Hide Nav Show Nav
SOLR_PROP

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

S.I. No. 18/1987:

MEDICAL PREPARATIONS (CONTROL OF SALE) REGULATIONS, 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:—

Citation.

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

Commencement.

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

Revocation.

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.

Interpretation.

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.

Medical preparations on prescription only.

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."

Restrictions on dispensing of prescriptions.

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 ).

Exemptions for emergency sale or supply.

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.

Labelling of dispensed medical preparations.

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.

Pharmacy records.

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).

Prohibition of advertising to the public.

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.

Prohibition of sale after expiry date.

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 ).

Exemptions.

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.

Enforcement.

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.

Evidence of result of test, examination or analysis.

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.

Transitional provisions.

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).

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

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:

"g" for gram, "mcg" for microgram ,
"mg" for milligram , "ml" for millilitre.
Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Acebutolol Hydrochloride B
Acecarbromal B
Acepromazine Maleate B
Acetanilide B
Acetarsol A
Acetazolamide B
Acetazolamide Sodium B
Acetohexamide B
Acetophenazine Maleate B
Acetylcholine Chloride B 0.2 per cent External
Acetylcysteine B
Aconite B 1.3 per cent External
Acrosoxacin A
Actaplanin A
Actinomycin C A
Actinomycin D A
Acyclovir A
Ardrenaline B (1) 0.6 per cent

(1) By inhaler

(2) External

Adrenaline Acid Tartrate B (1) 1.0 per cent

(1) By inhaler

(2) External

Adrenaline Hydrochloride B (1) 0.6 per cent

(1) By inhaler

(2) External

Adrenocortical Extract A
Alclofenac B
Alclomethasone Dipropionate A
Alcuronium Chloride A
Aldosterone A
Alfacalcidol B
Alfentanil Hydrochloride A
Allergen Extracts B
Allopurinol A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Allyloestrenol A
Almitrine B
Aloxiprim B

800mg (MD)

3.6mg (MDD)

Alphadolone Acetate A
Alphaxalone A
Alprazolam A
Alprenolol B
Alprenolol Hydrochloride B
Alprostadil A
Alseroxylon B
Amantadine Hydrochloride B
Ambenonium Chloride A
Ambutonium Bromide B
Amcinonide B
Ametazole Hydrochloride B
Amethocaine A Any use except local ophthalmic use
Amethocaine Gentisate A Any use except local ophthalmic use
Amethocaine Hydrochloride A Any use except local ophthalmic use
Amikacin Sulphate A
Amiloride Hydrochloride B
Aminocaproic Acid B
Aminoglutethimide B
Aminopterin Sodium A
Amiodarone Hydrochloride B
Amiphenazole Hydrochloride B
Amitriptyline A
Amitriptyline Embonate A
Amitriptyline Hydrochloride A
Ammonium Bromide B
Amodiaquine Hydrochloride B Prophylaxis of malaria
Amoxapine A
Amoxycillin A
Amoxycillin Trihydrate A
Amphetamine Sulphate A
Amphomycin Calcium A
Amphotericin A
Ampicillin A
Ampicillin Sodium A
Ampicillin Trihydrate A
Amrinone B
Amsacrine A
Amygdalin A
Amylobarbitone A
Amylobarbitone Sodium A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Amylocaine Hydrochloride A Any use except local ophthalmic use
Ancrod A
Androsterone A
Angiotensin Amide B
Anterior Pituitary Extract A
Antimony Barium Tartrate B
Antimony Dimercaptosuccinate B
Antimony Lithium Thiomalate B
Antimony Pentasulphide B
Antimony Potassium Tartrate B
Antimony Sodium Tartrate B
Antimony Sodium Thioglycollate B
Antimony Sulphate B
Antimony Trichloride B
Antimony Trioxide B
Antimony Trisulphide B
Apiol A
Apomorphine B
Apomorphine Hydrochloride B
Aprotinin A
Arbaprostil A
Arecoline Hydrobromide B
Argipressin A
Arsenic A
Arsenic Triiodide A
Arsenic Trioxide A
Arsphenamine A
Aspirin B

650mg (MD)

4.0g (MDD)

Astemizole B
Atenolol B
Atracurium Besylate A
Atropine B

(1) Internal:

(a) by inhaler

(b) otherwise than by inhaler

(b) 300mcg

(MD)

1mg

(MDD)

(2) External (except local ophthalmic use)
Atropine Methobromide B

(1) Internal:

(a) by inhaler

(b) otherwise than by inhaler

(b) 400mcg

(MD)

1.3mg

(MDD)

(2) External (except local ophthalmic use)
Atropine Methonitrate B

Internal:

(a) by inhaler

(b) otherwise than by inhaler

(b) 400mcg

(MD)

1.3mg

(MDD)

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Atropine Oxide Hydrochloride B

(1) Internal:

(a) by inhaler

(b) otherwise than by inhaler

(b) 360mcg

(MD)

1.2mg

(MDD)

(2) External (except local ophthalmic use)
Atropine Sulphate B

(1) Internal:

(a) by inhaler

(b) otherwise than by inhaler

(b) 360mcg

(MD)

1.2mg

(MDD)

(2) External (except local ophthalmic use)
Auranofin B
Azapropazone B
Azathioprine A
Azathioprine Sodium A
Azidocillin Potassium A
Azlocillin Sodium A
Aztreonam A
Bacampicillin Hydrochloride A
Bacitracin A
Bacitracin Methylene Disalicylate A
Bacitracin Zinc A
Baclofen B
Barbitone A
Barbitone Sodium A
Barium Carbonate B
Barium Chloride B
Barium Sulphide B
Beclamide B
Beclomethasone A
Beclomethasone Dipropionate A
Belladonna Herb B

(1) Internal

(2) External

(1) 1mg of the alkaloids (MDD)
Belladonna Root B

(1) Internal

(2) External

(1) 1mg of the alkaloids (MDD)
Bemegride B
Bemegride Sodium B
Benapryzine Hydrochloride B
Bendrofluazide B
Benethamine Penicillin A
Benorylate B

1.2g (MD)

5.5g (MDD)

Benoxaprofen B
Benperidol A
Benserazide Hydrochloride B
Bentiromide A
Benzathine Penicillin A
Benzbromarone B
Benzhexol Hydrochloride B
Benzilonium Bromide B

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Benzocaine A Any use except local ophthalmic use
Benzoctamine Hydrochloride B
Benzoyl Peroxide B 5.0 per cent External
N-Benzoyl Sulphanilamide A
Benzquinamide B
Benzquinamide Hydrochloride B
Benzthiazide B
Benztropine Mesylate B
Benzydamine Hydrochloride B
Benzylpenicillin Calcium A
Benzylpenicillin Potassium A
Benzylpenicillin Sodium A
Bepridil Hydrochloride B
Betahistine Hydrochloride B
Betamethasone A
Betamethasone Adamantoate A
Betamethasone Benzoate A
Betamethasone Dipropionate A
Betamethasone Sodium Phosphate A
Betamethasone Valerate A
Betaxolol Hydrochloride B
Bathanechol Chloride B
Bethanidine Sulphate B
Bezafibrate B
Bifonazole B
Biperiden Hydrochloride B
Biperiden Lactate B
Bismuth Glycollylarsanilate A
Bleomycin A
Bleomycin Sulphate A
Bornaprine Hydrochloride B
Bretylium Tosylate B
Bromazepam A
Bromhexine Hydrochloride B
Bromocriptine Mesylate B
Bromvaletone B
Brotizolam A
Budesonide A
Bufexamac B
Buflomedil Hydrochloride B
Bufuralol Hydrochloride B
Bumetanide B
Bunolol Hydrochloride B

