Herbal And Homeopathic Remedies

Question 1

True or false, food supplements and cosmetics do not require a marketing authorisation?

Answer 1

True

Question 2

Who can unlicensed herbal products be supplied to?

Answer 2

Individual patients following a face to face consultation

Question 3

True or false, licensed herbal medicines is a legal class?

Answer 3

True

Question 4

Which type of herbal remedies require a marketing authorisation?

Answer 4

Licensed herbal medicines

Question 5

What does the medicines for human use senecio and miscellaneous amendments order 2008 prohibit?

Answer 5

It prohibits the sale, supply and importation of any medicinal product consisting of or containing senecio

Question 6

Give two examples of herbal products that are restricted for sale and supply in pharmacies only and under the supervision of a pharmacist?

Answer 6

Areca and Canadian hemp

Question 7

Which products can herbal practitioners supply in lower strengths and quantities which would otherwise be restricted to pharmacies?

Answer 7

Alcaloids

Question 8

What does the medicines (aristolochia and mu tong) prohibition order 2001 prohibit?

Answer 8

Not permissible in the uk to import, manufacture, sell or supply any unlicensed medicine which contains the named herbal ingredients.

Question 9

What does the medicines for human use (kava-kava) prohibition order 2002 prohibit?

Answer 9

The sale, supply and importation of unlicensed medicines containing kava-kava except those for external use only

Question 10

Which herbal products can a pharmacist sell?

Answer 10

Part 1, part 2, GSL, THMR, food supplements and cosmetics

Question 11

Which herbal products can a herbal practitioner sell?

Answer 11

Part 2, GSL, THMR, food supplements and cosmetics

Question 12

Which herbal products can any shop keeper sell?

Answer 12

GSL, THMR, food supplements and cosmetics

Question 13

True or false, THMs do not have to prove efficacy but do have to prove safety and quality?

Answer 13

True

Question 14

What conditions apply in order for a herbal product to have traditional herbal registration?

Answer 14

Established that use is not harmful, can be used without need for medical practitioner to diagnose, prescribe or monitor. Product intended to be administered externally, orally or inhaled. Product intended to be administered at a particular dose and strength. 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. The efficacy of the product is plausible on the basis of long standing use.

Question 15

What must appear on the label of a THMP?

Answer 15

Statement that the product is a traditional herbal product, statement that patient must consult doctor/another HCP if symptoms persist or if they experience any adverse effects

Question 16

True or false, all manufacturers of a THMP will require a manufacturers licence?

Answer 16

True

Question 17

True or false, a licence is not required to wholesale deal THMPs?

Answer 17

False- need wholesale dealers licence

Question 18

What does any company that imports a THMP from a non-EU country need in order to do this?

Answer 18

A wholesalers import licence

Question 19

Give the statement that any advertisement for a THMP must state.

Answer 19

“Traditional herbal medicinal product for use in (specify indication) exclusively based upon long-standing use as a traditional remedy”

Question 20

Give the 3 types of licences for homeopathic medicinal products.

Answer 20

Product licence of right, simplified registration scheme and national rules scheme for homeopathic medicinal products

Question 21

Which homeopathics are granted a product licence of right?

Answer 21

Products on the market before the medicines act which have indications for minor conditions suitable for self treatment

Question 22

True or false, products authorised by the simplified registration scheme are not allowed to have a specific therapeutic indication?

Answer 22

True

Question 23

True or false, simplified registration scheme products are restricted to oral and external use?

Answer 23

True