Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
LAWxPERT Anmelden Kostenloses Konto

S.L. 458.63 · Permission For The Supply Of Medicines For (S.L. 458.63)

S.L. 458.63 Art. 8Rights pertaining to the Licensing Authority.

In KraftAmtlicher Text

(1) The Licensing Authority shall have the right to amend, suspend or revoke the permission at any time:

(a) if any information in the application on which the permission was granted is found to be either false or incomplete;

(b) if a material change of circumstances has occurred in relation to the application which was not duly reported by the applicant;

(c) if the permission holder does not adhere to all the conditions as established by these regulations or under the Act; or

(d) for any other circumstances which the Licensing Authority considers fit.

(2) Furthermore, the Licensing Authority has the right to request the applicant for any relevant additional information at any time.

SCHEDULE

(regulations 4 and 6) For each application for €4,000 the first year For each application for €6,000 subsequent years