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Buphenine Hydrochloride B
Bupivacaine A Any use except local ophthalmic use
Bupivacaine Hydrochloride A Any use except local ophthalmic use
Buprenorphine A
Buprenorphine Hydrochloride A
Buserelin A
Buspirone Hydrochloride B
Busulphan A
Butacaine Sulphate A Any use except local ophthalmic use
Butobarbitone A
Butobarbitone Sodium A
Butorphanol Tartrate A
Butriptyline Hydrochloride A
Calcifediol B
Calcitonin B
Calcitriol B
Calcium Amphomycin A
Calcium Benzamidosalicylate B
Calcium Bromide B
Calcium Bromidolactobionate B
Calcium Carbimide B
Calcium Folinate B
Calcium Metrizoate B
Calcium Sulphaloxate A
Camazepam A
Candicidin A
Canrenoic Acid A
Cantharidin B 0.01 per cent External
Capreomycin Sulphate A
Captopril B
Carbachol B
Carbamazepine B
Carbenicillin Sodium A
Carbenoxolone Sodium B

(2) 2.0 per cent

(1) Pellet

(2) Gel

(1) 5mg

(MD)

25mg (MDD)

Carbidopa B
Carbimazole B
Carbocisteine B
Carbon Tetrachloride B
Carboplatin A
Carboprost Tromethamol A
Carbromal B
Carbuterol Hydrochloride B
Carfecillin Sodium A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Carindacillin Sodium A
Carisoprodol B
Carmustine A
Carperidine A
Cefaclor A
Cefadroxil A
Cefapirin Sodium A
Cefazedone Sodium A
Cefonicid Sodium A
Cefoperazone Sodium A
Cefotaxime Sodium A
Cefotiam Hydrochloride A
Cefoxitin Sodium A
Cefsulodin Sodium A
Ceftazidime A
Ceftizoxime Sodium A
Ceftriaxone Sodium A
Cefuroxime Sodium A
Cephalexin A
Cephalexin Sodium A
Cephaloridine A
Cephalothin Sodium A
Cephamandole Nafate A
Cephazolin Sodium A
Cephradine A
Cerium Oxalate B
Chenodeoxycholic Acid B
Chloral Hydrate B External
Chlorambucil A
Chloramphenicol A
Chloramphenicol Cinnamate A
Chloramphenicol Palmitate A
Chloramphenicol Sodium Succinate A
Chlordiazepoxide A
Chlordiazepoxide Hydrochloride A
Chlorhexadol B
Chlormadinone Acetate A
Chlormerodrin B
Chlormethiazole A
Chlormethiazole Edisylate A
Chlormezanone B
Chloroform B (1) 5.0 per cent

(1) Internal

(2) External

Chloroquine Phosphate B Prophylaxis of malaria
Chloroquine Sulphate B Prophylaxis of malaria
Chlorothiazide B
Chlorotrianisene A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of Administration Maximum dose and Maximum daily dose
Chlorphenoxamine Hydrochloride B
Chlorpromazine B
Chlorpromazine Embonate B
Chlorpromazine Hydrochloride B
Chlorpropamide B
Chlorprothixene B
Chlorprothixene Hydrochloride B
Chlortetracycline A
Chlortetracycline Calcium A
Chlortetracycline Hydrochloride A
Chlorthalidone B
Chlorzoxazone B
Cholecalciferol B

(1) Internal

(2) External

(1) 0.075mg (equivalent to 3,000 iu Vitamin D) (MDD)
Cholestyramine B
Choline Magnesium Trisalicylate B
Chorionic Gonadotrophin A
Ciclacillin A
Ciclobendazole B
Ciclopirox A
Cimetidine A
Cimetidine Hydrochloride A
Cinchocaine B 3.0 per cent Any use except local ophthalmic use
Cinchocaine Hydrochloride B Equivalent of 3.0 per cent of Cinchocaine Any use except local ophthalmic use
Cinchophen B
Cinnarizine B
Cinoxacin A
Ciprofibrate B
Ciprofloxacin Hydrochloride A
Cisplatin A
Clavulanic Acid A
Clenbuterol Hydrochloride B
Clidinium Bromide B
Clindamycin A
Clindamycin Hydrochloride A
Clindamycin Palmitate Hydrochloride A
Clindamycin Phosphate A
Clioquinol B (1) 35mg

(1) Treatment of mouth ulcers

(2) External (other than treatment of mouth ulcers)

(1) 280mg

(MDD)

Clobazam A
Clobetasol Propionate A
Clobetasone Butyrate A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of Administration Maximum dose and Maximum daily dose
Clofazimine B
Clofibrate B
Clomacran Phosphate B
Clomiphene Citrate A
Clomipramine A
Clomipramine Hydrochloride A
Clomocycline A
Clomocycline Sodium A
Clonazepam A
Clonidine B
Clonidine Hydrochloride B
Clopamide B
Clopenthixol Decanoate B
Clopenthixol Hydrochloride B
Clorexolone B
Clostebol Acetate A
Clotiazepam A
Clotrimazole B

External:

(1) Cream

(2) Powder

(3) Solution

Clovoxamine A
Cloxacillin Benzathine A
Cloxacillin Sodium A
Cloxazolam A
Clozapine A
Cocaine A
Cocaine Hydrochloride A
Cocculus Indicus A
Codeine Phosphate A Equivalent of 1.5 per cent of Codeine Equivalent of 20mg of Codeine (MD)
Co-dergocrine Mesylate B
Colaspase A
Colchicine A
Colestipol Hydrochloride B
Colistin Sulphate A
Colistin Sulphomethate A
Colistin Sulphomethate Sodium A
Coniine B
Conium Leaf B 7.0 per cent External
Corticotrophin A
Cortisone A
Cortisone Acetate A
Co-tetroxazine A
Co-trimoxazole A
Cropropamide B
Crotethamide B
Croton Oil A
Croton Seed A
Curare A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of Administration Maximum dose and Maximum daily dose

α-Cyanobenzyl-6-O-

β-D-glucopyranosyl-

β-D-glucopyranoside

B

0.1 per cent
α-Cyanobenzyl-β-D-glucopyranosiduronic Acid B 0.1 per cent
Cyanocobalamin B 25mcg

25mcg

(MDD)

Cyclandelate B
Cyclobarbitone A
Cyclobarbitone Calcium A
Cyclofenil A
Cyclopenthiazide B
Cyclopentolate Hydrochloride B
Cyclophosphamide A
Cycloserine A
Cyclosporin A
Cyclothiazide B
Cyproterone Acetate A
Cytarabine A
Cytarabine Hydrochloride A
Dacarbazine A
Danazol B
Dantrolene Sodium B
Dapsone B
Dapsone Ethane Ortho Sulphonate B
Daunorubicin Hydrochloride A
Deanol Bitartrate B 26mg (MDD)
Debrisoquine Sulphate B
Delorazepam A
Demecarium Bromide B
Demeclocycline A
Demeclocycline Calcium A
Demeclocycline Hydrochloride A
Deoxycortone Acetate A
Deoxycortone Pivalate A
Deptropine Citrate B
Dequalinium Chloride B

(1)

