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In Hungary for the API distributors, the relevant regulations states that "Importers, manufacturers and distributors of active pharmaceutical ingredients established or established in Hungary must notify OGYÉI of the data on their activities no later than 60 days before the planned commencement of their activities . If OGYÉI deems it necessary, it shall notify the applicant within 15 days of receipt of the notification that it intends to carry out an inspection. In this case, the activity cannot be started until authorized by OGYÉI."
Is there anyone, who has experience with API distribution in Hungary who can help to understand how common the inspections by the authorities after the notification of API distribution activities? whether for drop shipment of APIs where no warehouse exist, is the API distribution notification still needed? Or in case of a local warehouse, whether the authorities require a GDP compliant warehouse with full QMS?