Med's Law Flashcards
Medical devices regulations 2002
Covers non-medicinal products pharmacists deal with
Misuse of drugs act 1971& regulations 2001
Controls the supply of meds that are likely to be misused
What is (reg 2) medicinal products
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
Steps of marketing authorisation
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
Homeopathic products
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
Medicinal products must contain
Is an appliance in which
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
Herbal products
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
what is CAM
Can be used with or in place of orthadox medicine
Stimilates body to heal itself
Hollistic
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
Homeopathy
Minimal dose, single remedy
Potenistation process - take original extract from product and formulate it