0.25mg

(1) Internal:

throat lozenges or throat pastilles

(2) 1.0 per cent

(2) External:

paint

Deserpidine B
Desferrioxamine Mesylate B
Desfluorotriamcinolone A
Desipramine Hydrochloride A
Deslanoside B
Desmopressin B
Desogestrel A
Desonide A
Desoxymethasone A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of Administration Maximum dose and Maximum daily dose
Dexamethasone A
Dexamethasone Acetate A
Dexamethasone Isonicotinate A
Dexamethasone Phenylpropionate A
Dexamethasone Pivalate A
Dexamethasone Sodium Phosphate A
Dexamethasone Sodium m-Sulphobenzoate A
Dexamethasone Troxundate A
Dexamphetamine Sulphate A
Dexfenfluramine Hydrochloride A
Dextromethorphan Hydrobromide B Internal Equivalent of 15mg of Dextromethorphan (MD)
Equivalent of 75mg of Dextromethorphan (MDD)
Dextromethorphan Resinate B Internal Equivalent of 30mg of Dextromethorphan (MD)
Equivalent of 75mg of Dextromethorphan (MDD)
Dextromoramide Hydrochloride A
Dextromoramide Tartrate A
Dextropropoxyphene Hydrochloride B
Dextropropoxyphene Napsylate B
Dextrothyroxine Sodium B
Diazepam A
Diazoxide A
Dibenzepin Hydrochloride A
Dichloralphenazone B
Dichlorphenamide B
Diclofenac Sodium B
Dicylomine Hydrochloride B Internal (other than liquid preparations intended for infants)

10mg (MD)

60mg (MDD)

Dienoestrol A
Diethanolamine Fusidate A
Diethylcarbamazine B
Diethylcarbamazine Citrate B
Diethylpropion Hydrochloride A
Difenoxin Hydrochloride A
Diflucortolone Valerate A
Diflunisal B
Digitalin B

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of Administration Maximum dose and Maximum daily dose
Digitalis Leaf B
Digitalis Prepared B
Digitoxin B
Digoxin B
Dihydralazine Sulphate B
Dihydrocodeine Tartrate A Equivalent of 1.5 per cent of Dihydrocodeine Equivalent of 10mg of Dihydrocodeine (MD)
Dihydroergotamine Mesylate B
Dihydrostreptomycin A
Dihydrostreptomycin Sulphate A
Dihydrotachysterol B

0.075mg

(MDD)

Di-iodohydroxyquinoline B
Diloxanide Furoate B
Diltiazem Hydrochloride A
Dimercaprol B
Dimethisoquin Hydrochloride B Any use except local ophthalmic use
Dimethisterone A
Dimethothiazine Mesylate B
Dimethyl Sulphoxide A
Dimethyltubocurarine Bromide A
Dimethyltubocurarine Chloride A
Dimethyltubocurarine Iodide A
Dinoprost A
Dinoprost Trometamol A
Dinoprostone A
Diphenoxylate Hydrochloride B
Dipipanone Hydrochloride A
Dipyridamole B
Disopyramide B
Disopyramide Phosphate B
Distigmine Bromide B
Disulfiram B
Dithranol B 1.0 per cent
Dobutamine Hydrochloride B
Domperidone B
Dopamine Hydrochloride A
Dothiepin A
Dothiepin Hydrochloride A
Doxapram Hydrochloride A
Doxazosin Mesylate A
Doxepin Hydrochloride A
Doxorubicin A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Doxycycline A
Docycycline Calcium Chelate A
Doxycycline Hydrochloride A
Doxylamine Succinate B

10mg (MD)

40mg (MDD)

Droperidol A
Drostanolone A
Drostanolone Propionate A
Dydrogesterone A
Dyflos B
Econazole B External (except vaginal use)
Econazole Nitrate B External (except vaginal use)
Ecothiopate Iodide A
Edrophonium Chloride A
Embutramide A
Emepronium Bromide B
Emetine B 1.0 per cent
Emetine Bismuth Iodide B
Emetine Hydrochloride B Equivalent of 1.0 per cent of Emetine
Encainide B
Endralazine B
Enoximone A
Ephedrine B External (except local ophthalmic use)
Ephedrine Hydrochloride B External (except local ophthalmic use)
Ephedrine Sulphate B External (except local ophthalmic use)
Epicillin A
Epithiazide B
Epoprostenol
Sodium A
Ergocalciferol B

0.075mg (equivalent to 3,000 iu Vitamin D)

(MDD)

Ergometrine Maleate B
Ergometrine Tartrate B
Ergot, Prepared B
Ergotamine Tartrate B
Erythromycin A
Erythromycin Estolate A
Erythromycin Ethyl Carbonate A
Erythromycin Ethyl Succinate A
Erythromycin Lactobionate A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Erythromycin Phosphate A
Erythromycin Stearate A
Erythromycin Thiocyanate A
Estazolam A
Estramustine Phosphate A
Etafedrine Hydrochloride B
Ethacrynic Acid B
Ethambutol Hydrochloride B
Ethamivan B
Ethamsylate B
Ethchlorvynol B
Ethebenecid B
Ethiazide B
Ethinyl Androstenediol A
Ethinyloestradiol A
Ethionamide B
Ethisterone A
Ethoglucid A
Ethoheptazine Citrate A
Ethopropazine Hydrochloride A
Ethosuximide B
Ethotoin B
Ethyl Biscoumacetate B
Ethyl Loflazepate A
Ethylmorphine Hydrochloride A Equivalent of 0.2 per cent of Ethylmorphine

Equivalent of 7.5 mg of Ethylmorphine

(MD)

Ethyloestrenol A
Ethynodiol Diacetate A
Etidronate Disodium B
Etifoxine A
Etodolac B
Etofenamate B
Etomidate A
Etoposide A
Etorphine
Hydrochloride A
Etretinate B
Famotidine A
Fazadinium
Bromide A
Felodipine A
Felypressin A
Fenbufen B
Fencamfamin Hydrochloride A
Fenclofenac B
Fenfluramine Hydrochloride A
Fenofibrate B
Fenoprofen B

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Fenoprofen Calcium B
Fenoterol Hydrobromide B
Fentanyl Citrate A
Feprazone B
Ferrous Arsenate B
Flavoxate Hydrochloride B
Flecainide Acetate B
Floctafenine B
Fluanisone A
Flubendazole B
Fluclorolone Acetonide A
Flucloxacillin Sodium A
Flucytosine A
Fludiazepam A
Fludrocortisone Acetate A
Flufenamic Acid B
Flumethasone A
Flumethasone Pivalate A
Flunarizine Hydrochloride B
Flunisolide A
Flunitrazepam A
Fluocinolone Acetonide A
Fluocinonide A
Fluocortin Butyl A
Fluocortolone A
Fluocortolone Hexanoate A
Fluocortolone Pivalate A
Fluorometholone A
Fluorouracil A
Fluorouracil Trometamol A
Fluoxetine A
Fluoxymesterone A
Flupenthixol Decanoate B
Flupenthixol Hydrochloride B
Fluperolone Acetate A
Fluphenazine Decanoate B
Fluphenazine Enanthate B
Fluphenazine Hydrochloride B
Fluprednidene Acetate A
Fluprednisolone A
Fluprostenol Sodium A
Flurandrenolone A
Flurazepam Hydrochloride A
Flurazepam Monohydrochloride A
Flurbiprofen B
Fluspirilene A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Flutamide A
Fluvoxamine Maleate B
Folic Acid B

500mcg

(MDD)

Formocortal A
Foscarnet Sodium A
Fosfestrol Sodium A
Framycetin Sulphate A
Frusemide B
Furazolidone B
Fusafungine A
Fusidic Acid A
Gallamine Triethiodide A
Gelsemine B 0.1 per cent
Gelsemium B

25mg (MD)

75mg (MDD)

Gentamicin A
Gentamicin Sulphate A
Gestronol A
Gestronol Hexanoate A
Ginkgo biloba B
Glibenclamide B
Glibornuride B
Gliclazide B
Glipizide B
Gliquidone B
Glisoxepide B
Glucagon B
Glutethimide A
Glyceryl Trinitrate B
Glycopyrronium Bromide B

