New rules for medicine labelling take effect

2 minute read

New rules have been launched to ensure clearer and more meaningful information on medicine labels for consumers


New rules were introduced this month to ensure clearer and more meaningful information on medicine labels for consumers.

The new requirements will apply to both prescription and non-prescription medicines bought at pharmacies and other retail outlets and are designed to improve safer usage, particularly for people with allergies, and to reduce accidental overdoses.

The move is the first update to labelling regulations for more than 15 years and will align Australian labelling more closely to international standards.

“Many higher risk over-the-counter medicines will be required to include a health panel with details of active ingredients, uses, warnings and directions for use,” Federal Health Minister Sussan Ley said.

“These changes will also require that a space must be included for pharmacists to apply dispensing labels to prescription medicines.”

Consultations with the healthcare industry and the public over the past five years by the Therapeutic Goods Administration had identified the safety concerns with labelling, the minister said.

These included: a lack of awareness of active ingredients in medicines; inconsistent placement of information; difficulties in identifying advisory statements such as contraindications; complexity and legibility issues.

Head of the TGA, Professor John Skerritt, said new minimum text height requirements for names and quantities of active ingredients would improve the readability of labels for high-risk medicines.

“To allow easier identification by both consumers and medical practitioners, this information must also be placed adjacent to, or below, the name of the medicine,” Professor Skerritt said.

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