S.I. No. 18/1987 - Medical Preparations (Control of Sale) Regulations, 1987

S.I. No. 18 of 1987.

MEDICAL PREPARATIONS (CONTROL OF SALE) REGULATIONS, 1987.

ARRANGEMENT OF ARTICLES

Article

1. Citation.

2. Commencement.

3. Revocations.

4. Interpretation.

5. Medical preparations on prescription only.

6. Restrictions on dispensing of prescriptions.

7. Exemptions for emergency sale or supply.

8. Labelling of dispensed medical preparations.

9. Pharmacy records.

10. Prohibition on advertising to the public.

11. Prohibition of sale after expiry date.

12. Exemptions.

13. Enforcement.

14. Evidence of result of test, examination or analysis.

15. Transitional provisions.

16. Amendment of definition of "sell" in the Medical Preparations (Advertisement and Sale) Regulations, 1958.

FIRST SCHEDULE

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

SECOND SCHEDULE

Substances which, when contained in certain medical preparations may be dispensed in the manner prescribed for a preparation which is or which contains a substance specified in Part B of the First Schedule.

THIRD SCHEDULE

Substances not to be contained in a medical preparation sold or supplied under the exemption conferred by Article 7 (2).

FOURTH SCHEDULE

Cautionary and warning notices for dispensed medical preparations.

FIFTH SCHEDULE

Certificate stating results of test, examination or analysis.

S.I. No. 18 of 1987.

MEDICAL PREPARATIONS (CONTROL OF SALE) REGULATIONS, 1987.

The Minister for Health in exercise of the powers conferred on him by sections 5 and 65 of the Health Act, 1947 (No. 28 of 1947) as amended by section 39 of the Health Act, 1953 (No. 26 of 1953) and by section 36 of the Misuse of Drugs Act, 1977 (No. 12 of 1977), hereby makes the following Regulations:—

1 Citation.

1.

1. These Regulations may be cited as the Medical Preparations (Control of Sale) Regulations, 1987.

2 Commencement.

2.

2. These Regulations shall come into operation on the 1st day of July, 1987.

3 Revocation.

3.

3. The Medical Preparations (Control of Sale) Regulations, 1966 ( S.I. No. 261 of 1966 ), the Medical Preparations (Control of Sale) (Amendment) Regulations, 1971 ( S.I. No. 272 of 1971 ) and the Medical Preparations (Control of Sale) (Amendment) Regulations, 1976 ( S.I. No. 82 of 1976 ) are hereby revoked.

4 Interpretation.

4.

4. (1) In these Regulations:—

"the Act" means the Health Act, 1947 ;

"aerosol" means a product which is dispersed from its container by a propellent gas or liquid;

"authorised person" has the meaning assigned to it in subsection (3) of section 2 of the Pharmacy Act, 1962 (No. 14 of 1962);

"controlled drug" has the meaning assigned to it by Section 2 of the Misuse of Drugs Act, 1977 ;

"dosage unit" means—

• (a) where a medical preparation 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 medical preparation is not in any such form that quantity of the preparation 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 and references to medical preparations for external use shall be read accordingly except that such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;

"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;

"inhaler" does not include an aerosol;

"MDD" means maximum daily dose;

"MD" means maximum dose;

"maximum strength" 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 medical preparation, and

• (b) the maximum percentage of a substance contained in a medical preparation 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 medical preparation, as one of its active ingredients, which is lawfully on the market in the State on, or immediately before, the date of signature of these Regulations;

"parental administration" means administration by breach of the skin or mucous membrane;

"prescription", except in the expression "medical prescriptions", means a prescription issued by a registered medical practitioner or a registered dentist;

"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);

"repeatable prescription" means a prescription which may be dispensed more than once;

"sale by way of wholesale dealing" means sale to a person who buys for one or more of the following purposes—

• (a) sale 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, nursing home, clinic or similar institution;

"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 ;

"sell" includes distribute or offer or keep for sale or distribution and cognate words shall be construed accordingly;

"the Society" means the Pharmaceutical Society of Ireland.

• (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 Medical preparations on prescription only.

5.

5. (1) Subject to the provisions of these Regulations a person shall not sell a medical preparation of any of the following classes except in accordance with a prescription, namely—

• (a) any medical preparation which is or which contains a substance specified in column 1 of the First Schedule;

• (b) any medical preparation which is intended for parenteral administration;

• (c) any medical preparation which is or which contains a new chemical molecule.