1mg (MD)

2mg (MDD)

Glymidine B
Gonadorelin A
Gramicidin A 0.2 per cent External
Griseofulvin A
Growth Hormone A
Guanacline Sulphate B
Guanethidine Monosulphate B
Guanfacine Hydrochloride B
Guanoclor Sulphate B
Guanoxan Sulphate B
Halazepam A
Halcinonide A
Haloperidol A
Haloperidol Decanoate A
Haloxazolam A
Harmine A
Heparin A External
Heparin Calcium A External
Heptabarbitone A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Hexachlorophane B External:

(a) 2.0 per cent

(b) 0.1 per cent

(c) 0.75 per cent

(a) soaps

(b) aerosols

(c) preparations other than soaps and aerosols

Hexamethonium Bromide A
Hexamethonium Iodide A
Hexamethonium Tartrate A
Hexamine Phenylcinchoninate B
Hexobarbitone A
Hexobarbitone Sodium A
Hexoestrol A
Hexoestrol Dipropionate A
L-Histidine Hydrochloride B Dietary or nutritive use
Homatropine B (1) Internal

(1) 0.15mg

(MD)

0.45mg

(MDD)

(2) External (except local ophthalmic use)
Homatropine Hydrobromide B

0.2mg (MD)

0.6mg

(MDD)

Homatropine Methylbromide B

2mg (MD)

6mg (MDD)

Hydralazine Hydrochloride B
Hydrargaphen B Local application to skin
Hydrobromic Acid B
Hydrochlorothiazide B
Hydrocodone Resinate A
Hydrocodone Tartrate A
Hydrocortisone A
Hydrocortisone Acetate A
Hydrocortisone Butyrate A
Hydrocortisone Caprylate A
Hydrocortisone Hydrogen Succinate A
Hydrocortisone Sodium Phosphate A
Hydrocortisone Sodium Succinate A
Hydroflumethiazide B
Hydromorphone Hydrochloride A
Hydroxocobalamin B

25mcg

(MDD)

Hydroxychloroquine Sulphate B Prophylaxis of malaria
Hydroxyprogesterone A
Hydroxyprogesterone Enanthate A
Hydroxyprogesterone Hexanoate A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Hydroxyurea A
Hydroxyzine
Embonate B
Hydroxyzine Hydrochloride B
Hyoscine B (1) 0.15 per cent (1) Internal
(2) External (except local ophthalmic use)
Hyoscine Butylbromide B
(1) Internal:
(a) By inhaler
(b) Otherwise than by inhaler

(b) 3mg

(MD)

9mg (MDD)
(2) External
Hyoscine Hydrobromide B (1) Internal:
(a) By inhaler
(b) Otherwise than by inhaler

(b) 300mcg

(MD)

900mcg (MDD)

(2) External

(except local ophthalmic use)

Hyoscine Methobromide B (1) Internal:
(a) By inhaler
(b) Otherwise than by inhaler

(b) 2.5mg

(MD)

7.5mg

(MDD)

(2) External
Hyoscine Methonitrate B (1) Internal:
(a) By inhaler
(b) Otherwise than by inhaler

(b) 2.5mg

(MD)

7.5mg

(MDD)

(2) External
Hyoscyamine B (1) Internal:
(a) By inhaler
(b) Otherwise than by inhaler

(b) 300mcg

(MD)

1mg (MDD)
(2) External
(3) Preparations for the relief of asthma in the form of cigarettes, smoking mixtures or fumigants which contain Hyoscyamine as an alkaloid of Stramonium
Hyoscyamine Hydrobromide B (1) Internal:
(a) By inhaler
(b) Otherwise than by inhaler

(b) Equivalent of 300mcg of Hyoscyamine

(MD)

Equivalent of 1mg of Hyoscyamine

(MDD)

(2)External
Hyoscyamine Sulphate B (1) Internal:
(a) By inhaler
(b) Otherwise than by inhaler

(b) Equivalent of 300mcg of Hyoscyamine

(MD)

Equivalent of 1mg of Hyoscyamine

(MDD)

(2) External
Ibuprofen A Rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza

400mg (MD)

1,200mg

(MDD)

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Idoxuridine A
Ifosfamide A
Ignatius Bean B
Imipramine A
Imipramine Hydrochloride A
Imipramine Resinate A
Impromidine Hydrochloride A
Indapamide Hemihydrate B
Indomethacin B
Indoprofen B
Indoramin Hydrochloride B
Inosine Pranobex A
Interferon Alfa A
Interferon Beta A
Interferon Gamma A
Iodamide B
Iodamide Meglumine B
Iodamide Sodium B
Iopamidol B
Iopromide B
Ipratropium Bromide B
Iprindole Hydrochloride A
Iproniazid Phosphate A
Isoaminile B
Isoaminile Citrate B
Isocarboxazid A
Isoconazole Nitrate B External
(except vaginal use)
Isoetharine B
Isoetharine
Hydrochloride B
Isoetharine Mesylate B
Isoniazid B
Isoprenaline Hydrochloride B
Isoprenaline Sulphate B
Isopropamide Iodide B Equivalent of
2.5mg of
Isopropamide
(MD)
Equivalent of
5.0mg of
Isopropamide (MDD)
Isotretinoin A
Isoxicam B
Isoxsuprine Hydrochloride B
Jaborandi B External
Kanamycin Sulphate A
Ketamine Hydrochloride A
Ketazolam A
Ketoconazole B
Ketoprofen B
Ketotifen Fumarate B

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Labetolol Hydrochloride B
Lanatoside C B
Lanatoside Complex A, B and C B
Latamoxef Disodium A
Leuprorelin Acetate A
Levallorphan Tartrate B
Levamisole A
Levamisole Hydrochloride B
Levodopa A
Levonorgestrel A
Levorphanol Tartrate A
Lidoflazine A
Lignocaine A Any use
except local
ophthalmic use
Lignocaine Hydrochloride A Any use
except local
ophthalmic use
Lincomycin A
Lincomycin Hydrochloride A
Liothyronine Sodium B
Lisinopril B
Lisuride Maleate B
Lithium Carbonate A Equivalent of
5mg of
Lithium
(MD)
Equivalent of
15mg of Lithium
(MDD)
Lithium Sulphate A Equivalent of
5mg of
Lithium
(MD)
Equivalent of
15mg of
Lithium
(MDD)
Lobeline B (1) Internal (1) 3mg
(MD)
9mg (MDD)
(2) External
Lobeline Hydrochloride B (1) Internal (1) Equivalent of
3mg of
Lobeline
(MD)
Equivalent of
9mg of
Lobeline
(MDD)
(2) External
Lobeline Sulphate B (1) Internal (1) Equivalent
of 3mg
of Lobeline
(MD)
Equivalent of
9mg of
Lobeline
(MDD)
(2) External
Lofepramine A
Lomustine A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Loperamide Hydrochloride B Treatment of acute diarrhoea
Loprazolam Mesylate A
Lorazepam A
Lormetazepam A
Loxapine B
Loxapine Succinate B
Luteinising Hormone A
Lymecycline A
Lynoestrenol A
Lypressin A
Mafenide A
Mafenide Acetate A
Mafenide Hydrochloride A
Mafenide Propionate A 5.0 per cent Eye drops
Magnesium Fluoride B
Magnesium Metrizoate B
Mandragora Autumnalis B
Mannomustine Hydrochloride A
Maprotiline Hydrochloride B
Mazindol A
Mebanazine A
Mebendazole B
Mebeverine Hydrochloride B

100mg (MD)

300mg

(MDD)

