- producing and working to SOPs
- dispensing of prescription/ supervision of dispensing technicians and assistants
- maintain PMRs
- release of medicine to patient/ representative with advice on use
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Professional interaction with the law
- police
- GPhC inspectors
- MHRA inspectors
- CQC inspectors
- Border Force Officers
- Training Standards Officers
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Legislative framework
- NHS administrative law
- Civil law
- UK parliamentary legislation
- EU Law (concept of EU law retained) (retained EU law bill)
- What a pharmacist is is legally defined
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What is 'law'?
the regulation of human affairs and human relationships
complex concepts of rights, duties, rules, regulations, authority, morality, settling disputes, dynamism
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Criminal law (statute law)
deals w the relationship between an individual and the state
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civil law
deals w relationships between individuals
tort and breach of duty of care
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Judicial precedent
Common law
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Administrative law
Part of civil law which deals with supervisory roles courts have in relation to the activities of public bodies
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Tort
Wrongful act for which someone can be sued for damages in a civil court
Whether intentionally or by negligence
misdiagnosis, inappropriate prescribing, dispensing error
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Judicial precedence
The principles of judicial precedence are such that when a case is decided in higher courts, lower courts have to follow the decision
Judges can manipulate the common law provided without having to wait for parliament to enact legislation
Judges can be su
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The courts
Criminal/ civil
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How does parliamentary law come into effect?
- Green and White papers
- Private Member's Bill
- Act of Parliament
- Delegated legislation
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Green papers
consultive documents- what the gov might do
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White papers
form proposals- what the gov will do, given the acceptance of a parliamentary majority
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Acts of parliament may be:
1- self-contained, ie constituent acts
2- provide delegated (secondary) legislation, ie are enabling acts
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Advantages of delegated legislation
- saves time (enacted by an appropriate minister)
- greater flexibility
- greater speed of action and implementation in an emergency
- allows greater use of consultation with qualified and technical experts
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Checks on delegated legislation
- parliament usually imposes limitations within the Enabling Act on the extent to which a Minister may legislate
- the Delegated Powers and Regulatory Reform Committee has responsibility of reviewing all Statutory Instruments presented to parliament
- Cou
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The Humans Medicines Regulations 2012
Delegated legislation under the European Communities Act 1972
Governs most day-to-day aspects of medicines control
One of the consequences of Brexit is that this legislation needs to be amended
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The European Union (Withdrawal) Act 2018
exists to convert existing EU law that exists in the UK into domestic law
In effect to create a new category of law, EU retained law
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The Human Medicines (Amendment etc) (EU exit) regulations 2021
deals with the details of moving legislation into place post-Brexit
delegated legislation under the European Union (Withdrawal) Act 2018
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Misceallenous legislation concerning
- Customs and Excise
- Health and Safety
- Control of hazardous substances
- Consumer protection
- Employment
- Retailing
- Confidentiality/ data protection
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Current UK pharmaceutical legislation
- Medicines Act 1968
- Misuse of Drugs Act 1971
- Poisons Act 1972 and Rules
- Health Act 2006
- Humans Medicines Regulation 2012
- The Humans Medicines (Amendment etc) (EU exit) Regulations 2021
- Medicines and Medical Devices Act 2021
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primary legislation
Act of Parliament
Misuse of Drugs Act 1971
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secondary (delegated) legislation
Orders- Misuse of Drugs Act (Amendment Order 2008)
Regulations- Notification and Supply to Addicts Regulations 1997
Rules- Misuse of Drugs Act Tribunal Rules 1974
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parliamentary procedure in enacting legislation
consultation (investigation by: working parties, gov inquiries, Royal Commissions)-> consultive document (green papers, white papers) -> sponsored bill (enacted by gov or private minister) -> bill drafted into House of Commons -> bill passed to House of L
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criminal law
state v defendant
public action
apprehension and disposition
magistrate court- Crown court for trial by jury
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civil law
plaintiff v defendant
private action
compensation and restitution of wrongdoers
country court- high court
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Other cards in this set
Card 2
Front
Dispensing
Back
- producing and working to SOPs
- dispensing of prescription/ supervision of dispensing technicians and assistants
- maintain PMRs
- release of medicine to patient/ representative with advice on use
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