Irish Medicines Board Act 1995

F28[Authorised officers.

32B

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,

F29[(l) inspect and copy or extract information from any data, including data that constitutes personal data within the meaning of—

(i) the Data Protection Regulation, or

(ii) Part 5 of the Data Protection Act 2018.]

(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.]

F30[(12) In this section, "Data Protection Regulation" means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 201620 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).]

Annotations

Amendments:

F28

Inserted (22.07.2007) by Irish Medicines Board (Miscellaneous Provisions) Act 2006 (3/2006), s. 17, S.I. No. 543 of 2007.

F29

Substituted (25.05.2018) by Data Protection Act 2018 (7/2018), s. 182(a), S.I. No. 174 of 2018.

F30

Inserted (25.05.2018) by Data Protection Act 2018 (7/2018), s. 182(b), S.I. No. 174 of 2018.