Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Avoiding of falsified medicines: An overview of the legal situation and the impact on the pharmaceutical industry - with a focus on regulatory implementation

Maria Keyser (Abschlußjahr: 2018)

Summary
Language: English
Falsified medicinal products are a growing risk worldwide and affect all regions of the world. For counterfeiters, it is a profitable market, as falsified medicines are difficult to detect and are more lucrative than for example illegal drugs. The medicinal products are falsified in terms of identity, manufacture or source and often contain inferior, fake or no ingredients as well as incorrect dosages of the active ingredients or other ingredients.  The illegal medicinal products not only reach the patient by illegal route but also unnoticed through the legal supply chain. This poses a significant threat to public health.
In order to counteract the risk of falsification and to prevent the entry of falsified medicinal products into the legal supply chain, Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products was published in the Official Journal of the European Union on 1 July 2011 and entered into force on 21 July 2011. Directive 2011/62/EU provides the basis for a series of measures to prevent and combat falsified medicinal products. One of these measures is the introduction of two safety features, the Unique Identifier and the anti-tampering device.  The Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council defines the exact provisions and technical details of the safety features which must be placed on the packaging of medicinal products for human use.
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 regulatory implementation of the two safety features and the impact on product information of medicinal products.
Pages: 51, Annexes: 1, Pages : 2