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Прекласифициране на лекарствени продукти - поява и развитие на концепцията

В. Белчева, E. Григоров, И. Гетов


Процесът на пререгистриране на лекарствени продукти от такива, отпускани по лекарско предписание, в лекарства без рецепта (OTC) в САЩ започва през 1972 г. и все още продължава. Oсновава се на поправката Durham-Humphrey от 1951 г., която изменя Федералния закон за храни, лекарства и козметика (FD&C), приет през 1938 г. Поради свободната им и широка достъпност, от значение е OTC лекарствата да се употребяват правилно и рационално, следователно да са свързани с ниска честота на сериозни нежелани лекарствени реакции или нежелани събития, както и нисък потенциал за увреждане в случай на злоупотреба.


Reclassification, medicinal products, birth, concept

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