Medicinal Products (Prescription and Control of Supply) Regulations 2003
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) Regulations 2003.
Commencement
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paragraphs: These Regulations shall come into operation on the 11th day of November 2003.
Revocations
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paragraphs: 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
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paragraphs: (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;