Mebhydrolin B
Mebhydrolin Napadisylate B
Mecamylamine Hydrochloride B
Mecillinam A
Meclofenoxate
Hydrochloride B
Medazepam A
Medicinal Opium A (1) Equivalent of 0.02 per cent of anhydrous morphine (1) Liquids

(1) Equivalent of 3mg of anhydrous morphine

(MD)

(2) Equivalent of 0.04 per cent of anhydrous morphine (2) Solids

(2) Equivalent of 3mg of anhydrous morphine

(MD)

Medigoxin B
Medrogestone A
Medroxyprogesterone Acetate A
Medrysone A
Mefenamic Acid B
Mefruside B
Megestrol A
Megestrol Acetate A
Meglumine Iodoxamate B
Meglumine Ioglycamate A
Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Meglumine Iotroxate B
Melphalan A
Melphalan Hydrochloride A
Menotrophin A
Mepenzolate Bromide B

25mg (MD)

75mg (MDD)

Mephenesin B
Mephenesin Carbamate B
Mepindolol B
Mepivacaine Hydrochloride A Any use except local ophthalmic use
Meprobamate B
Meptazinol Hydrochloride A
Mequitazine B
Mercaptopurine A
Mercuric Chloride B
Mercuric Iodide B
Mersalyl B
Mersalyl Acid B
Mesterolone A
Mestranol A
Metaraminol Tartrate B
Metergoline A
Metformin Hydrochloride B
Methacycline A
Methacycline Calcium A
Methacycline Hydrochloride A
Methadone Hydrochloride A
Methallenoestril A
Methandienone A
Methapyrilene Fumarate A
Methapyrilene Hydrochloride A
Methaqualone A
Methicillin Sodium A
Methixene B
Methixene Hydrochloride B
Methocarbamol B
Methocidin A Throat lozenges and throat pastilles
Methohexitone Sodium A
Methoin B
Methoserpidine B
Methotrexate A
Methotrexate Sodium A
Methotrimeprazine B
Methotrimeprazine Hydrochloride B
Methotrimeprazine Maleate B

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose

Methoxamine

Hydrochloride

B 0.25 per cent Nasal sprays or nasal drops not containing liquid paraffin as a vehicle
Methsuximide B
Methyclothiazide B
Methylamphetamine Hydrochloride A
Methyldopa B
Methyldopate Hydrochloride B
Methylephedrine Hydrochloride B
Methylphenidate Hydrochloride A
Methylphenobarbitone A
Methylprednisolone A
Methylprednisolone Acetate A
Methylprednisolone Sodium Succinate A
Methyltestosterone A
Methylthiouracil B
Methyprylone A
Methysergide Maleate B
Metirosine A
Metoclopramide Hydrochloride B
Metolazone B
Metoprolol Tartrate B
Metronidazole B
Metyrapone B
Mexiletine Hydrochloride B
Mezlocillin Sodium A
Mianserin Hydrochloride B
Miconazole B External (except vaginal use)
Miconazole Nitrate B External (except vaginal use)
Midazolam A
Minocycline A
Minocycline Hydrochloride A
Minoxidil B
Misoprostol A
Mithramycin A
Mitobronitol A
Mitomycin C A
Mitozantrone Hydrochloride A
Molindone Hydrochloride B
Molsidomine B
Mopidamol A
Morazone Hydrochloride B

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Morphine Hydrochloride A (1) Equivalent of 0.02 per cent of anhydrous morphine (1) Liquids

(1) Equivalent of 3mg of anhydrous morphine

(MD)

(2) Equivalent of 0.04 per cent of anhydrous morphine; equivalent of 300 mcg of anhydrous morphine (2) Solids

(2) Equivalent of 3mg of anhydrous morphine

(MD)

Morphine Sulphate A (1) Equivalent of 0.02 per cent of anhydrous morphine (1) Liquids

(1) Equivalent of 3mg of anhydrous morphine

(MD)

(2)Equivalent of 0.04 per cent of anhydrous morphine; equivalent of 300mcg of anhydrous morphine (2) Solids

(2) Equivalent of 3mg of anhydrous morphine

(MD)

Mupirocin A
Mustine Hydrochloride A
Nabilone A
Nabumetone B
Nadolol B
Naftidrofuryl Oxalate B
Nalbuphine Hydrochloride A
Nalidixic Acid B
Nalorphine Hydrobromide A
Nalorphine Hydrochloride A
Naloxone Hydrochloride A
Naltrexone Hydrochloride A
Nandrolone Decanoate A
Nandrolone Laureate A
Nandrolone Phenylpropionate A
Naphazoline Hydrochloride B (1) 0.05 per cent (1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle
(2) 0.015 per cent (2) Eye drops
Naphazoline Nitrate B 0.05 per cent Nasal sprays or nasal drops not containing liquid paraffin as a vehicle
Naproxen B
Naproxen Sodium B
Natamycin A
Nedocromil Sodium B
Nefopam Hydrochloride B
Neomycin A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Neomycin Oleate A
Neomycin Palmitate A
Neomycin Sulphate A
Neomycin Undecanoate A
Neostigmine Bromide B
Neostigmine Methylsulphate B
Netilmicin Sulphate A
Nialamide A
Nicardipine Hydrochloride B
Niclosamide B
Nicotine Resinate B
Nicoumalone B
Nifedipine B
Nifenazone B
Nikethamide B
Nimetazepam A
Nimodipine B
Nimorazole B
Niridazole B
Nitrazepam A
Nitrofurantoin B
Nitrofurazone B
Nizatidine A
Nomifensine Maleate A
Noradrenaline B
Noradrenaline Acid Tartrate B
Nordiazepam A
Norethandrolone A
Norethisterone A
Norethisterone Acetate A
Norethisterone Heptanoate A
Norethynodrel A
Norfloxacin A
Norgestrel A
Nortriptyline Hydrochloride A
Novobiocin Calcium A
Novobiocin Sodium A
Nux Vocima Seed B
Nystatin A
Octacosactrin A
Oestradiol A
Oestradiol Benzoate A
Oestradiol Cypionate A
Oestradiol Dipropionate A
Oestradiol Diundecanoate A
Oestradiol Enanthate A
Oestradiol Phenylpropionate A
Oestradiol Undecanoate A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Oestradiol Valerate A
Oestriol A
Oestriol Di-Hemisuccinate A
Oestrogenic Substances Conjugated A
Oestrone A
Omeprazole B
Opipramol Hydrochloride A
Orciprenaline Sulphate B
Orphenadrine Citrate B
Orphenadrine Hydrochloride B
Ouabain B
Ovarian Gland Dried A
Oxamniquine B
Oxandrolone A
Oxantel Pamoate B
Oxatomide B
Oxazepam A
Oxazolam A
Oxiconazole Nitrate B
Oxedrine Tartrate B
Oxolinic Acid B
Oxpentifylline B
Oxprenolol Hydrochloride B
Oxybuprocaine Hydrochloride B Any use except local ophthalmic use
Oxycodone Hydrochloride A
Oxycodone A
Pectinate Oxymetholone A
Oxypertine B
Oxypertine Hydrochloride B
Oxyphenbutazone B
Oxyphencyclimine Hydrochloride B
Oxyphenonium Bromide B

5mg (MD)

15mg (MDD)

Oxytetracycline A
Oxytetracycline Calcium A
Oxytetracycline Dihydrate A
Oxytetracycline Hydrochloride A
Oxytocin, natural B
Oxytocin, synthetic B
Pancuronium Bromide A
Papaveretum A
Papaverine B (1) By inhaler
(2) otherwise than by inhaler

(2) 50mg

(MD)

150mg

(MDD)

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Papaverine Hydrochloride B (1) By inhaler
(2) otherwise than by inhaler

