. /.WORLD TRADE
ORGANIZATIONG/TBT/N/ARG/52
26 July 2002
(02-4155)
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.
5. Title, number of pages and language(s) of the notified document:   National Drug, Food
and Medical Technology Administration (ANM AT) Resolution No. 2814/2002  (two pages,
in Spanish).
6. Description of content:  It is internationally accepted that there is a group of medicinal
preparations which are considered to be equivalent in view of the characteristics of their
pharmaceutical form and/or the means by which they are administered.  Since one of the
objectives of bioavailability studies is to determine the rate of absorption of an active
ingredient, there is no need for such studies to be carried out for products administered via
the parenteral, pulmonary, topical, dermal or mucosal routes or solutions for oraladministration.  By reason of the above, it should be specified more precisely that medicinal
preparations are exempt from the requirement to conduct equivalency studies.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Protection of public health.
8. Relevant documents:  National Drug, Food and Medical Technology Administration
(ANMAT) Resolution No. 3185/1999.
9. Proposed date of adoption:  -
Proposed date of entry into force:  24 June 2002
10. Final date for comments:   -G/TBT/N/ARG/52
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. Rosa 651, 4th floor, Sector 22 (1322)
Buenos Aires
Fax:  54 11 4349-4038
Tel.:  54 11 4349-4037
E-mail:  vcamal@mecon.gov.ar