4.—(1) F4[Subject to subsection (4), the] principal functions of the Board shall be—

(a) the licensing of the manufacture, preparation, importation, distribution and sale of medicinal products,

F4[(b) to exercise the powers conferred on the competent authority by Directive No. 2001/83/EC of 6 November 2001⁵, F5[other than those powers conferred by Article 5.3 of the said Directive,]

(c) to exercise the powers conferred on the supervisory authority by Regulation (EC) No. 726/2004 of 31 March 2004⁷,

(d) to exercise the powers conferred on the competent authority by Directive No. 2001/82/EC of 6 November 20016,]

(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,

F6[(k) to establish and administer a service—

(i) for the receipt of applications from persons proposing to export any description of medicinal products, cosmetic products, veterinary medicinal products or medical devices, and

(ii) for the issue to such persons of certificates containing any statement relating to such description of such products or devices as the Board considers appropriate after having regard to—

(I) the law (whether under any enactment or rule of law or otherwise) in the State which is for the time being applicable to such description of such products or devices, and

(II) the law (whether under any enactment or rule of law or otherwise) in the place to which such description of such products or devices is to be exported which is for the time being applicable to such description of such products or devices,]

(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.

F7[(o) to exercise the powers conferred on the competent authority by Council Directive 98/79/EC of the 27th October, 1998³ and the European Communities (In Vitro Diagnostic Medical Devices) Regulations, 2001]

F8[(p) to exercise the powers conferred on the competent authority by Council Directive 90/385/EEC of 20 June 1990⁴ and the European Communities (Active Implantable Medical Devices) Regulations, 1994 (S.I. No. 253 of 1994) and Council Directive 93/42/EC of 14 June 1993⁵ and the European Communities (Medical Devices) Regulations, 1994 (S.I. No. 252 of F9[1994),]]

F10[(q) ...]

F11[(r) the authorisation of persons under section 24 of the Misuse of Drugs Act 1977 (as amended by section 9 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006),

(s) to exercise the powers conferred on the competent authority by Directive 2001/20/EC of 4 April 2001⁸,]

F12[(t) to exercise the powers conferred on the competent authority by Council Directive 76/768/EEC of 27 July 1976⁹, as amended, Commission Directive 95/17/EC of 19 June 1995¹⁰ and the European Communities (Cosmetic Products) Regulations 2004 (S.I. No. 870 of 2004),]

F11[(u) to exercise the powers conferred on the competent authority by Directive 2004/23/EC of 31 March 2004¹¹,

F13[(v) to exercise the powers conferred on the competent authority and the authority responsible for notified bodies by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017¹ and carry out the functions conferred on the Authority under Regulation 3(3)(a) of the European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 (S.I. No. 547 of 2017),

(w) to exercise the powers conferred on the competent authority and the authority responsible for notified bodies by Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017² and carry out the functions conferred on the Authority under Regulation 3(3)(b) of the European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 (S.I. No. 547 of 2017),

(x) to perform such other functions as are conferred on the Board by this or any other enactment (including any statutory instrument made thereunder).]]

(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.

F4[(4) The Board shall exercise the powers conferred on it under a paragraph of subsection (1) as the competent authority or the supervisory authority in accordance with any regulations made by the Minister, or the Minister for Agriculture and Food, for the purposes of giving effect to a Council Directive, Directive, Council Regulation or Commission Directive referred to in the paragraph.

(5) The Board shall, in exercising the powers referred to in subsection (1)(q), comply with any directive or guideline issued by the Minister to the Board in respect of policy in relation to controlled drugs.]