Browsing by Subject "herbal medicinal product"

Herbal preparations are widely used nowadays and the information given has developed a lot during the last decades. Herbal preparations haven`t been acknowledged as medicines and therefore their efficacy and adverse effects are still often underrated. In 2005 along the changes in legislation differently legislated group of herbal preparations was retired. Nowadays herbal preparations are divided to drugs and food products. The aim of the study was to make oneself familiar with the legislation of these products and the evolution of the pharmaceutical information given. The aim also was to compare warnings, prohibitions, contraindications and their evolution to prevalent legislation. The material of the study consisted of product information summaries, patient information leaflets and labeling of herbal medicines, traditional herbal medicines and their predecessors. In addition to this there was also other legislative material. Only herbal medicines and traditional herbal medicines according to directive 2004/24/EY of the European parliament and the council`s definition were taken in to account. According to 2004/24/EY herbal medicinal products is any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations. There were all together 194 products included in the study. Documentation of 184 products was found on paper in Fimea`s archives. Of the remaining five out of ten products it was found some basic information in electronic rohdos-register and of one product on an on paper final act. Data of these six products was only used partly because of its deficiencies. The data of four products wasn`t found. Under a more detailed study there was all together 184 products between 1964 and 2011. The material was divided to time periods 1964 - 1983, 1984 - 1987, 1988 - 1995, 1996 - 2005 and 2006 - 2011 by the changes in legislation. The information given of herbal preparations was the most affected by the changes in legislation in 1994 and 2005. The amount of new licenses was increasing until the time period 1988 - 1995. Licenses were granted the most during 1988 - 1955. After 1996 the amount of warnings, prohibitions and contraindications rose and many of the products that got the license in previous time period 1966 - 1955 left the market or transferred under the food legislation. As well many products with less consumption left the market because new studies demanded were expensive and cumbersome. In 2005 along the changes in legislation a clear change in attitudes came true, when a vague group of herbal preparations was removed and herbal preparations were divided into pharmaceuticals and food products. Along this change it has become easier for health care professionals to assess the risks and benefits of herbal preparations and advise the clients while making the decisions.