Buch(elektronisch)2017

Guide to EU Pharmaceutical Regulatory Law (Seventh Edition)

Shorthose, Sally; Kluwer Law International (Firm)issuing body; Wolters Kluwer (Firm)issuing body

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Abstract

About the Editor and Authors --Foreword --List of Abbreviations --Brexit --Overview of European Pharmaceutical Regulatory Requirements --Overview of Intellectual Property Rights --Clinical Trials --Obtaining a Marketing Authorisation --Conditional Marketing Authorisations --Supplementary Protection Certificates --Paediatrics --Advertising Medicinal Products for Human Use --Pharmacovigilance --Variations to Marketing Authorisations --Combination Products --Abridged Procedure --Orphan Drugs --Biopharmaceuticals --Homeopathic, Herbal, and Traditional Herbal Medicinal Products --Advanced Therapy Medicinal Products --Vaccines --Medical Devices --Parallel Trade --Competition Law in the Pharmaceutical Sector --and Publications --Table of Cases --Directives --Other Legislation --Regulations.