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Part Two: Regulation and Circulation of Medical Products
Chapter One: Marketing Authorization and Authorized Marketer
Part Two: Regulation and Circulation of Medical Products
Chapter One: Marketing Authorization and Authorized Marketer
Article (4) Evaluation of Product's satisfaction of Research Information
Marketing authorization of the new medical product or for a new use or adopting a new method shall be issued by the Ministry depending on the evaluation of the product's satisfaction of research information that proves its effectiveness, safe use, conformity with the approved quality standards or marketing approvals of the product issued by the reference states, provided that the applicant has the right to market the product in accordance with the intellectual property and trademark rules.
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