• (2) Sub-article (1) (a) shall not apply as respects a medical preparation where there is an entry in relation to a substance in the medical preparation 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 a pharmaceutical form is specified in column 4 of the said Schedule opposite the mention of the substance, contained in a medical preparation, in column 1 thereof, the medical preparation is sold or supplied in such form; and

• (c) where a manner of administration is specified in column 4 of the said Schedule opposite the mention of the substance, contained in a medical preparation, in column 1 thereof, the medical preparation is sold or supplied only for such manner of administration; and

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

• (e) where the preparation 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 medical preparation, in column 1 thereof, it is in a container or package labelled to show a maximum dose not exceeding that so specified; and

• (f) where the preparation 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 medical preparation, in column 1 thereof, it is in a container or package labelled to show a maximum daily dose not exceeding that so specified.

• (3) Sub-article (1) shall not apply as respects a medical preparation which is intended exclusively for veterinary use and is sold in a container or package which is labelled with the words "For Animal Treatment Only".

• (4) Sub-article (1) (b) shall not apply as respects a medical preparation which contains insulin.

• (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 in pursuance of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 ( S.I. No. 210 of 1984 ).

• (6) Sub-article (2) shall not apply as respects a medical preparation which contains two or more substances each of which is a controlled drug.

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

6 Restrictions on dispensing of prescriptions.

6.

6. (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 medical preparation—

• (a) where neither the number of occasions on which nor the intervals at which a medical preparation 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 medical preparation 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 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 medical preparation, 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 medical preparation 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 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 medical preparation 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 (not being less than three days) 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 9 (3), forthwith record on the prescription the quantity of each preparation supplied by him and the date on which he supplied each such quantity and the name and address of the person by whom such preparation was sold or supplied.

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

• (b) The medical preparations to which this sub-article applies are—

• (i) any preparation intended for external use which is or which contains a substance specified in Part I of the Second Schedule, and

• (ii) any preparation intended for use as an oral contraceptive which is or which contains a substance specified in Part II of the Second Schedule.

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

• (5) The prescription in the case of a medical preparation, which by virtue of these Regulations may not be sold 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) Notwithstanding the provisions of these Regulations an authorised person may dispense a medical preparation 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.

• (7) The provisions of sub-articles (2), (3), (4), (5) and (6) shall not apply to a preparation which is a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations, 1979 ( S.I. No. 32 of 1979 ).

7 Exemptions for emergency sale or supply.

7.

7. (1) It shall not be a contravention of article 5 (1) or article 6 for a person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts, 1875 to 1977 to sell or supply a medical preparation otherwise than in accordance with a prescription where—

• (a) the authorised person by whom or under whose supervision the preparation is to be sold or supplied has been requested to sell or supply the preparation 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 preparation is sold or supplied in accordance with the directions of the practitioner requesting it, and

• (d) subject to sub-article (3), the preparation is not a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations, 1979;

• (2) It shall not be a contravention of article 5 (1) or article 6 for a person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts, 1875 to 1977 to sell or supply a medical preparation otherwise than in accordance with a prescription where—

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

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

• (ii) that treatment with the preparation 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 preparation for the person;

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

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

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

• (c) subject to sub-article (3), the preparation does not consist of or contain a substance specified in the Third Schedule and is not a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations, 1979; and

• (d) the container or package of the preparation is labelled so as to show—

• (i) the date on which the preparation is sold or supplied,

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

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

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

• (v) the name and address of the shop from which the preparation was sold or 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 preparation consists of or contains Phenobarbitone or Phenobarbitone Sodium (but no other substance specified in the Third Schedule or in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations, 1979) and is sold or supplied for the treatment of epilepsy.

8 Labelling of dispensed medical preparations.

8.

8. (1) In this article "dispensed medical preparation" means a medical preparation—

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

• (b) sold or 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 preparation is to be sold or supplied, or

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

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

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

• (b) the name and address of the person by whom the preparation was sold or supplied;

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

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

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

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

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

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 preparation is not being sold or supplied on foot of a prescription, the directions for use of the preparation;

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

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

• (i) such of the cautionary and warning notices specified in the Fourth 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 medical preparation is supplied in the container and outer package (if any) provided by the manufacturer or person responsible for placing the product on the market and any of the information originally contained thereon has not been removed or obscured.

9 Pharmacy records.

9.

9. (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 sale or supply of a medical preparation which by virtue of these Regulations may not be sold 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 preparation is sold or supplied in accordance with a prescription or in compliance with article 7 (1)—

• (i) the date on which the preparation is sold or supplied;

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

• (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 preparation is prescribed;

• (v) the date of the prescription; and

• (vi) in relation to the sale or supply of a preparation in compliance with article 7 (1), the date on which the prescription is received;

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

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

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

• (iii) where the sale or 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 sale or supply.

• (c) where the preparation is sold or supplied in accordance with article 7 (2)—

• (i) the date on which the preparation is sold or supplied;

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

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

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

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

• (vi) where the sale or 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 sale or supply.

