Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

"Die Nachzulassung" – Legal requirements and regulations regarding the pharmaceutical quality of medicinal products from the notification of 1978 until today ***

Bettina Geng (Abschlußjahr: 2008)

On January 1st 1978 the new pharmaceutical law "Gesetz zur Neuordnung des Arzneimittelrechts" (AMNG) of August 24th 1976 came into force. It replaced the old pharmaceutical law "Gesetz über den Verkehr mit Arzneimitteln" of May 16th 1961. Key elements of the new law were improvement of the safety of medicinal products, compliance with international standards and transposition of directive 65/65/EWG, 75/318/EWG and 75/319/EWG into the German pharmaceutical law.

Since then medicinal products can only be placed on the market if a marketing authorisation has been granted for the respective medicinal product. The AMNG of 1976 defines the requirements regarding quality, safety and efficacy of a medicinal product that have to be fulfilled as prerequisite for granting of a marketing authorisation. For medicinal products that have already been marketed when the AMNG came into force transitional provisions were granted. Under certain circumstances continuing marketing of the old medicinal products was allowed. Nevertheless the proof of quality, safety and efficacy according to the new legal requirements had to be provided during the renewal procedure (so-called "Nachzulassung") for these products as well.

The aim of the thesis is to provide a review of the history of the German "Nachzulassung". It gives an overview of the legal requirements and demands concerning the pharmaceutical quality of medicinal products containing chemical active substances and of traditional medicinal products from the notification of 1978 until today.
 
Pages: 70, Annexes: pages: 11