Irish Medicines Board (Miscellaneous Provisions) Act 2006
|
Insertion of new sections 32A to 32F into Irish Medicines Board Act 1995 (authorised officers, etc.). |
17.— The Irish Medicines Board Act 1995 is amended by inserting the following after section 32: | |
“Interpretation of sections 32A to 32F inclusive. | ||
32A.— In this section and sections 32B to 32F inclusive— | ||
‘ authorised officer ’ means— | ||
(a) a person appointed under section 32B(1) to be an authorised officer, or | ||
(b) an officer of customs and excise; | ||
‘ inspect ’ includes search; | ||
‘ premises ’ means any place, ship or other vessel, aircraft, railway wagon or other vehicle, and includes a container used to transport relevant things; | ||
‘ record ’ includes, in addition to a record in writing— | ||
(a) a disc, tape, sound-track or other device in which information, sounds or signals are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in legible or audible form, | ||
(b) a film, tape or other device in which visual images are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in visual form, and | ||
(c) a photograph, | ||
and any reference to a copy of a record includes— | ||
(d) in the case of a record to which paragraph (a) applies, a transcript of the sounds or signals embodied therein, | ||
(e) in the case of a record to which paragraph (b) applies, a still reproduction of the images embodied therein, and | ||
(f) in the case of a record to which paragraphs (a) and (b) apply, such a transcript together with such a still reproduction; | ||
‘ relevant person ’ means— | ||
(a) the Minister, | ||
(b) the Chief Executive, | ||
(c) the Chief Executive Officer of the Health Service Executive, or | ||
(d) the Council of the Pharmaceutical Society of Ireland; | ||
‘ relevant thing ’ means— | ||
(a) any medicinal product, cosmetic product or medical device, and | ||
(b) any article or substance used in the manufacture, processing or storage of any medicinal product, cosmetic product or medical device; | ||
‘ this Act ’ includes any regulations— | ||
(a) made under this Act, or | ||
(b) referred to in section 34(4). | ||
Authorised officers. | ||
32B.— (1) A relevant person— | ||
(a) may appoint such and so many persons as the relevant person thinks fit to be authorised officers for the purposes of this Act, and | ||
(b) shall furnish each authorised officer appointed by the relevant person with a warrant of the authorised officer’s appointment. | ||
(2) An authorised officer (other than an authorised officer who is an officer of customs and excise) shall, when performing a function imposed under this Act on an authorised officer, produce his or her warrant for inspection if requested to do so by a person affected by the performance of that function. | ||
(3) For the purposes of this Act, an authorised officer may— | ||
(a) subject to subsection (5), enter (if necessary by the use of reasonable force), at all reasonable times, any premises at which he or she has reasonable grounds for believing that— | ||
(i) any trade, business or activity connected with the manufacture, processing, disposal, export, import, distribution, sale, supply, storage, packaging or labelling of any relevant thing is or has been carried on, or | ||
(ii) books, records or other documents (including documents stored in non-legible form) relating to such trade, business or activity are kept, | ||
(b) at such premises inspect and take copies of, any books, records, other documents (including documents stored in non-legible form) or extracts therefrom, which he or she finds in the course of his or her inspection, | ||
(c) remove any such books, records or other documents from such premises and detain them for such period as he or she reasonably considers to be necessary for the purposes of his or her functions under this Act, | ||
(d) carry out, or have carried out, such tests, examinations, analyses, inspections and checks of— | ||
(i) the premises, | ||
(ii) any relevant thing at the premises, or | ||
(iii) any equipment, machinery or plant at the premises, | ||
as he or she reasonably considers to be necessary for the purposes of his or her functions under this Act, | ||
(e) require any person at the premises or the owner or person in charge of the premises and any person employed there to give to him or her such assistance and information and to produce to him or her such books, records or other documents (and in the case of documents or records stored in non-legible form, produce to him or her a legible reproduction thereof) that are in that person’s power or procurement, as he or she may reasonably require for the purposes of his or her functions under this Act, | ||
(f) without payment, take samples of any relevant thing found at the premises for the purposes of any test, examination or analysis, | ||
(g) direct that such relevant thing found at the premises as he or she, upon reasonable grounds, believes contravenes a provision of this Act not be sold or distributed or moved from the premises, without his or her consent, | ||
