Cap. 458 Art. 3Functions of the Licensing Authority.

(1) The Superintendent of Public Health shall be the

Licensing Authority for the purposes of this Act.

(2) The Licensing Authority shall have the following functions:

(a) to establish standards to ensure the quality, safety and efficacy of medicinal products;

(b) to establish standards for the operation of pharmacies;

(c) to establish standards for the manufacture, preparation, assembly, packing, packaging or re-packing and labelling of medicinal products or any substance which is used or is intended to be used in such products;

(d) to establish standards for the operation of wholesale distribution;

(e) to establish standards for the testing or analysis of medicinal products or any substance which is used or is intended to be used therein;

(f) to establish standards for the carrying out of clinical trials;

(g) to establish standards for the reporting of adverse reactions, serious adverse reactions or suspected unexpected adverse reactions and make provision for the collection or submission of related information from any person or activity regulated by or under this Act;

(h) to establish standards in relation to the advertising of medicinal products;

(i) to advise the Minister in the making of regulations in respect of the classification of medicinal products;

(j) to issue, renew, amend, vary, suspend or revoke marketing authorisations for medicinal products;

(k) to withdraw or recall medicinal products from the market in the interest of public health; and

(l) to ensure compliance with international obligations entered into by the Government of Malta in relation to any matter regulated by or under this Act;

(m) to issue, renew, amend, vary, suspend or revoke any authorisation or licence that may be required by or under this Act;

(n) to carry out inspections of any activity, service or procedures in relation to medicinal products and to do all such things as may be necessary for the purpose of ensuring compliance with any provisions of this Act, or made thereunder v;

(o) to authorise the advertising and promotion of medicinal products;

(p) to carry out any other activity as may be prescribed;

(q) to advise the Minister on any matter connected with its functions or any other provision of this Act.

(3) The Licensing Authority may by rules delegate any of its functions referred to in subarticle (2)(l), (m), (n) and (o) to the Medicines Authority.

(4) The Licensing Authority shall levy such fees as may be prescribed for the purpose of this Act: Provided that such regulations may provide for the waiving of such fees in such circumstances as may be prescribed.

(5) For the proper exercise of its functions, the Licensing Authority may establish advisory committees as it may deem necessary.