Med's Law Flashcards

1
Q

Medical devices regulations 2002

A

Covers non-medicinal products pharmacists deal with

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2
Q

Misuse of drugs act 1971& regulations 2001

A

Controls the supply of meds that are likely to be misused

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3
Q

What is (reg 2) medicinal products

A

A medicinal product is any substance(s) presented as having properties of preventing or treating disease
Or is administered to humans with a vie to restore/modify a physiological function by exerting a pharmacological/ immunological/ metabolic action, or making a medicinal diagnosis

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4
Q

Steps of marketing authorisation

A

A medicinal product must have a marketing authorisation ( product license)
Must be obtained from the MHRA ( medicines and healthcare products regulatory agency)
The manufacturer submits an application which must include ( intended use, side effects, safety studies, manufacturing process etc) and if it meets standards of safety, efficacy and quality the product is granted

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5
Q

Homeopathic products

A

Contain no active ingredient
They believe the more dilute the product the better
To register must prove safety and quality but not efficacy
Nothing other than placebo effect

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6
Q

Medicinal products must contain

Is an appliance in which

A

CE mark to show device meets all regulatory requirements

Intended for diagnosis/ treatment but doesn’t achieve it’s main action pharmacologically, immunologically or by metabolic means

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7
Q

Herbal products

A

Doesn’t have to comply with the law
Traditional herbal medicines do apply with the law but don’t need a marketing authorisation
They need a Traditional herbal registration number

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8
Q

what is CAM

A

Can be used with or in place of orthadox medicine

Stimilates body to heal itself

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9
Q

Hollistic

A
Treat the whole body rather than the condition
Group 1- well regulated, diagnosis
Group 2- not well regulated 
Group 3- element of diagnosis 
A&B
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10
Q

Homeopathy

A

Minimal dose, single remedy

Potenistation process - take original extract from product and formulate it

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