NPIndependent national procedures are strictly limited to medicines which are to be authorised and marketed in only one Member State (MS). This procedure is nowadays rarely followed for new products.
New Molecular EntityNew Molecular Entities (NMEs) are compounds that emerge from the process of medicine discovery, that are not a version or derivative of an existing, previously investigated/approved substance. They have promising activity against a particular target thought to be important in a disease,(...)
NMENew Molecular Entities (NMEs) are compounds that emerge from the process of medicine discovery, that are not a version or derivative of an existing, previously investigated/approved substance. They have promising activity against a particular target thought to be important in a disease,(...)
No Observed Adverse Effect LevelThe no observed adverse effect level (NOAEL) is the highest tested dose of a medicine at which there is no increase in the frequency of any adverse effects (biological or statistically significant) when compared to its control.
Although the NOAEL approach involves some consideration of(...)
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