IRISH MEDICINES BOARD ACT, 1995

• (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,

• F32[(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.]

• F33[(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).]

32C. F34[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).]

32D. F35[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.]

32F. F36[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.]

F37[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.]

32G. F38[Substitution by pharmacists in case of medicinal product shortage.

32G.—(1) Where the Minister, having consulted with the Health Service Executive and the Health Products Regulatory Authority, is of the opinion that—

• (a) there is a medicinal product shortage,

• (b) arising from that shortage, there is likely to be a negative impact on the health service or the health needs of patients that cannot be addressed via other mechanisms, and

• (c) a protocol under this section would assist in addressing the impacts referred to in paragraph (b),

he or she may prepare and issue a protocol to registered pharmacists authorising registered pharmacists to supply such alternative medicinal product or products as are specified in the protocol for the medicinal product that is in short supply under such conditions as are specified in the protocol and without the need for a further prescription.

• (2) In the preparation and issuing of a protocol under this section, the Minister shall act in accordance with regulations made under section 32H and shall consult with the bodies referred to in subsection (1) in relation to the content of the protocol.

• (3) A protocol prepared and issued under this section shall specify—

• (a) the medicinal product that is in short supply,

• (b) the substitutable product,

• (c) the circumstances in which the registered pharmacist may supply the substitutable product,

• (d) the time period for which the protocol is in place, and

• (e) such other conditions or information in respect of the supply by a registered pharmacist of the substitutable medicinal product as the Minister considers appropriate.

• (4) The Minister may, where appropriate and following consultation with the Health Products Regulatory Authority and the Health Service Executive, amend the time period during which the protocol is in place or any conditions specified in the protocol.

• (5) The Minister shall publish or cause to be published each protocol issued (or amended) under this section in such form and manner, including on a website maintained by or on behalf of the Minister, as the Minister considers appropriate.]

32H. F39[Regulations governing protocol.

32H.—(1) The Minister shall make regulations providing for the issuing and operation of a protocol.

• (2) Without prejudice to the generality of subsection (1), such regulations shall include—

• (a) the procedures for the preparation and review of a protocol including in relation to—

• (i) the assessment of the impact of the medicinal product shortage on the provision of a health service and the health needs of patients,

• (ii) the assessment of existing mechanisms to address the negative impacts of a medicinal product shortage, including the availability of appropriate alternatives,

• (iii) the identification of a substitutable medicinal product and any conditions that should apply in accordance with its supply, and

• (iv) the persons who shall be consulted in relation to the preparation and review,

• (b) the procedure for the notification of a protocol (including any amendment made to the protocol) to registered pharmacists,

• (c) the procedure for the operation of a protocol, and

• (d) the requirements in relation to the notification of the supply of a substitutable medicinal product under a protocol to the person who prescribed the medicinal product that is in short supply.]

32I. F40[Reporting of information to support the security of supply of medicines.

32I.—(1) The Health Products Regulatory Authority may require a relevant person to provide to the Authority, in such form and manner and within such period as may be prescribed by regulations made by the Minister, such information in relation to medicinal products within the possession or control of the relevant person as the Authority considers necessary for the purpose of the management of the availability of medicinal products in the State, including—

• (a) the monitoring of the current and future supply of medicinal products, and

• (b) the identification and management of medicinal product shortages.

• (2) A relevant person shall comply with a requirement set out in regulations made under subsection (1).

• (3) In this section, "relevant person" means the following persons involved in the manufacture or supply of a medicinal product:

• (a) the holder of a manufacturer’s authorisation granted under Regulation 8 of the Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539 of 2007);

• (b) the holder of a marketing authorisation granted in accordance with the Medicinal Products (Control of Placing on the Market) Regulations 2007;

• (c) the holder of a community marketing authorisation within the meaning of the Medicinal Products (Control of Placing on the Market) Regulations 2007;

• (d) the holder of a wholesaler’s authorisation granted under Regulation 9 of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. No. 538 of 2007);

• (e) a retail pharmacy business within the meaning of the Pharmacy Act 2007;

• (f) a hospital;

• (g) such other persons or legal entities, being persons or entities authorised or entitled to supply medicinal products, as may be prescribed in regulations made by the Minister.]

33. Offences by bodies corporate.

33.—(1) Where an offence under this Act has been committed by a body corporate and is proved to have been committed with the consent or connivance of or to be attributable to any neglect on the part of a person being a director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in any such capacity, that person as well as the body corporate shall be guilty of an offence and be liable to be proceeded against and punished as if he or she were guilty of the first-mentioned offence.

