S.I. No. 256/1996 - Medicinal Products (Prescription and Control of Supply) Regulations, 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.

1. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) Regulations, 1996.

2 COMMENCEMENT

2.

2. These Regulations shall come into operation on the 1st day of September, 1996.

3 REVOCATIONS

3.

3. The Medical Preparations (Prescription and Control of Supply) Regulations, 1993 ( S.I. No. 69 of 1993 ) are hereby revoked.

4 INTERPRETATION

4.

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.

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 column 4 of the said Schedule opposite the mention of the substance, contained in a medicinal product, in column 1 thereof, the medicinal product is supplied in such form; and

( d ) where a manner of administration is specified in column 4 of the said Schedule opposite the mention of the substance, contained in a medicinal product, in column 1 thereof, the medicinal product is supplied only for such manner of administration; and

( e ) where the container or package of a medicinal product is labelled to show a use specified in column 4 of the said Schedule opposite the mention of a substance, contained in such medicinal product, in column 1 thereof, the medicinal product is supplied in such a container or package so labelled and which does not show any use not so specified; and

( f ) where the product is one for which a maximum dose is specified in column 5 of the said Schedule opposite the mention of a substance, contained in a medicinal product, in column 1 thereof, it is in a container or package labelled to show a maximum dose not exceeding that so specified; and

( g ) where the product is one for which a maximum daily dose is specified in column 5 of the said Schedule opposite the mention of a substance, contained in a medicinal product, in column 1 thereof, it is in a container or package labelled to show a maximum daily dose not exceeding that so specified; and

( h ) where the product is one for which a maximum period of treatment is specified in column 3 of the said Schedule opposite the mention of a substance, contained in a medicinal product, in column 1 thereof, it is in a container or package labelled to show a maximum period of treatment not exceeding that so specified.

• (3) Sub-article (1) shall not apply as respects a medicinal product which is specified in the Second Schedule.

• (4) Sub-article (1) shall not apply as respects a medicinal product which is intended exclusively for veterinary use and is supplied in a container or package which is labelled with the words "For Animal Treatment Only"

• (5) Sub-article (1)(c) shall cease to apply in respect of a new chemical molecule after the period of three years beginning with the date on which the relevant product authorisation was granted by the Irish Medicines Board.

• (6) Sub-article (2) shall not apply in the case of a medicinal product containing a substance specified in Part 1 of the Third Schedule unless the product —

• (a) is the subject of a product authorisation,

• (b) is supplied in the original container and outer package (if any) supplied by the manufacturer or person responsible for placing the product on the market, and

• (c) is in a presentation, labelled by the manufacturer or person responsible for placing the product on the market, showing that the said product is of a classification which may be supplied without a prescription.

• (7) The container and outer package of a medicinal product, which by reason of paragraphs (f) or (g) of sub-article (2) is supplied without a prescription, shall be labelled to show the words "Warning. Do not exceed the stated dose."

6 RESTRICTIONS ON MEDICINAL PRODUCTS EXEMPTED FROM PRESCRIPTION CONTROL

6.

6. (1) Subject to sub-article (2), a person shall not supply a medicinal product which, by reason of sub-articles (2) or (3) of article 5, may be supplied without a prescription unless he is a person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons in accordance with the Pharmacy Acts, 1875 to 1977 and such supply is effected by or under the personal supervision of an authorised person.

• (2) Sub-article (1) shall not apply to the supply of a medicinal product which contains a substance specified in Part 2 of the Third Schedule provided that the supply of the product concerned is not otherwise prohibited by virtue of these Regulations.

7 RESTRICTIONS ON DISPENSING OF PRESCRIPTIONS

7.

7. (1) For the purposes of these Regulations a prescription shall comply with the following requirements, that is to say, it shall—

• (i) be in ink and be signed by the person issuing it with his usual signature and be dated by him;

• (ii) except in the case of a health prescription, specify the address of the person issuing it;

• (iii) clearly indicate the name of the person issuing it and state whether he is a registered medical practitioner or a registered dentist; and

• (iv) specify the name and address, and age if under 12, of the person for whose treatment it is issued.

