Cap. 483 Art. 5Licensing of blood establishments.

(1) It shall not be lawful for any person to carry out any activity listed in subarticle (2) other than in accordance with a licence issued under article 3.

(2) he activities referred to in sub-article (1) are:

(a) the collection of human blood components, whatever their intended purpose; and

(b) the testing of human blood components, whatever their intended purpose; and

(c) their preparation, storage and distribution when intended for transfusion, unless any such activity is undertaken in a blood establishment licensed for that purpose by the Licensing Authority. transfusion activities where such activities are performed by a hospital blood bank; or

(b) any person carrying out any of the activities referred to in subarticle (2) where that person carries out that activity on behalf of, and pursuant to, a contractual arrangement with -

(i) a blood establishment which is licensed under this Part to carry out the activity in question; or

(ii) a person responsible for the management of a hospital blood bank.

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

(5) 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.

(6) 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 submitted in accordance with this Act and regulations made thereunder;

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

(7) When the Licensing Authority grants a licence following an application, it shall give notice in writing to the blood establishment specifying -

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

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

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

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

(10) A blood establishment may not make any substantial and shall be accompanied by the prescribed fee.

(12) For the purpose of this article, a substantial change in a blood establishment’s activities is any change -

(a) to the sites from which the blood 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 those activities which the blood establishment has been licensed to undertake.