The effect of the European traditional use directive on the register of herbal medicinal products in Spain.
نویسندگان
چکیده
BACKGROUND Directive 2004/24/EC, which came into force in 2011, created new regulatory requirements for traditional herbal medicines (THM). This study compared the Spanish THM registry before and after the Directive came fully into force in 2011. METHODS We consulted the herbal medicinal plant and drug catalogues (General Council of the Official Colleges of Pharmacists), the website of the European Medicines Agency (EMA), and retail web sites. RESULTS Of 315 THM (from 39 companies) licensed in Spain in 2010, only 48 (10 companies) remained licensed in 2013, mainly due to their withdrawal: the EMA had received just 123 applications from Spain and at least 34% formerly licensed THM had shifted to the less strictly regulated food sector, while up to 54% might have disappeared from the market. However, there is still a significant presence of retail websites making illegal health claims. CONCLUSION In Spain, the public health benefits of the Directive 2004/24/EC might be less than expected.
منابع مشابه
Application of techniques in collection and harvesting of herbal medicine
Interest in traditional medicine and in particular herbal medicine has increased in both developed and developing countries over the past two decades. Some reported adverse events following the use of certain herbal medicines have been associated with a variety of possible explanations, including the inadvertent use of the wrong plant species, adulteration with undeclared other medicines. The s...
متن کاملApplication of techniques in collection and harvesting of herbal medicine
Interest in traditional medicine and in particular herbal medicine has increased in both developed and developing countries over the past two decades. Some reported adverse events following the use of certain herbal medicines have been associated with a variety of possible explanations, including the inadvertent use of the wrong plant species, adulteration with undeclared other medicines. The s...
متن کاملMedicinal and aromatic plants-new product development for povertyrReduction
Traditional Medicine is very culture based. Every ethnic group has had its traditional medicine based on its indigenous knowledge base. Most traditional medicine systems utilize herbs (plants) as the main source of their therapeutic substances, although minerals and animal products are also utilized. traditional knowledge has often played a role in the development of modern science. Greater eff...
متن کاملMedicinal and aromatic plants-new product development for povertyrReduction
Traditional Medicine is very culture based. Every ethnic group has had its traditional medicine based on its indigenous knowledge base. Most traditional medicine systems utilize herbs (plants) as the main source of their therapeutic substances, although minerals and animal products are also utilized. traditional knowledge has often played a role in the development of modern science. Greater eff...
متن کاملScientific evaluation of herbal medicinal products by the HMPC.
On 31 May/1 June and on 21/22 July 2005, the Committee on Herbal Medicinal Products (HMPC), which was founded in September 2004, met for the 5th and the 6th time, respectively, at the offices of the European Agency for the Evaluation of Medicinal Products (EMEA). A number of guidance documents has been elaborated by the Committee’s drafting groups on organisational matters, on quality and on sa...
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ورودعنوان ژورنال:
- Gaceta sanitaria
دوره 29 3 شماره
صفحات -
تاریخ انتشار 2015