WORLD TRADE
ORGANIZATIONG/TBT/N/ARG/141
22 October 2003
(03-5587)
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 agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:   Idem  National
enquiry point
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):   Medicinal preparations
for human use - reference substance
5. Title, number of pages and language(s) of the notified document:   Primary Reference
Substance - Nystatin   (1 page, in Spanish).
6. Description of content:   This Resolution establishes Nystatin  as a primary reference
substance for microbiological assessment.  As a result of microbiological assessment, thesubstance concerned was assigned a potency of 4945 International Units (IU)/mg as
Nystatin, determined in comparison with the 2nd International Standard for Nystatin,
established by the World Health Organization (WHO) in 1982.
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health.
8. Relevant documents:   National Drug, Food and Medical Technology Administration
(ANMAT) Resolution No. 5492/2003.
9. Proposed date of adoption:  17 October 2003  (Official Journal)
Proposed date of entry into force:  27 October 2003
10. Final date for comments:   -
./.G/TBT/N/ARG/141
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 other body:
Focal Point of the Argentine Republic
National Directorate of Domestic Trade (DNCI)Avda. J. A. Roca 651, 4
th floor, Sector 2
(C1067ABB) Buenos Aires
Tel.:  (54 11) 4349-4067
Fax:  (54 11) 4349-4072
E-mail:  focalotc@mecon.gov.ar
Web site:  http://www.puntofocal.gov.ar