Package Insert (Paperback)

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.