. /.WORLD TRADE
ORGANIZATIONG/TBT/N/ARG/12
14 May 2001
(01-2456)
Committee on Technical Barriers to Trade Original: Spanish
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6:
1. Member to Agreement notifying:  ARGENTINA
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible: National Drug, Food and Medical Technology Administration
(ANMAT)
Name and address (including telephone and fax numbers and E-mail and Web site
addresses, if available) of the agency or  authority designated to handle comments
regarding the notification if different from above:
Avda. de Mayo 869, Buenos Aires
Tel.:  54-11 4340-0800
Fax:  54-11 4340-4578URL:  www.anmat.gov.ar
E-mail:  webmaster@anmat.gov.ar
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):  Medical specialities.
5. Title, number of pages and language(s) of the notified document:  ANMAT Resolution
No. 6897/2000, 3 pages in Spanish.
6. Description of content:   Stipulates that information related to control methods, production,
pharmacotechnical testing, stability studies and operational and control capacity given on
applications for inclusion in the medical specialities register will be assessed in accordance
with the health risk presented by the main ac tive ingredients of the medical speciality in
question.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Laboratories wishing to record a speciality in the Drugs Register are now required to prove
that they are in a position to carry out the Good Manufacturing and Monitoring Practices
established in ANMAT Resolution No. 853/1999.
8. Relevant documents:  ANMAT Resolution No. 853/1999
9. Proposed date of adoption:  -
Proposed date of entry into force:  13 December 2000
10. Final date for comments:  -G/TBT/N/ARG/12
Page 2
11. Texts available from: National enquiry point [  X ] or address, telephone and fax
numbers and E-mail and Web site addresses, if available, of another body:  
Punto Focal de la República Argentina
Dirección Nacional de Comercio InteriorAvda. J. A. Roca 651, Piso 4°, Sector 22
(1322) Buenos Aires
Tel.:  54 11 4349-4038
Fax:  54 11 4349-4037
E-mail:  vcamal@secind.mecon.gov.ar