Sustaining Generic Medicines Markets in Europe

Sustaining generic medicines markets 9518 GlossaryActive substance: that component of a medicine that gives it its therapeutic effect.ATC classification: a standard for classifying drugs into different groups according to the organor system on which they act and their chemical, pharmacological and therapeutic properties.Bio-availability: the amount of an active substance that is absorbed by the organism and thespeed at which this occurs when introduced in a given dosage form.Bio-equivalence: bio-equivalent medicines contain the same amount of active substance andhave the same bio-availability when administered in equal doses under equal conditions.Copy: an off-patent medicine that is neither an originator medicine, nor a licensed medicine, nora generic medicine through the Abridged Procedure and has, for example, been approvedthrough the Well-Established Use Procedure. For a copy, bio-equivalence with the originatormedicine has not been approved.Data exclusivity: the period of time during which the application for marketing authorisation of ageneric medicine cannot refer to the pre-clinical and clinical documentation of the originatormedicine.Defined daily dose: the assumed average daily dose of a medicine needed to treat its mainindication in an adult person weighing 70 kg.Dosage: amount of a medicine that is administered to a patient.Generic medicine: a medicinal product that has the same qualitative and quantitativecomposition in active substances and the same pharmaceutical form as the reference medicinalproduct, and whose bio-equivalence with the reference medicinal product has been demonstratedby appropriate bio-availability studies (Directive 2004/27/EC). A generic medicine is approvedthrough the Abridged Procedure and marketed by a company other than the originator medicinecompany.Generic substitution: procedure by which a physician prescribes a specific medicine, but thepharmacist replaces it by a generic medicine that has the same active substance and bioavailabilityas the medicine that is prescribed.