Cap. 483 Art. 12Supervision and licensing.

(1) It shall not be lawful for any person to carry out any activity in connection with testing, processing, preservation, storage or distribution of human tissue and cells intended for human applications otherwise than in accordance with a licence issued under article 3.

(2) A licence shall not be required for -

(a) the storage and distribution of, and the performance of compatibility tests on, tissues and cells exclusively for use within hospital facilities; or which is licensed under this Part to carry out the activity in question;

(c) the direct distribution of specified tissues and cells for immediate transplantation to the recipient as long as the supplier is licensed for such activity.

(3) The application for the grant of a licence shall be made to the Licensing Authority and shall be accompanied by the prescribed fee.

(4) The application shall contain the information as may be prescribed and shall be submitted in the form and in the manner as may by rules be laid down by the Licensing Authority.

(5) Where an application is received by the Licensing Authority, it may -

(a) grant or refuse any application;

(b) grant such licence in respect of particular sites or activities only;

(c) grant such licence subject to conditions;

(d) refuse to process the application if such application has not been filed in accordance with this Act and regulations made thereunder;

(e) request the applicant to furnish it with additional information as it may deem necessary.

(6) When the Licensing Authority grants an application for licence, it shall give notice in writing to the tissues and cells establishment specifying -

(a) the activities which the establishment may undertake under this Act and regulations made thereunder at each site in respect of which a licence is granted;

(b) the conditions which apply to the undertaking of those activities; and

(c) the tissues and cells preparation processes which the establishment may carry out.

(7) The Licensing Authority may at any time remove or vary any of the licence conditions, or may impose additional conditions.

(8) When the Licensing Authority removes or varies any condition or imposes any additional condition, it shall inform in writing the establishment in question giving reasons for its decision.

(9) A tissues and cells establishment may not make any substantial change in the activities which it undertakes without the prior written approval of the Licensing Authority.

(10) Any application for approval to make a substantial change in the activities of the tissues and cells establishment shall be made

(a) to the sites from which the establishment operates or to the activities to be carried out at each site;

(b) which would result in breach of this Act or regulations made thereunder or of any condition specified by the Licensing Authority; or

(c) to the quality system which is likely to have a substantial impact on the conduct of, or might compromise the safety of, any of the activities which the establishment has been licensed to undertake.

(12) The Licensing Authority shall suspend or revoke the licence of a tissues and cells establishment or of a tissue or cell 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.