Irish Medicines Board Act, 1995
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Functions of Board. |
4.—(1) The principal functions of the Board shall be— | |
(a) the licensing of the manufacture, preparation, importation, distribution and sale of medicinal products, | ||
(b) subject to subsection (4), to exercise the powers conferred on the competent authority by Council Directive No. 65/65/EEC of 26 January 1965, as amended, and any regulations under the Health Act, 1947 , giving effect to that Directive as amended, | ||
(c) to exercise the powers conferred on the supervisory authority by Council Regulation (EEC) No. 2309/93 of 22 July 1993(3) , | ||
(d) to exercise the powers conferred on the competent authority by Council Directive No. 81/851/EEC of 28 September 1981(4) , | ||
(e) to exercise the powers specified in the Control of Clinical Trials Acts, 1987 and 1990, and conferred on the Board by section 35 , | ||
(f) to establish and administer a service for obtaining and assessing information as regards the safety, quality and efficacy of medicinal products, | ||
(g) to establish and administer a service for obtaining and assessing reports on any adverse effects of medicinal products in use in the State, | ||
(h) to advise the Minister and others concerned as to the precautions or restrictions, if any, subject to which medicinal products may be marketed or continued in use in the State, | ||
(i) to arrange for the collection and dissemination of information relating to medicinal products including, in particular, information concerning the pharmacological classification and therapeutic efficacy of such products, | ||
(j) to furnish, whenever it is so requested by the Minister, advice to the Minister in relation to the licensing of the manufacture, importation, distribution and sale of medicinal products and in relation to the standards of manufacturing practice (including quality control) of medicinal products, | ||
(k) to furnish, whenever it is so requested by the Minister, advice to the Minister in relation to the certification for export or any other purpose of medicinal products manufactured in the State, | ||
(l) to establish and administer a service for the inspection of any service for the collection, screening, processing and quality control facilities and procedures in respect of human blood, blood components, blood products and plasma derivatives for the purpose of ensuring the safety and quality of blood, blood components, blood products and plasma derivatives and to advise the Minister in relation to such general or particular matters arising out of the administration of such a service as the Minister may refer to the Board, | ||
(m) if so requested, to advise the Minister or others concerned on such matters relating to medical devices as may be referred to it and are connected with the functions or activities of, or the services provided by, the Board, | ||
(n) to furnish, whenever it so thinks fit or is so requested by the Minister, advice to the Minister in relation to any matter connected with the functions or activities of, or the services provided by, the Board. | ||
(2) The Board shall also have and enjoy all those functions that were vested in the former Board immediately before the establishment day and are not specified in subsection (1). | ||
(3) The Board shall have all such powers as are necessary or expedient for the performance of its functions. | ||
(4) Upon such day as the Minister may by order appoint, the Board shall be the competent authority for the purposes of Council Directive No. 65/65/EEC of 26 January 1965, as amended, and for the purposes of any regulations under the Health Act, 1947 , giving effect to that Directive, as amended, and the Minister shall cease to be such authority. | ||
(5) In this section “medical device” means an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which— | ||
(a) is intended by the manufacturer to be used in relation to human beings for the purpose of— | ||
(i) diagnosis, prevention, monitoring, treatment or alleviation of disease, | ||
(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, | ||
(iii) investigation, replacement or modification of the anatomy or of a physiological process, or | ||
(iv) control of conception; | ||
and | ||
(b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means. | ||