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place a product on the market may submit an application to the Federal Office for Safety in Health Care (BASG) to determine whether this product falls within the definition of a medicinal product or a veterinary [...] Section 49a AMG or Section 2 (5) TAMG. Alternatively, persons wishing to place a product on the market can submit an informal enquiry to BASG by e-mail , which is answered by e-mail without a formal expert [...] BGBl. I 122/2021, as amended. We would like to point out that a fee-based application for qualification/classification can only be made by a manufacturer or authorised representative legally based in Austria
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for the registration of a traditional herbal medicinal product? 3. Under which conditions can a medicinal product be registered in accordance with Article 12 AMG? 4. What is a ‘corresponding’ herbal medicinal [...] exclusively designed for administration in accordance with a specified strength and posology. A corresponding product has been in medicinal use throughout a period of at least 30 years, including at least 15 years [...] No additional demonstration of the traditional use is required when a reference is made to a Community Monograph according to Article 16(h)3 of Directive 2001/83. For combinations with vitamins or minerals
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