. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/ARG/251 
18 June 2009 
 (09-2993) 
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:   Administración Nacional de Medicamentos, Alimentos y Tecnología 
Médica , ANMAT (National Drug, Food and Medical Technology Administration) 
Avda. de Mayo 869 (C1084AAD), Ciudad Autónoma de Buenos Aires 
Tel.: 54-11-4342-8684 
Fax: 54-11-4340-0800, Ext. 1173 E-mail: direccion@anmat.gov.ar 
Name and address (including telephone  and fax numbers, E-mail and website 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:  
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:   "Registro de 
Especialidades Medicinales (REM) - Nueva Inscripción " (Register of Medicinal 
Preparations - Registration renewal) (1 page, in Spanish).  
6. Description of content:   Article 8 of Law No. 16.463 provides that authorizations for 
the preparation and sale of medicines may be cancelled:  (a) at the request of the owner;  (b) in the event of any change, alteration or failure to comply with the conditions of authorization;  (c) upon expiry of the time period established in Article 7 (five years);  or (d) when, as a result of scientific developments, the product no longer 
serves any useful therapeutic purpose. 
 With regard to the cancellation of authorizations under Article 8(c) of the Law, which is the most frequent grounds for cancellation, ANMAT has duly established the information and documentation requirements for the renewal of entries in the Register of Medicinal Preparations, whilst maintaining the requirements concerning 
the product, its therapeutic validity and its safety parameters. G/TBT/N/ARG/251 
Page 2  
 
  6. Description of content:  (cont'd) 
ANMAT has deemed it necessary to review the regulations governing all products 
which are currently entered in the Register of Medicinal Preparations, and has established the following:  
- Laboratories that own medicinal preparations the registration certificates 
(authorizations) of which have ceased to be valid following the expiry of the time period provided for in Article 7 of the Law, and reiterated in Article 8(c) thereof, may apply to renew their registration within one hundred and eighty (180) calendar days as of 15 May 2009; 
 
- once this period has elapsed, if no request for registration renewal - or 
cancellation if appropriate - has been received, certificates which have ceased to be valid will be cancelled pursuant to the corresponding administrative decree.  
7. Objective and rationale, including the natu re of urgent problems where applicable:   A 
review of the regulations is required given the considerable number of certificates 
which are no longer valid and for which no application for either registration renewal or cancellation has been submitted.  There is, therefore, a need to re-establish record-keeping principles, namely organization, standardization, consistency, accuracy and reliability, which are essential to the proper functioning of control 
activities. 
8. Relevant documents:   L a w  ( Ley) No. 16.463, Decrees ( Decretos ) Nos. 9763/64 and 
150/92 (amended text of 1993), ANMAT Resolutions ( Disposiciones ) Nos. 818/98 and 
2066/2009. 
9. Proposed date of adoption: 
Proposed date of entry into force: } - 
10. Final date for comments:   - 
11. Texts available from:  National enquiry point [ X] or address, telephone and fax 
numbers, E-mail and website addresses,  if available, of other body:  
Punto Focal de la Republica Argentina 
Dirección Nacional de Comercio Interior Avda. Julio. A. Roca 651, Piso 4°, Sector 2 (C1067ABB) Ciudad Autónoma de Buenos Aires 
Tel.: 54 11 4349 4067 
Fax: 54 11 4349 4072 E-mail: focalotc@mecon.gov.ar Text available at:  http://www.puntofocal.gov.ar/notific_arg.htm