legal issues

Question 1

what is statutory professional regulation

Answer 1

regulations that ensure practitioners are qualified

Question 2

what CAMS require statutory professional regulations

Answer 2

osteopathy and chiropracts

Question 3

what does a lack of statutory professional regulations mean

Answer 3

anyone can practice
do not have to adhere to standards or register

Question 4

what does the medicines act require

Answer 4

a product licence given by the Medicines and Healthcare products Regulatory Agency is required which is given with clinical trials, and strict dosage, purity controlling.

Question 5

what can herbal products not say if they aren’t authorized by the MHRA

Answer 5

cannot make medicinal claims (claims of curing/treating/preventing) but can have health claims

Question 6

what are herbal medicines required to do

Answer 6

be registered as traditional herbal medicines or have marketing authorization by MHRA if produced industrially (classed as ingredient if made on site ex: unprocessed herbs)

Question 7

what is required for herbs to be licenced by the Traditional herbal registration

Answer 7

produce bibliographic evidence of traditional use, used medicinally for at least 30 years (at least 15 years relating to the eu) and need to be under good manufacturing practices (safety monitoring, quality control and some patient info on dose and side effects)

Question 8

what is required for herbs to be given market authorization by the MHRA

Answer 8

safety quality efficacy demonstration needed (clinical trials). and have product information sheet. for example: foxglove can only be made available via prescription

Question 9

what are some problems of unlicenced herbal medicines

Answer 9

1. no specific standard of safety and quality
2. no requirement for dose and adverse drug reaction info
3. manufacturing quality varies
4. strength and dose may vary
5. may have fewer side effect warnings but be less safe (don’t need to be accurate)
6. no patient information needed

Question 10

what is meant by licensed herbal products

Answer 10

licenced herbal products are products either registered as traditional herbal medicines or have marketing authorization by MHRA if they are produced industrially.

Question 11

what is meant by unlicensed herbal products

Answer 11

unlicenced herbal products are not registered as traditional herbal medicines or have marketing authorization by MHRA. if they are produced industrially and not on site the sale and import of these products is illegal.

Question 12

what evidence is required and not required from herbal products

Answer 12

licensed herbal products need to either:
a. produce bibliographic evidence of traditional use, used medicinally for at least 30 years (at least 15 years relating to the eu) and need to be under good manufacturing practices (safety monitoring, quality control and some patient info on dose and side effects)

b.safety quality efficacy demonstration needed (clinical trials). and have product information sheet.

if produced industrially. if not they can be sold as ingredients or nutritional supplements which have no specific standards of safety, efficacy and quality

whether a product is licenced or unlicenced herbal practitioners need no qualifications or experience