2.— (1) In this Act—

“Act of 1970” means the Health Act 1970;

“Act of 2007” means the Pharmacy Act 2007;

“authorisation holder”—

(a) means the holder of a marketing authorisation granted pursuant to Regulation 10(1) of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007), and

(b) includes the holder of—

(i) a product authorisation within the meaning of those Regulations,

(ii) a parallel import licence within the meaning of those Regulations,

(iii) an authorisation granted by the Commission of the European Community under—

(I) Council Regulation (EEC) No. 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, ¹ or

(II) Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ²,

or

(iv) an authorisation granted by the Board under Article 126a of Directive 2001/83/EC;

“Board” means the Irish Medicines Board;

“brand name”, in relation to a medicinal product, means—

(a) a medicinal product marketed in the State under a name (not being a common name) which identifies the medicinal product to the extent that no other medicinal product is marketed in the State under that name, or

(b) a medicinal product marketed in the State under a common name in conjunction with another name (which may be the name of the pharmaceutical company connected with the medicinal product) which identifies the medicinal product to the extent that no other medicinal product is marketed in the State under those names,

and references in this Act to “branded” shall be construed accordingly;

“branded product” means a branded interchangeable medicinal product named on a prescription referred to in section 7(1), 8(1), 9(1) or 10(1);

“clinical exemption”, in relation to a branded interchangeable medicinal product named on a prescription, means an exemption under section 13(1), in so far as that prescription is concerned, from the medicinal product being substituted by a substitute medicinal product;

“common name”, in relation to a medicinal product, includes any of the following:

(a) the international non-proprietary name of the medicinal product;

(b) the scientific name of the medicinal product;

(c) if the medicinal product contains only one active substance, the name of the active substance;

(d) if the medicinal product contains 2 or more active substances, the names of each of the active substances;

“community pharmacy contractor” means a pharmacist, company or other body corporate, or partnership, who has entered into an agreement with the Executive to provide community pharmacy services to eligible persons under section 59 of the Act of 1970;

“deemed application” means an application referred to in section 18(4) or (5);

“deemed condition” means a condition which is attached to a deemed listed item by virtue of the operation of section 17(5) only;

“deemed listed item” means a listed item which is on the Reimbursement List by virtue of the operation of section 17(5) only;

“dietary food for a special medical purpose” means a food—

(a) specifically processed or formulated, and intended—

(i) for the dietary management of patients, and

(ii) to be used under medicinal supervision,

or

(b) intended for the exclusive or partial feeding of patients—

(i) with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete—

(I) ordinary foodstuff,

(II) one or more nutrients contained in ordinary foodstuff, or

(III) metabolites,

or

(ii) with other medically determined nutrient requirements whose dietary management cannot be achieved only by—

(I) modification of the normal diet,

(II) the use of a foodstuff for a particular nutritional use, or

(III) a combination of the modification of the normal diet and the use of a foodstuff for a particular nutritional use;

“Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, ³ as amended by—

(a) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC ⁴,

(b) Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community Code relating to medicinal products for human use ⁵,

(c) Directive 2004/24/EC of the European Parliament and the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use ⁶,

(d) Directive 2004/27/EC of the European Parliament and the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use ⁷,

(e) Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004 ⁸,

(f) Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products ⁹,

(g) Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use ¹⁰, and

(h) Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products ¹¹;

“Drug Payment Scheme” means the scheme for the time being in force administered by the Executive for the purposes of section 59(2) of the Act of 1970;

“equivalent relevant price”, in relation to an item or listed item which is marketed in another Member State, means the price, in that other Member State, of the item or listed item, as the case may be, which is, in all the circumstances of the case, the nearest equivalent to the relevant price of the item or listed item, as the case may be;

“Executive” means the Health Service Executive;

“ex-factory price”, in relation to a medicinal product, means the price of the product as agreed between the Executive and the supplier of that product;

“foodstuff for a particular nutritional use” means a foodstuff—

(a) which, owing to its special composition or manufacturing process, is clearly distinguishable from a foodstuff for normal consumption,

(b) which clinical evidence shows is suitable for its claimed nutritional purpose, and

(c) which is marketed in such a way as to indicate its suitability for its claimed nutritional purpose;

“General Medical Services Scheme” means the scheme for the time being in force administered by the Executive for the purposes of section 58 of the Act of 1970;

“group of interchangeable medicinal products” shall be construed in accordance with section 4(1);

“ingredient cost”, in relation to a medicinal product, means the cost of the product arrived at by adding together—

