Irish Medicines Board Act , 1995

1. Interpretation.

1.—(1) In this Act unless the context otherwise requires—

F1["administer", in relation to a medicinal product (and whether or not the product has been dissolved or dispersed in, or diluted or mixed with, any other substance), means to administer the product to a natural person—

(a) orally,

(b) by injection or other introduction into the body of the person, or

(c) by external application,

and whether or not by direct contact with the body of the person;]

F2["authorised medicinal product" means a medicinal product that is authorised under the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007) or Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004^7, as amended;]

“the Board” means the Irish Medicines Board;

“the Chief Executive” means the chief executive officer of the Board;

“a committee” means a committee appointed under section 9;

“cosmetic product” has the meaning assigned to it by Council Directive No. 93/35/EEC of 14 June 1993^1;

F1["drug precursor" means a scheduled substance as defined in Article 2 of Council Regulation (EC) No. 111/2005 of 22 December 2004^1;]

“the establishment day” means the day appointed by the Minister under section 2;

“the former Board” means the National Drugs Advisory Board established under the Health (Corporate Bodies) Act, 1961;

“functions” includes powers and duties and references to the performance of functions includes as respects powers and duties, references to the exercise of the powers and the carrying out of the duties;

F3["medical device" means a medical device which falls within any of the definitions of "medical device" in—

(a) Article 1 of Council Directive 90/385/EEC of 20 June 1990^2,

(b) Article 1 of Council Directive 93/42/EEC of 14 June 1993^3, or

(c) Article 1 of Directive 98/79/EC of 27 October 1998^4;

"medicinal product" has the meaning assigned to it by Directive 2001/83/EC of 6 November 2001^5, as amended from time to time;]

F2["medicinal product shortage" means where the current or anticipated supply of an authorised medicinal product or products that is placed on the market does not meet the current or, as the case may be, anticipated demand for that medicinal product or products;]

F2["medicinal product that is in short supply" means, in relation to a medicinal product shortage, the authorised medicinal product or products that is the subject of the medicinal product shortage;]

“the Minister” means the Minister for Health;

F1["premises" includes any aircraft, hovercraft, ship, stall or vehicle;]

F2["protocol" means a protocol issued by the Minister undersection 32G;]

“recognised trade unions and staff associations” means the trade unions and staff associations recognised by the Board for the purpose of negotiations which are concerned with the remuneration, conditions of employment or working conditions of officers of the Board and employees of the F3[Board;]

F1["registered dentist" means a person registered in the register established under the Dentists Act 1985;

"registered medical practitioner" means a person registered in the General Register of Medical Practitioners established under the Medical Practitioners Act 1978;

"registered nurse" means a person whose name is entered in the register of nurses maintained under section 27 of the Nurses Act 1985;

F2["registered pharmacist" means a person registered in the register of pharmacists established under section 13 of thePharmacy Act 2007;]

F2["substitutable medicinal product" means the medicinal product or products that registered pharmacists are authorised under a protocol to supply in substitution for the medicinal product that is in short supply;]

"veterinary medicinal product" has the meaning assigned to it by Directive 2001/82/EC of 6 November 2001^6, as amended from time to time.]

(2) In this Act—

(a) a reference to any enactment shall, unless the context otherwise requires, be construed as a reference to that enactment as amended or extended by or under any subsequent enactment including this Act,

(b) a reference to a section is a reference to a section of this Act unless it is indicated that reference to some other enactment is intended,

(c) a reference to a subsection, paragraph or subparagraph is a reference to the subsection, paragraph or subparagraph of the provision in which the reference occurs unless it is indicated that reference to some other provision is intended.

2. Establishment day.

2.—The Minister may by order appoint a day to be the establishment day for the purposes of this Act.

3. Establishment of Irish Medicines Board.

3.—(1) On the establishment day there shall stand established a board to be known as the Irish Medicines Board (in this Act referred to as “the Board”) to perform the functions conferred on it by or under this Act.

(2) The Board shall be a body corporate with perpetual succession and an official seal and power to sue and be sued in its corporate name and, with the consent of the Minister, to acquire, hold and dispose of land or an interest in land and to acquire, hold and dispose of any other property.

(3) The Board shall, subject to the provisions of this Act, be independent in the exercise of its functions.

F4[(4) The body that, immediately before the commencement of section 36 of the Health (Pricing and Supply of Medical Goods) Act 2013, was known as the Irish Medicines Board shall, from such commencement, cease to be known by that name and instead be known as the Health Products Regulatory Authority.]