• (2) Subject to sub-articles (3) and (4) the following provisions shall be complied with in the dispensing of a prescription for the supply of a medicinal product—

• (a) where neither the number of occasions on which nor the intervals at which a medicinal product which is or which contains a substance specified in Part A of the First Schedule may be supplied are specified in a prescription, the prescription may be dispensed on one occasion only;

• (b) where neither the number of occasions on which nor the intervals at which a medicinal product which is or which contains a substance specified in Part B of the First Schedule but which does not contain a substance specified in Part A of the said Schedule, may be supplied are specified in a prescription, the prescription may be dispensed on such number of occasions within the period of six months after the date thereon as the person dispensing the prescription considers appropriate having regard to the specified rate of dosage;

• (c) where the intervals at which a medicinal product, which is or which contains a substance specified in Part A of the First Schedule may be supplied, are specified in a prescription but the number of occasions on which it may be supplied are not so specified, the prescription may be dispensed on not more than three occasions;

• (d) where the intervals at which a medicinal product which is or which contains a substance specified in Part B of the First Schedule but which does not contain a substance specified in Part A of the said Schedule, may be supplied are specified in a prescription, the prescription may be dispensed at those intervals within the period of six months after the date thereon;

• (e) where the number of occasions on which a medicinal product, which is or which contains a substance specified in either Part A or Part B of the First Schedule, may be supplied is specified in a prescription but the intervals at which it may be supplied are not so specified, the prescription may be dispensed at such intervals as the person dispensing the prescription considers appropriate having regard to the specified rate of dosage;

• (f) where the dispensing of a prescription has been completed the person who dispensed it shall forthwith write or print prominently on the prescription the word "dispensed" and the date on which it was dispensed;

• (g) where the prescription is dispensed in part, the person who so dispensed it shall, if it is not being preserved in accordance with article 10(3), forthwith record on the prescription the quantity of each product supplied by him and the date on which he supplied each such quantity and the name and address of the person by whom such product was supplied;

• (h) where a medical prescription is issued in respect of a medicinal product to which article 5(1)(b) or (c) applies or which contains a substance specified in Part A of the First Schedule, such prescription shall not be a repeatable prescription unless the intervals of supply or the number of occasions of supply has been written thereon in the prescriber's own handwriting or prescriber's own typed script.

• (3)
• (a) The prescription in the case of a medicinal product to which this sub-article applies may be dispensed in accordance with this article as it relates to a product which is or which contains a substance specified in Part B of the First Schedule.

• (b) The medicinal products to which this sub-article applies are—

• (i) any product intended for external use which is or which contains a substance specified in Part 1 of the Fourth Schedule,

• (ii) any product intended for use as an oral contraceptive which is or which contains a substance specified in Part 2 of the Fourth Schedule, and

• (iii) any product containing hydrocortisone sodium succinate or triamcinolone acetonide specifically intended for the treatment of ulceration of the mouth.

• (4) The prescription in the case of a medicinal product to which article 5(1)(b) or (c) applies shall be dispensed in accordance with this article as it relates to a product which is or which contains a substance specified in Part A of the First Schedule.

• (5) The prescription in the case of a medicinal product, which by virtue of these Regulations may not be supplied except in accordance with a prescription, shall —

• (a) not be dispensed after the end of the period of six months from the date specified on the prescription; and

• (b) except in the case of Sodium Fluoride Tablets, be dispensed on one occasion only where it is issued by a registered dentist.

• (6) The prescription in the case of a medicinal product which consists of or contains a substance specified in Part C of the First Schedule shall not be dispensed except in a hospital.

• (7) Notwithstanding the provisions of these Regulations, an authorised person may dispense a medicinal product to which this article applies, where a prescription is not in accordance with sub-article (1) by reason only that one of the conditions specified in sub-article (1) is not fulfilled, where the authorised person exercises due diligence and care, and is satisfied that it is safe to do so.

• (8) The provisions of sub-articles (2), (3), (4), (5) and (7) shall not apply to a product which is a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations, 1988 ( S.I. No. 328 of 1988 ) or any amendment thereof.

8 EXEMPTIONS FOR EMERGENCY SUPPLY

8.