• (2) Where the affairs of a body corporate are managed by its members, subsection (1) shall apply in relation to the acts and defaults of a member in connection with his or her functions of management as if he or she were a director or manager of the body corporate.

34. Repeal and transitional provisions.

34.—(1) Section 65 of the Health Act, 1947 is hereby repealed.

• (2) The National Drugs Advisory Board (Establishment) Order, 1966 (S.I. No. 163 of 1966), is hereby revoked.

• (3) A licence granted or renewed under regulations under the said section 65 and in force immediately before the commencement of this section shall continue in force after such commencement as if granted or renewed under regulations under section 32 and may be revoked or amended accordingly.

• (4) Regulations under the said section 65 in force immediately before the commencement of this section shall continue in force after such commencement and may be amended or revoked, as if made under section 32.

35. Amendment of enactments.

35.—(1) The enactments specified in column (3) of the Schedule to this Act at any reference number are hereby amended to the extent specified in column (4) of that F41[Schedule 1] at that reference number.

• (2) References to the Minister in the Control of Clinical Trials Act, 1987, other than sections 17 and 18, shall, on and after the commencement of this section, be construed as references to the Board.

• (3) References to the Minister in the Control of Clinical Trials and Drugs Act, 1990, other than section 5, shall, on and after the commencement of this section, be construed as references to the Board.

36. Expenses.

36.—The expenses incurred by the Minister in the administration of this Act shall, to such extent as may be sanctioned by the Minister for Finance, be paid out of moneys provided by the Oireachtas.

37. Laying of orders and regulations before Houses of Oireachtas.

37.—Every order or regulation made by the Minister under this Act shall be laid before each House of the Oireachtas as soon as may be after it is made and, if a resolution annulling the order or regulation is passed by either such House within the next subsequent 21 days on which that House has sat after the order or regulation is laid before it, the order or regulation shall be annulled accordingly but without prejudice to the validity of anything previously done thereunder.

38. Short title and commencement.

38.—(1) This Act may be cited as the Irish Medicines Board Act, 1995.

• (2) This Act shall come into operation on such day or days as, by order or orders made by the Minister, may be fixed therefor either generally or with reference to any particular purpose or provision and different days may be so fixed for different purposes and different provisions.

F42[SCHEDULE 1] Amendment of Enactments

Section 35.

Reference Number	Number and Year	Short Title	Amendment
(1)	(2)	(3)	(4)
1.	No. 12 of 1961	Poisons Act, 1961	In section 3 (3) (a), “section 32 of the Irish Medicines Board Act, 1995” shall be substituted for “section 65 of the Health Act, 1947”.
			In section 3 (3) (b), “section 32” shall be substituted for “section 65”
2.	No. 28 of 1987	Control of Clinical Trials Act, 1987	In section 2(3)(b)(i), “and have not later than 6 weeks after being so notified, made a recommendation to the Minister on the proposal” shall be deleted.
			In section 2(3)(b)(ii), “the Board, not later than 6 weeks after being so notified” shall be substituted for “the Minister”.
			In section 4(1), “after consultation with the National Drugs Advisory Board” shall be deleted.
			In section 5(1), “after consultation with the National Drugs Advisory Board and” shall be deleted.
			In section 7, “after consultation with the National Drugs Advisory Board” shall be deleted.
3.	No. 17 of 1990	Control of Clinical Trials and Drugs Act, 1990	In section 5(2), “under Article 4 of the National Drugs Advisory Board (Establishment) Order, 1966” shall be deleted.
			In section 5(2)(b), “a committee or subcommittee established under section 9 of the Irish Medicines Board Act, 1995” shall be substituted for “a committee established under Article 18 of the National Drugs Advisory Board (Establishment) Order, 1966 (S.I. No. 163 of 1966),”.

F43[Section 32D. SCHEDULE 2 IRISH MEDICINES BOARD ACT 1995 (AS AMENDED BY THE IRISH MEDICINES BOARD (MISCELLANEOUS PROVISIONS) ACT 2006) Certificate Stating Results of Test, Examination or Analysis

This certificate is issued by me, the undersigned, for the purpose of section 32D of the Irish Medicines Board Act 1995 (as amended by section 17 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006), being—

¹.

I hereby certify that I received, on the day of, from² of a sample of the relevant thing/the relevant thing*, being³ for test, examination or analysis; which was undamaged, duly sealed and marked⁴.

I further certify that the said sample/relevant thing* has been tested, examined or analysed by me or under my direction and that the results are as follows—

⁵.

Signature

Date

Address]

Footnotes