Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 411/2

7 February 2014

Dear Sirs,

Commercial Information Circular No. 119/2014

Argentina : Additional Requirements for Pharmaceutical Importers

The National Administration of Drugs, Food and Medical Technology ("Administración Nacional de Medicamentos, Alimentos y Tecnología Médica"/ANMAT in Spanish) of Argentina issued Decrees No. 7066/2013 and No. 7425/2013 in November and December 2013 respectively to establish additional requirements for pharmaceutical importers.

2.Decree No. 7066/2013 requires companies authorised by the ANMAT to produce, condition, import and/or export drugs and/or active pharmaceutical ingredients to submit annually the site master file ("archivo maestro de sitio"/AMS in Spanish) in digital form.

3.Decree No. 7425/2013 requires companies planning to produce and import medical devices and in vitro diagnostic devices to obtain a prior authorisation from the ANMAT. Companies must comply with the "Good Manufacturing Practices for Medical Devices and In Vitro Diagnostic Devices" approved by Mercosur Resolution No. 20/2011.

4.For details, traders are advised to consult their importers in Argentina and/or the Argentine Decrees (in Spanish), which are available at:

Decree No. 7066/2013 (relevant to paragraph 2 above):
http://www.infoleg.gob.ar/infolegInternet/anexos/220000-224999/222574/norma.htm

Decree No. 7425/2013 (relevant to paragraph 3 above):
http://www.infoleg.gob.ar/infolegInternet/anexos/220000-224999/223563/norma.htm.

ENQUIRIES

5.For enquiries about the content of this circular, please contact Miss S Y TANG at telephone number 2398 5405.

Yours faithfully,

(Ms Cindy CHENG)

for Director-General of Trade and Industry