Irish Medicines Board (Miscellaneous Provisions) Act 2006
|
Amendment of section 32 of Irish Medicines Board Act 1995 (regulations). |
16.— Section 32 of the Irish Medicines Board Act 1995 is amended— | |
(a) in subsection (2)— | ||
(i) by substituting “, cosmetic products or medical devices” for “or cosmetic products”, | ||
(ii) in paragraph (a)— | ||
(I) by inserting “administration,” after “supply,”, and | ||
(II) by inserting “, or the device or devices,” after “the product or products”, | ||
(iii) in paragraph (b)— | ||
(I) by inserting “, or the device or devices,” after “the product or products”, and | ||
(II) by inserting “or such device or devices” after “such product or products”, | ||
(iv) in paragraph (c)— | ||
(I) by inserting “, or the device or devices,” after “the product or products”, | ||
(II) by substituting “, authorisation or certificate for such product or products or such device or devices” for “for the advertisement of such products”, and | ||
(III) by substituting “or products or such device or devices which is or are” for “which is”, | ||
(v) in paragraph (d)— | ||
(I) by inserting “, or the device or devices,” after “the product or products”, | ||
(II) by inserting “, or such device or devices,” after “such product or products” where it twice appears, | ||
(vi) in paragraphs (e), (f) and (g), by inserting “, authorisations or certificates” after “licences”, | ||
(vii) in paragraph (h)— | ||
(I) by inserting “, authorisation or certificates” after “of licences”, | ||
(II) by inserting “, or the device or devices,” after “products”, | ||
(III) by inserting “, authorisations or certificates” after “or licences”, | ||
(viii) by substituting the following for paragraphs (i), (j), (k), (l) and (m): | ||
“(i) the issuing of notices by authorised officers, within the meaning of section 32A, to the owners, occupiers or operators of premises requiring such owners, occupiers or operators to cease an activity— | ||
(i) relating to the product or products, or the device or devices, to which the regulations relate, and | ||
(ii) which, in the opinion of the authorised officer concerned, may pose a risk to human or animal health, | ||
(j) subject to subsection (9), the specification that a reference to the supply of a medicinal product in— | ||
(i) any regulations made under this section (whether made before, on or after the commencement of subsection (7)), or | ||
(ii) any regulations referred to in section 34(4), | ||
includes the administration of the product, | ||
(k) subject to subsection (10), the prohibition of the administration of a medicinal product, or a class of medicinal products, specified in the regulations except by a member of a relevant profession in his or her capacity as such member, or— | ||
(i) by a person, or a class of persons, specified in the regulations (which may be, or include, a person, or a class of persons, concerned in the provision of a health service, whether the health service is provided in a hospital, nursing home or clinic or otherwise), and | ||
(ii) in accordance with the conditions, if any, specified in the regulations in relation thereto, | ||
(l) subject to subsection (11) and without prejudice to the generality of any regulations made under paragraph (k), the prohibition of the sale or other supply of a medicinal product, or class of medicinal products, specified in the regulations except— | ||
(i) pursuant to a prescription issued by a member of a relevant profession in his or her capacity as such member, | ||
(ii) pursuant to a prescription issued by a registered nurse— | ||
(I) who— | ||
(A) is specified in the regulations as being a registered nurse who may, or | ||
(B) belongs to a class of registered nurses specified in the regulations as being a class of registered nurses any member of which may, | ||
issue a prescription in relation to the medicinal product, or class of medicinal products, as the case may be, concerned, and | ||
(II) in accordance with such conditions, if any, as are specified in the regulations in relation thereto, | ||
or | ||
(iii) by such person, in or for such emergency circumstances and in accordance with such conditions, if any, as are specified in the regulations in relation thereto, | ||
(m) the regulation and control of medicinal products that are subject to classification under Article 70 of Directive 2001/83/EC of 6 November 2001 12 and, in particular, in the case of such a medicinal product the classification of which is a medicinal product not subject to medical prescription, the prohibition of the sale or other supply of the medicinal product except— | ||
(i) by a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts 1875 to 1977 and in accordance with such conditions, if any, as are specified in the regulations in relation thereto, or | ||
(ii) subject to subsection (12), by a person other than a person referred to in subparagraph (i) and in accordance with such conditions, if any, as are specified in the regulations in relation thereto, | ||
(n) without prejudice to the generality of section 3 (1) of the European Communities Act 1972 , giving effect to acts of the institutions of the European Communities relating to medicinal products for human use, cosmetic products or medical devices, | ||
