Export obligation monitoring required for advance authorizations on imported drugs; regional authorities must initiate action after maximum fulfillment period. Advance Authorization for import of approved and unapproved drugs allowed without registration is subject to a pre-import condition and a six-month export obligation from first import; authorization validity is twenty-four months with possible six-month revalidation so the maximum period for fulfilling the export obligation may extend to thirty-six months from grant. Regional Authorities must monitor E.O. compliance and initiate appropriate action immediately after the maximum period for fulfillment expires.
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Export obligation monitoring required for advance authorizations on imported drugs; regional authorities must initiate action after maximum fulfillment period.
Advance Authorization for import of approved and unapproved drugs allowed without registration is subject to a pre-import condition and a six-month export obligation from first import; authorization validity is twenty-four months with possible six-month revalidation so the maximum period for fulfilling the export obligation may extend to thirty-six months from grant. Regional Authorities must monitor E.O. compliance and initiate appropriate action immediately after the maximum period for fulfillment expires.
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