Herbal & homeopathic remedies Flashcards

1
Q

What is the definition of a herbal medicinal product?

A

A medicinal product whose only active ingredients are:

  • herbal substances
  • herbal preparations
  • or both
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2
Q

Fungi is classed as being a herbal substance. True or false?

A

True

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3
Q

A herbal substance is defined as being a plant or part of a plant, algae, fungi or lichen. True or false?

A

True

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4
Q

A herbal preparation is not defined in HMR 2012. True or false?

A

False - defined as being a preparation obtained by subjecting herbal substances to processes such as extraction, distillation etc.

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5
Q

Licensed herbal medicines do not require MAs. True or false?

A

False - require MA, legal classification etc.

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6
Q

Unlicensed herbal products are not industrially produced and cannot be supplied to patients. True or false?

A

False - they are not industrially produced but are supplied to individual patients - following face to face consultation

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7
Q

Herbal remedies that are not medicines do not require MA or traditional herbal registration, True or false?

A

True - e.g. food supplements or cosmetics

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8
Q

What are the conditions in which a herbal practitioner can prescribe unlicensed herbal products?

A

One-to-one consultation and patient must be present in person

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9
Q

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?

A

True

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10
Q

Herbal practitioners are required to be registered with the health & care professions council. True or false?

A

False

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11
Q

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?

A

False - under supervision of pharmacist

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12
Q

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?

A

True

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13
Q

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?

A

True

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14
Q

What sort of herbal products are mentioned in part I HMR?

A

Anthelmintics (treatment of worms)1

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15
Q

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?

A

False - 30 years anywhere and 15 EU

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16
Q

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?

A

True

17
Q

THR mark will be present on all traditional herbal medicine that are registered and this is similar to an MA number. True or false?

A

True

18
Q

What needs to be present on the label of a traditional herbal medicine?

A

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

19
Q

Traditional herbal meds need to prove they are effective. True or false?

A

False

20
Q

Traditional herbal medicines need to prove quality and safety. True or false?

A

True

21
Q

All manufacturer’s of traditional herbal meds will require a manufacturer’s licence. True or false?

A

True

22
Q

Wholesalers dealing with traditional herbal meds don’t require a wholesale dealer’s licence. True or false?

A

False - require

23
Q

Any company which imports traditional herbal meds from non-eu country will need a wholesaler’s licence. True or false?

A

True

24
Q

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?

A

True

25
Q

Product licence of right is for products on the market before the medicines act. True or false?

A

True

26
Q

Simplified registration scheme is for homepathics since the medicines act. True or false?

A

True

27
Q

No therapeutic indication is allowed on products under the simplified registration scheme. True or false?

A

True

28
Q

Products under the simplified registration scheme can only be used externally, not orally. True or false?

A

False - can be used orally and externally only

29
Q

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?

A

True

30
Q

Homeopathic products under the national rules scheme will have a MA number. True or false?

A

False - NR number in place of MA