“Herbalism is a traditional medicinal or folk сиалис купить киев practice based on the use of plants and plant extracts. Herbalism is also known as botanical medicine, medical herbalism, herbal medicine, herbology, and phytotherapy.” 1 These medicines use plant-based materials for the treatment of specific symptoms or diseases with many herbs and herbal formulations having been used for centuries within different cultures e.g. India and China.
Today, the public is more informed about their health and the options available to them to prevent and/or treat disease. Couple this knowledge with the current focus on organics and health foods, herbal medicines have become increasingly popular. The traditional herbs and herbal formulations used in India and China are making their way into Europe and so increasing the range of herbal medicines available.
Because of this trend, it is even more important that people are aware that herbal medicines do have a physiological effect on the body and therefore, should be used with care. Until recently, the regulation of herbal remedies within the UK has been fairly relaxed but particular safety concerns have come to light, for example, the interaction of St John’s Wort with some conventional medicines.
At the moment most herbal remedies within the UK are unlicensed as they are exempt from holding a product licence or marketing authorisation as per the exemption outlined in Section 12 of the Medicines Act 1968.
On the 30th October 2005 a new scheme the “Traditional Herbal Medicines Registration Scheme” was introduced within the UK which is also a requirement of the European Directive on Traditional Herbal Medicinal Products (2004/24/EC). This is a simplified registration scheme where remedies are required to meet standards of safety and quality but not necessarily the same level of efficacy as for a fully licensed product.
Currently there are approximately 500 herbal medicines which have a product licence (marketing authorisation). In order to obtain a product licence, a company has to demonstrate that their herbal medicine meets certain standards of safety, quality and efficacy. For many, it has been difficult to meet the required criteria and this is one of the reasons why the Traditional Herbal Medicines Registration Scheme has been introduced.
Due to safety and quality concerns, the sale of unlicensed herbal remedies is no longer allowed and all herbal medicines must have either a Traditional Herbal Registration (THR) or a Product Licence (PL). There is, however, one exception to this and that’s where the herbal remedy can meet both of the following requirements:
1) it is legally on the UK market as an unlicensed herbal remedy in accordance with s12(2) of the Medicines Act 1968 and was also legally on the UK market under s12(2) at 30 April 2004Licensed herbal medicines can be readily identified by a unique nine number Product Licence number on the product container or packaging with the prefix “PL”.
As long as the herbal remedy does meet these two requirements, it will qualify for transitional protection and, therefore, can continue to be marketed as an unlicensed herbal remedy until 30 April 2011 provided it continues to comply with the requirements of s12(2