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Dale and Appelbe's Pharmacy and Medicines Law.

Author: Joy Wingfield; Karen Pitchford
Publisher: London : Pharmaceutical Press, 2017.
Edition/Format:   eBook : Document : English : 11th edView all editions and formats
Summary:
This 11th edition of Dale and Appelbe's Pharmacy and Medicines Law is your guide to law and ethics for pharmacy practice in the UK. It covers law and professional regulation and is firmly established as the definitive student textbook and reference work on this subject in the UK. Fully updated to include changes to pharmacy laws and regulation.
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Wingfield, Joy.
Dale and Appelbe's Pharmacy and Medicines Law.
London : Pharmaceutical Press, ©2017
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Joy Wingfield; Karen Pitchford
ISBN: 9780857113153 0857113151
OCLC Number: 1020029483
Description: 1 online resource (570 pages)
Contents: Cover --
Title Page --
Copyright --
Contents --
Preface to the Eleventh Edition --
Foreword --
About the contributors --
Introduction --
Development of the law in relation to pharmacy, medicines and poisons --
List of legislation --
European law --
UK law --
Cases --
Cases before the European Court of Justice --
Cases before national courts and authorities, United Kingdom --
Abbreviations and acronyms --
Chapter 1: Sources of law --
Introduction --
European law --
The European institutions --
British law --
Statute law --
Administrative law --
Professional law --
Civil law --
Human rights in the UK --
The court system --
How to find the law --
Statute law --
Case law --
Finding European law --
Examples of European law --
Human rights law --
Key human rights in relation to healthcare practice --
Morals, ethics and law --
Summary --
Further reading --
Websites --
Chapter 2: Human medicines: scope of regulation --
Consolidation of Medicines Legislation (2012) --
The Human Medicines Regulations 2012 --
Part 1 General provisions --
Definition ofmedicinal product --
Special provisions restricting scope --
Classification ofmedicines --
Licensing authority andMinisters --
Advertisements relating to medicinal products --
General interpretation --
Part 2 Administration --
Commission on Human Medicines --
British Pharmacopoeia Commission --
Part 11 Pharmacovigilance --
Falsified Medicines-Part 12A Sale of medicines to the public at a distance --
Part 16 Enforcement --
Inspection, sampling and seizure --
Part 17 Legal proceedings --
Medical devices --
Conformity: CEmarking --
Summary --
Further reading --
Websites --
Chapter 3: Human medicines: the licensing system --
Marketing authorisations for human medicines --
Implications of marketing authorisations and definitions --
Revocation, variation or suspension --
Post-authorisation requirements. Generic products --
Borderline products --
Immunity from liability for unauthorised medicinal products --
Early Access to Medicines Scheme --
Parallel importing --
Legal basis for parallel imports --
Marketing authorisations for parallel imports --
Registration certificates for homoeopathic medicines for human use --
Product Licences of Right for homoeopathic (and anthroposophic) medicines for human use --
Registration of traditional herbal medicinal products --
Article 126a authorisations --
Falsified Medicines Directive --
Manufacturer's and Wholesale Dealer's Licences --
Issue of licences --
Manufacturer's licences --
Wholesale dealer's licences --
Considerations common to manufacturer's and wholesale dealer's licences --
Fees for licences --
Pharmacovigilance --
Exemptions --
Exemptions for clinical trials --
Exemptions for doctors and dentists --
Exemptions for pharmacists --
Exemptions for nurses and midwives --
'Specials' --
Mixing of medicines --
Hospitals --
Summary --
Further reading --
Websites --
Chapter 4: Human medicines: advertising --
Advertising under Part 14 of the Human Medicines Regulations 2012 --
Definitions --
Requirements related to advertising --
Duties of holders of marketing authorisations (HMRs Reg.281) --
Scrutiny by Ministers --
General principles --
Advertisements directed to the public (HMRs Regs.282-292) --
Vaccination campaigns --
Form and content of advertisements --
Prohibition of supply to the public for promotional purposes --
Advertising to persons qualified to prescribe or supply --
Abbreviated advertisements --
Writtenmaterial accompanying promotions --
Medical sales representatives --
Advertisements for registered homoeopathic products --
Advertisements for traditional herbalmedicinal products --
Holders of 'specials manufacturer's licences'. Free samples for persons qualified to prescribe or supply medicinal products --
Inducements and hospitality --
Monitoring of advertising --
Summary --
Further reading --
Websites --
Chapter 5: Pharmacy businesses --
Lawfully conducting a retail pharmacy business --
Responsible Pharmacist --
The Responsible Pharmacist Regulations --
Registration of pharmacy premises --
Change of ownership --
Premises retention fees --
Titles, descriptions and emblems --
Standards in pharmacies --
Summary --
Further reading --
Websites --
Chapter 6: Human medicines: Pharmacy Medicines --
Pharmacy Medicine defined --
Exemptions in cases involving another's default --
