Irish Medicines Board Act, 1995

Regulations.

32.—(1) The Minister may by regulations make such provision as he or she considers necessary or expedient for the purposes of this Act.

(2) Without prejudice to the generality of subsection (1), regulations under this section may, in relation to medicinal products for human use or cosmetic products, make provision for—

(a) the regulation (including the control) of the manufacture, production, preparation, importation, distribution, sale, supply, placing on the market, advertisement or promotion of the product or products to which the regulations relate,

(b) the prohibition of the manufacture, preparation, importation, distribution, sale or offering or keeping for sale of the product or products to which the regulations relate either absolutely or subject to specified conditions (including the granting by the Board of licences for the manufacture, preparation, importation, distribution or sale of such product or products),

(c) the prohibition of the advertisement of the product or products to which the regulations relate either absolutely or subject to specified conditions (including the grant by the Board of a licence for the advertisement of such products) and the prohibition of the sale or offering or keeping for sale of any such product which is advertised in contravention of such regulations,

(d) the regulation and control of the packaging and labelling of the product or products to which the regulations relate and, in particular, for the specification of information relating to such product or products to be contained on any packet used in the sale, supply or distribution of such product or products or on a label attached to such packet,

(e) the determination of the classes of persons to whom licences under the regulations are to be granted,

(f) the specification of conditions for the grant, suspension, retention, amendment or renewal of licences under the regulations,

(g) the refusal or revocation of licences under the regulations,

(h) the requiring of applicants for or holders of licences under the regulations to furnish specified information in regard to the constitution, manufacture, importation, storage, distribution, sale or advertisement of the product or products to which their applications or licences relate,

(i) the enforcement and execution of the regulations by and the conferral of such powers as the Minister considers appropriate for the purpose of such enforcement and execution on the following persons—

(i) officers of the Minister,

(ii) officers of the Board,

(iii) health boards and their officers,

(iv) with the consent of the Minister for Finance, officers of Customs and Excise,

(v) with the consent of the Minister for Enterprise and Employment, officers of that Minister, and

(vi) officers of the Pharmaceutical Society of Ireland,

(j) the giving and taking (without payment) of samples of the product or products to which the regulations relate and the carrying out of tests, examinations and analyses of such samples,

(k) the determination of the classes of persons to be responsible for the carrying out of tests, examinations and analyses of samples of the product or products to which the regulations relate and the means by and the manner in which such test, examination or analysis is to be made,

(l) the prescribing of the certificate or other evidence to be given of the result of any test, examination or analysis and the classes of persons by and to whom such certificate or evidence is to be given,

(m) any certificate or other evidence prescribed under paragraph (l) of this subsection and given in respect of the test, examination or analysis of a sample shall, as respects that sample, be evidence for all purposes of the result of such test.

(3) Any regulation made by the Minister under this Act may contain such incidental or consequential provisions as appear to the Minister to be necessary or expedient for the purpose of implementing the provisions of this Act.

(4) A person who contravenes a regulation under this section shall be guilty of an offence and shall be liable—

(a) on summary conviction, to a fine not exceeding £1,500 or to imprisonment for a term not exceeding one year, or to both,

(b) on conviction on indictment—

(i) in the case of a first offence, to a fine not exceeding £100,000 or to imprisonment for a term not exceeding 10 years or to both,

(ii) in the case of a second or subsequent offence to a fine not exceeding £250,000, or to imprisonment for a term not exceeding 10 years or to both.

(5) An offence under this section may be prosecuted by the Minister, the Board, the Pharmaceutical Society of Ireland or the health board in whose functional area the offence is committed.

(6) Notwithstanding subsection (4) of section 10 of the Petty Sessions (Ireland) Act, 1851 , summary proceedings for an offence under the section may be instituted within two years from the date of the offence.