(2) Equivalent of 50mg of Papaverine

(MD)

Equivalent of 150mg of Papaverine

(MDD)

Paracetamol B

1g (MD)

4g (MDD)

Paraldehyde B
Paramethadione B
Paramethasone Acetate A
Parathyroid Gland A
Pargyline Hydrochloride A
Pecilocin A
Pemoline A
Pempidine Tartrate B
Penamecillin A
Penbutolol Sulphate B
Penfluridol A
Penicillamine B
Penicillamine Hydrochloride B
Pentagastrin A
Pentazocine Hydrochloride A
Pentazocine Lactate A
Penthienate Methobromide B

5mg (MD)

15mg (MDD)

Pentobarbitone A
Pentobarbitone Sodium A
Pentolinium Tartrate B
Perhexiline Maleate B
Pericyazine B
Permethrin B
Perphenazine B
Pethidine Hydrochloride A
Phenacetin A 0.1 per cent External
Phenazone B External
Phenazone Salicylate B
Phenazone and Caffeine Citrate B
Phenbutrazate Hydrochloride A
Phenelzine Sulphate A
Phenethicillin Potassium A
Phenformin Hydrochloride B
Phenglutarimide Hydrochloride B
Phenindione B
Phenmetrazine Hydrochloride A
Phenobarbitone A
Phenobarbitone Sodium A
Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Phenoperidine Hydrochloride A
Pheothrim B
Phenoxybenzamine Hydrochloride B
Phenoxymethylpenicillin A
Phenoxymethylpenicillin Calcium A
Phenoxymethylpenicillin Potassium A
Phenprocoumon B
Phensuximide B
Phentermine Hydrochloride A
Phentermine Resinate A
Phentolamine Hydrochloride B
Phentolamine Mesylate B
Phenylbutazone A
Phenylbutazone Sodium A
Phenylephrine Hydrochloride B (1) Internal (other than controlled release capsules and tablets, nasal sprays and nasal drops)

(1) 10mg (MD)

40mg (MDD)

(2) controlled release capsules and tablets

(2) 20mg (MD)

40mg (MDD)

(3) 0.5 per cent (3) nasal sprays and nasal drops
(4) External (except local ophthalmic use)
Phenylmethylbarbituric Acid A
Phenylpropanolamine Hydrochloride B

Internal:

(1) all preparations except controlled release capsules, nasal sprays and nasal drops

(1) 25mg (MD)

100mg (MDD)

(2) controlled release capsules

(2) 50mg (MD)

100mg (MDD)

(3) 2.0 per cent (3) nasal sprays and nasal drops
Phenytoin B
Phenytoin Sodium B
Pholcodine B 1.5 per cent 20mg (MD)
Pholcodine Citrate B Equivalent of 1.5 per cent of Pholcodine

Equivalent of 20mg of Pholcodine

(MD)

Pholcodine Tartrate B Equivalent of 1.5 per cent of Pholcodine

Equivalent of 20mg of Pholcodine

(MD)

Phthalylsulphathiazole B
Physostigmine B
Physostigmine Aminoxide Salicylate B
Physostigmine Salicylate B

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Physostigmine Sulphate B
Picrotoxin B
Pilocarpine B
Pilocarpine Hydrochloride B
Pilocarpine Nitrate B
Pimozide B
Pinacidil B
Pinazepam A
Pindolol B
Pipenzolate Bromide B 5mg (MD)
15mg (MDD)
Piperacillin Sodium A
Piperazine Oestrone Sulphate A
Piperidolate Hydrochloride B 50mg (MD)
150mg
(MDD)
Pipothiazine Palmitate B
Pipradrol Hydrochloride A
Piracetam B
Pirbuterol Acetate B
Pirbuterol Hydrochloride B
Pirenzepine Hydrochloride A
Piretanide B
Piritramide A
Piromidic Acid A
Piroxicam B
Pirprofen B
Pituitary Gland (Whole Dried) B
Pituitary Powdered (Posterior Lobe) B
Pivampicillin Hydrochloride A
Pivmecillinam A
Pivmecillinam Hydrochloride A
Pizotifen B
Pizotifen Maleate B
Podophyllum B
Podophyllum Indian B
Podophyllum Resin B 20.0 per External
cent
Poldine Methylsulphate B 2mg (MD)
6mg (MDD)
Polidexide B
Polyestradiol Phosphate A
Polymyxin B Sulphate A
Polythiazide B
Poppy Capsule A
Potassium Arsenite B 0.0127
per cent
Potassim Bromide B
Potassium Canrenoate A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Potassium Clorazepate A
Potassium Perchlorate B
Practolol B
Pralidoxime Chloride B
Pralidoxime Iodide B
Pralidoxime Mesylate B
Prazepam A
Prazosin Hydrochloride B
Prednisolone A
Prednisolone Acetate A
Prednisolone Butylacetate A
Prednisolone Hexanoate A
Prednisolone Pivalate A
Prednisolone Sodium Phosphate A
Prednisolone Sodium m- Sulphobenzoate A
Prednisolone 21-Steaglate A
Prednisolone m-Sulphobenzoate A
Prednisone A
Prednisone Acetate A
Prenalterol Hydrochloride B
Prenylamine Lactate B
Prilocaine Hydrochloride A Any use except local ophthalmic use
Primidone B
Probenecid B
Probucol B
Procainamide Hydrochloride B
Procaine Hydrochloride A Any use except local ophthalmic use
Procaine Penicillin A
Procarbazine Hydrochloride A
Procaterol Hyrdochloride B
Prochlorperazine Edisylate B
Prochlorperazine Maleate B
Prochlorperazine
Mesylate B
Procyclidine Hydrochloride B
Progesterone A
Proguanil Hydrochloride B Prophylaxis of malaria
Prolactin A
Proligestone A
Prolintane Hydrochloride A
Promazine Embonate B
Promazine Hydrochloride B

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Propafenone Hydrochloride B
Propanidid B
Propantheline Bromide B 15mg (MD)
45mg (MDD)
Propizepine A
Propofol A
Propranolol Hydrochloride B
Propylthiouracil B
Proquazone B
Proscillaridin B
Protamine Sulphate B
Prothionamide B
Protirelin B
Protriptyline Hydrochloride A
Proxymetacaine Hydrochloride B Any use except local ophthalmic use
Pseudoephedrine Hydrochloride B

Internal:

(1)All preparations except controlled release capsules and tablets

(1) 60mg (MD)

180mg (MDD)

(2) Controlled release capsules and tablets (2) 180mg (MDD)
Pseudoephedrine Sulphate B

Internal:

(1) All preparations except controlled release capsules and tablets

(1) 60mg (MD)

180mg (MDD)

(2) Controlled release capsules and tablets (2) 180mg (MD)
Pyrantel Embonate B
Pyrantel Tartrate B
Pyrazinamide B
Pyridostigmine Bromide B
Pyridoxine Hydrochloride B 50mg (MD)
100mg
(MDD)
Pyrimethamine B
Quazepam A
Quinalbarbitone A
Quinalbarbitone Sodium A
Quinestradol A
Quinestrol A
Quinethazone B
Quinidine B
Quinidine Bisulphate B
Quinidine Phenylethylbarbiturate A
Quinidine Polygalacturonate B
Quinidine Sulphate B
Quinine B 100mg (MD)
300mg
(MDD)

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Quinine Bisulphate B

Equivalent of 100mg of Quinine

(MD)

Equivalent of 300mg of Quinine

(MDD)

Quinine Dihydrochloride B

Equivalent of 100mg of Quinine

(MD)

Equivalent of 300mg of Quinine

(MDD)

Quinine Ethyl Carbonate B

Equivalent of 100mg of Quinine

(MD)

