Tag Archives: Argentina

INVIMA+ANMAT: inter-agency collaboration activities

During the last Summit of Regulatory Authorities of Regional Reference that took place in Acapulco, Mexico, on the 10th to 21st of February, the representatives of Colombia’s INVIMA and Argentina’s ANMAT, Dr. Blanca Elvira Cajigas de Acosta and Dr. Carlos A. Chiale, … Continue reading

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Americas Health Authorities Meeting

On the 20th and 21st of February of 2014, representatives of the five Latin-American Health Authorities of Regional Reference recognized by the Pan American Health Organization, plus those of the FDA, Health Canada, and El Salvador’s regulatory agency met in … Continue reading

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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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Argentina: checklist for GMP inspections of API facilities

On the 3rd of September 2013, ANMAT (regulatory agency in Argentina) issued a new Disposition establishing the guidelines and checklists that will be used by its inspectors for GMP inspections of sites of manufacturing, elaboration, fractionating, distribution, commercialization, exports and imports … 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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Labeling update Argentina: gluten-free/gluten-containing compulsory claim

Last month, after active lobbying by the Argentinian Association of Assistance to Celiacs, (ACELA) ANMAT decided to incorporate in the labeling texts of all drug products, information about their content of gluten. Celiac disease is a condition that damages the … Continue reading

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