8. (1) It shall not be a contravention of article 5(1) or article 7 for a person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts, 1875 to 1977 to supply a medicinal product otherwise than in accordance with a prescription where -

• (a) the authorised person by whom or under whose supervision the product is to be supplied has been requested to supply the product for a particular patient by a registered medical practitioner or registered dentist who by reason of an emergency is unable to furnish a prescription immediately,

• (b) the practitioner concerned has undertaken to furnish a prescription within 72 hours,

• (c) the product is supplied in accordance with the directions of the practitioner requesting it, and

• (d) subject to sub-article (3), the product is not a controlled drug specified in Schedule 1, 2, 3 or 4 to the Misuse of Drugs Regulations, 1988 or any amendment thereof.

• (2) It shall not be a contravention of article 5(1) or article 7 for a person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts, 1875 to 1977 to supply a medicinal product otherwise than in accordance with a prescription where —

• (a) the authorised person by whom or under whose supervision the product is to be supplied has at such shop interviewed the person requesting the product and has satisfied himself—

• (i) that there is an immediate need for the product to be supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay,

• (ii) that treatment with the product has on a previous occasion been prescribed by a registered medical practitioner for the person, and

• (iii) that he can in the circumstances safely specify the appropriate dose of the product for the person;

• (b) no greater quantity of the product than will provide 5 days' treatment is supplied, except where the product

• (i) is an aerosol for the relief of asthma, an ointment or a cream, and has been made up in a container elsewhere than at the place of supply, and the smallest container that the authorised person has available is supplied,

• (ii) is an antibiotic for oral administration in liquid form, and the smallest quantity that will provide a full course of treatment is supplied,

• (iii) is an oral contraceptive, and a quantity sufficient for a full cycle is supplied;

• (c) subject to sub-article (3), the product does not consist of or contain a substance specified in the Fifth Schedule and is not a controlled drug specified in Schedule 1, 2, 3 or 4 to the Misuse of Drugs Regulations, 1988 or any amendment thereof; and

• (d) the container or package of the product is labelled so as to show -

• (i) the date on which the product is supplied,

• (ii) the name of the product, being either the proprietary name, or the non-proprietary name, with the name of the manufacturer or of the person responsible for placing the product on the market,

• (iii) the quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the product,

• (iv) the name of the person requesting the product,

• (v) the name and address of the shop from which the product was supplied, and (vi)the words "Emergency Supply".

• (3) The conditions specified in paragraph (d) of sub-article (1) and in paragraph (c) of sub-article 2 shall not apply where the product consists of or contains methylphenobarbitone, phenobarbitone or phenobarbitone sodium (but no other substance specified in the Fifth Schedule or in Schedule 1, 2, 3 or 4 to the Misuse of Drugs Regulations, 1988 or any amendment thereof) and is supplied for the treatment of epilepsy.

9 LABELLING OF DISPENSED MEDICINAL PRODUCTS

9.

9. (1) In this article "dispensed medicinal product" means a medicinal product —

( a ) supplied by a registered medical practitioner or registered dentist for or to a patient under his care, or

( b ) supplied by or under the supervision of an authorised person —

• (i) in accordance with a prescription or specification furnished by the person to whom the product is to be supplied, or

• (ii) in circumstances where the person under whose supervision the product is supplied exercises his own judgement as to the treatment required.

• (2) Subject to sub-article (3), the container or outer package of a dispensed medicinal product shall be labelled to show the following particulars —

• (a) the name of the person to whom the product is to be administered;

• (b) the name and address of the person by whom the product was supplied;

• (c) the date on which the product was dispensed;

• (d) unless the prescriber otherwise directs, the name of the product, being either the proprietary name, or the non-proprietary name with the name of the manufacturer or of the person responsible for placing the product on the market;

• (e) where the product is being supplied on foot of a prescription, such of the following particulars as the prescriber may specify, —

• (i) directions for use of the product, and

• (ii) precautions relating to the use of the product,

or, where an authorised person, in the exercise of his professional skill and judgement, is of the opinion that any of such particulars are inappropriate and has taken such steps as in all the circumstances are reasonably practicable to consult with the prescriber but has been unable to do so, particulars of the same kind as those requested by the prescriber as appear to the authorised person to be appropriate;

• (f) where the product is not being supplied on foot of a prescription, the directions for use of the product;

• (g) the words "Keep out of the reach of children";

• (h) where the product is for external use only, the words "For external use only";

• (i) such of the cautionary and warning notices specified in the Sixth Schedule as are in the opinion of the authorised person, deemed to be appropriate.

