Originator or Original Medicine
An original medicine or reference medicine is a medicine that has a marketing authorization granted on the basis of a complete dossier, containing comprehensive data relating to its chemical quality, the results of toxicology and pharmacology studies (in laboratory animals) and the results of the clinical trial program (studies in patients). An authorised medicine is sold exclusively by the company that developed it, for the length of its protection under patent.
A generic or equivalent medicine is a medicine that has the same active ingredient, the same strength and the same pharmaceutical form as the original medicine, but is authorised after the protection afforded by the patent has lapsed, subject to documentation of its chemical quality and demonstration of bioequivalence to the original medicine. As the medicine is bioequivalent, reference may be made to the clinical and toxicological-pharmacological tests carried out by the originator.
A generic or equivalent medicine is a medicine that has the same active ingredient, the same strength and the same pharmaceutical form as the original medicine, but is authorised after the protection afforded by the patent has lapsed, subject to documentation of its chemical quality and demonstration of bioequivalence to the original medicine. As the medicine is bioequivalent, reference may be made to the clinical and toxicological-pharmacological tests carried out by the originator.
