S.L. 483.6 Art. 3The Licensing Authority. Cap. 586.

(1) The Superintendent of Public Health shall be the

Licensing Authority for the purposes of these regulations.

(2) The Licensing Authority, hereinafter referred to as "the Authority", shall have the following functions:

(a) to ensure that procurement organisations and transplantation centres have in place a framework for quality and safety in accordance with regulation 4;

(b) to indicate to the procurement organisations and transplantation centres which activities they may undertake;

(c) to establish conditions applicable to procurement organisations and transplantation centres;

(d) to issue, renew, amend, vary, suspend or revoke any licence that may be required by or under these regulations;

(e) to carry out inspections of procurement organisations, conditions of procurement and transplantation centres and to organize control measures in such procurement organisations and transplantation regularly and in any case not less than once every two years;

(f) to grant, suspend, or withdraw, as appropriate, the authorisations of procurement organisations or transplantation centres or prohibit procurement organisations or transplantation centres from carrying out their activities where control measures demonstrate that such organisations or centres are not complying with the requirements of these regulations;

(g) to establish guidelines concerning the conditions of the inspections and control measures, and on the training and qualification of the officials involved in order to reach a consistent level of competence and performance;

(h) to put in place a reporting system and management procedure for serious adverse events and reactions as provided for in regulation 11(1) and (2);

(i) to issue appropriate guidance to healthcare establishments, professionals and other parties involved in all stages of the chain from donation to transplantation or disposal, which may include guidance for the collection of relevant post-transplantation information to evaluate the quality and safety of the organs transplanted;

(j) supervise organ exchange with other Member States and with third countries as provided for in regulation 18(1);

(k) to ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ transplantation activities, in conformity with the Data Protection Act and European Union legal provisions on the protection of personal data, in particular Directive 95/46/EC.

(3) The Licensing Authority may by rules delegate any of the functions referred to in sub-regulation (2) to any other body it deems competent. Such a body may also assist the Authority in carrying out its functions.

(4) The Licensing Authority shall levy such fees as may be prescribed for the purpose of this Act.