ministerial Act
number 112, November 19th 1993 and annex technical regulation on drugs fractioning
(BRASIL. Ministério da Saúde. Portaria SVS/MS n.º 112, de 19 de novembro de 1993.
Aprova o regulamento técnico, referente a fracionamento de medicamento. Diário Oficial daUnião da República Federativa do Brasil, Brasília, nov. 1993.); Brazil. Ministerial Act
number 2,814, May 29
th 1988, on the identity and quality procedures for drugs. (BRASIL.
Ministério da Saúde. Portaria GM/MS n.º 2.814, de 29 de maio de 1998. Trata de
Procedimentos a serem observados pelas empresas produtoras, importadoras, distribuidoras
e do comércio farmacêutico, objetivando a comprovação da identidade e qualidade demedicamentos. Diário Oficial da União da República Federativa do Brasil. Brasília, 18 nov.
de 1998.)
9. Proposed date of adoption:
Proposed date of entry into force: }Not stated
10. Final date for comments:   7 February 2003
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/Brasil
Phone.: 55 61 448 1078
E-mail: rel@anvisa.gov.br
http://www.inmetro.gov.br/barreirastecnicas
http://www.anvisa.gov.br/base/visadoc/CP/CP[3591-1-0].PDF