Last week saw the end of the “sell through” period for the Traditional Herbal Medicinal Products Directive (THMPD); as such we have withdrawn any of our products that would be considered unlicensed herbal medicines under the scheme.
The Traditional Herbal Medicinal Products Directiveis a complicated issue as, unlike other EC regulations that govern vitamin and mineral supplements, it doesn’t reference any “positive lists” for permissible ingredients. The MHRA document which defines what constitutes a medicinal product (Guidance Note 8) is pretty vague. In fact, the MHRA address most herbal medicines on a case by case basis meaning it can be very difficult to decipher what requires a license (THR) and what doesn’t.
The Traditional Herbal Medicinal Products Directive has meant we have had to discontinue products which would be defined as herbal medicines, as the cost of licensing is too prohibitive for us as a company.
Whilst we are disappointed that a system has been created which is weighted against smaller manufacturers, it has become an unfortunate necessityin order to improve the quality of products in this sector. Unscrupulous or poor quality manufacturers that produce sub-standard products have a negative impact on the whole industry. If THMPD succeeds in improving upon that problem then it will be a good thing. It’s just a shame that all the genuine manufacturers are adversely affected at the same time.
As many of you know, we have been focused on achieving FDA compliance for many months now. With that complete, it is possible we will consider pursuing some THR products in the future.