Irish Medicines Board (Miscellaneous Provisions) Act 2006
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Amendment of section 4 of Irish Medicines Board Act 1995 (functions of Board). |
11.— Section 4 of the Irish Medicines Board Act 1995 is amended— | |
(a) in subsection (1)— | ||
(i) by substituting “Subject to subsection (4), the” for “The”; | ||
(ii) by substituting the following for paragraphs (b), (c) and (d): | ||
“(b) to exercise the powers conferred on the competent authority by Directive No. 2001/83/EC of 6 November 20015, | ||
(c) to exercise the powers conferred on the supervisory authority by Regulation (EC) No. 726/2004 of 31 March 2004 7 , | ||
(d) to exercise the powers conferred on the competent authority by Directive No. 2001/82/EC of 6 November 20016,”; | ||
(iii) by substituting the following for paragraph (k): | ||
“(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,”; | ||
(iv) in paragraph (p), by substituting “1994),” for “1994).”; and | ||
(v) by inserting the following after paragraph (p): | ||
“(q) to exercise, subject to subsection (5), the powers specified in section 14 (1) of the Misuse of Drugs Act 1977 (as amended by section 7 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006), | ||
(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 2001 8 , | ||
(t) to exercise the powers conferred on the competent authority by Council Directive 76/768/EEC of 27 July 1976 9 , as amended, Commission Directive 95/17/EC of 19 June 1995 10 and the European Communities (Cosmetic Products) Regulations 2004 ( S.I. No. 870 of 2004 ), | ||
(u) to exercise the powers conferred on the competent authority by Directive 2004/23/EC of 31 March 2004 11 , | ||
(v) to perform such other functions as are conferred on the Board by this or any other enactment (including any statutory instrument made thereunder).”; | ||
and | ||
(b) by substituting the following for subsections (4) and (5): | ||
“(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.”. | ||