• (3) It shall be sufficient compliance with paragraphs (d), (g), (h), and (i) of sub-article (2) if the dispensed medicinal product is supplied in the original container and outer package (if any) as supplied by the manufacturer or person responsible for placing the product on the market, accompanied by the relevant patient information leaflet (if any), and any of the information originally made available in the presentation of the product has not been removed or obscured in the course of supply.

10 PHARMACY RECORDS

10.

10. (1) Subject to sub-articles (2), (3) and (5), a person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts, 1875 to 1977 shall, in respect of every supply of a medicinal product which by virtue of these Regulations may not be supplied except in accordance with a prescription, enter or cause to be entered in a register kept for that purpose, the following particulars, that is to say—

• (a) where the product is supplied in accordance with a prescription or in compliance with article 8(1) —

• (i) the date on which the product is supplied;

• (ii) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the product;

• (iii) the name of the prescriber and where he is not known to the authorised person, his address;

• (iv) the name and address of the person for whom the product is prescribed;

• (v) the date of the prescription; and

• (vi) in relation to the supply of a product in compliance with article 8(1), the date on which the prescription is received;

• (b) where the product is supplied in the dispensing of a repeatable prescription on a second or subsequent occasion —

• (i) the date on which the product is supplied, and a reference to an entry in the aforementioned register which was made on the first occasion on which the product was supplied in the dispensing of that prescription; or

• (ii) the particulars specified in sub-article (1)(a); and

• (iii) where the supply on the last previous occasion was at another shop, the name and address of such shop and the reference to the entry in the aforementioned register for such shop in respect of such supply.

• (c) where the product is supplied in accordance with article 8(2)—

• (i) the date on which the product is supplied;

• (ii) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the product;

• (iii) the name and address of the person requiring the product;

• (iv) the nature of the emergency which rendered it necessary to supply the product otherwise than in accordance with a prescription;

• (v) the name of the prescriber who on the previous occasion prescribed the product and where he is not known to the authorised person, his address; and

• (vi) where the supply on the previous occasion was at another shop, the name and address of such shop and the reference to the entry in the aforementioned register for such shop in respect of such supply.

• (d) where the supply is by way of wholesale dealing or is a supply referred to in article 13 (a) and no order or invoice, or copy thereof, relating to such supply has been retained by the supplier —

• (i) the date on which the product is supplied;

• (ii) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the product;

• (iii) the name and address and trade, business or profession of the person to whom the product is supplied; and

• (iv) the purpose for which the product is supplied.

• (2) The provisions of sub-article (1) shall not apply where —

• (a) the product is supplied in accordance with a health prescription, or

• (b) a separate record of the supply is made in accordance with article 16 of the Misuse of Drugs Regulations, 1988, or

• (c) the supply is by way of wholesale dealing and the order or invoice relating to the supply or a copy thereof is retained by the supplier, or

• (d) the supply is to a sampling officer.

• (3) A person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts, 1875 to 1977 shall preserve for a period of two years from the relevant date

• (a) the register kept under sub-article (1);

• (b) in the case of a health prescription, the duplicate copy thereof and in the case of any other prescription, the prescription; and

• (c) every order or invoice referred to in sub-article (2)(c).

• (4) In sub-article (3) "the relevant date" means —

• (a) in relation to paragraph (a) the date on which the last entry is made in the register; and

• (b) in relation to paragraphs (b) and (c) —

• (i) where the product is supplied in accordance with a repeatable prescription, the date on which the prescription is dispensed for the last time, and

• (ii) in every other case, the date on which the product is supplied.

• (5) The requirements of sub-article (1) shall be satisfied in the case of computerised records provided that the information required to be kept by virtue of the said sub-article is also retained in the form of a print-out for each day on which the shop is open. Such print-out shall be dated and certified, on the day to which the print-out relates or within the period of twenty four hours thereafter, by the authorised person by whom the shop is managed.

