Traditional Herbal Medicines
Legislation
The European Directive (2204/24/EC) came into force on 30th April 2011 which required some herbal products to be registered as Traditional Herbal Medicines (THRs). This legislation is being strictly enforced in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). All the products in our THR range meet the specific requirements stipulated by the MHRA.
In order to register a product with the MHRA as a Traditional Herbal Medicine, a pharmaceutical dossier of information was required to demonstrate that the product met specific standards of safety and quality. This involved testing all raw materials and finished tablets for authentication, purity and stability to ensure that they complied with medicinal manufacturing standards.
There are some herbs in the market that have been licensed as THRs when it is not necessary for them to be. Suppliers of these products are simply leveraging the THR trademark and using it as a marketing tool. Registering herbs unnecessarily limits the claims that can be made about the product. When consumers use these products for reasons other than stated on the packaging it is necessary for the supplier to report the misuse to drug safety authorities. In addition, unnecessarily registering herbs may also drive down the permitted level, limiting the efficacy of the product and therefore rendering it unmarketable.
Our packaging
Our THR cartons have been approved by the MHRA to ensure that they provided the correct information about the products, including details about side effects and warnings to all consumer groups. We have also added Braille to our outer cartons for the visually impaired.
Based on the packaging, it is possible to determine a Traditional Herbal Medicine from alternative products as they carry a THR logo. This informs the consumer that this product complies with medicinal manufacturing standards and has been registered by the MHRA.
You will also notice that Traditional Herbal Medicines bear a claim on the packaging based on the 30 years evidence of traditional use that was provided in the registration dossier. This claim will enable our consumers to make a more informed choice about these products they are buying.
Patient Information Leaflet
As for all medicines, a patient information leaflet is required. We spent a great deal of time on our patient information to ensure that it carried all the required information in an easy to read format. User testing of the patient information leaflet was completed by a group of consumers to ensure that this leaflet was accessible to all ages. All this extra effort with our packaging helps decipher the complexities of herbal products to our consumers.
Setting the standard
Registering the Nature's Best herbal products as Traditional Herbal Medicines was an important step for the company, as it meant that it was possible to define our existing products with guaranteed quality and safety. Before this regulation came into force, the herbal market was largely unregulated and unscrupulous companies were able to sell products of poor quality and safety. Nature’s Best products have always been of the highest quality and have been manufactured according to medicinal standards, but now all products must meet these specific standards of safety and quality to help protect public health.
Exclusive to Nature's Best
Finally, we believe our Traditional Herbal Medicines are unique from our competitors as we did not make any compromises in order to comply with the legislation. All our registration dossiers are exclusive to our company's products and we were involved at every stage of the registration process. They are all manufactured and tested in the UK and have been developed with the right potency at affordable prices.
