Medicinal Product Liability: Adverse Drug Reactions and Insufficient Product Information

Medicines constitute exceptional products, since besides their therapeutic effects, they can also cause adverse reactions. This two-dimensional character leads, in the clear majority of cases, to the acknowledgment that a defective medicinal product is a product with inadequate information, rather than one with manufacturing and design defects. 

Following a brief presentation of the history of medicines, the current academic book contains an introductory presentation of legal and medical definitions of medicinal products, along with their distinction from borderline products under the EU regulatory regime. The book then describes a medicine’s life cycle from development (R&D, clinical trials) to marketing authorisation (application for an MA, preparation/revision of SmPC and PL) and post-marketing surveillance (variations, pharmacovigilance). In parallel, it outlines Greek legal theory and jurisprudence on medicinal product liability in comparison with the respective provisions and jurisprudence of common law countries. In general, the book addresses fundamental issues of medicinal product liability and medicinal products’ information from both a regulatory and litigious aspect.

Oct 2017   P.N.Sakkoulas Law Publications