• (6) References in this article to a register shall include the computerised records and daily printout referred to in sub-article (5).

11 KEEPING OF RECORDS IN THE CASE OF CERTAIN MEDICINAL PRODUCTS

11.

11. (1) A person who supplies or administers a medicinal product which consists of or contains mifepristone shall keep a register of such supply or administration showing —

• (a) the date of such supply or administration,

• (b) the name and address of the recipient,

• (c) the dosage form, strength and quantity of the product supplied or administered, (d) the purpose or circumstances of the supply or administration, and

• (e) the signature of the person who made the supply or administration.

• (2) The register referred to in sub-article (1) shall be preserved for a period of two years from the date on which the last entry was made therein.

12 PROHIBITION OF SUPPLY AFTER EXPIRY DATE

12.

12. A person shall not supply any medicinal product for use as such after the date specified thereon by the manufacturer thereof as its expiry date.

13 Prohibition of mail order supply

13.

13. (1) A person shall not supply by mail order any medicinal product.

• (2) A person who is the owner or occupier of any premises shall not use or permit the use of any such premises for the receipt, collection or transmission of orders or correspondence in connection with the supply by mail order of medicinal products.

• (3) In the circumstances where the particular address of the premises referred to in sub-article (2) are not identifiable due to the use of a post office box, telephone number or an electronic mail address, sub-article (2) shall apply on the basis that the subscriber to the server providing such post office box, telecommunication or electronic mail facilities is the occupier of premises being used for or in connection with the supply by mail order of medicinal products.

• (4) A person, who is the provider of services such as post office boxes, telecommunication or electronic mail address facilities as referred to in sub-article (3) to a person who may be acting in contravention of this article, shall on demand made by —

• (a) an officer of the Minister,

• (b) an officer of the Pharmaceutical Society of Ireland,

• (c) an officer of a health board, or

• (d) an officer of the Irish Medicines Board,

who, in the case of an officer of the Minister, is authorised in writing by the Minister, in the case of an officer of the Pharmaceutical Society of Ireland, is authorised in writing by that Society, in the case of an officer of a health board, is authorised in writing by the board and in the case of an officer of the Irish Medicines Board, is authorised in writing by the board, in that behalf, furnish such particulars as may be requested in order to positively identify the subscriber concerned.

14 EXEMPTIONS

14.

14. (1) The provisions of articles 5, 6 and 13 of these Regulations, shall not apply as respects—

• (a) the supply of a medicinal product to—

• (i) a University or other institution concerned with higher education or scientific research for the purposes of such education or research,

• (ii) a sampling officer, an officer of the Irish Medicines Board or a Public Analyst in connection with the performance of his duties,

• (iii) a person who requires the product for the purpose of enabling him to comply with any requirements made by or in pursuance of any enactment relating to the medical treatment of persons employed or carried by that person in any trade or business carried on by him,

• (iv) a person employed or engaged 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 .

• (b) the supply of a medicinal product by way of wholesale dealing.

• (2) The provisions of articles 5 and 6 of these Regulations, shall not apply as respects—

• (a) the supply of a medicinal product by an authorised person in the course of a service provided by a hospital, or by a registered nurse in the course of a service provided by a hospital other than a hospital providing community mental health services, where the medicinal product is supplied in accordance with the written directions of a registered medical practitioner or registered dentist notwithstanding that those directions do not fulfil the conditions specified in article 7(1).

• (b) the supply of a medicinal product by a registered nurse, in the course of a service provided by a hospital providing community mental health services to patients, where the medicinal product so supplied is in a quantity sufficient for a period of treatment not exceeding three days and the supply is in accordance with the written directions of a registered medical practitioner of that service, notwithstanding that those directions do not fulfil the conditions specified in article 7(1).

• (c) the supply of a medicinal product to a patient of his by a registered medical practitioner or registered dentist in the course of his professional practice.

15 ENFORCEMENT AND EXECUTION

15.

15. (1) The enforcement and execution of the provisions of these Regulations may be carried out by—

• (a) officers of the Minister,

• (b) officers of the Pharmaceutical Society of Ireland,

• (c) health boards and their officers,

• (d) officers of the Irish Medicines Board.

