Medicinal Products (Prescription and Control of Supply) Regulations, 1996

• Jurisdiction: Ireland
• Citation: IR SI 256/1996
• Year: 1996

S.I. No. 256 of 1996.
MEDICINAL PRODUCTS (PRESCRIPTION AND CONTROL OF SUPPLY) REGULATIONS, 1996
Arrangement of Articles
Article
1. Citation
2. Commencement
3. Revocations
4. Interpretation
5. Medicinal products on prescription only
6. Restrictions on medicinal products exempted from prescription control
7. Restrictions on dispensing of prescriptions
8. Exemptions for emergency supply
9. Labelling of dispensed medicinal products
10. Pharmacy records
11. Keeping of records in the case of certain medicinal products
12. Prohibition of supply after expiry date
13. Prohibition of mail order supplies of medicinal products 14 Exemptions for supply in certain circumstances
15. Enforcement and execution
16. Evidence of result of test, examination or analysis
17. Transitional provisions
FIRST SCHEDULE
Substances which when contained in medicinal products are subjected to prescription control and the circumstances excluding certain products from such control.
SECOND SCHEDULE
Other medicinal products excluded from prescription control
THIRD SCHEDULE
Substances which when contained in certain non prescription medicinal products may be supplied in non pharmacy outlets.
FOURTH SCHEDULE
Substances which, when contained in certain medicinal products, may be dispensed in the manner prescribed for a product which is or which contains a substance specified in Part B of the First Schedule.
FIFTH SCHEDULE
Substances not to be contained in a medicinal product supplied under the exemption conferred by Article 8(2).
SIXTH SCHEDULE
Cautionary and warning notices for dispensed medicinal products.
SEVENTH SCHEDULE
Certificate stating results of test, examination or analysis.
S.I. No. 256 of 1996.
Medicinal Products (Prescription and Control of Supply) Regulations, 1996.
In exercise of the powers conferred on the Minister for Health by section 32 of the Irish Medicines Board Act, 1995 (No. 29 of 1995), which said powers are delegated to me by the Health (Delegation of Ministerial Functions) Order, 1996 ( S.I. No. 24 of 1996 ), I, Brian O'Shea, Minister of State at the Department of Health, hereby make the following Regulations:—
	1 CITATION 1	1. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) Regulations, 1996.
	2 COMMENCEMENT	2. These Regulations shall come into operation on the 1st day of September, 1996.
	3 REVOCATIONS	3. The Medical Preparations (Prescription and Control of Supply) Regulations, 1993 ( S.I. No. 69 of 1993 ) are hereby revoked.
	4 INTERPRETATION	4. (1) In these Regulations:—
"the Act" means the Irish Medicines Board Act, 1995 ;
"aerosol" means a product which is dispersed from its container by a propellant gas or liquid;
"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 article 4 of the European Communities (Recognition of Qualifications in Pharmacy) Regulations, 1991 ( S.I. No. 330 of 1991 );
"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;
"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 is 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 prescription" means a prescription issued in connection with arrangements made under section 59 of the Health Act, 1970 (No. 1 of 1970), on a form supplied by or on behalf of a health board;
"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;
"new chemical molecule" means a substance, not being a substance specified in any of the Schedules to these Regulations, which was not contained in a medicinal product, as one of its active ingredients, which was lawfully on the market in the State on, or immediately before, the 19th day of January 1987;
"parenteral administration" means administration by breach of the skin or mucous membrane;
"prescription", except in the expression "medical prescription", means a prescription issued by a registered medical practitioner or a registered dentist;
"premises" includes any aircraft, hovercraft, ship, stall or vehicle;
"product authorisation" means an authorisation granted in pursuance of the Medical Preparations (Licensing and Sale) Regulations, 1996 ( S.I. No. 43 of 1996 );
"registered dentist" means a person registered in the register established under the Dentists Act, 1985 (No. 9 of 1985) and includes any person entitled to be so registered by virtue of section 27(2)(c) of the said Act;
"registered medical practitioner" means a person registered in the register established under the Medical Practitioners Act, 1978 (No. 4 of 1978) and includes any person entitled to be so registered by virtue of section 27(2)(c) of the said Act;
"registered nurse" means a person registered in the register established under the Nurses Act, 1985 (No. 18 of 1985);
"repeatable prescription" means a prescription which may be dispensed more than once;
"supply" includes sell, distribute or offer or keep for sale 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, 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;
"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 ;
(2) In these Regulations, unless the context otherwise indicates, any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations
or, as the case may be, to a Schedule thereto; any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article, and any reference in a sub-article to a paragraph shall be construed as a reference to a paragraph of that sub-article.
	5 MEDICINAL PRODUCTS ON PRESCRIPTION ONLY	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) Sub-article (1)(a) shall not apply as respects a medicinal product where there is an entry in relation to a substance in the medicinal product in one or more of columns 3, 4 and 5 of the First Schedule; and
( a ) where the maximum strength of the substance does not exceed that, if any, specified in column 3 of the said Schedule opposite the mention of that substance in column 1 thereof; and
( b ) where the maximum pack size of the medicinal product does not exceed that, if any, specified in column 3 of the said Schedule opposite the mention in column 1 thereof of a substance contained in the said product; and
( c ) where a pharmaceutical form is specified in...