4. Functions of Board.

4.—(1) F5[Subject tosubsection (4), the] principal functions of the Board shall be—

(a) the licensing of the manufacture, preparation, importation, distribution and sale of medicinal products,

F5[(b) to exercise the powers conferred on the competent authority by Directive No. 2001/83/EC of 6 November 2001^5,F6[other than those powers conferred by Article 5.3 of the said Directive,]

(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,]

(e) to exercise the powers specified in the Control of Clinical Trials Acts, 1987 and 1990, and conferred on the Board by section 35,

(f) to establish and administer a service for obtaining and assessing information as regards the safety, quality and efficacy of medicinal products,

(g) to establish and administer a service for obtaining and assessing reports on any adverse effects of medicinal products in use in the State,

(h) to advise the Minister and others concerned as to the precautions or restrictions, if any, subject to which medicinal products may be marketed or continued in use in the State,

(i) to arrange for the collection and dissemination of information relating to medicinal products including, in particular, information concerning the pharmacological classification and therapeutic efficacy of such products,

(j) to furnish, whenever it is so requested by the Minister, advice to the Minister in relation to the licensing of the manufacture, importation, distribution and sale of medicinal products and in relation to the standards of manufacturing practice (including quality control) of medicinal products,

F7[(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,]

(l) to establish and administer a service for the inspection of any service for the collection, screening, processing and quality control facilities and procedures in respect of human blood, blood components, blood products and plasma derivatives for the purpose of ensuring the safety and quality of blood, blood components, blood products and plasma derivatives and to advise the Minister in relation to such general or particular matters arising out of the administration of such a service as the Minister may refer to the Board,

(m) if so requested, to advise the Minister or others concerned on such matters relating to medical devices as may be referred to it and are connected with the functions or activities of, or the services provided by, the Board,

(n) to furnish, whenever it so thinks fit or is so requested by the Minister, advice to the Minister in relation to any matter connected with the functions or activities of, or the services provided by, the Board.

F8[(o) to exercise the powers conferred on the competent authority by Council Directive 98/79/EC of the 27th October, 1998^3and the European Communities (In Vitro Diagnostic Medical Devices) Regulations, 2001]

F9[(p) to exercise the powers conferred on the competent authority by Council Directive 90/385/EEC of 20 June 1990^4and the European Communities (Active Implantable Medical Devices) Regulations, 1994 (S.I. No. 253 of 1994) and Council Directive 93/42/EC of 14 June 1993^5and the European Communities (Medical Devices) Regulations, 1994 (S.I. No. 252 ofF10[1994),]]

F11[(q) ...]

F12[(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,]

F13[(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 1995^10and the European Communities (Cosmetic Products) Regulations 2004 (S.I. No. 870 of 2004),]

F12[(u) to exercise the powers conferred on the competent authority by Directive 2004/23/EC of 31 March 2004^11,

F14[(v) to exercise the powers conferred on the competent authority and the authority responsible for notified bodies by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017^1and carry out the functions conferred on the Authority under Regulation 3(3)(a) of the European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 (S.I. No. 547 of 2017),

(w) to exercise the powers conferred on the competent authority and the authority responsible for notified bodies by Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017^2and carry out the functions conferred on the Authority under Regulation 3(3)(b) of the European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 (S.I. No. 547 of 2017),

(x) to perform such other functions as are conferred on the Board by this or any other enactment (including any statutory instrument made thereunder).]]

(2) The Board shall also have and enjoy all those functions that were vested in the former Board immediately before the establishment day and are not specified in subsection (1).

(3) The Board shall have all such powers as are necessary or expedient for the performance of its functions.

F5[(4) The Board shall exercise the powers conferred on it under a paragraph ofsubsection (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 insubsection (1)(q), comply with any directive or guideline issued by the Minister to the Board in respect of policy in relation to controlled drugs.]

5. Conferral of additional functions on Board.

5.—(1) The Minister may, if he or she so thinks fit or, if so requested by the Minister for Agriculture, Food and Forestry, by order—

(a) confer on the Board such additional functions connected with the functions for the time being of the Board or the services or activities that the Board is authorised for the time being to provide or carry on (including functions for the purpose of giving effect to any directive, regulation or other act adopted by an institution of the European Communities in relation to medicinal products F15[, veterinary medicinal products, cosmetic products, drug precursors or medical devices]) as he or she considers appropriate, and

(b) make such provision as he or she considers necessary or expedient in relation to matters ancillary to or arising out of the conferral on the Board of functions under this section or the performance by the Board of functions so conferred.

