Herbal & homeopathic remedies Flashcards
What is the definition of a herbal medicinal product?
A medicinal product whose only active ingredients are:
- herbal substances
- herbal preparations
- or both
Fungi is classed as being a herbal substance. True or false?
True
A herbal substance is defined as being a plant or part of a plant, algae, fungi or lichen. True or false?
True
A herbal preparation is not defined in HMR 2012. True or false?
False - defined as being a preparation obtained by subjecting herbal substances to processes such as extraction, distillation etc.
Licensed herbal medicines do not require MAs. True or false?
False - require MA, legal classification etc.
Unlicensed herbal products are not industrially produced and cannot be supplied to patients. True or false?
False - they are not industrially produced but are supplied to individual patients - following face to face consultation
Herbal remedies that are not medicines do not require MA or traditional herbal registration, True or false?
True - e.g. food supplements or cosmetics
What are the conditions in which a herbal practitioner can prescribe unlicensed herbal products?
One-to-one consultation and patient must be present in person
HMR restrictions on the sale and supply do not apply if herbal medicinal product is manufactured or assembled by a ‘herbalist practitioner’ on the premises they occupy which can exclude the pubic. True or false?
True
Herbal practitioners are required to be registered with the health & care professions council. True or false?
False
Herbal medicines listed under part 1 of HMR can only be obtained from registered pharmacies but sale/supply doesn’t have to be in presence of pharmacist. True or false?
False - under supervision of pharmacist
Plants listed in part II of HMR can only be sold in herbal medicines following a one-to-one consultation with a practitioner at the max dose specified in columns. True or false?
True
For part II plants, if dose exceeds that specified in columns 2 and 3, the herbal medicine containing these plants can only be obtained from a registered pharmacy under supervision of pharmacist. True or false?
True
What sort of herbal products are mentioned in part I HMR?
Anthelmintics (treatment of worms)1
To gain a traditional herbal registration, a product has to have been in medical use for a continuous period of at least 20 years anywhere in world and in EU for continuous period of 15 years. True or false?
False - 30 years anywhere and 15 EU
To gain a traditional herbal registration, there has to be sufficient information about traditional use so that established use is not harmful and pharmacological effects are plausible. True or false?
True
THR mark will be present on all traditional herbal medicine that are registered and this is similar to an MA number. True or false?
True
What needs to be present on the label of a traditional herbal medicine?
Statement that the product is a THR for use for specific purposes by reason of long-standing use
Statement that user should consult doctor or other HCP if symptoms persist or if ADR not mentioned occur
Traditional herbal meds need to prove they are effective. True or false?
False
Traditional herbal medicines need to prove quality and safety. True or false?
True
All manufacturer’s of traditional herbal meds will require a manufacturer’s licence. True or false?
True
Wholesalers dealing with traditional herbal meds don’t require a wholesale dealer’s licence. True or false?
False - require
Any company which imports traditional herbal meds from non-eu country will need a wholesaler’s licence. True or false?
True
When advertising a traditional herbal med, there needs to be an additional statement that indicates the product is a traditional herbal med that specifies the indications. True or false?
True
Product licence of right is for products on the market before the medicines act. True or false?
True
Simplified registration scheme is for homepathics since the medicines act. True or false?
True
No therapeutic indication is allowed on products under the simplified registration scheme. True or false?
True
Products under the simplified registration scheme can only be used externally, not orally. True or false?
False - can be used orally and externally only
Homeopathics under the national rules scheme are allowed to have indications for the relief or treatment of minor (not major) symptoms and conditions. True or false?
True
Homeopathic products under the national rules scheme will have a MA number. True or false?
False - NR number in place of MA
