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Malta's medicines regulator. It authorises medicines, monitors their safety and handles clinical trial applications under the European Union's rules.
The Malta Medicines Authority's stated mission is to safeguard public health through the regulation of medical products and pharmaceutical activities for human use. Its site covers registration of medicinal products, pharmacovigilance and adverse reaction reporting, inspections, advertising, and access to medicines without a marketing authorisation. Its clinical trials page explains that the EU Clinical Trials Regulation, in application since 31 January 2022, replaced Directive 2001/20/EC with a single submission through the Clinical Trials Information System. Its address is Sir Temi Zammit Buildings, Malta Life Sciences Park, San Ġwann; the coordinates are the OpenStreetMap point for the Life Sciences Park.
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