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,
The Directive 2011/7/EU was incorporated into the Greek Legislation by Law 4152/2013 foreseeing both transactions between private businesses and between private businesses and public authorities. It includes all medical supplies (consumables and pharmaceuticals) from government services (National Health System hospitals and EOPPY). The new Directive, which has entered in force since May 9th 2013, repeals

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