ABSTRACT
INTRODUCTION Once anewmedicinal product for humanusehas beenapprovedbyaHealthAuthority (HA), for example, the US Food & Drug Administration (FDA), the European Commission, or a national European Union (EU) Member State HA, the holder of the marketing authorization (MA) has the right to place the product on the market. Then many years of dedicated efforts in research, development, nonclinical and clinical investigation come to fruition. Developmental activities however continue to some extent for several reasons. Preauthorization research, development, nonclinical and clinical investigation describe at the time of approval a “model” of themedicinal product. The MA Holders (MAHs) may obtain the MA from the HA under conditions that require them to undertake additional studies within a defined time frame and with subsequent reporting obligations.
