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Trade and Industry Department The Government of the Hong Kong Special Administrative Region
Brand Hong Kong - Asia world city
MY COLOUR

Commercial Information Circulars

24-hour hotline : 23 922 922

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

Ref : EIC 411/2

20 April 2015

Dear Sirs,

Commercial Information Circular No. 271/2015

Argentina : Traceability System for Pharmaceutical Products

The National Administration of Drugs, Food and Medical Technology ("Administración Nacional de Medicamentos, Alimentos y Tecnología Médica"/ANMAT in Spanish) of Argentina issued Decree No. 963/2015 on 26 January 2015 to implement the traceability system for pharmaceutical products, which entered into force on 1 March 2015. The traceability system covers all pharmaceutical products, whether they have registered or may register in the future, containing any of the active pharmaceutical ingredients (API) as set out in Annex I of Decree No. 963/2015, either as a generic drug or in association with other APIs.

2.Laboratories which are holders of certificates for pharmaceutical products must include in the packing of each pharmaceutical product, a device with the capability to store a unique code in accordance with the recommendations of GS1 standard, including:

  • the commercial code of the product (Global Trade Item Number/GTIN);
  • a serial number of up to 20 alphanumeric characters;
  • product batch number; and
  • expiry date.
Regardless of the device used, all required information must be provided in human-readable format.

3.For details, traders are advised to consult their importers in Argentina and/or the Argentine Decree (in Spanish) at:
http://www.infoleg.gob.ar/infolegInternet/anexos/240000-244999/241473/norma.htm.

ENQUIRIES

4.For enquiries about the content of this circular, please contact Mr Lewis LAU at telephone number 2398 5405.

Yours faithfully,

(Ms Cindy CHENG)
for Director-General of Trade and Industry

Note: While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.