Equivalent of 300mg of Quinine

(MDD)

Quinine Glycerophosphate B

Equivalent of 100mg of Quinine

(MD)

Equivalent of 300mg of Quinine

(MDD)

Quinine Hydrobromide B

Equivalent of 100mg of Quinine

(MD)

Equivalent of 300mg of Quinine

(MDD)

Quinine Hydrochloride B

Equivalent of 100mg of Quinine

(MD)

Equivalent of 300mg of Quinine

(MDD)

Quinine Iodobismuthate B

Equivalent of 100mg of Quinine

(MD)

Equivalent of 300mg of Quinine

(MDD)

Quinine Phenylcinchoninate B

Equivalent of 100mg of Quinine

(MD)

Equivalent of 300mg of Quinine

(MDD)

Quinine Phosphate B

Equivalent of 100mg of Quinine

(MD)

Equivalent of 300mg of Quinine

(MDD)

Quinine Salicylate B

Equivalent of 100mg of Quinine

(MD)

Equivalent of 300mg of Quinine

(MDD)

Quinine Sulphate B

Equivalent of 100mg of Quinine

(MD)

Equivalent of 300mg of Quinine

(MDD)

Quinine Tannate B

Equivalent of 100mg of Quinine

(MD)

Equivalent of 300mg of Quinine

(MDD)

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Quinine and Urea Hydrochloride B
Ranitidine Hydrochloride A
Rauwolfia Serpentina B
Rauwolfia Vomitoria B
Razoxane A
Reproterol Hydrochloride B
Rescinnamine B
Reserpine B
Rifampicin A
Rifamycin A
Rimiterol Hydrobromide B
Ritodrine Hydrochloride B
Rolitetracycline Nitrate A
Rosoxacin A
Sabadilla B
Salbutamol B
Salbutamol Sulphate B
Salcatonin B
Salcatonin Hydrated Polyacetate B
Salmefamol B
Salsalate B
Saralasin Acetate B
Secbutobarbitone A
Secbutobarbitone Sodium A
Secretin B
Selegiline Hydrochloride B
Sera and Antisera:—
Botulin Antitoxin A
Diphtheria Antitoxin A
Gas-gangrene Antitoxin (Oedematiens) A
Gas-gangrene Antitoxin (Perfringens) A
Gas-gangrene Antitoxin (Septicum) A
Mixed Gas-gangrene Antitoxin Leptospira A
Antiserum A
Rabies Antiserum A
Scorpion Venom Antiserum A
Snake Venom Antiserum A
Tetanus Antitoxin A
Serum Gonadotrophin A
Silver Sulphadiazine A
Sissomicin A
Sissomicin Sulphate A
Snake Venoms B

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Sodium Acetrizoate B
Sodium Aminosalicylate B
Sodium Antimonyl-gluconate B
Sodium Arsanilate B
Sodium Arsenate B
Sodium Arsenite B 0.013 per cent
Sodium Bromide B
Sodium Cromoglycate B Administration through the nose
Sodium Ethacrynate B
Sodium Fluoride B (1) 0.33 per cent

(1) Dentifrices

(2) other preparations for use in the prevention of dental caries in the form of:—

(a) tablets or drops

(a) 2.2mg (MDD)
(b) 0.2 per cent (b) mouth rinses other than those for daily use
(c) 0.05 per cent (c) mouth rinses for daily use
Sodium Fusidate A
Sodium Metrizoate B
Sodium Monofluoro-Phosphate B 1.14 per cent Dentifrice
Sodium Stibogluconate B
Sodium Valproate B
Sotalol Hydrochloride B
Spectinomycin A
Spectinomycin Hydrochloride A
Spiramycin A
Spiramycin Adipate A
Spironolactone A
Stannous Flouride B 0.62 per cent Dentifrice
Stanolone A
Stanozolol A
Stilboestrol A
Stilboestrol Dipropionate A
Streptodornase B External
Streptokinase B External
Streptomycin A
Streptomycin Sulphate A
Strophanthin-K B
Strychnine B
Strychnine Arsenate B
Strychnine Hydrochloride B
Styramate B
Succinyl-sulphathiazole B
Sucralfate B
Sufentanil Citrate A
Sulbactam Sodium A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Sulbactam Tosylate A
Sulbenicillin Sodium A
Sulconazole Nitrate B
Sulfacytine A
Sulfadoxine A
Sulfamono-methoxine A
Sulindac B
Suloctidil B
Sulphacetamide A
Sulphacetamide Sodium A
Sulphadiazine A
Sulphadiazine Sodium A
Sulphadimethoxine A
Sulphadimidine A
Sulphadimidine Sodium A
Sulphafurazole A
Sulphafurazole Diethanolamine A
Sulphaguanidine B
Sulphaloxic Acid B
Sulphamerazine A
Sulphamerazine Sodium A
Sulphamethizole A
Sulphamethoxazole A
Sulphamethoxy-diazine A
Sulphamethoxy-pyridazine A
Sulphamethoxy-pyridazine Sodium A
Sulphamoxole A
Sulphanilamide A
Sulphaphenazole A
Sulphapyridine A
Sulphapyridine Sodium A
Sulphasalazine A
Sulphathiazole A
Sulphathiazole Sodium A
Sulphaurea A
Sulphinpyrazone B
Sulpiride B
Sulthiame B
Sutoprofen B
Suxamethonium Bromide A
Suxamethonium Chloride A
Suxethonium Bromide A
Tacrine Hydrochloride A
Talampicillin A
Talampicillin Hydrochloride A
Talampicillin Napsylate A
Tamoxifen A
Tamoxifen Citrate A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Taurolidine B
Teicoplanin A
Temazepam A
Teniposide A
Tenoxicam B
Terazosin Hydrochloride B
Terbutaline B
Terbutaline Sulphate B
Terodiline Hydrochloride B
Terlipressin A
Testosterone A
Testosterone Acetate A
Testosterone 17ß Chloral Hemiacetal A
Testosterone Cyclohexylpropionate A
Testosterone Cypionate A
Testosterone Decanoate A
Testosterone Enanthate A
Testosterone Isocaproate A
Testosterone Phenylpropionate A
Testosterone Propionate A
Testosterone Undecanoate A
Tetrabenazine B
Tetracosactrin A
Tetracosactrin Acetate A
Tetracycline A
Tetracycline Hydrochloride A
Tetracycline Phosphate Complex A
Tetrazepam A
Thallium Acetate A
Thallous Chloride A
Thiambutosine B
Thiamphenicol A
Thiamphenicol Glycinate Hydrochloride A
Thiamphenicol Palmitate A
Thiethylperazine B
Thiethylperazine Malate B
Thiethylperazine Maleate B
Thiocarlide B
Thioguanine A
Thiopentone Sodium A
Thiopropazate Hydrochloride B
Thioproperazine Mesylate B
Thioridazine B
Thioridazine Hydrochloride B

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Thiosinamine A
Thiotepa A
Thiothixene B
Thiouracil B
Thymoxamine Hydrochloride B
Thyroid B
Thyrotrophin A
Thyroxine Sodium B
Tiamulin Fumarate A
Tiaprofenic Acid B
Tibezonium Iodide A
Tibolone A
Ticarcillin Sodium A
Tienilic Acid B
Tigloidine Hydrobromide B
Timolol Maleate B
Tinidazole B
Tioconazole B
Tizanidine Hydrochloride A
Tobramycin Sulphate A
Tocainide Hydrochloride B
Tofenacin Hydrochloride B
Tofisopam A
Tolazamide B
Tolazoline Hydrochloride B External
Tolobuterol Hydrochloride B
Tolbutamide B
Tolbutamide Sodium B
Tolmetin Sodium B
Tramazoline Hydrochloride B
Tranexamic Acid B
Tranylcypromine Sulphate A
Trazodone Hydrochloride B
Treosulfan A
Tretinoin B
Triamcinolone A
Triamcinolone Acetonide A
Triamcinolone Diacetate A
Triamcinolone Hexacetonide A
Triamterene B
Triazolam A
Triclofos Sodium B
Trifluoperazine B
Trifluoperazine Hydrochloride B
Trifluperidol A
Trifluperidol Hydrochloride A
Trilostane A
Trimazosin Hydrochloride B

