Annotation
Licensing of medicines
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Introduction |
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The Medicines Act 1968 requires that all medicines manufactured or marketed in the UK have been authorised by the licensing authority, the Medicines Control Agency. The aim of the licensing system is to ensure that medicines are examined for efficacy, safety, and quality. Pharmaceutical companies apply for a product licence for a particular drug, and in their submission they include the indication, dose, route of administration, and age group of patient for which this applies. The licensing arrangements constrain pharmaceutical companies in that they cannot promote either an unlicensed product or a licensed product for an unlicensed indication. Doctors, however, are not restricted to prescribing licensed medicines or for licensed indications.
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Drug toxicity and licensing |
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The Medicines Act was a response to some of the major cases of
drug toxicity that occurred in the late 1950s and early 1960s. Two of
these resulted in significant morbidity and mortality for the
developing fetus and the newborn
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