Dale and Appelbe's Pharmacy and Medicines Law 13th ed
Dale and Appelbe's Pharmacy and Medicines Law 13th ed

Medical Law

Dale and Appelbe's Pharmacy and Medicines Law 13th ed

Edited by David H. Reissner · Christopher A. Langley
Pharmaceutical Press August 2025

Specifications

ISBN-13
9780857114938
Publisher
Pharmaceutical Press
Publication
August 2025
Format
Paperback
Jurisdiction
U.K. ? Countri(es) for reference only

Details

Dale and Appelbe’s Pharmacy and Medicines Law covers law and professional regulation and is firmly established as the definitive student textbook and reference work on this subject in Great Britain.

This edition has been extensively revised to include:

  • New chapters on Hospital pharmacy and Online pharmacy
  • Expanded coverage of manufacturing and clinical trials
  • Addition of new case law to many of the chapters
  • Topical issues are covered and illustrated by action taken by regulators

Changes in the law since the 12th edition, including:

  • Regulations governing veterinary medicines.
  • Many changes resulting from Brexit, and the Windsor Framework which came into force on 1 January 2025.
  • New legal duties of superintendent pharmacists and responsible pharmacists.
  • Chief pharmacists.
  • Original pack dispensing.
  • New case law on pharmacist supervision.
  • Medical examiners

From tte Foreword in the new edition:

"Pharmacy has an honourable tradition as keeper of the health professions' body of knowledge and professional conscience when it comes to medicines and the complex laws governing their safe and effective use. This new, 13th edition of Dale and Appelbe's Pharmacy and Medicines Law provides essential underpinning for this unique and enduring aspect of the pharmacy professions' vocation”

Duncan Rudkin, CEO, General Pharmaceutical Council, April 2025

Table of Contents

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
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