(a) the ex-factory price of the product, and

(b) the wholesale mark-up (if any) of the product;

“interchangeable medicinal product” means a medicinal product which falls within a group of interchangeable medicinal products;

“item” means a drug, medicine or medical or surgical appliance which is not on the Reimbursement List;

“listed item” means a drug, medicine or medical or surgical appliance for the time being on the Reimbursement List;

“List of Interchangeable Medicinal Products” shall be construed in accordance with section 4 (1);

“Long Term Illness Scheme” means the scheme for the time being in force administered by the Executive for the purposes of section 59(3) of the Act of 1970;

“medical device” means a medical device which falls within any definition of “medical device” in—

(a) Article 1 of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of Member States relating to active implantable medical devices ¹², as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market ¹³,

(b) Article 1 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ¹⁴, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market, or

(c) Article 1 of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ¹⁵;

“medicinal product” has the meaning assigned to it by Directive 2001/83/EC;

“Minister” means the Minister for Health;

“patient”, in relation to a prescription, means the person named on the prescription and in respect of whose treatment the prescription is issued;

“pharmacist” means a registered pharmacist within the meaning of the Act of 2007;

“pharmacy owner” has the meaning assigned to it by section 2 of the Act of 2007;

“prescriber”, in relation to a prescription, means the person referred to in paragraph (a), (b) or (c) of the definition of “prescription” who issued the prescription;

“prescription” means a prescription issued by—

(a) a registered medical practitioner within the meaning of section 2 of the Medical Practitioners Act 2007 or a registered dentist within the meaning of section 2 of the Dentists Act 1985,

(b) a person, in another Member State, who is, in the other Member State, of equivalent status to a registered medical practitioner or registered dentist referred to in paragraph (a) where—

(i) the address of that person in the other Member State, as the person issuing the prescription, is shown on the prescription,

(ii) the person is not connected with any practice of dentistry or medicine in the State, and

(iii) the prescription has not been issued with a view to enabling the supply of a medicinal product by mail order,

or

(c) a registered nurse within the meaning of section 2(1) of the Nurses and Midwives Act 2011;

“reference price” shall be construed in accordance with section 24;

“reimbursement”, in relation to a listed item, means the reimbursement of all or part of the cost of the listed item, and includes any other means of offsetting such cost;

“Reimbursement List” shall be construed in accordance with section 17(1);

“reimbursement price” has the meaning assigned to it by regulation 2 of the Health Professionals (Reduction of Payments to Community Pharmacy Contractors) Regulations 2011 (S.I. No. 300 of 2011);

“relevant group of interchangeable medicinal products” means a group of interchangeable medicinal products which consists of, or includes, 2 or more interchangeable medicinal products which are listed items;

“relevant listed items” means all the listed items which fall within a relevant group of interchangeable medicinal products;

“relevant price”—

(a) in relation to an item or a listed item which is a medicinal product, means the ingredient cost of the item, and

(b) in relation to a listed item which is—

(i) a medical device,

(ii) a foodstuff for a particular nutritional use, or

(iii) a dietary food for a special medical purpose,

means the reimbursement price of the listed item;

“relevant scheme” means—

(a) the General Medical Services Scheme,

(b) the Drug Payment Scheme,

(c) the Long Term Illness Scheme, or

(d) any other scheme for the time being in force administered by the Executive for the purposes of section 59 of the Act of 1970;

“retail pharmacy business” means a retail pharmacy business, within the meaning of section 2 of the Act of 2007, which is registered under that Act;

“set”, in relation to a reference price for a group of interchangeable medicinal products, means set under section 24(1) or (2);

“specified”, in relation to a form, means specified under section 28;

“substitute medicinal product”, in relation to a branded interchangeable medicinal product prescribed for a person, means another interchangeable medicinal product which falls within the same group of interchangeable medicinal products as the branded interchangeable medicinal product.

(2) Any reference in a provision of this Act to an authorisation holder of a medicinal product includes a person nominated in writing by the authorisation holder to act on behalf of the authorisation holder in respect of that provision in so far as it relates to that medicinal product.

(3) For the purposes of this Act, an active substance in a medicinal product may be the same as another active substance in another medicinal product notwithstanding that the 2 medicinal products contain different salts, esters, ethers, isomers or mixtures of isomers, or the 2 medicinal products contain different complexes or derivatives of the active substance concerned, provided that the 2 active substances do not significantly differ in relation to safety or efficacy in respect of human use.