(o) such incidental, supplementary and consequential provisions as appear to the Minister to be necessary or expedient for the purposes of the regulations.”, | ||
(b) by substituting the following for subsections (3) and (4): | ||
“(3) Without prejudice to the generality of subsection (2)(o), regulations under subsection (2)(n) may contain such incidental, supplementary and consequential provisions as appear to the Minister to be necessary for the purposes of the regulations (including provisions repealing, amending or applying, with or without modification, other law, exclusive 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 €2,000 or imprisonment for a term not exceeding one year or both, | ||
(b) on conviction on indictment— | ||
(i) in the case of a first offence, to a fine not exceeding €120,000 or imprisonment for a term not exceeding 10 years or both, | ||
(ii) in the case of any subsequent offence, to a fine not exceeding €300,000 or imprisonment for a term not exceeding 10 years or both.”, | ||
(c) by inserting the following after subsection (6): | ||
“(7) Any reference (howsoever expressed) to the supply of a medicinal product in— | ||
(a) any regulations made under this section (whether made before, on or after the commencement of this subsection), or | ||
(b) any regulations referred to in section 34(4), | ||
shall not include the administration of the product unless it is otherwise specified pursuant to subsection (2)(j). | ||
(8) Subject to subsection (13), regulations made under this section may specify that a reference (howsoever expressed) to the sale or supply of a medicinal product or medical device in— | ||
(a) the regulations, or | ||
(b) other regulations made under this section (including made before the commencement of this subsection), or referred to in section 34(4), which the first-mentioned regulations amend, | ||
include the giving of the product or device, as the case may be, whether with or without payment, in the course of the provision of a health service (whether the health service is provided in a hospital, nursing home or clinic or otherwise). | ||
(9) The Minister shall only make regulations under this section to provide for a specification referred to in subsection (2)(j) if the Minister, after having had regard to the nature and purpose of the medicinal product concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that the specification is in the best interests of the persons to whom the product is usually administered. | ||
(10) The Minister shall only make regulations under this section to provide for a prohibition and exception to the prohibition referred to in subsection (2)(k) if the Minister, after having had regard to the nature and purpose of the medicinal product, or class of medicinal products, concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that the prohibition and exception to the prohibition is in the best interests of the persons to whom the medicinal product, or class of medicinal products, as the case may be, is usually administered. | ||
(11) The Minister shall only make regulations under this section to provide for a prohibition and exception to the prohibition referred to in subsection (2)(l) if the Minister, after having had regard to the nature and purpose of the medicinal product, or class of medicinal products, concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that the prohibition and exception to the prohibition is in the best interests of the persons to whom the medicinal product, or class of medicinal products, as the case may be, is usually administered. | ||
(12) The Minister shall only make regulations under this section to provide for the exception referred to in subsection (2)(m)(ii) if the Minister, after having had regard to the nature and purpose of the medicinal product concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that it is reasonably safe to permit the medicinal product to be sold or otherwise supplied by a person other than a person referred to in subsection (2)(m)(i). | ||
(13) The Minister shall only make regulations under this section to provide for a specification referred to in subsection (8) if the Minister, after having had regard to the nature and purpose of the medicinal product or medical device concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that the specification is in the best interests of the persons to whom the product or device, as the case may be, is usually given in the course of the provision of a health service. | ||
(14) In this section, ‘ relevant profession ’ means— | ||
(a) for the purposes of subsection (2)(k), any profession a member of which may, before the commencement of this subsection, and in his or her capacity as such member, have lawfully administered a medicinal product, | ||
(b) for the purposes of subsection (2)(l), any profession a member of which may, before the commencement of this subsection, and in his or her capacity as such member, have lawfully issued a prescription for a medicinal product.”. | ||