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found, their irreversible elimination must be initiated in a documented manner (plan of action in the course of the hearing of the parties) before a license can be issued. The authorisation is issued by the [...] reached the end of the substantive inspection. I intend to move my location. What has to be done? A relocation is a substantial change within the meaning of Section 65 of the Austrian Medicines Act (AMG). "Section [...] program, require a permit from the Federal Office for Safety in Health Care within the meaning of Section 63(1)[...]." Changes of address are subject to approval, therefore an application for a change of the
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