Labelling Requirements.

Overview of TGA Labelling Requirements

• TGA (Therapeutic Goods Administration) sets out labelling requirements for medicinal products to ensure safety and efficacy.

• Key legislative documents include:

  • Therapeutic Goods Order No. 69: Dictates necessary contents of labels.

  • Required Advisory Statements: Outlines mandatory warning labels.

General Labelling Requirements

• All medicinal labels, regardless of classification, must meet specific guidelines:

  • Visibility: Labels must be clearly visible and not obscured.

  • Language: Information must be presented in English.

  • Durability: Labels should withstand environmental factors (e.g., oils) without fading or rubbing off.

  • Legibility: Text must be easily readable, avoiding decorative fonts that compromise clarity.

  • Text Size: Minimum text height of 1.5 mm.

  • Contrast: Characters must strongly contrast with the background to enhance readability.

  • Units of Measurement: Only metric units are permissible; no imperial or non-standard measurements such as teaspoons or fluid ounces.

Retail Sale Product Labelling Requirements

• Retail sale products (over-the-counter) must contain specific information:

  • Name of Medicine: Must clearly denote the product.

  • Active Ingredients: All active ingredients must be listed clearly.

  • Quantity of Active Ingredients: Should specify the proportions contained.

  • Dosage Form: Indicate if the product is a tablet, capsule, liquid, cream, etc.

  • Package Content: Total amount of medicine in the package.

  • Batch Number: Must be included for tracking purposes.

  • Expiry Date: Indicates the last date the product may be used.

  • Register Number: Must include either AUST-L or AUST-R number for identification.

  • Storage Conditions: Instructions on how to store the product (e.g., refrigeration).

  • Warning Statements: Any relevant warning or advisory information must be present.

Extemporaneously Dispensed Products Labelling Requirements

• Extemporaneous products are those prepared specifically for individual patients and must include:

  • Name and Form: Indicate the specific medicine and its form.

  • Quantity in Package: Specify how much medicine is dispensed.

  • Ingredient List: List all ingredients in descending order.

  • Patient's Name: Specific to the individual for whom it is prepared.

  • Dispensing Date: When the medicine is provided.

  • Expiry Date: Clearly state that after this date, the product should not be used.

  • Usage Instructions: Detailed instructions on how to use the medicine (e.g., dosage).

  • Practitioner's Details: Name and physical address of the prescribing practitioner for contact.

  • Importance of Ingredient Listing: Ensures the patient is aware of all components, particularly for allergy concerns. This is essential for safety, especially in emergency situations.

  • Name and contact details of prescribing practitioner and dispensary entity

Additional Notes

• Contact Information: Must be a physical address; phone numbers or emails are insufficient for legal purposes.

• If the product is dispensed by a different entity than the one that created it, both sets of details must be included.

• Additional warning statements may be included based on specific patient consultations (e.g., if a product contains a herb known for adverse reactions).

• Always ensure that relevant storage instructions are also conveyed clearly to ensure the product's integrity.