(2) The Minister may by order amend or revoke an order under this section (including an order under this subsection).

6. Chairperson of Board.

6.—(1) The Minister shall appoint a member of the Board to be chairperson of the Board.

(2) Where the chairperson of the Board ceases to be a member of the Board he or she shall also thereupon cease to be chairperson of the Board.

(3) The chairperson of the Board may at any time resign his or her office as chairperson by letter sent to the Minister and the resignation shall, unless previously withdrawn in writing, take effect at the commencement of the meeting of the Board held next after the Board has been informed by the Minister of the resignation.

(4) The chairperson of the Board shall, unless he or she sooner dies or otherwise ceases to be chairperson by virtue of subsection (2) or (3), hold office until the expiration of his or her period of membership of the Board but, if he or she is re-appointed as a member of the Board, he or she shall be eligible for re-appointment as chairperson of the Board.

(5) F16[…]

7. Members of Board.

7.—(1) The number of members of the Board shall be 9.

(2) The Minister shall, as soon as may be after the establishment day, appoint persons to be members of the Board.

(3) Except as provided for by the preceding subsection, the members of the Board shall be appointed from time to time as occasion requires by the Minister.

(4) The Minister when appointing a member shall fix such member's period of membership which shall not exceed 5 years and, subject to this section, membership shall be on such terms as the Minister determines.

(5) A member of the Board may at any time resign his or her membership by letter addressed to the Minister and the resignation shall take effect from the date specified therein or upon receipt of the letter by the Minister, whichever is the later.

(6) A member of the Board may at any time be removed from membership of the Board by the Minister if, in the Minister's opinion, the member has become incapable through ill-health of performing his or her functions, or has committed stated misbehaviour, or his or her removal appears to the Minister to be necessary for the effective performance by the Board of its functions.

(7) If a member of the Board dies, resigns, becomes disqualified or is removed from office, the Minister may appoint a person to be a member of the Board to fill the casual vacancy so occasioned.

(8) A member of the Board whose period of membership expires by the effluxion of time shall be eligible for re-appointment as a member of the Board.

F17[(9) Of the members of the Board—

(a) one shall be the chairperson of the Advisory Committee for Human Medicines,

(b) one shall be the chairperson of the Advisory Committee for Veterinary Medicines, and

(c) one shall be the chairperson of the Advisory Committee for Medical Devices,

but no member shall be the chairperson of more than one of those committees.]

7A. F18[Remuneration and allowances for expenses of members of Health Products Regulatory Authority

7A.A member of the Health Products Regulatory Authority shall be paid, out of moneys at the disposal of the Authority, such remuneration (if any) and such allowances for expenses as the Minister, with the consent of the Minister for Public Expenditure and Reform, may from time to time determine.]

8. Meetings of Board.

8.—(1) The Board shall hold such and as many meetings as may be necessary for the performance of its functions.

(2) The Minister shall fix the date, time and place of the first meeting of the Board.

(3) The quorum for a meeting of the Board shall be 5.

(4) At a meeting of the Board—

(a) the chairperson of the Board shall, if present, be the chairperson of the meeting, and

(b) if and so long as the chairperson of the Board is not present or if the office of the chairperson is vacant, the members of the Board who are present shall choose one of their members to be chairperson of the meeting.

(5) At a meeting of the Board, each member of the Board present shall have a vote and every question shall be determined by a majority of votes of the members present and voting on the question and, in the case of an equal division of votes, the chairperson of the meeting shall have a casting vote.

(6) The Board may act notwithstanding one or more vacancies among its members.

(7) F19[…]

(8) Subject to the provisions of this Act, the Board shall regulate, by standing orders or otherwise, the procedure and business of the Board.

(9) The Board shall, as soon as may be after its establishment, provide itself with a seal.

(10) The seal of the Board shall be authenticated by the signature of its chairperson or another member of the Board authorised by it to act in that behalf and by the signature of an officer of the Board authorised by it to act in that behalf.

(11) Judicial notice shall be taken of the seal of the Board and every document purporting to be an instrument made by the Board and to be sealed with the seal (purporting to be authenticated in accordance with subsection (10)) of the Board shall be received in evidence and be deemed to be such instrument without proof unless the contrary is shown.

9. Advisory committees.