Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Empfehlungen zur Erstellung eines Maßnahmeplans unter Anpassung an die aktuellen gesetzlichen Vorgaben unter spezieller Berücksichtigung der 12. AMG-Novelle ***

Matthias Wilken (Abschlußjahr: 2005)

Language: German
 
According to the German Drug Law (Arzneimittelgesetz AMG) the adequate processing of complaints - due to the deficient nature of a product or the incorrectness of other information concerning the safety of a drug, e.g. reports on adverse drug reactions if in the scope of responsibility of the pharmaceutical entrepreneur. Should such information result in the need to take measures in order to prevent further damage, the pharmaceutical entrepreneur must ensure that a standardized course of action - a so-called alarm or measures plan is established in the company.

The first recommendations by Bundesverband der Pharmazeutischen Industrie e.V. (BPI) for the development of company-internal alarm or measures plans were published as early as in the 1970s. Meanwhile these recommendations have been revised several times, adapting them to changing legal framework conditions most recently in1996.

The years in between saw various amendments to the Arzneimittelgesetz. The 12th AMG amendment in 2004 brought far-reaching changes with regard to pharmacovigilance, transposing Directive 2001/83/EC with European pharmacovigilance provisions into German law. Furthermore with the latest AMG amendment also the framework conditions for clinical trials changed, in consequence of Directive 2001/20/EC. These and more changes, mainly in the Operation Ordinance for Pharmaceutical Entrepreneurs (Betriebsverordnung für pharmazeutische Unternehmer PharmBetrV), call for an update of the BPI recommendations. With the 14thAMG amendment, which is currently under preparation and intended to transpose the Review 2004, further changes also in respect of pharmacovigilance will come about. The present paper reflects the status of information available in late April 2005.

This paper wants to provide a form of checklist that takes up existing legal provisions. Itis intended to make a basis for a company-internal measures plan, tailormade for the individual needs of an enterprise.

Pages : 44