Foreword from Duncan Rudkin, CEO, General Pharmaceutical Council
1. Introduction to the law in Great Britain
- European Law
- Domestic legislation
- Investigations into deaths
2. The regulation of pharmacy and other healthcare professions
- Regulation of the pharmacy profession
- Education and training of pharmacists
- Registration
- Registration as a pharmacy technician
- Other conditions for registration as a pharmacy professional
- Registration appeals
- Standards for pharmacy professionals
- Guidance to support the standards for pharmacy professionals
- Revalidation and continuing professional development
- Non-registered support staff
- Registered pharmacy premises
- Standards for pharmacy premises
- Inspectorate
- Regulation of healthcare professions – the catalyst for change
- The Care Quality Commission
- Health Improvement Scotland and Healthcare Inspectorate Wales
- Overseas practitioners
- Regulated roles in Scotland
- Non-surgical cosmetic procedures
- Professional Standards Authority for Health and Social Care
- The future of healthcare regulation
- Notifiable Diseases
3. National Health Service law
- Introduction - NHS structure in Great Britain
- England
- Legislative framework
- Pharmaceutical lists and market entry.
- The NHS Constitution
- NHS directions and policy statements
- NHS Guidance
- Scotland
- Wales
4. Human medicines and medical devices: scope of regulation
- Consolidation of medicines legislation
- The Human Medicines Regulations 2012
Part 1 General
Part 2 Administration
Part 11 Pharmacovigilance
Part 16 Enforcement
5. Human medicines: manufacturing, clinical trials and marketing
- Manufacturer’s licences
- Patents
Active substances - Exemptions from the need for a manufacturer’s licence
- Issue, suspension and revocation of licences
- Good manufacturing practice and other licence conditions
- Self-regulation of the pharmaceutical industry
- Clinical trials.
- Marketing authorisations
- Pharmacovigilance
- Article 126a products
- Product licences of right
- Orphan drugs
- Generic products
- Advanced therapy medicinal products.
- Biological medicinal products and biosimilars
- Borderline products
- Immunity from liability for unauthorised medicinal products
- Early Access to Medicines Scheme (EAMS)
- Importing
- Registration certificates for homeopathic medicines for human use
- Registration of traditional herbal medicinal products
- E-cigarettes
- Falsified Medicines
- Special medicinal products
6. Human medicines: wholesale dealing and brokering
- Importing
- Conditions of sales by way of wholesale dealing
- Persons to whom Pharmacy medicines and Prescription Only Medicines may be sold by wholesale
- Wholesale dealing from a pharmacy
- Wholesale dealing of veterinary products
- Exemptions
- Brokering
7. Lawfully conducting a retail pharmacy business
- The significance of lawfully conducting a retail pharmacy business
- The definition of lawfully conducting a retail pharmacy business
- The role and duty of responsible pharmacists
- Superintendent pharmacists
- Future changes to the law
- Professional responsibilities
- Restricted titles, descriptions and emblems
8. Online pharmacy services
- The context for additional regulation
- Regulators
- Risk
- Advertising
- NHS terms of service
- Online market places – poisons and chemicals etc.
- Veterinary medicinal products
- GPhC
- Care Quality Commission (CQC), Health Improvement Scotland (HIS) and Healthcare Inspectorate Wales (HIW)
9. Hospital pharmacy and other relevant pharmacy services
- Definition of hospital
- NHS trusts and NHS foundation trusts
- Registration with the General Pharmaceutical Council
- Regulation by the GPhC
- Regulation by the Care Quality Commission, Health Improvement Scotland and Healthcare Inspectorate Wales
- Manufacturing medicinal products
- Wholesaling, and hub & spoke dispensing
- Prescriptions
- Patient Group Directions (PGDs)
- Exemption from the requirement to supply Prescription Only Medicines in accordance with a prescription
- Exemptions for NHS trusts and foundation trusts from other HMR requirements
- Sale or supply of medicines subject to general sale and Pharmacy medicines – exemptions
- Administration
- Directions
- Adulterated medicinal products
- Medicines not of the nature or quality demanded
- Chief pharmacists
- Controlled drugs
- Supplementary prescribers
- Restrictions on the labelling of aspirin, paracetamol and elemental iron.
- Chloroform
10. Human medicines: General sale medicines
- Definition of medicinal products subject to general sale
- General Sale List Order
- Sale at or from pharmacies
- Conditions applicable to medicinal products subject to general sale
- Sales on aircraft and trains
- Automatic machines
- Retail pack sizes of certain products
- Products not to be on general sale
11. Human medicines: Pharmacy medicines
- Pharmacy medicines defined
- Marketing authorisations for Pharmacy medicines
- Product licences of right
- Restrictions on sale or supply
- Supervision
- Self-selection or open display
- Sale of stimulant laxatives
12. Human medicines: Prescription Only Medicines
- Prescription Only Medicines defined
- Marketing authorisations for Prescription Only Medicines
- Product licences of right
- Sale or supply of Prescription Only Medicines
- Prescriptions
- Administration of Prescription Only Medicines
- Products exempt from Prescription Only control
- Drugs to procure abortion
- Drugs and devices for contraception
- Pharmacy records
- Labelling of dispensed medicines.
