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

Cap. 483 · cap/483 (Cap. 483)

Cap. 483 Art. 13Revocation or suspension of licence.

PART IV

In KraftAmtlicher Text

(1)(a) The Licensing Authority may suspend or revoke the licence of a tissues and cells establishment on one or more of the following grounds:

(i) that the establishment has failed, in any material respect, to comply with the requirements of this Act or regulations made thereunder;

(ii) that the information given by the blood establishment was false or incomplete in any material respect.

(b) In addition the Licensing Authority shall suspend or revoke the licence of a tissues and cells establishment or of a tissues or cells preparation process if inspections or control measures demonstrate that such an establishment or process does not comply with the requirements of this Act and regulations made thereunder.

(2) Prior to suspending or revoking the licence of a blood establishment, the Licensing Authority shall serve a notice on the blood establishment stating that it intends to suspend or revoke its licence with effect from the date specified in the notice, giving reasons for such decision: Provided that such suspension or revocation shall take effect immediately when the Licensing Authority considers that it is necessary in the interests of safety.

(3) In those cases where -

(a) the establishment has failed, in any material respect, to comply with the requirements of this Act or regulations made thereunder; or

(b) the information given by the establishment was false or incomplete in any material respect, and the the Licensing Authority may serve a notice on the responsible person of the establishment:

(i) identifying the requirements of which the establishment is in breach or, in the case of false and incomplete information, the further information which is required;

(ii) identifying the action which the establishment is required to take; and

(iii) giving the timescale within which the blood establishment shall take the action identified in subparagraph (ii).

(4) If the establishment fails to comply with the requirements set out in the notice within the specified timescale, the Licensing Authority may, by a notice served on the establishment, suspend or revoke the licence of the establishment.

(5) Any suspension shall be for such period as the Licensing Authority shall consider necessary having regard to the reasons for the suspension.

(6) The suspension or revocation of an licence may be total, or limited to a particular activity or to one or more activities carried out at a particular site or sites, or to a particular tissue and cell.