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Rejection of application If any document submitted by an applicant for grant of licence for import or manufacture or test licence or permit for personal use or permission to import or manufacture investigational medical device or new in vitro diagnostic medical device or permission to conduct of clinical investigation or clinical performance evaluation is found to be misleading, or fake, or fabricated, the application, after giving an opportunity to the applicant of being heard, shall be summarily rejected. 93. Debarment of applicant (1) Whoever himself or, any other person on his behalf, or applicant is found to be guilty of submitting misleading, or fake, or fabricated documents, may, after giving him an opportunity to show cause as to why such an order Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 76 of 248 should not be made, in writing, stating the reasons thereof, be debarred by the Central Licensing Authority or the State Licensing Authority, as the case may be, for such period as it may deem proper. (2) Where an applicant is aggrieved by an order made by the Central Licensing Authority or the State Licensing Authority, as the case may be, under sub-rule (1), such applicant may, within thirty days of the receipt of the order, make an appeal to the Central Government or the State Government, as the case may be, and that Government may, after such enquiry as it considers necessary, and after affording an opportunity of being heard, make such order as it may deem proper.
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