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Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches

Delphi Gm Coppens1, Helga Gardarsdottir1,2, Marie L De Bruin1,3

  • 1Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

Regenerative Medicine
|November 5, 2020
PubMed

Keywords:
advanced therapy medicinal productclinical practicecommercial developmentdrug regulatory sciencehospital exemptionimplementation processlicense holdersnational licensing provisions

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