Abstract
Currently, a global change in the approach to herbal medicinal products can be observed and in many countries new regulations are developed for this class of products. Implementation of such legislation is necessary to guarantee the quality, safety, and efficacy of herbal medicinal products. The Dutch policy is to facilitate this process and to effect a smooth transition. To achieve this, the Dutch government has laid down a Royal Decree on Herbal Food Products, which aims at increasing the safety of food supplements containing medicinal herbs. In addition, it financially supports the activities of the private Committee for the Assessment of Phytomedicines. This committee’s explicit goal is to set up a self-regulating system for monitoring the quality, safety, and efficacy of herbal medicinal products. For this purpose, it has developed operational methodology and explored some of the specific problems in this respect. This arrangement is made in anticipation of specific European guidelines for herbal medicinal products.
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Decreto por el que se reforma la Ley General de Salud (Decrete for the Amending of the General Health Act)
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This article is based on a presentation prepared by the authors and given by Willem Schölten at the 36th D1A Annual Meeting, June 10–15, 2000, San Diego, California.
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Scholten, W.K., Halkes, S.B.A. Introducing a System for the Assessment of Quality, Safety, and Efficacy of Herbal Medicinal Products in the Netherlands. Ther Innov Regul Sci 35, 461–468 (2001). https://doi.org/10.1177/009286150103500214
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DOI: https://doi.org/10.1177/009286150103500214