Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
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S.L. 458.47 · Good Clinical Practice And (S.L. 458.47)

S.L. 458.47 Art. 9Issuing of authorisation.

In KraftAmtlicher Text

(1) The Authority shall issue the authorisation only after verifying the accuracy of the particulars provided by the applicant pursuant to regulation 8 by means of an inquiry carried out by its agents.

(2) The Authority shall take all appropriate measures to ensure that the procedure for granting an authorisation is completed within ninety days from the receipt of a valid application.

(3) The Authority may require from the applicant further information concerning the particulars supplied pursuant to regulation 8(1), including in particular information concerning the qualified person at the disposal of the applicant in accordance with regulation 8(1)(e): Provided that where the Authority exercises that right, the application of the time-limits aforementioned shall be suspended until the additional data required have been supplied.