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What Is Meant By 'marketing Authorisation'? |
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Answer» Marketing Authorisation is a set of regulatory requirements specified on the ARTG and any other requirements imposed by a relevant Delegate of the SECRETARY UPON product listing or registration. Examples of regulatory requirements include, but are not limited to, compliance with REGISTERED formulations, special storage and transportation conditions, shelf life, labelling, batch release testing requirements etc. The Marketing Authorisation is equivalent to a Certificate of Registration or a Certificate of Listing for a medicinal product under the Therapeutic GOODS Act 1989. Marketing Authorisation is a set of regulatory requirements specified on the ARTG and any other requirements imposed by a relevant Delegate of the Secretary upon product listing or registration. Examples of regulatory requirements include, but are not limited to, compliance with registered formulations, special storage and transportation conditions, shelf life, labelling, batch release testing requirements etc. The Marketing Authorisation is equivalent to a Certificate of Registration or a Certificate of Listing for a medicinal product under the Therapeutic Goods Act 1989. |
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