High Quality Content by WIKIPEDIA articles! A package insert or
prescribing information (in Europe, Patient information leaflet for
human medicines or Package Leaflet for veterinary medicines) is a
document provided along with a prescription medication to provide
additional information about that drug.In the United States, the
Food and Drug Administration (FDA) determines the requirements for
patient package inserts. Other national or international
organizations that regulate medical information include the
European Medicines Agency (EMEA), and the Japanese Ministry of
Health, Labour, and Welfare (MHLW). Other country-specific
agencies, especially in the case of EU (European Union) countries
and candidates, plus countries of South America and many in Asia
and the Far East, rely heavily on the work of these three primary
regulators. Unless otherwise stated, all information in this
article refers to patient package inserts in the United States.
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