Cap. 458 чл. 106Power of Minister to make regulations.

The Minister may, after consultation with the Licensing

Authority, amend the schedules to this Act, prescribe by regulations anything that may be prescribed under this Act and make provision on any matter relating to medicinal products, poisons and pharmacies in order to give fuller effect to the provisions of this Act, and, in particular, but without prejudice to the generality of the aforesaid, shall by such regulations regulate or otherwise provide for:

(a) the grant of marketing authorisations;

(b) the manufacture of medicinal products and raw materials used in such manufacture;

(c) the wholesale distribution of medicinal products;

(d) the sale and supply of medicinal products;

(e) the licensing of pharmacies;

(f) the reporting of adverse drug reactions;

(g) advertising in respect of medicinal products, and the presentation and information contained in the advert: Provided that the advertising of certain medicinal products or classes of medicinal products may, by such regulations, be prohibited;

(h) the conduct of clinical trials;

(i) the classification of medicinal products;

(j) the testing of medicinal products;

(k) the regulation of homeopathic medicinal products; radiopharmaceuticals and medicinal products derived from human blood and human plasma; immunological products, and herbal products;

(l) the roles and responsibilities of a licence or authorisation holder;

(m) the roles and responsibilities of the managing pharmacist, responsible person and qualified person;

(n) standards of good practice in the manufacture, wholesale, distribution and dispensing of medicinal products: Provided that in the case of dispensing the Minister may take the opinion of the Pharmacy Board;

(o) the recognition of equivalent standards for medicinal product quality and efficacy in relation to such countries as may be prescribed;

(p) the recognition of equivalent standards for good practice in manufacture in relation to such countries as may be prescribed;

(q) the fees that may be levied and the funds wherein such fees may be deposited by the Licensing Authority, the Medicines Authority and any other Committee established by or under this Act or regulations made thereunder;

(r) the regulation of the use of medical devices for medical and, or research purposes, but without prejudice to the generality of this paragraph, the Minister may make regulations for all or any of the following purposes:

(i) for prescribing the conditions under which the authorisations may be granted, renewed, suspended, transferred or cancelled;

(ii) for providing the manner in which applications for the grant, renewal, suspension, transfer or cancellation of the authorisations or of any one or more categories or classes thereof are to be made;

(iii) for providing the manner in which applications for such authorisations and approvals as may be prescribed are to be publicised and for providing the manner in which any person who may be prejudiced by such the authorisations and approvals may make an objection or representation thereon;

(iv) for establishing the duration of the validity of the authorisations or of any one or more categories or classes thereof;

(v) for establishing the qualifications that certain key personnel involved in or with the premises may be required to possess;

(vi) for regulating inspections to be carried out at the premises;

(vii) for prescribing the inventory controls, registers, records and databases that have to be kept by the licence holder at the premises and any financial guarantees which the licence holder shall have to give;

(viii) for the establishment of quality controls and quality assurances, other than those already established under this Act, and any matter in relation to any activity carried on any premises or by any person licensed under this legislation;

(ix) for establishing the fees leviable in respect of the authorisations, approvals and for any other service provided by the Medicines Authority such as scientific advice or other work as may be deemed necessary for the Medicines Authority to carry out its function: Provided that regulations made under this sub-paragraph may establish the minimum and the maximum of any fees leviable in respect of the authorisations, approvals and for any other service provided by the Medicines Authority such as scientific advice or other work as may be deemed necessary for the Medicines Authority to carry out its function; and

(x) for establishing the penalties or administrative sanctions to which any offender against the provisions of this Act or any regulations made thereunder shall be liable;

(s) the establishing of offences and the relative penalty in relation to the contravention of any provisions of this Act or regulations issued under this Act which penalty shall not be less than a fine (multa) of twelve thousand euro (€12,000) and not exceeding one hundred and twenty thousand euro (€120,000) or to imprisonment for a term not exceeding two years, or to both such fine and imprisonment;

(t) exceptions to any provision in the interest of public health.