L03: The Law, Medicines Act & Licensing of Medicines

• UK legal system


  3 legal systems in the UK - England and Wales, Northern Ireland and Scotland
• Categories of law in England and Wales

  • Common law (originates from judges)
  • Statute law (created by Parliament in form of legislation)
• Statute law takes precedence over common law
• Areas of law in England and Wales

  • Private law (applies to people in private relations as citizens or organisations)
  • Public law (applies to everyone)
• Both private and public law may include statute law (i.e. legislation)
• Types of legislation


  • Primary legislation (Acts of parliament)
  • Secondary legislation (Statutory instruments, regulations, orders, rules, directions)
• Statutory instruments (SI)


  Set out by the Act to give detail of implementation
• Codes of practice


  Not legislation but support legislation, set standards for how to comply with legislation
• If found to have breached legislation and not followed relevant code then highly likely to be found guilty of a criminal offence
• Medicines Act 1986


  Was the main legislation until 2012 to regulate authorisation, sale & supply of medicinal products for human use
• Human Medicines Regulations (HMR) 2012


  More concise version of Medicines Act 1986 that mostly replaced it, but registration and conduct of pharmacies remain under Medicines Act 1968
• Reasons why legislation and regulation is needed for medicines

  • Advertising
  • Claims
  • Evidence
  • Quality
  • Safety
• Definition of medicinal product

  Any substance or combination of substances presented as having properties of preventing or treating disease in human beings or any substance or combination of substances that may be used or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting pharmacological, immunological or metabolic action or making a medical diagnosis
• Parts of Human Medicines Regulations 2012


  • General provisions
  • Administration
  • Manufacturing and wholesaling
  • Requirement for authorisation
  • Marketing
  • Pharmacovigilance
  • Dealings with medicinal products
• Manufacturing Authorisation (MA)


  Manufacturers must hold this to manufacture medicinal products
• Wholesale Distribution Authorisation (WDA)

  Wholesalers must hold this to wholesale medicinal products
• Marketing Authorisation (Product License)

  Medicinal products must be licensed and given this unique identifier before being placed on the UK market, sets out agreed terms and conditions of use
• How Marketing Authorisations are obtained

  1. Manufacturers submit evidence to MHRA of safety, quality and efficacy

  2. Summary of Product Characteristics (SPC or SmPC) defines what the medicine is to be used to treat, dosing, side effects, contraindications
• Other types of authorisations

  • Certification of homeopathic medicinal products
  • Traditional herbal registrations
  • Article 126a authorisations
  • Borderline substances
  • Exemptions to requirement for marketing authorisation
• Unlicensed medicines


  'Specials' - certain prescribers may prescribe these to fulfil special patient needs where no licensed alternative are available
• Unlicensed use of a medicine

  'Off-label' - certain prescribers may prescribe these to fulfil special patient needs where no licensed alternative are available
• Categories of medicines


  • Prescription Only Medicines (POM)
  • Pharmacy medicines (P)
  • General Sales List (GSL)
• Prescription Only Medicines (POM)


  May only be sold or supplied with a prescription, includes Controlled Drugs (CDs)
• Pharmacy medicines (P)


  May only be sold or supplied from registered pharmacies by or under supervision of a pharmacist
• General Sales List (GSL)

  Can with reasonable safety be sold or supplied to public without pharmacist supervision, may be sold from premises which are not registered pharmacies, must be in original pack
• Medicinal products that can only be licensed as POM

  • Parenteral administration (injections)
  • Controlled drugs
  • Radiation emitting drugs (cancer treatment)
• Some medicinal products may only be licensed as POM or P medicines, others may be licensed as POM, P and/or GSL medicines depending on factors like pack size
• Responsibilities of MHRA


  • Enforce legislation for human medicines
  • Operate the licensing system
  • Regulate manufacture, sale, supply and advertising for human medicines
  • Ensure product labels, leaflets, prescribing information and advertising meets legislative requirements
  • Administer a system of continuous safety monitoring (pharmacovigilance)
  • Aim to ensure safety, quality and efficacy