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You must comply with regulatory requirements when making OTC medicines.
OTC medicines must be manufactured in accordance with the legislated Good Manufacturing Practice (GMP) standards to ensure their quality, safety and efficacy.
We regulate these activities to protect public health and ensure OTC medicines remain safe and effective.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to over-the-counter medicines. You may also have to meet obligations that apply to all medicines and all products.