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Clear labelling helps ensure biologicals are used safely and effectively.
Labelling and packaging for biologicals must be clear, accurate, and durable. Labels must be in English, easy to read, securely attached and include key details in metric units.
Biologicals cannot be advertised to the public but may advertised exclusively to certain health professionals. Advertising to health professionals is strictly controlled and must be evidence-based.
These rules help ensure safety, traceability, and public trust. We monitor compliance to protect consumers and support informed decisions.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information about biologicals, and specific types of biologicals. You may also have to meet obligations that apply to all products.