Learning Outcomes
Development of the ability to recognise und understand the main interpretative issues related to the taught provisions, to use appropriate interpretative methods for solving them, to present und critically evaluate the opinions supported about them in science and jurisprudence and to apply correctly the provisions in the framework of practical exercises.
Course Content (Syllabus)
The introductory course of the Program aims to introduce students to the legal concept of medicine, and in particular that intended for human use, based on the current Directive 2001/83 (L 311 of 28.11.2001 p. 67), better known as Community Pharmaceutical Code, the provisions of which have been transposed into Greek law, with the joint ministerial decision of the Ministries of Economy and Finance and of Health and Social Solidarity under data DYG 3(a) 83657/30.12.2005 (B 59/2006). This Directive has, in some of its parts, been amended by Directive 2011/62/EU, regarding the prevention of the entry of counterfeit medicines into the legal supply chain (L 174/1.7.2011), and in their entirety the new provisions have been included in today's basic Greek pharmaceutical legislation, the inter-ministerial decision, DYG3a/G.P. 32221, (B' 1049/2013). Based on the current legislation, the individual discriminations and corresponding legal treatment of medicines are analyzed, such as prescription and non-prescription, generic and archetype or reference medicines, as well as orphan medicines governed by Regulation 141/2000. At the same time, other provisions are presented that refer to the competent regulatory - control authorities, not only in the Greek area, but also in the EU area, with references to relevant global initiatives, which aim at a globalized safe and effective circulation of medicines. Civil and criminal law issues are also included in this introductory course, as deleted from the relevant EU and national law regulations.