Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
European decentralised procedures for marketing authorisation Differences and similarities between applications of veterinary and human medicinal products ***
Dr. Markus Beßeling (Abschlußjahr: 2006)
Human and veterinary pharmaceutical industries are linked through many close relations. Most European pharmaceutical legislation for veterinary pharmaceuticals is modified on rules which were developed for the human pharmaceutical counterpart. That resulted in partly similar and partly the same regulatory requirements.
The detailed investigations on example of the two decentralised multi-state application procedures present the regulatory background of the two types of products. In principal the requirements for veterinary and human medicinal products are the same but human legislation is more densely. The application procedures are equal; however the human Mutual Recognition and Decentralised Procedure are more flexible with their starting days and coordination group meetings. Veterinary medicinal applications have to comply with demands, i.e. consumer safety, which is unknown for human pharmaceuticals. Above all the risk-benefit evaluation is different. Evaluation of human medicinal products considers mainly the possible risk to public heath and in contrast to this, veterinary medicinal risk-benefit assessment reveals more dimensions and includes also possible risk to animal health and possible risks to the environment.
Overall the regulatory setting of pharmaceuticals for human and animal use is surprisingly parallel but in detail often different. There are necessary differences and doubtful similarities, which should always be kept in mind whenever legislation is developed in order to harmonise human and veterinary regulatory surrounding as much as possible.
Pages: 39, Annexes: Pages 4