Irish Medicines Board Act 1995
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;]
“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 19931;
F1["drug precursor" means a scheduled substance as defined in Article 2 of Council Regulation (EC) No. 111/2005 of 22 December 20041;]
“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;
F2["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 19902,
(b) Article 1 of Council Directive 93/42/EEC of 14 June 19933, or
(c) Article 1 of Directive 98/79/EC of 27 October 19984;
"medicinal product" has the meaning assigned to it by Directive 2001/83/EC of 6 November 20015, as amended from time to time;]
“the Minister” means the Minister for Health;
F1["premises" includes any aircraft, hovercraft, ship, stall or vehicle;]
“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 F2[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;
"veterinary medicinal product" has the meaning assigned to it by Directive 2001/82/EC of 6 November 20016, 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.
Annotations
Amendments:
F1
Inserted (22.07.2007) by Irish Medicines Board (Miscellaneous Provisions) Act 2006 (3/2006), s. 10(a), (b), (d), (f), S.I. No. 543 of 2007.
F2
Substituted (22.07.2007) by Irish Medicines Board (Miscellaneous Provisions) Act 2006 (3/2006), s. 10(c), (e), S.I. No. 543 of 2007.
F3
Inserted by Health (Miscellaneous Provisions) Act 2024 (23/2024), s. 8, not commenced as of date of revision.
Modifications (not altering text):
C3
Prospective affecting provision: definitions inserted by Health (Miscellaneous Provisions) Act 2024 (23/2024), s. 8, not commenced as of date of revision.
F3["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 20047, as amended;]
...
F3["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;]
F3["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;]
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F3["protocol" means a protocol issued by the Minister under section 32G;]
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F3["registered pharmacist" means a person registered in the register of pharmacists established under section 13 of the Pharmacy Act 2007;]
F3["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;]
C4
References to a "registered medical practitioner" construed (3.07.2008) by Medical Practitioners Act 2007 (25/2007), s. 108(1), S.I. No. 231 of 2008.
Construction of references to registered medical practitioner and Medical Council, etc.
108.— (1) Every reference to a registered medical practitioner contained in any enactment or any statutory instrument shall be construed as a reference to a registered medical practitioner within the meaning of section 2.
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