Masterarbeit

Investigation on Melatonin as a Substance: A Closer Consideration of Differences and Similarities in the Legal Principles Applicable to Melatonin Containing Products at the International, European and National Level - Including a potential regulatory strategy to obtain a marketing authorisation for Germany

Juliane Merz (2016)

Summary
Language: English
The neurohormone melatonin has been a substance of great interest to science for decades. The substance regulates the circadian rhythm in the mammalian organism. However, the key-element of the 24h sleep and wake cycle is simultaneously a powerful antioxidant and radical scavenger. The use of melatonin in tumour treatment has been researched as well as treatment of other degenerative diseases and disorders like dementia or Alzheimer. The great interest of science is due to the high number of treatment possibilities derived from the properties of melatonin.
Products containing melatonin have been distributed as dietary supplements in the US since the 90s. They are used to treat a variety of health care problems such as sleep disorders, to slow down the physiological aging process, and as preventative therapy for degenerative processes. The substance was so heavily promoted, that throughout the 90s sales were higher than acetyl-salicylic-acid preparations. Melatonin products are available as dietary supplements in a wide range of doses. Only marginal quality standards are required in relation to this product category.
There is no harmonisation for the substance in the European market. Therefore food supplements are available in some European countries, whereas in Germany and some other European countries melatonin is only distributed as a medicinal product available only on prescription.
This master thesis compares the legal requirements in the European Union and Germany, and in the US, for medicinal products, for food supplements and dietetic supplements for special medical purposes as sub-group of the supplemental balanced diet. The different requirements to melatonin products resulting from the diverse classifications are presented in details. Special focus is placed on the probable effects for the consumer with regard to consumers / patients safety.
Based on the findings of the investigation an approval strategy will be defined for melatonin containing products for the European and especially for the German market.
Pages: 45
Annexes pages: 10