Module 18 2021

07/02/2021

WHAT ARE THE MEDICINES REGULATIONS

 Basis for regulation of medicines in the EU • 2001/83/EC (as amended)  Definition of a medicine from 2001/83/EC: ● Medicinal product: ● (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; ● or ● (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

The Organisation for Professionals in Regulatory Affairs

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Jargon Buster

 The medicinal substance is often referred to by a number of different terms:  Active ingredient  API – Active Pharmaceutical Ingredient

 Active Substance  Drug Substance

 NCE - New Chemical Entity  NME – New Molecular Entity

The Organisation for Professionals in Regulatory Affairs

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