• (2) Subject to sub-article (3) and (4) any such officer, or body as set out in sub-article (1); (with, in the case of an officer of the Minister, a written authorisation of the Minister, in the case of an officer of the Pharmaceutical Society of Ireland, a written authorisation of that Society, in the case of an officer of a health board, a written authorisation of the board and in the case of an officer of the Irish Medicines Board, a written authorisation of the board), may at any reasonable time, for the purpose of ascertaining whether or not there is or has been a contravention of these Regulations,—

• (a) enter premises of any class or description,

• (b) inspect any substance or product which is stored, or offered or kept for supply at such premises,

• (c) require the production of and if he thinks fit, take copies of any prescription, order, invoice or other document or of any entry in any register at such premises,

• (d) take (without payment) samples of any medicinal product or substance stored, or offered or kept for supply at such premises for test, examination or analysis,

• (e) seize and detain any medicinal product, substance or article which he has reasonable cause to believe to be a product, substance or article in relation to which, or by means of which, an offence under section 32 of the Act in relation to these Regulations is being committed, and any document which he has reasonable cause to believe to be a document which may be required as evidence in proceedings under the Act.

• (3) Sub-article (2) shall not apply as respects any of the following premises—

• (a) such part of any premises as is used by a registered medical practitioner or registered dentist for carrying on his professional practice, or

• (b) a premises used only as a private dwelling.

• (4) So much of sub-article (2) as enables officers of the Pharmaceutical Society of Ireland to enter premises of any class or description shall not apply as respects any of the following premises—

• (a) a hospital;

• (b) the premises of a manufacturer of a medicinal product.

• (5) For the purpose of exercising any of the powers specified in sub-article (2), the person having that power may, so far as is reasonable necessary, in order to secure that the provisions of the Regulations are duly observed, require any person, having authority to do so, to break open any container or package, or to open any vending machine, or to permit him to do so.

• (6) Where a person seizes any medicinal product, substance, article or document in the exercise of such a power as is specified in sub-article (2), he shall inform the person from whom it is seized, and, in the case of any medicinal product seized from a vending machine, the person whose name and address are stated on the machine, or if no name and address are so stated, the occupier of the premises on which the machine stands or to which it is affixed.

• (7) Notwithstanding anything contained in this article, where a person claiming to exercise a power by virtue of this article, is required to produce his credentials, the right shall not be exercisable except on production of those credentials.

• (8) A person shall not wilfully obstruct or interfere with the exercise of a power by a person duly exercising such power as is specified in sub-article (2).

16 EVIDENCE OF RESULT OF TEST, EXAMINATION OR ANALYSIS

16.

16. (1) In any proceedings for an offence under section 32 of the Act in relation to these Regulations a certificate signed by—

• (a) the State Chemist, or

• (b) a public analyst appointed under section 10 of the Sale of Food and Drugs Act, 1875, or

• (c) a chemist or analyst appointed by the Pharmaceutical Society of Ireland for that purpose, stating the result of any test, examination or analysis of a sample shall, with regard to that sample, be evidence for all purposes of such result.

• (2) The certificate referred to in sub-article (1) shall be in the form set out in the Seventh Schedule.

17 TRANSITIONAL PROVISIONS

17.

17. Any register, prescription, order or invoice required to be retained under Article 10(3) of the Medical Preparations (Prescription and Control of Supply) Regulations, 1993 shall, for the purposes of article 15, be regarded as being retained under Article 10(3).

(Articles 5. 6 and 7)

FIRST SCHEDULE

Substances which when contained in medicinal products are subjected to prescription control and the circumstances excluding certain products from such control.

In this Schedule:—

• (a) the designation of the Part of the Schedule in which a particular substance listed in column 1 is contained is indicated by the letter A, B or C as the case may be in column 2;

• (b) entries specified in columns 2, 3, 4 and 5 relate to the substances listed in column 1 against which they appear and where, in relation to a particular substance listed in column 1, an entry in column 3, 4 or 5 bears a number or letter it relates only to such entries in the other of those columns as bear the same number or letter;

• (c) the entries in column 5 shall be read subject to the note at the end of the Schedule; and

(d ) the following abbreviations are used: