Argentina: Site Master File now required by ANMAT for national sites

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Regulatory Affairs in Latin America

Starting on November 19th, 2o13, sites in Argentina approved by ANMAT to manufacture or package, in own or contract facility, or import or export, both drug products and APIs, have to submit their Site Master Files (SMF) annually. This is stated in the new disposition 7066/13 that you can access here (in Spanish).

The file has to be submitted to the front desk of the National Institute of Medicines (INAME) in the format of a PDF file in a CD or DVD. Paper submissions are not required nor accepted. All critical changes to the SMF are to be notified with a new SMF.

Companies have 30 days from publication of the regulation to comply and present their SMF. For the annual submission, new SMFs have to be sent 12 months from the last submission.

An annex specifying the required content for the SMF is attached to the new regulation. Here…

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