12(21)-1 Labelling of RMPs BB

Intended Learning Outcomes

  • Understanding packaging information and labelling requirements for relevant medicinal products (RMPs).

Relevant Medicinal Products (RMPs)

  • Categories:

    • GSL (General Sales List) medicines (e.g., aspirin).

    • P medicines (Pharmacy medicines).

    • POM (Prescription Only Medicines).

Legislation Underpinning Labelling of Medicines

  • Human Medicines Regulations 2012:

    • Part 13: Packaging and Leaflets.

    • Schedule 24: Packaging information requirements.

    • Schedule 25: Specific packaging provisions.

  • Misuse of Drugs Regulations 2001: Additional labelling requirements for controlled drugs (CDs).

Labelling Requirements for RMPs

  • Must be:

    • Easily legible.

    • Comprehensible.

    • Indelible.

  • Language:

    • English only, or English plus one or more other languages.

    • Braille format on outer packaging required for the product name.

Schedule 24: Outer & Immediate Packaging Information Requirements

  • Must include:

    • Name of medicinal product.

    • Common names of up to 3 active substances.

    • Qualitative and quantitative statement of active substances per dosage unit or volume/weight.

Common Name Definition

  • INN (International Non-proprietary Name): Generic name.

  • Example listings:

    • INN: ibuprofen; Brand: Nurofen®.

    • INN: paracetamol; Brand: Aspirin®.

Specific Labelling for Medicines

  • P medicine: "P" in a rectangle.

  • POM: "POM" in a rectangle.

  • CD (Schedules 2 & 3): Label requirements.

Additional Packaging Information

  • May include symbols, diagrams, or pictures for clarity.

  • No promotional material allowed.

Exceptions to Labelling Requirements

  • Blister packs placed in compliant outer packaging.

  • Small packaging unable to display all required information.

Additional Requirements for Paracetamol-containing Products

  • Must state: "Contains paracetamol" unless included in product name.

  • Warning: "Do not take more than label tells you. Talk to your doctor if not improving."

  • Special wording for children regarding overdose risks.

Public Awareness Survey Findings (YouGov, 2012)

  • 1 in 6 parents (17%) unaware Calpol contains paracetamol.

  • High percentages unaware common products like Disprol (68%) and Medised (79%) contain paracetamol.

  • Confusion overall regarding paracetamol’s effective treatments.