Herbal medicines Flashcards
What are herbal products?
ο Herbal products are
preparations of the whole plant
or parts of it
. eg. Ginseng,
Black cohosh, Gingko biloba,
Saw palmetto, Calendula,
Evening Primrose oil
What is a herbal medicine?
a product is a herbal medicine if the active ingredients are herbal substances and or herbal preparations only.
What is a herbal preparation?
ο A herbal preparation is a preparation obtained when herbal substances are subjected to specific processes, which include:
Extraction, distillation, expression, fractionation, purification
concentration, fermentation
ο The herbal substance produced can be:
reduced or powdered herbal substance, a tincture, an extract
an essential oil, an expressed juice or
a processed exudate (rich protein oozed out of its source).
What is the
Traditional Herbal Medicine Registration Scheme (THMRS)?
ο The THM registration scheme is operated by the MHRA and products must be registered in order to be marketed in the UK. The requirements of the Traditional Herbal Medicine Registration Scheme came into effect on 1 May 2011
ο A THMRS is only granted if the medicine is used for minor health conditions where medical supervision is not required (eg a cold).
What is the Eligibility for the THMRS?
ο You must ensure the indication of the herbal medicine is agreed under legislation. The indication is the medical condition the product has traditionally been used to treat. Check the permitted indications to see if the herbal product is eligible under the directive on traditional herbal products.
ο You must also show evidence that the herbal medicinal product has been traditionally used to treat the stated condition for a minimum of 30 years, 15 years of which must have been in the European Union (EU).
What are the exemptions for THMRS?
ο If you’re a herbal practitioner, you don’t need a licence to supply herbal medicines you create on your premises to patients following one-to-one consultations.
Further info about THMRS
ο The THMRS number must be included on the label of all packaging for such products.
ο If a patient requests advice on a suitable manufactured herbal product, only authorised preparations (i.e. those bearing a THMRS or PL number) should be recommended
