Tag Archives: electronic submission

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

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 … Continue reading

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ANMAT launches online platform to report drug adverse reactions

On July 10th, 2013, ANMAT implemented a system for electronic submission of reports on adverse reactions to drug products.  The system consists on an online form accessible from the website of the National System of Pharmacovigilance. You can access the online … Continue reading

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