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Relevant regulations in Hungary states that "Importers, manufacturers and distributors of active pharmaceutical ingredients 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."
do you have any experience whether for drop shipment model of APIs without the presence of a local warehouse, is it still needed to be registered as API distributor or in case of having a local warehouse, does the authority requires a GDP compliant warehouse with full QMS? Is the inspection common or are they just requiring the notification to relevant authority before the start of the API distribution activities?