L10: Packaging and Labelling

• Parts of the Human Medicines Regulations 2012

  • General provisions
  • Administration
  • Manufacturing & wholesaling
  • Requirement for authorisation
  • Marketing authorisations
  • Certification of homeopathic medicinal products
  • Traditional herbal registrations
  • Article 126a authorisations
  • Borderline substances
  • Exemptions to requirement for marketing authorisation
  • Pharmacovigilance
  • Dealings with medicinal products
  • Packaging & leaflets
  • Advertising
  • British Pharmacopoeia
  • Enforcement
  • Miscellaneous
• It is an offence for anyone other than the MA holder to sell (or offer to sell) or supply (or offer to supply) a medicine (human) which does not comply with the packaging legislation or without a leaflet. Offenders can face a fine, conviction or imprisonment.
• Package


  Enclosure for one or more containers
• Container


  Inner receptacle which actually contains the medicine
• Labelling Requirements for MA Holders


  • Name of medicinal product (must also be in Braille)
  • Strength & pharmaceutical form
  • Whether intended for babies, children or adults (where appropriate)
  • Active substance common name (for up to 3 active substances)
  • Qualitative & quantitative expression of the active substance (common name) per dosage unit or for a given volume or weight
  • Pharmaceutical form & contents by weight, volume or number of doses
  • The method of administration
  • Where appropriate, space for the prescribed dose to be indicated (i.e., POMs require space for a dispensing label)
  • A warning that the product must be stored out of the reach & sight of children
  • Any applicable special warnings
  • Any applicable storage precautions
  • Expiry date (month and year)
  • Manufacturer's batch number (lot no.)
  • Name & address of MA holder
  • Marketing Authorisation number (Product licence no.)
  • Legal category if P or POM and if not a POM, instructions for use
  • Any special disposal precautions
  • A list of all excipients for injectable, topical or eye products or in any other case, excipients with a recognised action or effect
• Excipient


  A constituent of a medicine other than the active substance, added in the formulation for a specific purpose. Most are inactive, some have a known action and must be declared.
• MHRA Guidance for MA Holders on Best Design Practice for Safety


  • Packaging & labelling must be approved by MHRA (includes changes) before marketed
  • Labelling can contribute to medication error
  • Critical information together (same field of view)
  • Full name on 3 non-opposing faces (at least)
  • Generic cephalosporins Tallman lettering
  • Express different strengths of the same drug in the same manner (e.g., 250mg, 500mg, 750mg, 1000mg and NOT 1g)
  • No trailing zeros (e.g., 2.5mg and NOT 2.50mg)
  • 'micrograms' is spelled out in full (not abbreviated)
  • Positive administration instructions only
  • Consider colour to ensure accurate identification & selection
• The legislation allows symbols, diagrams, pictures or additional information on labelling, in line with the summary of product characteristics (SmPC), but not promotional.
• Labelling Requirements for Paracetamol Products

  • 'Contains paracetamol' unless already stated in product name
  • 'Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor' adjacent to dose directions
  • If intended for over 12-year-olds 'Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well'
  • If intended for under 12-year-olds 'Do not give anything else containing paracetamol while giving this medicine. Talk to a doctor at once if your child takes too much of this medicine, even if they seem well'
  • Either the leaflet or the packaging must include the explanation 'This is because too much paracetamol can cause delayed, serious liver damage'

  
• Paracetamol overdose untreated can result in irreversible hepatotoxicity & death. The number of deaths from paracetamol overdose in England & Wales has led to legislation changes in 1998 to restrict pack sizes.

  
• Labelling Requirements for Codeine & Dihydrocodeine Products

  • Over-the-counter (P & GSL) packs MUST include the warning 'Can cause addiction, for three days only'
  • Max. pack size of 32 tablets

  
• Leaflet Requirements

  • A leaflet (patient information leaflet or PIL) must be included unless all required information is on packaging
  • Requirement also applies to products dispensed in accordance with a prescription
  • Publicly available by MHRA
  • In accordance with the SmPC
  • Patient education & safety
• Leaflet Requirements for MA Holders

  • Name of medicinal product
  • Strength & pharmaceutical form
  • Whether intended for babies, children or adults (where appropriate)
  • Active substance common name (for up to 3 active substances)
  • Drug pharmaco-therapeutic group or type of activity (lay language)
  • Therapeutic indications
  • Contraindications (e.g., pregnancy, breastfeeding)
  • Precautions
  • Interactions (medicines and other substances)
  • Special warnings (e.g., possible effects on ability to drive & operate machinery)
  • Instructions for use (e.g., dose, route, frequency etc)
  • Adverse reactions (i.e., ALL known side-effects in descending order of frequency)
  • Reference to expiry date, storage requirements, active ingredients & excipients, name & address of MA holder, name & address of manufacturer
  • Information on adverse event reporting
  • Date last revised
  • Additional requirements for Paracetamol, codeine & dihydrocodeine products (warnings)
  • Additional requirements for Radiopharmaceuticals
• Legal Requirements of Dispensing Labels

  • Patient name
  • Name & Address of supplier (e.g., supplying pharmacy)
  • Date supplied
  • Product name (include quantity, product name/form, strength where appropriate)
  • Directions for use
  • Precautions relating to product use (e.g., 'For external use only' on a cream)
• Good Practice & Guidance for Dispensing Labels

  • 'Keep out of reach & sight of children'
  • Dispense & Check boxes for operator(s) initials
  • Cautionary & Advisory Labels (CALs)
• Good labelling practice for directions includes using the patient's full name (not just initials) and title to distinguish between family members.