Medicinal Products (Prescription and Control of Supply) Regulations 2003

• Jurisdiction: Ireland

I, Micheál Martin, Minister for Health and Children, in exercise of the powers conferred on me by section 32 of the Irish Medicines Board Act, 1995 (No. 29 of 1995), as adapted by the Health (Alteration of Name of Department and Title of Minister) Order, 1997 ( S.I. No. 308 of 1997 ) hereby make the following Regulations:-
	Citation	1. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) Regulations 2003.
	Commencement	2. These Regulations shall come into operation on the 11th day of November 2003.
	Revocations	3. The Medicinal Products (Prescription and Control of Supply) Regulations 1996 ( S.I. No. 256 of 1996 ), the Medicinal Products (Prescription and Control of Supply)(Amendment Regulations 1996 ( S.I. No 309 of 1996 ), the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 1999 ( S.I. No. 271 of 1999 ), the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2000 ( S.I. No. 116 of 2000 ) the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2002 ( S.I. No. 627 of 2002 ) and the Medicinal Products (Control of Paracetamol) Regulations 2001 ( S.I. No. 150 of 2001 ) are hereby revoked.
	Interpretation	4. (1) In these Regulations: -
“Act” means the Irish Medicines Board Act, 1995 ;
“active substance”, in respect of a medicinal product, means a substance which contributes to the pharmacological action of the medicinal product and cognate expressions shall be construed accordingly;
“aerosol” means a product which is dispersed from its container by a propellant gas or liquid;
“authorised officer” means an authorised officer appointed for the purposes of these Regulations under regulation 21;
“authorised person” has the meaning assigned to it by section 2 of the Pharmacy Act, 1962 (No. 14 of 1962) as amended by section 34 of the Misuse of Drugs Act 1977 and by regulation 4 of the European Communities (Recognition of Qualifications in Pharmacy) Regulations 1991 ( S.I. No. 330 of 1991 );
“Board” means the Irish Medicines Board;
“controlled drug” has the meaning assigned to it by Section 2 of the Misuse of Drugs Act, 1977 ;
“dosage unit” means -
(a) where a medicinal product is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other article, or
(b) where a medicinal product is not in any such form, that quantity of the product which is used as the unit by reference to which the dose is measured;
“European Pharmacopoeia” means the Pharmacopoeia referred to in subsection (3 of section 4 of the Pharmacopoeia Act, 1931 ( No 22 of 1931 ) (as inserted by section 35 of the Misuse of Drugs Act, 1977 ( No 12 of 1977 )) and which is for the time being in force.
“external use” means application to the skin, hair, teeth, mucosa of the mouth, throat nose, ear, eye, vagina or anal canal when a local action only in intended and extensive systemic absorption is unlikely to occur and references to medicinal products for external use shall be read accordingly except that such references shall not include transdermal delivery systems, throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething products;
“health board” means a board established under section 4 of the Health Act, 1970 (No. 1 of 1970), and the Eastern Regional Health Authority established by section 7 of the Health (Eastern Regional Health Authority) Act, 1999 (No. 13 of 1999);
“health prescription” means a prescription issued in connection with arrangements made under section 59 or section 67 of the Health Act, 1970 (No. 1 of 1970), on a form supplied by or on behalf of a health board;
“homeopathic medicinal product” means any medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or in absence thereof, by the pharmacopoeia currently used officially in the Member States;
“hospital” includes a clinic, nursing home or similar institution;
“inhaler” does not include an aerosol;
“maximum daily dose” or “MDD” means the maximum quantity of a substance contained in the amount of a medicinal product for internal use which it is recommended should be taken or administered in any period of 24 hours;
“maximum dose” or “MD” means the maximum quantity of a substance contained in the amount of a medicinal product for internal use which it is recommended should be taken or administered at any one time;
“maximum pack size” or “MPS” means the maximum quantity of a medicinal product by weight, volume or number of dosage units contained in the pack presentation for supply;
“maximum period of treatment” or “MPT” means the maximum period specified in days in respect of the amount of a medicinal product which it is recommended should be taken or administered during the period so specified;
“maximum strength” or “MS” means such of the following as may be specified -
