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
The Directorate-General of Enterprise and Industry of the European Commission (ENTR) commenced its Late Payments Information Campaign in the member states; a seminar was held in Athens in hotel Hilton on June 27th, 2014.   The EU, in its effort to harmonize EU citizen rights and in order to reduce the negative impact of late
The new European Directive 2011/7/EU introduced important legal changes in its effort to combat late payments in commercial transactions. Soon after, the Directorate-General of Enterprise and Industry of the European Commission (ENTR) commenced its Late Payments Information Campaign in the member states. A seminar was held in Athens in hotel Hilton at the27th of June,
Last Thursday June 19th, the presentation about ESIDIS, the national e-procurement system, which took part at the Business Association of Medical and Biotechnological Products highlighted a new era of public procurement in Greece. The presentation, led by a representative of the Division of Information of the General Secretariat of Commerce (SGC) of the Ministry of
The Regulation 536/2014’s purpose is the growth acceleration of pharmaceutical research via clinical trials in the European Union. Its provisions are directly applicable in the legal systems of the Member States (without requiring integration) and replace the national procedure of notification and approval by the permit authorities. This process will be assisted through a new
I recently attended the annual EU Pharma Law Forum in Brussels at the 14th & 15th of May, 2014. Competition issues in the Pharma Industry have been key discussion points among EU officials and international law firms. Also highlighted was –once more- the intense regulation in the pharma business that creates high costs in authorization,
6/5/2014: Ιoanna Michalopoulou has presented key aspects on Pharma Compliance and the Way Forward at GET2WORK – DIGITAL4PHARMA. Anticorruption, data protection, confidential information and intellectual property rights, patient safety, competition and antitrust law, sales and marketing ethics – all among the issues presented here are at the forefront of legal challenges faced by international law
Ioanna Michalopoulou at “Medical Devices & Diagnostics conference” on Friday 18th October 2013. Following the establishment of the Price Index Observatory, this presentation contains updated information on public tenders for medical devices in Greece. Contents include: – Historical Data on Greek Public Tenders (2010-2013) – Legalization of Public Expenditure BEFORE the Price Index – Legalization