What are Herbal Medicines?
“Herbalism is a traditional medicinal or folk medicine 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.
Current Trends and Regulations
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.
Currently herbal medicines can reach the market via the following three routes:
o Unlicensed herbal remedies
o Registered traditional herbal medicines
o Licensed herbal medicines
a) Unlicensed herbal remedies
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.
b) Registered traditional herbal medicines
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.
c) Licensed herbal medicines
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. Licensed herbal medicines can be readily identified by a unique nine number Product Licence number on the product container or packaging with the prefix “PL”.
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
2) was also legally on the UK market under s12(2) at 30 April 2004
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). 2
All companies must take note that any herbal remedy which does not have a Traditional Herbal Registration or a Product Licence after 30 April 2011 will not be allowed to sell or market their remedy. If it is already on the market, the Medicines and Healthcare products Regulatory Agency (MHRA) will insist that it is withdrawn even if the company has submitted their application and are waiting for approval.
Recently, the MHRA demonstrated their authority to withdraw a product from the market. They discovered that Neal’s Yard Remedies’ homeopathic product “Malaria Officinalis 30c” didn’t have a product licence even though all homeopathic remedies are classed as medicines and this product was clearly to be used for the treatment or prevention of malaria. The company have now withdrawn this remedy.3
Today, the challenge for herbal companies is to provide the correct information to satisfy the criteria and standards set by the MHRA in order to continue selling their herbal remedies. With tight budgets and lack of resources, it is important to consultant a regulatory professional who has experience in liaising with the MHRA and deals with regulations on a day-to-day basis. A regulatory compliance consultancy, such as Global Regulatory Services, can help ease this extra regulatory burden and ensure that herbal remedies can continue to be offered to the public as a safe alternative and/or complementary product to conventional medicine.