Cap. 458 Art. 6Functions of the Medicines Authority.

(1) The Medicines Authority shall have the following functions:

(a) to carry out those such functions as may be delegated to it by the Licensing Authority in terms of article

3(3);

(b) to assist and advise the Licensing Authority on any matter relating to the regulation of medicinal products and related activities;

(c) to undertake such activities and projects as may be necessary or expedient for the proper exercise of its functions;

(d) to establish such procedures as may be necessary for obtaining and assessing information as regards the safety, quality and efficacy of medicinal products to be placed on the market in Malta;

(e) to establish such procedures as may be necessary to make such assessments of medicinal product safety, quality and efficacy as it may deem necessary for those products to be placed on the market in Malta;

(f) to establish such procedures as may be necessary for monitoring and obtaining reports on the quality, safety or efficacy of medicinal products;

(g) to make recommendations to the Licensing Authority in relation to standards and licensing;

(h) to advise the Licensing Authority on the precautions or restrictions to which medicinal products may be subjected for their marketing or continued use in Malta;

(i) to furnish, whenever it so thinks fit or is so requested by the Licensing Authority, advice or make recommendations to the Licensing Authority in relation to any matter connected with its functions; and

(j) to notify the EU Commission of non-prescription medicinal products which in its judgement are at risk of falsification and may inform the EU Commission of medicinal products which may be deemed not to be at risk according to the criteria set out in Article 54a(2b) of Directive 2001/83/EC as amended.

(2) For the proper exercise of its functions, the Medicines Authority may require the production of such information or documents as may be necessary for any of its functions and may seek expert advice from any person, who is not a member of the Medicines Review Board, possessing the necessary qualifications and experience, and may also establish such advisory committees as it may deem necessary, either for general or specific purposes.

(3) The Medicines Authority shall levy such fees as may be prescribed for the purposes of this Act: Provided that such regulations may provide for the waiving of such fees in such exceptional circumstances as may be prescribed.