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

Edited by: David H. Reissner, Christopher A. Langley

ISBN13: 9780857114938

Previous Edition ISBN: 9780857114204

To be Published: July 2025

Publisher: Pharmaceutical Press

Country of Publication: UK

Format: Paperback

Price: £70.00

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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

Subjects:: Medical Law and Bioethics

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