• (d) where the sale is by way of wholesale dealing or is a sale referred to in article 12 (a), and no order or invoice, or copy thereof, relating to such sale has been retained by the seller—

• (i) the date on which the preparation is sold;

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

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

• (iv) the purpose for which the preparation is sold.

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

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

• (b) a separate record of the sale or supply is made in accordance with article 16 of the Misuse of Drugs Regulations, 1979, or

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

• (d) the sale or 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 preparation is sold or 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 preparation is sold or 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 print-out referred to in sub-article (5).

10 Prohibition of advertising to the public.

10.

10. (1) A person shall not issue or display or cause to be issued or displayed any advertisement which is likely to lead to the use of any medical preparation which by virtue of these Regulations may not be sold except in accordance with a prescription.

• (2) In this article the term "advertisement" includes every form of advertising, whether in a publication, or by the display of any notice, or by means of any catalogue, price list, letter (whether circular or addressed to a particular person) or other document or by words inscribed on any article, or by the exhibition of a photograph or cinematograph film, or by way of sound recording, sound broadcasting or television or in any other way.

• (3) This article shall not apply to—

• (i) any labelled container or package of a medical preparation, or any leaflet supplied with such preparation, where that preparation is sold or supplied with a view to administration to a person in accordance with a prescription;

• (ii) any representation made or any advertisement sent or supplied exclusively, or any advertisement included in a journal or other publication supplied or directed mainly or exclusively to, or any cinematographic film, video or sound recording played to:—

• (a) persons who in the usual course of their business or profession may lawfully prescribe, sell, supply, manufacture, compound or administer the medical preparation to which the advertisement relates, or

• (b) persons who in the course of such business or profession provide training or instruction to persons undergoing training with a view to obtaining a qualification in such business or profession, or

• (c) persons who in the course of such business or profession as aforesaid are engaged in the preparation or publication of advertisements;

• (d) members of either House of the Oireachtas, officials of a Government Department or of a health board, members and officials of the National Drugs Advisory Board or members of the governing body of a hospital or similar institution.

11 Prohibition of sale after expiry date.

11.

11. (1) A person shall not sell any medical preparation for use as such after the date specified thereon as its expiry date.

• (2) In sub-article (1) "expiry date" means the date specified on the container or outer package of a medical preparation by the manufacturer thereof pursuant to article 6 (1) (h) of the Medical Preparations (Advertisement and Sale) Regulations, 1958 ( S.I. No. 135 of 1958 ).

12 Exemptions.

12.

12. The provisions of article 5 of these Regulations, shall not apply as respects

• (a) the sale of a medical preparation 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 National Drugs Advisory Board or a Public Analyst in connection with the performance of his duties,

• (iii) a person who requires the preparation 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 applicances supplied for the purpose of section 59 of the Health Act, 1970 .

• (b) the sale of a medical preparation by way of wholesale dealing.

13 Enforcement.

13.

13. (1) The enforcement and execution of the provisions of these Regulations and the prosecution of offences under section 65 of the Act in relation to these Regulations may be carried out—

• (a) by officers of the Minister,

• (b) by the Pharmaceutical Society of Ireland and its officers,

• (c) by health boards and their officers.

• (2) Subject to sub-articles (3) and (4) any such officer as aforesaid (with in the case of an officer of the Minister, a written authorisation of the Minister and in the case of an officer of the Pharmaceutical Society of Ireland, a written authorisation of that Society and in the case of an officer of a health board, a written authorisation of the board), may, at all reasonable times, 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 preparation which is stored, or offered or kept for sale 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, and

• (d) take (without payment) samples of any substance or preparation stored, or offered or kept for sale at such premises for test, examination or analysis.

• (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 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, nursing home, clinic or similar institution;

• (b) the premises of a manufacturer or wholesaler of a medical preparation.

14 Evidence of result of test, examination or analysis.

14.

14. (1) In any proceedings for an offence under section 65 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 Fifth Schedule.

15 Transitional provisions.

15.

15. Any prescriptions required to be retained under article 7 of the Medical Preparations (Control of Sale) Regulations, 1966, shall, for the purposes of article 13, be regarded as prescriptions kept for the purposes of article 9 (3).

16 Amendment of definition of "sell" in the Medical Preparations (Advertisement and Sale) Regulations, 1958.

16.

16. Article 2 of the Medical Preparations (Advertisement and sale) Regulations, 1958 ( S.I. No. 135 of 1958 ) is amended by the insertion after the definition of "local authority" of the following definition—

""sell" includes distribute or offer or keep for sale or distribution."

FIRST SCHEDULE

Articles 5 and 6

Substances which when contained in medical preparations are subjected to prescription control and the circumstances excluding certain preparations 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 or B 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 bears 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: