s2 w2 Flashcards
Herbal and Homeopathics Poisons
what is defintion of herbal medicinal product?
A medicinal product whose only active ingredients are herbal substances or herbal preparations (or both).
what is defintion of herbal substance?
A plant or part of a plant, algae, fungi or lichen, or an unprocessed exudate of plant, defined by the plant part used and botanical name of the plant, either fresh or dried, but otherwise unprocessed.
what is defintion of herbal preparation?
A preparation obtained by subjecting herbal substances to processes such as extraction, distillation, expression, fractionation, purification, concentration or fermentation, and includes comminuted or powdered herbal substances, a tincture, an extract, an essential oil, an expressed juice or processed exudate.
what is defintion of traditional herbal medicinal product?
a herbal medicinal product to which regulation 125 applies
what are the types of herbal remedies?
1.) Licensed herbal
• Need marketing authorisation (MA-PL), legal classification
2.) Registered traditional herbal medicines
• Hold traditional herbal registration (THR)
3.) Unlicensed herbal products
• Not industrially produced
• Supplied to individual patients
i. Following a face-to-face consultation
4.) Not medicines not require MA or THR
• Food supplements or cosmetics
Medicinal products can be sold without MA?
FALSE
- this is illegal and they either need a MA or a THR
what do herbal practitioners do?
- Use specialist knowledge to prescribe or persons seeking treatment and accept legal liability
- May practise from consulting rooms or may operate from a shop where they also act as a dealer
when do HMR restrictions NOT apply?
a. Herbal medicinal product is manufactured or assembled by a herbalist practitioner
• On premises they occupy
• Which can exclude public
b. Herbal medicinal product is for administration to a person
• After being requested by or on behalf of that person and
• In that persons presence
MHRA may ban the sale or supply of herbal remedies if suspected adverse effects results from use
TRUE
what is medicines 2001 order
not permissable to manufacture import or sell any unlicensed medicine in the UK which contains named herbal ingredients
what is medicines for human use 2002 order?
prohibits sale, supply and importation of unlicensed medicines containing Kava-kava, except external use
what are THMS registration conditions?
A. Use without need for medical practitioner to diagnose, prescribe or monitor product’s use
B. Product intended to be administered at particular strength/ dosage
C. Product intended to be administered externally, orally or by inhalation
D. Product has been in medicinal use for
– continuous period of at least 30 years, and
– in EU for continuous period of at least 15 years
E. Sufficient information about “traditional use,” so that:
what is the THMR?
- manufactured, finished, OTC traditional herbal medicines are covered by a registration scheme
- This is known as the Traditional Herbal Medicines Registration Scheme (THMRS)
- All registered products are given a registration number (THR) similar to a MA number
how do THMP need to be labelled?
- ) Statement that product is a traditional herbal medicinal product
- For use for specific purposes by reason of long standing use - ) Statement that user should consult
- Doctor or health care practitioner if symptoms persist or
- If adverse effects not mentioned on the package or package leaflet occur
THMP require this statemtn onf adverts “raditional herbal medicinal products for use in [specify one or more indications for the product consistent with the terms of the registration] exclusively based upon long standing use as a traditional remedy”
TRUE
