Regulation impact statement: General requirements for labels for medicines

The purpose of this Regulation Impact Statement (RIS) is to assist the Australian Government decision making process on how to address problems that have been identified in relation to the labelling of medicines in Australia.

A number of options to address the identified issues are examined in the RIS, including the risk to consumer safety if no action is taken.

These options have been developed following consultation conducted by the Therapeutic Goods Administration (TGA) in 2012, 2014 and 2015. Stakeholders participating in these consultations were industry peak bodies and key health professional and consumer groups including:

• Generic Medicines Industry Association (now the Generic and Biosimilar Medicines Association)
• Medicines Australia
• Australian Self Medication Industry
• Complementary Healthcare Council of Australia (now Complementary Medicines Australia)
• The Pharmacy Guild of Australia
• Pharmaceutical Society of Australia
• Society of Hospital Pharmacists of Australia
• Council of Australian Therapeutic Advisory Groups
• Australian Medical Association
• Royal Australasian College of Physicians
• Consumer Health Forum of Australia

A comparison of medicine labelling requirements applied by overseas regulators has also been undertaken. These agencies include Health Canada, the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, European Medicines Agency and New Zealand Medicines and Medical Devices Safety Authority (Medsafe).

Certification

How to access a pdf document

• Signed letter from TGA's National Manager to the Office of Best Practice Regulation (pdf,67kb)
• Signed letter from the Office of Best Practice Regulation assessing that the RIS is compliant with the Government's RIS requirements and the RIS is consistent with best practice (pdf,85kb)