G/TBT/N/ARG/385  
31 January  2020 
(20-0761) 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 government involved (Articles 3.2 and 7.2):  
2. Agency responsible : Administración Nacional de Medicamentos, Alimentos y Tecnología 
Medica , ANMAT (National Drug, Food and Medical Technology Administration)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authorit y designated to handle comments 
regarding the notification shall be indicated if different from above:  
Enquiry point (see section 11)  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [X], 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 ; Medicaments ( ICS 11 .120.10)  
5. Title, number of pages and language(s) of th e notified document : "Especialidades 
medicinales diseñadas con tecnología nanométrica " ("Medicinal preparations designed 
with nanotechnology") (10 pages, in Spanish)  
6. Description of content : The notified text establishes the definitions, requirements an d 
guidelines for the registration of nanopharmaceutical medicinal preparations that have a 
qualitative and quantitative composition, delivery platform, therapeutic indication and 
proposed route of administration with a history of safe use in other register ed products 
and for which there is evidence of effective marketing and sufficient information for their 
risk/benefit profile.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Specification of the scientific and technic al requirements needed to reliably 
demonstrate the effectiveness and safety of medicinal products with a nanoscale delivery 
platform ; Protection of human health or safety ; Quality requirements  
8. Relevant documents:  
• Decree No. 1490/1992  
http://servicios.infoleg.gob.ar/infolegInternet/anexos/5000 -
9999/9909/texact.htm  
• Decree No. 150/92 (amended text 1993)  
http://servicios.infoleg.gob.ar/infolegInternet/anexos/5000 -
9999/8196/texact.htm  
9. Proposed date of adoption : 22 January 2 020; date of publication of the explanatory 
note (page 10)  
Proposed date of entry into force : 22 March 2 020 G/TBT/N/ARG/385  
- 2 - 
  10. Final date for comments : Not indicated  
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Punto Focal OTC -OMC de la República Argentina  (TBT-WTO Focal Point of the Argentine 
Republic)  
Subsecretaría de Políticas para el Mercado Interno (Undersecretariat for Domestic 
Market Policies)  
Avda. Julio A. R oca 651 Piso 4° Sector 23A (C1067ABB)  
Ciudad Autónoma de Buenos Aires  
Argentina  
Tel.: (+54) 11 4349 4067  
Email: focalotc@produccion.gob.ar  
http://www.puntofocal.gov.ar/formularios/notific_arg.php  
http://www.puntofocal.gob.ar/  
https://members.wto.org/crnattachments/2020/TBT/ARG/20_0703_00_s.pdf