G/TBT/N/ARG/292  
22 September 2015  
(15-4875)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: Spanish  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6. 
 
1. Notifying Member: ARGENTINA 
If applicable, name of local governme nt involved (Articles 3.2 and 7.2):  
2. Agency responsible: Administración Nacional de Medicamentos, Alimentos y Tecnología 
Médica , ANMAT (National Drug, Food and Medical Technology Administration) 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above: 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 lang uage(s) of the notified document: Autorización de 
expendio de especialidades medicinales con ingrediente farmacéutico activo (IFA) de actividad antimicrobiana  (Sales authorization for medicinal preparations with an 
antimicrobial active pharmaceutical ingredient (API)) (6 pages, in Spanish) 
6. Description of content: Requirements applicable to the presentation of medicinal 
preparations with an active pharmaceutical ingredient (AFI) exhibiting antimicrobial 
activity. The presentation of such products should be consistent with the dose, dose frequency and duration of treatment. 
The notified requirements include the following: 
 The request for the authorization of a new form of sales presentation for the 
medicinal preparations concerned, in respect of units, millilitres, grams, etc., 
should be made by sworn declaration. 
 Holders are given a period of 90 days to ensure that the sales presentation of the 
medicinal preparation in question, as registered in the Medicinal Preparations Register, is brought into line with the requirements. 
 The requirements do not apply to the presentation of products for use and 
distribution in hospitals. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: The rational use of medicines with a view to preventing antimicrobial 
resistance.  
8. Relevant documents: Resolución Conjunta MS N° 834/15 y SAGyP N° 391/15 "Estrategia 
Argentina para el Control de la Resistencia Antimicrobiana" (Joint Resolution of the Ministry 
of Health No. 834/15 and the Ministry of Agri culture, Livestock and Fisheries No. 391/15: 
"Argentine strategy for the control of antimicrobial resistance") http://www.infoleg.gob.ar/infolegInternet /anexos/245000-249999 /248651/norma.htm   G/TBT/N/ARG/292 
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  9. Proposed date of adoption: September 2015 
Proposed date of entry into force: As specified in each case.  
10. Final date for comments: - 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresse s, if available, of other body:  
Punto Focal de la República Argentina 
Dirección Nacional de Comercio Interior 
Avda. Julio A. Roca 651, Piso 4°, Sector 2 (C1067ABB) Ciudad Autónoma de Buenos Aires 
Fax: 54 11 4349 4072 
Tel.: 54 11 4349 4067 Email: focalotc@mecon.gov.ar  
Text available at: http://www.puntofocal.gov.ar/fo rmularios/registro_arg10.php  
https://members.wto.org/crnattachments/2015/TBT/ARG/15_3741_00_s.pdf