Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Vitamins as Medicinal Products – Regulatory Considerations ***

Dr. Frauke Hätzelt (Abschlußjahr: 2009)

Language: English

Vitamins are well-known essential nutrients, they need to be ingested regularly although in minimal amounts and prolonged lack of vitamins leads to serious diseases and eventually to death. Many of their biochemical functions are well-known. Still many other mechanisms of action are not yet fully understood, e.g. of the antioxidative vitamins C, A and E.
From a legal demarcation point of view, vitamins are special as they may fall in three legal product classes - medicinal products, cosmetics or food.

The three product classes overlap in some aspects of their legal definitions. Products containing vitamins often fall in these borderline areas. But demarcation of such borderline cases is crucial, as the consequences for development and marketing of these products are very different depending on the classification. Borderline situations occur, when food or cosmetics are presented in dose forms. In these cases the intended purpose represents the demarcation criterion. Only medicinal products are intended to treat or prevent diseases. The purposes of food (and cosmetic) products come closest to this when they are intended to maintain health and reduce disease risks. Food supplements (Directive 2002/46/EC), food for particular nutritional uses, i.e. for persons with disturbed digestion or metabolism or persons in special physiological conditions (Directive 89/398/EEC), and a sub-category thereof, food for special medicinal purposes (Directive 1999/21/EC) fall in this borderline area.
The claims allowed on food with regards to their health-related purpose, delimiting them to presentation medicinal products, have recently been regulated in the Nutrition and Health Claims Regulation (EC) No1924/2006. The conditions and authorisation procedures of health-related claims have been defined and the EFSA was assigned as authority carrying out the scientific evaluations.
The demarcation of vitamin products with regards to the functional definition of medicinal products is more difficult, as the medicinal purpose is defined to be achieved through pharmacological, immunological or metabolic action. Vitamins exert such actions also when they act as nutrients. As the pharmaceutical law does not provide further definitions, the homeostasis model (Council of Europe, 2008) for differentiating plant-based food supplements and medicinal products might provide a common understanding for vitamins as well. The medically normal status of the body/ metabolism is described as homeostasis. Effects of vitamins which keep the body in homeostasis are nutritional functions while medicinal products aim at restoring the status when it is out of homeostasis or at intentionally bringing it out of homeostasis.
The future introduction of EU-harmonised maximum allowed daily amounts of vitamins in food supplements will provide for delimitation of food supplements by upper permissible values of vitamin concentration. These limits aim at safe nutritional intake and do not take potential medicinal effects of vitamins into account, which may occur below these limits. These limits are therefore not of relevance for the demarcation of a vitamin product as a medicinal product according to the functional definition of Directive 2001/83/EC.

For medicinal products containing vitamins two specific characteristics of vitamins in relation to EU pharmaceutical law should be considered.
Vitamins are so-called atypical actives, their main field of industrial utilisation is not in pharmaceuticals, the GMP quality requirements for pharmaceutical actives represent competitive disadvantage for pharmaceutical companies in the vitamin business.
When a product containing solely vitamins is intended for prevention and treatment of deficiency, certain simplifications of the required non-clinical and clinical documentation for marketing authorisation dossiers apply. Bibliographic documentation should - to a large degree if not even completely - be sufficient, for single compounds as well as for the prevalent fixed combinations of vitamins, according to Directive 2001/83/EC, Arts.10a or 10b and according to the fixed combination guidelines.

Pages: 54