Extensive Web use has become a global phenomenon which has nonetheless brought to surface certain issues -personal data protection being one of them. The health industry is certainly positively influenced by the increasing new technological developments that lead to the improvement of medical services. Although the design of websites, accessible both to Healthcare Professionals and
Health-related web research may be efficient; however, it entails the risk of misinformation both for the general public and for health care professionals (HCP). At the same time, social media tools such as Facebook and Twitter have introduced a whole new set of changes regarding the advertising of medicinal products and medical devices. A harmonized
Medical device advertising lacks harmonization within the EU as there is no specific chapter nor any particular EU legislation dedicated either to advertising or to the promotion of medical devices. The general legal European framework for medical devices (MD) includes three Medical Devices Directives -Directive 93/42/EEC, Directive 90/385/EEC and Directive 98/79/EEC- which focus on the
Α.The advertising of medicinal products.   The Directive 2001/83/EC on the Community Code relating to medicinal products for human use provides a harmonized framework for the advertising and promotion of medicines. The directive has been implemented to Greek law via Ministerial Decision ΔΥΓ3α/οικ.82161.   According to the Directive’s Article 86, “advertising of medicinal products shall include
“Foremost, corrupt countries are less safe.  Corruption thwarts economic development, traps entire populations in poverty, and leaves countries without a credible justice system.  Corrupt officials who put their personal enrichment before the benefit of their citizenry create unstable countries.”  Leslie Caldwel, Assistant US Attorney General, North Carolina, October 2014. During the recent EU Healthcare Ethics
We are glad to announce that Mrs. Ioanna Michalopoulou LL.M. has been certified by Seton Hall University in EU Healthcare Compliance, Ethics & Regulation following her participation in the EU Compliance Program, which took place  in Paris on 17-21st November 2014.
The new law (4281/2014) on Public Procurements was published on the 8th of August, 2014. In its second part, the new law incorporates the EC Regulation 1336/2013 which in turn amended Directives 2004/17/EC, 2004/18/EC and 2009/81/EC of the European Parliament and the EU Council. The new law foresees rules in awarding public contracts and was
The European Federation of Pharmaceuticals Industries and Associations (EFPIA), based on the Treaty of European Union, represents today most of the pharmaceutical companies in Europe, performing a mainly scientific role. Its purpose is to facilitate the release of medical products in Europe and to work towards the improvement of human health. EFPIA believes that this
It is well-known that in order for a drug to freely circulate in the market, it must have received a circulation permit that ensures its harmless and competent character.  For this reason, along with the permit application, the full results of pharmacological, toxicological and clinical tests must be submitted for approval. It’s worth noting however,
An important legislative milestone on judicial settlement with public authorities was reached with the Supreme Court’s Decision 766/2014, ending standing inklings of preferential treatment of the public sector vis-à-vis private companies. Specifically, a public entity hospital filed against a commercial company at the Supreme Court, seeking to overturn a prior decision of the Appeal Court
This presentation contains an overview of recent Greek jurisprudence on parallel trade in the pharmaceutical industry. Contents include circulars, laws and recent case studies   [slideshare id=37525674&doc=lgparalleltrade30514en-140731022204-phpapp02]
A full update on clinical trials legislation in Greece. Contents include: Ι. Clinical Trials Legal Framework ΙΙ. New Clinical Trials Legislative Framework (ΔΥΓ39(a)/18910/21.2.2013 suppl. Directive 2001/20/ΕC) Approval Process Types of Studies III. Personal Data Protection (Law 2472/97 DIRECTIVE 95/46/EC) in the light of New Ministry Decision a. Patient Consent in Clinical Studies IV. Legal Liability/Indemnity