ΝΟΜΙΚΗ ΚΑΙ ΔΕΟΝΤΟΛΟΓΙΚΗ ΣΥΜΜΟΡΦΩΣΗ ΣΤΗΝ ΠΡΟΩΘΗΣΗ ΦΑΡΜΑΚΩΝ

Legal and Ethical Compliance in the Promotion of Medicinal Products Stefanos Economou, Attorney-At-Law, DEA ISBN 978-960-622-973-2 Abstract: This book presents the European and national legislation on the promo- tion of medicinal products, as well as the provisions of the relevant Codes of Con- duct. Specifically, the restrictions in force on sale and promotion of medicinal prod- uct are analysed, including, the prohibition of advertising of medicinal products that doesnotmeettherelevantrequirements,theestablishmentofsalepricebytheState and the General Principles that underpin the advertising of medicinal products, as the Principle of Protection of Public Health, the Principle of Veracity, the Principle of Publication and the Principle of Documentation.The second part sheds light on spe- cific promotional activities, including Medical Information, Promotional Materials, and advertising on the internet. Lastly, the analysis outlines the steps that are crucial for the creation of a Compliance Programme, including the duties of a Compliance Officer, the contracts’review and control process, as well as risk assessment, and in- cludes practical guidelines, templates, risk analysis and sample contracts. COPYRIGHT All rights reserved. No part of this publication may be reproduced, stored in a re- trievalsystem,ortransmitted, inany formorbyanymeans,withoutthepriorpermis- sion of NOMIKI BIBLIOTHIKI S.A., or as expressly permitted by law or under the terms agreed with the appropriate reprographic rights organization. Enquiries concern- ing reproduction which may not be covered by the above should be addressed to NOMIKI BIBLIOTHIKI S.A. at the address below. DISCLAIMER The content of this work is intended for information purposes only and should not be treated as legal advice.The publication is necessarily of a general nature; NOMIKI BIBLIOTHIKI, the author and the contributors make no claim as to the comprehen- siveness or accuracy of the information provided; Information is not offered for the purpose of providing individualized legal advice. Professional advice should there- fore be sought before any action is undertaken based on this publication. Use of this work does not create an attorney-client or any other relationship between the user and NOMIKI BIBLIOTHIKI, or the author, or the rest of contributors. 23 Mavromichali str. | 106 80 | Athens | Greece T +30 210 3678 800 | F +30 210 3678 819 www.nb.org | info@nb.org © 2020, NOMIKI BIBLIOTHIKI S.A. LawPublishers inEurope