Masterarbeit

Regulatory and pharmaceutical demands on irradiated medicinal products in Germany and Europe ***

Dr. Christof Krummeich (2003)

This thesis discuss the regulation and the technical backgrounds on the use of ionising irradiation during the production of medicinal products in Germany and Europe. The existing regulation is described, compared and the scientific background is explained.

It is obvious that Germany has a strong and restrictive regulation on the use of ionising radiation even by "hard law" (§ 7 AMG and AMRadV Paragraph 1) in comparison to the EU-regulation which is only based on Guidelines (The use of ionising radiation in the manufacture of medicinal products. EUDRALEX Vol. 3 (3AQ4a) 07.1992 and Use of ionising radiation in the manufacture of medicinal products annex 12 EUDRALEX Vol. 4).

The technical details of the German AMRadV and the interpretation by the German authorities are comparable to the EU-guidelines but with clear and strict borderlines, which are not mentioned in the EU-guidelines. Therefore the German regulation shows in some parts a disharmonisation according to the European law which can lead to problems in the mutual recognition procedure.

The AMRadV describes technical standards for the use of ionising irradiation, which should not be in contradiction to European guidelines. Examples about this contradictions between the German and the European regulation is given and recommendations about a slight revise of the AMRadV to be in correspondence to the European regulation are made. But the strict German law is nevertheless a recommendable regulation for consumer protection and should be retained with some minor changes.

Moreover the pharmaceutical-technical demands are described, explained and discussed. For further information a slight digression to the use of ionising radiation in the production of blood products, medical devices, food production and industry is made.

Pages: 44