1101

• What is the focus of the legislation lectures in PMY1101?

  Introduction to legislation and pharmacy practice
• What does legislation regulate in society?

  Conduct of the members of society
• What is the purpose of law in society?

  To provide a framework to resolve disputes
• What is one of the most important sources of law in the UK?

  Legislation
• How is legislation divided in the UK?

  Into primary and secondary legislation
• What is the purpose of primary legislation?

  To introduce new law or amend existing law
• What does secondary legislation do?

  Completes the scheme set by primary legislation
• What is primary legislation?

  Acts of Parliament
• What are the three types of secondary legislation?

  Statutory Instruments, Orders of Council, Statutory Rules
• What are the two main divisions of law?

  Criminal law and civil law
• What does criminal law concern?

  Relationship between the individual and the state
• What can a breach of criminal law lead to?

  Prosecution and possible imprisonment
• What does civil law concern?

  Relationships between individuals
• What can a breach of civil law lead to?

  Defendant being sued for compensation
• What significant events influenced pharmacy legislation from 1968 to 1978?

  Thalidomide incident and new legislation
• What is the role of the MHRA?

  Ensures medicines and devices are safe
• What do the Human Medicines Regulations (2012) outline?

  Legislation for manufacture, prescribing, and dispensing
• What are the three main classes of drugs under Human Medicines Regulations?

  GSL, Pharmacy medicines, Prescription Only Medicines
• What does the Misuse of Drugs Act 1971 regulate?

  Dangerous drugs divided into schedules
• What are Controlled Drugs categorized into?

  Five schedules under the Misuse of Drugs Act
• What are the requirements for Controlled Drugs?

  Strict regulations on prescription and storage
• What do Veterinary Medicines Regulations define?

  Veterinary medicinal products (VMPs)
• What is the Pharmacy Order in Northern Ireland?

  Key legislation regulating pharmacy practice
• What is the focus of Lecture 2 in PMY1101?

  Introduction to the Profession and Practice of Pharmacy
• What does the Health Act 2006 require of pharmacies?

  To have a Responsible Pharmacist in charge
• What is the role of the Responsible Pharmacist?

  To ensure safe and effective pharmacy operation
• What does legislation in pharmacy include?

  Human Medicines Regulations, MHRA, and licensing
• What is the duty of care in pharmacy?

  To care for patients and avoid harm
• What are the Human Medicines Regulations (HMRs) for?

  Labelling, prescriptions, and supply
• What does the duty of candour require from pharmacists?

  To inform patients of mistakes in care
• What is a medicinal product defined as?

  A substance preventing or treating disease
• What is the task for the next lecture?

  Bring a medicine with box and PIL
• What does the term 'manufacturer's licence' cover?

  Manufacture and assembly of medicinal products
• What is required for a medicinal product to be marketed in the UK?

  A marketing authorisation (MA)
• Who grants the marketing authorisation?

  The MHRA (Medicines and Healthcare products Regulatory Agency)
• What does Part 4 of the Regulations outline?

  Requirements for medicinal product licensing
• What must all labelling of containers and packages be?

  Legible, comprehensible, and indelible
• What is defined as wholesale dealing?

  Selling or supplying for business purposes
• Who is exempt from licensing when preparing a product from a prescription?

  Doctors, dentists, and pharmacists
• What are Prescription Only Medicines (POMs)?

  Medicines supplied only on prescription