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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
Posted in Argentina, Uncategorized
Tagged Active Pharmaceutical Ingredients, ANMAT, API, Argentina, drug products, electronic submission, GMP, Good Manufacturing Practices, inspections, Latin America, National Regulatory Agency of Regional Reference, new Disposition, regulatory affairs, Site Master File, SMF
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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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