- Exemptions from the need for a prescription
- Exemption for supply in the event or anticipation of pandemic disease
- Exemptions from requirements for Prescription Only Medicines for certain persons,
including persons who supply under Patient Group Directions - Serious shortage protocols
13. Human medicines: exemptions from controls
- Exemption for supplies by doctors, dentists or other healthcare professionals to their patients
- Exemptions for midwives
- Patient Group Directions
- Other exemptions for sale, supply or administration by certain persons
- Serious shortage protocols
14. Controlled drugs and psychotropic and psychoactive substances
- Advisory Council on the Misuse of Drugs
- Class A, B and C drugs
- Restrictions and exemptions
- Prohibitions on possession, prescribing and supply
- Tribunals, advisory bodies and professional panels
- Scheduled substances: substances used in the manufacture of narcotic drugs or psychotropic substances
- Powers of the Secretary of State
- Regimes of control
- Poppy-straw
- Import and export
- Possession and supply
- Prescriptions for controlled drugs
- Emergency supplies
- Marking of containers
- Registers and records
- Destruction of controlled drugs
- Midwives and controlled drugs
- Requisitions
- Accountable Officers
- Standard operating procedures
- Substance misusers
- Safe custody of controlled drugs
- Offences, penalties and enforcement
- Psychoactive substances
15. Veterinary medicines
- Veterinary medicines and authorisations
- Pharmacovigilance
- Classification, prescription and supply of veterinary medicines
16. Human medicines: homoeopathic medicines
- Definition of homoeopathic medicinal products
- Product Licences of Right
- The Simplified Homeopathic Registration Scheme
- National Homoeopathic Rules Scheme
- Exemptions for medicinal products at high dilution
- Exemption for registered products
- Advertising
- Homeopathic practitioners
- Controversy
17. Human medicines: herbal medicinal products
- Definitions
- Herbal medicines with marketing authorisations
- Labelling for herbal medicinal products holding a marketing authorisation
- Registration of a traditional herbal medicinal product
- Labelling for traditional herbal medicinal products
- Sale or supply by a licence holder
- Exemptions
- Banned or restricted herbal ingredients in medicines
- Herbal products as food
- Malaria
- Concerns over illegal herbal products
- Advertising
- Herbal practitioners
18. Human medicines: labelling, packaging and packet leaflets
- Definitions
- Offences and enforcement
- Labelling and packaging
- Packaging leaflets
- Requirements relating to child safety
19. Human medicines: advertising
- Requirements related to advertising
- Free samples for persons qualified to prescribe or supply medicinal products
- Inducements and hospitality
- Enforcement
20. Pharmacopoeias and compendia
- British Pharmacopoeia and compendia
- European Pharmacopoeia
- Compliance with official standards
- Specified publications
21: Poisons, denatured alcohols, chemicals and prohibition orders
- Non-medicinal poisons: legal framework
- Sale and supply of regulated substances
- Storage of poisons in retail premises
- Labelling and packaging of regulated and reportable substances
- Reporting of suspicious transactions, disappearances and thefts
- Denatured alcohols
- Chemicals
- UK REACH and Safety Data Sheets
- Control of substances hazardous to health
- Regulation of drug precursors
- Prohibition orders
22: Medical Devices
- Definition
- The Cumberlege review
- Post-market surveillance
- Registration and the MHRA
- CE marking
- UKCA marking
- Future changes
23: Confidentiality and Data Protection
- Confidentiality
- Data protection
- Freedom of Information Act 2000
24: Professional conduct
- Behaving professionally at all times
- Standards for pharmacy professionals
- Guidance to support the Standards for pharmacy professionals
- Guidance to support the standards for pharmacy premises
25: Fitness to practise
- The role of the General Pharmaceutical Council
- Fitness to practise
- Grounds for finding impairment
- Students
- First registration and good character
- Interim orders
- Initial action in respect of allegations
- Disposal of allegations without hearings
- The Fitness to Practise Committee
- Principal hearings, stage 1: findings of facts
- Principal hearings, stage 2: impairment of fitness to practise
- Principal hearings, stage 3: sanction
- Disqualification – bodies corporate and their officers
- Disqualification – all pharmacy owners
- Appeals
- Professional Standards Authority for Health and Social Care (PSA)
- Restoration to the Register and registration following removal
26: Criminal and civil liability
- Sources of criminal law.
- Criminal offences created in legislation
- Common law offences
- Rehabilitation of offenders
- Civil liability
- Sources of civil law
- Tort
- Negligence
- Breach of statutory duty
- Confidentiality and data protection
- Vicarious liability
- Indemnity and contribution
- Immunity from civil liability
- Product liability
- Intellectual property rights
- Civil penalties
Appendixes
- The Standards for pharmacy professionals
- Specified medicinal products at high dilutions
- Patient Group Directions
- Schedule 1A to the Poisons Act: Regulated and Reportable Substances
