The Traditional Herbal Medicinal Products Directive
As 2011 approaches, more and more brand owners are resigned to the fact that in order to continue selling herbal medicinal products, these products need to be registered. All such products need to be produced on sites holding a current manufacturer's and Import authorisation. Proline Botanicals achieved this certification in January 2007 MIA number 27532. We are thus already in the position of manufacturing all of our products under current good manufacturing practice standards.
We are capable of producing and packaging tinctures and fluid extracts, either singly or as blends, teas, creams and gels and encapsulated products. As well as contract manufacture, we are able to assist in the completion of dossiers, stability testing, and work closely with the Medicines and Healthcare Products Regulatory Agency in co-operation with our clients. Proline is one of the very few companies dedicated solely to the manufacture of herbal medicines and has taken all of the requisite steps to ensure that this will continue.
Should you have contract manufacturing and THMP licensing requirements, contact Tony Carter at our Essendine office or e-mail
Tony.carter@prolinebotanicals.com.
Specials Manufacture
As the statutory regulation of herbalists approaches, whereby registered herbalists are likely to be classified as authorised healthcare professionals, the use of the specials regime for the production of bespoke herbal medicines becomes a reality. Again as a licensed manufacturer, Proline Botanicals will be able to undertake such specials work for our herbalist clients. This includes bespoke prescription services for those who do not wish to hold their own dispensary stock. Naturally all ingredients used are made at Proline Botanicals, are fully tested and fully traceable