Exemption for collection and delivery arrangements --
Summary --
Further reading --
Websites --
Chapter 7: Human medicines: General Sale Medicines --
General Sale List Medicines defined --
Conditions applying to retail sale or supply of General Sale List medicinal products --
Sales on aircraft and trains --
Automatic machines --
Retail pack sizes of certain products --
Aloxiprin, aspirin and paracetamol --
Ibuprofen --
Products not to be on general sale --
Summary --
Further reading --
Websites --
Chapter 8: Human medicines: Prescription Only Medicines --
Prescription Only Medicines defined --
Exemptions from Prescription Only control --
Medicinal products exempt due to conditions specified in Schedule 1 of the POM Order --
Preparations of aloxiprin, aspirin or paracetamol in the form of non-effervescent tablets or capsules exempt due tomaximum strength or quantity sold or supplied --
Preparations of pseudoephedrine salts or ephedrine base or salts exempt due to conditions --
High dilution products --
Sale or supply of Prescription Only Medicines --
Administration of Prescription Only Medicines --
Prescriptions --
Prescribing and administration by supplementary prescribers --
Due diligence clause. Forgeries --
Pharmacy records --
Particulars of prescriptions to be recorded --
Preservation of pharmacy records --
Labelling of dispensed medicines --
Exemptions from the need for a prescription --
Exemptions for hospitals, clinics and similar settings --
Exemptions for persons conducting retail pharmacy businesses --
Emergency supply by a pharmacist: pandemic diseases --
Exemption for supply in the event or anticipation of pandemic disease --
Exemptions from Prescription Only for certain persons, including persons who supply under Patient Group Directions --
Mixing of medicines --
Summary --
Further reading --
Websites --
Chapter 9: Human medicines: exemptions from controls --
Introduction --
Exemption for supplies by doctors, dentists or other healthcare professionals to their patients (HMRs Reg.223, as amended) --
Patient Group Directions --
Supply under a Patient Group Direction by NHS bodies and local authorities --
Supply under a Patient Group Direction to assist doctors or dentists --
Supply under a Patient Group Direction by independent hospitals, etc. (HMRs Reg.231) --
Supply under a Patient Group Direction by dental practices and clinics: England andWales (HMRs Reg.232) --
Supply under a Patient Group Direction by a person conducting a retail pharmacy business --
Supply under a Patient Group Direction to assist the police, etc. (HMRs Reg.234) --
Other exemptions for sale, supply or administration by certain persons (Sch. 17 to the HMRs) --
Midwives --
Registered nurses --
Registered optometrists --
Registered chiropodists and podiatrists --
Registered orthoptists --
Registered paramedics --
Public analysts, sampling officers and other such persons --
National Health Service drug testing --
Owners andmasters of ships --
Offshore installations --
Statutory requirements formedical treatment of employees. Persons employed or engaged in the lawful drug treatment services --
Holders of Controlled Drugs authorities --
Royal National Lifeboat Institution --
British Red Cross Society and other such organisations --
School and pre-school dental schemes --
Sale of salbutamol inhalers to schools --
Mountain rescue teams --
Occupational health schemes --
Operators or commanders of aircraft --
Operator of a train --
Universities, higher education institutions or institutions concerned with research --
Supplies by holders of marketing authorisations --
Summary --
Further reading --
Websites --
Chapter 10: Human medicines: wholesale dealing --
Conditions on sales by way of wholesale dealing --
Prescription Only and Pharmacy Medicines by wholesale dealing --
Wholesale dealing from a pharmacy --
Wholesale dealing of veterinary products --
Summary --
Further reading --
Websites --
Chapter 11: Human medicines: sale and supply of homoeopathic medicines --
Homoeopathic medicines for human use: licensing --
Medicinal products at high dilutions (homoeopathic medicines) --
Exemptions for medicinal products at high dilution (homoeopathic medicines) --
Homoeopathic medicines for treatment according to the judgement of the seller --
Homoeopathic medicines for which General Sale is permitted --
Exemption for certain (registered) homoeopathic medicinal products (HMRs Reg.243) --
Specified medicinal products at high dilutions --
Summary --
Further reading --
Websites --
Chapter 12: Human medicines: herbal medicines --
Definitions --
Registration of a traditional herbal medicinal product --
Labelling for traditional herbal medicinal products --
Sale or supply by a licence holder --
Herbal remedy --
Exemptions on sale or supply of certain herbal remedies --
Schedule 20 conditions on retail sale or supply --
Banned or restricted herbal ingredients in medicines.

Abstract:

This 11th edition of Dale and Appelbe's Pharmacy and Medicines Law is your guide to law and ethics for pharmacy practice in the UK. It covers law and professional regulation and is firmly established as the definitive student textbook and reference work on this subject in the UK. Fully updated to include changes to pharmacy laws and regulation.

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