(a) the maximum quantity of a substance by mass or volume contained in a dosage unit of a medicinal product, and
(b) the maximum percentage of a substance contained in a medicinal product calculated in terms of mass in mass (m/m), mass in volume (m/v) volume in mass (v/m) or volume in volume (v/v), as appropriate;
“the Minister” means the Minister for Health and Children;
“new chemical molecule” means a substance, not being a substance specified in any of the Schedules to these Regulations and which was not contained as an active substance in a medicinal product lawfully on the market in the State on, or immediately before, the 19th day of January 1987;
“package leaflet” means a leaflet containing information for the user which accompanies the medicinal product;
“pack size” means the quantity of a medicinal product by weight, volume or number of dosage units contained in the pack presentation intended for supply;
“parenteral administration” means administration by breach of the skin or mucous membrane;
“premises” includes any aircraft, hovercraft, ship, stall or vehicle;
“prescription” means a prescription issued by a registered medical practitioner, or registered dentist or by a practitioner of equivalent status practising in another Member State with the address of the practitioner in that Member State, as the person issuing the prescription, shown on the prescription, and the practitioner concerned is not connected with any practice of medicine or dentistry in the State and the prescription has not been issued with a view to enabling the supply of a medicinal product by mail order;
“product authorisation” means an authorisation granted and in force in pursuance of the Medicinal Products (Licensing and Sale) Regulations 1998 ( S.I. No. 142 of 1998 );
“registered dentist” means a person registered in the register established under the Dentists Act, 1985 (No. 9 of 1985);
“registered medical practitioner” means a person registered in the register established under the Medical Practitioners Act, 1978 (No. 4 of 1978);
“registered nurse” means a person registered in the register established under the Nurses Act, 1985 (No. 18 of 1985);
“registered optometrist” means a person registered in the Register of Optometrists established under the Opticians Acts, 1956 to 2003;
“repeatable prescription” means a prescription which may be dispensed more than once;
“sampling officer” means a person authorised by a health board to take samples for the purposes of the Sale of Food and Drugs Acts, 1875 to 1936 or in connection with any arrangements made for testing the quality or amount of the drugs, medicines and appliances supplied for the purpose of section 59 of the Health Act, 1970 or by officers of the Board in the enforcement and execution of Regulations made under the Act;
“supply” includes sell, distribute or offer or keep for sale, supply or distribution notwithstanding that the person supplied may be in another Member State of the European Community and cognate words shall be construed accordingly;
“supply by mail order” means any supply made, after solicitation of custom by the supplier, or by another person in the chain of supply whether inside or outside of the State, without the supplier and the customer being simultaneously present and using a means of communication at a distance, whether written or electronic, to convey the custom solicitation and the order for supply;
“supply by way of wholesale dealing” means the supply of a medicinal product to a person who obtains the product for one or more of the following purposes -
(a) supply in the course of a pharmaceutical business, or
(b) administration in the course of a professional practice, or
(c) for or in connection with a service provided by a hospital.
(2) In these Regulations, unless the context otherwise indicates, any reference to a regulation or Schedule shall be construed as a reference to a regulation contained in these Regulations or, as the case may be, to a Schedule thereto; any reference in a regulation to a paragraph shall be construed as a reference to a paragraph of that regulation, and any reference in a paragraph to a sub-paragraph shall be construed as a reference to a sub-paragraph of that paragraph.
	Medicinal Products subject to Prescription Control	5. (1) Subject to the provisions of these Regulations a person shall not supply a medicinal product of any of the following classes except in accordance with a prescription namely -
(a) any medicinal product which is or which contains a substance specified in column 1 of the First Schedule;
(b) any medicinal product which is intended for parenteral administration;
(c) any medicinal product which is or which contains a new chemical molecule.
(2) Paragraph (1)(a) shall not apply as respects a...