ms 1 Flashcards
what replaced the medicines act 1968?
HMR Human medicines regulation 2012
what is the definition of a medicine/medicinal product according to the human medicines regulation 2012?
medicinal product means
- any substance or a combination of substances having properties to prevent disease in human beings
- medicines or a combination of substances that may be administered to a human being with a view to restoring, correct, and modify a physiological function by exerting a pharmacological, immunological, or metabolic action
define human med regulation 2012?
HMR 2012 govern all the medicines that are sold, supplied and prescribed in the UK including those supplied by the NHS and private healthcare.
HMR regulate all aspects of the medicinal product
does the NHS legislations apply to the HMR 2012 only?
no, HMR control the legislations of the NHS and private practice
does the HMR regulate all aspects of the medicinal product
yes
what does the HMR regulate of a medicinal product?
marketing manufacture advertising and promotion packaging labelling sale supply and prescribing safety and quality post marketing surveillance
what is post-marketing surveillance called?
pharmacovigilance
who licenses all the medicines in the UK?
MHRA
what does MHRA Stand for?
medicines health and regulation agency
what is the function of the MHRA?
MHRA Provide licenses to the medicinal product. The government has set up MHRA to safeguard the public from harm and ensures medicinal products are safe from any ill side effects are brought forward
what is needed before a medicine can be sold in the UK?
before a medicine can be sold in the UK, a number of licenses are essential
- marketing authorization (aka product license)
- manufacturers and wholesale dealer license
who is responsible for issuing licenses?
MHRA
what is marketing authorisation?
what does a marketing authorisation include
includes information such as
-indication of use
-dosage
-recipients (maybe specific age ranges or restricted to adults)
-cautions that apply and possible contraindications
routes of administration
how can we search for a marketing authorisation of a product?
searching for marketing authorization is not user friendly, so we can use the SPC as it is a more user-friendly version of the marketing authorization
what does spc stand for
summary of product characteristics
what does a off-licensed product mean?
medicinal product which has a marketing authorisation but the use of product is outside the marketing authorisation
i.e. marketing authorisation states product used for eye but you use it for the ear
what does an unlicensed product mean?
when a product does not have a marketing authorisation
product could be made according to Rx in a specials unit
what are the classes of medicinal product?
POM
GSL
P MED
what does P medicine mean?
pharmacy only medicines