(h) secure for later inspection any premises or part of any premises in which a relevant thing is found or ordinarily kept, or books, records or other documents are found or ordinarily kept, for such period as may reasonably be necessary for the purposes of his or her functions under this Act, | ||
(i) without payment, take possession of and remove from the premises for any test, examination or analysis any relevant thing found there, and detain it for such period as he or she considers reasonably necessary for the purposes of his or her functions under this Act, | ||
(j) without payment, take samples of any relevant thing, detained pursuant to paragraph (i), for the purposes of any test, examination, or analysis, | ||
(k) where the taking of samples of any relevant thing pursuant to paragraph (f) or (j) is, for whatever reason, not practicable, without payment take the relevant thing concerned for the purposes of any test, examination or analysis, | ||
(l) inspect and copy or extract information from any data within the meaning of the Data Protection Acts 1988 and 2003, | ||
(m) require a person, having authority to do so, to break open any container or package, or to open any vending machine, or to permit him or her to do so, as he or she may reasonably require for the purposes of his or her functions under this Act, or | ||
(n) require a person, who makes available facilities such as post office boxes, telecommunications or electronic mail address or other like facilities, to give him or her such assistance and information as he or she may reasonably require for the purposes of his or her functions under this Act in any case where the officer has reasonable grounds for believing that any relevant thing is being supplied by mail. | ||
(4) When performing a function under this Act, an authorised officer may, subject to any warrant under subsection (6), be accompanied by such number of— | ||
(a) other authorised officers, | ||
(b) members of the Garda Síochána, or | ||
(c) persons with expertise relating to any relevant thing, | ||
as he or she considers appropriate in the circumstances of the case. | ||
(5) An authorised officer shall not enter a dwelling, other than— | ||
(a) with the consent of the occupier, or | ||
(b) in accordance with a warrant issued under subsection (6). | ||
(6) Upon the application of an authorised officer, a judge of the District Court, if satisfied that there are reasonable grounds for believing that— | ||
(a) a relevant thing is to be found in any dwelling, or is being or has been subjected to any process or stored in any dwelling, | ||
(b) a dwelling is occupied in whole or in part by an undertaking engaged in any trade, business or activity referred to in subsection (3)(a)(i), or | ||
(c) books, records or other documents (including documents stored in non-legible form) referred to in subsection (3)(a)(ii) are being stored or kept in any dwelling, | ||
may issue a warrant authorising a named authorised officer accompanied by such other authorised officers, members of the Garda Síochána, or persons with expertise relating to any relevant thing, as may be necessary, at any time or times, within one month of the date of issue of the warrant, to enter the dwelling and perform any of the functions of an authorised officer under subsection (3)(b) to (n). | ||
(7) Any person who— | ||
(a) obstructs or interferes with an authorised officer, a member of the Garda Síochána, or a person with expertise relating to any relevant thing, in the course of performing a function conferred on him or her by this Act or a warrant under subsection (6), | ||
(b) impedes the performance by the officer, member, or person with expertise, as the case may be, of such function or fails or refuses to comply with a request or requirement of, or to answer a question asked by, the officer, member, or person with expertise, as the case may be, pursuant to this section, or | ||
(c) in purported compliance with such request or requirement or in answer to such question gives information to the officer, member, or person with expertise, as the case may be, that he or she knows to be false or misleading in any material respect, | ||
shall be guilty of an offence. | ||
(8) Where an authorised officer, upon reasonable grounds, believes that a person has committed an offence under this Act, he or she may require that person to provide him or her with his or her name and the address at which he or she ordinarily resides. | ||
(9) A statement or admission made by a person pursuant to a requirement under subsection (3)(e) shall not be admissible as evidence in proceedings brought against that person for an offence (other than an offence under subsection (7)). | ||
(10) A person who falsely represents himself or herself to be an authorised officer shall be guilty of an offence. | ||
(11) Nothing in this section shall be taken to compel the production by any person of a document which he or she would be exempt from production in proceedings in a court on the ground of legal professional privilege. | ||
Taking of samples, etc., by authorised officers. | ||
32C.— (1) Subject to subsection (3), where an authorised officer takes a sample of a relevant thing pursuant to section 32B(3)(f) or (j), he or she shall— | ||
