Draft Ordinance on Complementary and Herbal Medicinal Products (KPAV) (36 pages and additional annexes, available in German, French and Italian)

With the recent revision of the Therapeutic Products Act (TPA, Stage 2), the legislative body is improving, amongst other things, the population's access to medicinal products. Due to this recent legislative changes and based on the adapted Art. 14 and 15 of the TPA, the ordinance describes the requirements for simpler access opportunities for various medicinal products used in complementary medicine. For several herbal, homeopathic and anthroposophic medicinal products as well as for some traditionally used Asiatic medicines the documentation requirements are reduced. For certain categories (with a low scientific risk profile), the marketing authorization procedure is reduced to a simple notification process. In separate annexes of the ordinance, the active substances allowed as components of those medicinal products are listed.