Modification of initial authorization conditions - Change of authorization holder and RELOCATION OF HEADQUARTERS/WORKING POINT - Legal entity THROUGH SALE-PURCHASE (UF-DSP)*
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The procedure is addressed to pharmaceutical units in situations where changes occur to the conditions that formed the basis for issuing the operating license - change of holder of the Operating License through modification of the legal entity (by sale-purchase) and change of the address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Directorate of Medicines Policy and Medical Devices within 5 working days from the date of the modification.
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In the case of a dispute between the beneficiary and the competent authority, the provisions of the common law are applicable.
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