(a) divide the sample into 3 approximately equal parts, | ||
(b) place each part into separate containers, and | ||
(c) forthwith seal and mark each such container in such a manner as to identify it as part of the sample taken by that authorised officer. | ||
(2) Where an authorised officer has complied with subsection (1), he or she shall— | ||
(a) offer one of the sealed containers to the owner or person for the time being in charge or possession of the relevant thing from which the sample concerned was taken, | ||
(b) retain one of the sealed containers, and | ||
(c) forward, or cause to be forwarded, one of the sealed containers for test, examination or analysis of the sample concerned by a person mentioned in section 32D(1)(a), (b) or (c). | ||
(3) Where a relevant thing is contained in a container and its division into parts pursuant to subsection (1) is, for whatever reason, not practicable, an authorised officer, who wishes to take samples of such relevant things for the purposes of any tests, examination or analysis shall take possession of 3 such containers belonging to the same batch, and each such container shall be deemed to be part of a sample for the purposes of subsection (1), and the provisions of subsections (1) and (2) shall apply thereto accordingly. | ||
(4) Where an authorised officer takes a relevant thing pursuant to section 32B(3)(k), he or she shall— | ||
(a) place the relevant thing in a container, | ||
(b) forthwith seal and mark the container in such a manner as to identify it as a relevant thing taken pursuant to that section, and | ||
(c) forward, or cause to be forwarded, the sealed container for test, examination or analysis of the relevant thing by a person mentioned in section 32D(1)(a), (b) or (c). | ||
Certificate of result of test, etc., of sample, etc. | ||
32D.— (1) In any proceedings for an offence under this Act, a certificate in the form specified in Schedule 2 to this Act signed by— | ||
(a) either— | ||
(i) the State Chemist, or | ||
(ii) another chemist employed or engaged at the State Laboratory and authorised by the State Chemist to sign the certificate, | ||
(b) either— | ||
(i) a public analyst appointed under section 10 of the Sale of Food and Drugs Act 1875 , or | ||
(ii) another analyst authorised by such a public analyst to sign the certificate, or | ||
(c) a chemist or analyst appointed by the Board or the Council of the Pharmaceutical Society of Ireland, | ||
stating the result of any test, examination or analysis of a sample of any relevant thing, or of a relevant thing, as the case may be, forwarded under section 32C(2)(c) or (4)(c) shall, with regard to that sample of the relevant thing, or the relevant thing, as the case may be, be evidence of the matters stated in the certificate unless the contrary is proved. | ||
(2) In proceedings for an offence under this Act, a relevant thing, or a package containing a relevant thing, that purports to bear the name of the manufacturer or importer of that thing, or of the person who placed that thing on the market, shall, unless the contrary is proved, be evidence that the relevant thing was manufactured or imported, or placed on the market, as the case may be, by the person so named. | ||
(3) In proceedings for an offence under this Act, a relevant thing, or a package containing a relevant thing, that bears a trademark shall, unless the contrary is proved, be evidence that the thing was manufactured by the person who at the time of the alleged commission of the offence owned that trademark. | ||
(4) In this section, ‘ trademark ’ has the same meaning as it has in the Trade Marks Act 1996 . | ||
Penalties for offences. | ||
32E.— (1) A person guilty of an offence under section 32B(7) or (10) shall be liable on summary conviction to a fine not exceeding €2,000, or to imprisonment for a term not exceeding 3 months, or to both. | ||
(2) On conviction for an offence under this Act, the court may, in addition to any other penalty— | ||
(a) order any relevant thing or any apparatus, equipment or other thing to which the offence relates, to be forfeited to a relevant person for destruction or other disposal as the relevant person thinks fit, | ||
(b) upon application made to it by or on behalf of the relevant person, order the person convicted of the offence to pay to the relevant person all or part of the costs of such destruction or disposal subject to such conditions, if any, as are specified in the order. | ||
Proceedings. | ||
32F.— (1) Summary proceedings for an offence under this Act may be brought and prosecuted by a relevant person. | ||
(2) Notwithstanding section 10 (4) of the Petty Sessions (Ireland) Act 1851 , summary proceedings for an offence under this Act may be instituted within 2 years from the date of the offence. | ||
(3) References in section 382 of the Companies Act 1963 to a company shall, for the purposes of this Act, be construed as including references to a body corporate (whether or not a company within the meaning of that section) charged on indictment with an offence under this Act.”. |