Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
The new Falsified Medicine Directive 2011/62/EU and its requirements for stakeholders ***
Sonja Seeberger (Abschlußjahr: 2012)
Summary
Language: English
The Falsified Medicine Directive 2011/62/EU was published on the 1st of July 2011 in the Official Journal of the European Union, amending the Directive 2001/83/EC in a number of places to provide measures for the protection of patients and consumer of the ever-increasing risk of falsified medicinal products while tightening the penalties for those behind the illegal activities. In the future there will be the obligation that medicinal products at risk of counterfeiting have to bear safety features to ensure authenticity and traceability. Furthermore there will be a strengthening of supervision for all actors in the distribution chain and additional measurements with respect to active pharmaceutical ingredients. A completely new chapter was inserted in the Directive to take actions regarding the increasing problem of illegal medicines purchased over the internet as according to the WHO approximately 50% of the medicinal products available via internet sales are falsified.
The Directive requires the EU Commission to provide specific measure in form of guideline, Implementation Acts and Delegation Acts. The process for Delegation Actsis a new regulatory procedure for amending or supplementing non-essential parts of a legislative act. The first transition of the measures into national law will be in force from the 2nd of January 2013 on but there is a longer transition period foreseen for several requirements like the safety features, which needs to be defined by Delegation Acts.
The aim of this master thesis is to provide an overview about the measures required by the Falsified Medicine Directive with the main focus on the safety features for medicines at risk of counterfeiting including the presentation of different verification systems that are currently in development by stakeholders in the EU.
Pages: 64, Annex: 1
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