L2 Law Flashcards
Primary care includes
GPs, dentists, community practitioners, optometrists
Secondary care
Hospitals
Medicines Act 1968 regulates
Manufacture, distribution and importation
MHRA
Medicines and Healthcare products Regulatory Agency (licensed the MA)
MHRA are advised by
Medicines Comission
Statutory Instruments
Orders and regulations (secondary legislation)
Much of the medicines act is now revoked by the
Human Medicines Regulation 2012
Human Medicines Regulations 2012 regulates
Manufacture, distribution, importation, sale and supply, labelling and advertising, pharmacovigilience
Licensing Authority is
Secretary of state and the minister of health social services and public safety
MHRA is part of the
Department of health
Mission of the MHRA
to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptable
MHRA are responsible for….
regulation of medicines, medical devices and equipment used in healthcare, the investigation of harmful incidents, looking after blood and blood products
Activities of the MHRA
Assessing safety, quality and efficacy of medicines for human use and authorising their sale or supply.
Overseeing that UK notified audit medical device manufacturers
Yellow card scheme
Operating a proactive compliance programme for medical devices
Sampling and testing of medicines
Regulation of clinical trials
Ensuring compliance with statutory obligations
Promoting good practice in the safe use of medicines and medical deivices
Managing the GPRD and BP
Information provision to public and professionals
GPRD
Geneal practice research database
What do we mean by devices?
All products except medicines used in healthcare for diagnosis, prevention, monitoring or treatment of illness or disability
Eg. of devices
Dressings, orthodontics, catheters, condoms, urine test strips, contact lenses
Enforcement of the HMR lies with
Secretary of state
General Pharmaceutical Council
“Drugs Authority” - local council
HMR also deals with
Supply of medicines to the public Labelling and containers Sales promotion Preparation of BP & other books of standards Pharmacovigilance
Registration of retail pharmacies lies with which act
Medicines Act of 1968
3 main aims of the HMR
Quality, safety and efficacy of a medicinal product
Marketing authorisation… “drug must…”
positive therapeutic effects must outweigh the risks to health of patients or of the public associated with the product
Part 1
General terminology and definitions
Who is the licencing authority for Europe
European medicines agency (EMA)
Advertisements are defined as
in relation to a medicinal product, includes anything designed to promote the prescribing, supply, sale or use of the product
Special provisions for pharmacies
excepts the need for manufacturing licence when extemporaneous dispensing
Medicinal Product is
any substance or combination of substances presented as having properties or treating or preventing disease in human beings, or that may be administered to human beings with a view to restoring, correcting or modifying physiological function by exerting a pharmacological, immunological or metabolic action or making a medical diagnosis
Medicinal purpose means any one or more of the following
treating or preventing disease
diagnosing disease or ascertaining the existence, degree or extent of a physiological action
contraception
inducing anesthesia
otherwise preventing or interfering with normal operation of a physiological function whether permanently or temporarily and whether by way of terminating, reducing or postponing or increasing or accelerating the operation of that function in any other way
Who is an appropriate practitioner in relation to a POM
doctor, dentist, supplementary prescriber, nurse independent prescriber and pharmacist independent prescriber
Exceptions: community nurse prescriber
certain laxatives, mebendazole, nystatin, etc
Exceptions: Optometrist independent prescriber
All POM except CDs and parenterals
Exceptions: EEA health professional
All POM except CDs
Part 2
Administration
2 Advisory bodies
Commission on human medicines (CHM)
British Pharmacopoeia Commission
Commission on human medicines function:
Advise appropriate ministers about: clinical trial regulations
Advise on: MPs, safety, quality and efficacy of MPs.
Promote yellow card scheme
INDEPENDENT EXPERT ADVICE TO MHRA
Who advises the CHM?
EAG (8 minister appointed members, meet once a month)
BP Commission funcitons
Prepare the BP, other compendia, EP etc.
BP
comprises descriptions and standards
EAG are appointed by
BPC or CHM
EAG also
undertake detailed examinations of issues before referral to CHM or BPC
Current established EAGs
HIV/Anti-infectives/Hepatology Biologicals/Vaccines Cardio/Diabetes/Renal/Resp/Allergy Chemistry, Pharmacy and Standards Clinical Trials Dermatology/Rheumatology/Gastrointestinal/Immunology Medicines for Women's Health Neurology/Pain Management/phychiarty Oncology and Haematology Peadiatrics Patient and Public Engagement Pharmacovigilance
Ministers are solely responsible for
Licencing
Hospitals
Practitioners premises
GPhC is responsible for
Register of Pharmacist, pharmacy technicians and pharmacy premises
Disciplinary control of the pharmacy profession
Restriction of titles
Sale and supply of MPs (POM and P - not GSL)
Registrar & chief executie of the GPhC keeps a register of
premises, pharmacists and pharmacy technicians
Who is responsible for the sale of GSL medicines
Local council
What do the GPhC regulate with regards to MPs?
Quality Purity Labelling Packaging Advertising