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Trimeprazine B
Trimeprazine Tartrate B
Trimetaphan Camsylate B
Trimetazidine B
Trimetazidine Hydrochloride B
Trimethoprim A
Trimipramine Maleate A
Trimipramine Mesylate A
Tropicamide B
Troxidone B
L-Tryptophan B

(1) Dietary or nutritive use

(2) Any external use

Tubocurarine
Chloride A
Tulobuterol
Hydrochloride A
Tyrothricin A Throat lozenges and throat pastilles
Uramustine A
Urapidil B
Urea Stibamine B
Urethane A
Uridine-5-Triphosphoric Acid B
Urofollitrophin A
Urokinase B
Ursodeoxycholic Acid B
Vaccines:—
Anthrax Vaccine (Bacillus Anthracis) A
Bacillus Calmette-Guerin Vaccine A
Percutaneous Bacillus Calmette-Guerin Vaccine A
Cholera Vaccine A
Diphtheria Vaccine A
Adsorbed Diphtheria Vaccine A
Diphtheria, and Tetanus Vaccine A
Adsorbed Diphtheria and Tetanus Vaccine A
Diphtheria, Tetanus and Pertussis Vaccine A
Adsorbed Diphtheria, Tetanus and Pertussis Vaccine A
Diphtheria, Tetanus and Poliomyelitis Vaccine A
Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine A
Eltor Vaccine A
Influenza Vaccine A
Measles Vaccine (Live Attenuated) A

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose
Pertussis Vaccine A
Plague Vaccine A
Pneumococcal Vaccine (Bacterial Antigen) A
Poliomyelitis Vaccine (Inactivated) A
Poliomyelitis Vaccine (Oral) A
Rabies Vaccine A
Rubella Vaccine (Live Attenuated) A
Smallpox Vaccine Dried Smallpox A
Vaccine A
Schick Control A
Schick Test Toxin A
Tetanus Vaccine A
Adsorbed Tetanus Vaccine A
Tetanus and Pertussis Vaccine A
Tuberculin Purified Protein Derivative A
Old Tuberculin A
Typhoid Vaccine A
Typhoid and Tetanus Vaccine A
Typhoid-paratyphoid A and B Vaccine A
Typhoid-paratyphoid A and B and Cholera Vaccine A
Typhoid-
paratyphoid A and B and Tetanus Vaccine A
Typhus Vaccine A
Yellow Fever Vaccine A
Valproic Acid B
Vancomycin Hydrochloride A
Vasopressin A
Vasopressin Tannate A
Vecuronium Bromide A
Veralipride B
Verapamil Hydrochloride B
Veratrine B
Veratrum (Green and White) B
Vidarabine A
Viloxazine Hydrochloride B
Vinblastine Sulphate A
Vincristine Sulphate A
Vindesine Sulphate A
Viomycin Pantothenate A
Viomycin Sulphate A
Vitamin A B

(1) Internal

(2) External

(1) 7.500 iu (2,250mcg Retinol equivalent) (MDD)

Circumstances excluding medical preparations from prescription control
Column 1 Column 2 Column 3 Column 4 Column 5
Substance Part in Schedule Maximum Strength Use, pharmaceutical form or manner of administration Maximum dose and Maximum daily dose

Vitamin A

Acetate

B

(1) Internal

(2) External

(1) Equivalent to 7,500 iu Vitamin A (2,250mcg Retinol equivalent) (MDD)

Vitamin A

Palmitate

B

(1) Internal

(2) External

(1) Equivalent to 7,500 iu Vitamin A (2,250mcg Retinol equivalent) (MDD)
Warfarin B
Warfarin Sodium B
Xamoterol Fumarate A
Xipamide Yohimbine B
Hydrochloride B
Zimeldine Hydrochloride A
Zomepirac Sodium B
Zopiclone A

Note: In relation to a medical preparation which contains more than one of the substances Atropine, Atropine Methobromide, Atropine Methonitrate, Atropine Oxide Hydrochloride, Atropine Sulphate, Hyoscine, Hyoscine Butylbromide, Hyoscine Hydrobromide, Hyoscine Methobromide, Hyoscine Methonitrate, Hyoscyamine, Hyoscyamine Hydrobromide or Hyoscyamine Sulphate, for the purposes of column 4, the maximum daily dose (MDD) is 1mg of the total alkaloids contained in the product which are derived from belladonna, hyoscyamus, stramonium or other solanaceous plant, and there is no maximum dose (MD).

Article 6 (3)

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.

PART I

Alclomethasone Dipropionate Fluocortolone Hexanoate
Beclomethasone Dipropionate Fluocortolone Pivalate
Betamethasone Fluorometholone
Betamethasone Benzoate Fluprednidene Acetate
Betamethasone Dipropionate Flurandrenolone
Betamethasone Sodium Phosphate Formocortal
Betamethasone Valerate Halcinonide
Clobetasol Propionate Hydrocortisone
Clobetasone Butyrate Hydrocortisone Acetate
Desonide Hydrocortisone Butyrate
Desoxymethasone Medrysone
Dexamethasone Methylprednisolone Acetate
Dexamethasone Sodium Phosphate Prednisolone
Diflucortolone Valerate Prednisolone Acetate
Fluclorolone Acetonide Prednisolone Hexanoate
Flumethasone Pivalate Prednisolone Sodium Phosphate
Fluocinolone Acetonide Prednisolone Steaglate
Fluocinonide Triamcinolone Acetonide.
Fluocortolone

PART II

Desogestrel

Ethinyloestradiol

Ethynodiol Diacetate

Levonorgestrel

Lynoestrenol

Mestranol

Norethisterone

Norethisterone Acetate

Article 7

THIRD SCHEDULE

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

Ammonium Bromide Methylphenobarbitone
Amylobarbitone Pemoline
Amylobarbitone Sodium Pentobarbitone
Barbitone Pentobarbitone Sodium
Barbitone Sodium Phenobarbitone
Butobarbitone Phenobarbitone Sodium
Butobarbitone Sodium Phentermine Hydrochloride
Calcium Bromide Phentermine Resinate
Calcium Bromidolactobionate Phenylmethylbarbituric Acid
Chlormethiazole Piracetam
Chlormethiazole Edisylate Potassium Bromide
Cyclobarbitone Prolintane Hydrochloride
Cyclobarbitone Calcium Quinidine Phenylethylbarbiturate
Embutramide Secbutobarbitone
Fencamfamin Hydrochloride Secbutobarbitone Sodium
Fluanisone Sodium Bromide
Heptabarbitone Strychnine Hydrochloride
Hexobarbitone Tacrine Hydrochloride
Hexobarbitone Sodium Thiopentone Sodium
Hydrobromic Acid
Meclofenoxate Hydrochloride
Methohexitone Sodium

Article 8 (2) (i)

FOURTH SCHEDULE

Cautionary and Warning Notices for Dispensed Medical Preparations.

Notice Examples of medical preparations for which the notice appearing opposite may be appropriate
1. Warning. May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink. Anti-histamines (except where intended for external use only), barbiturates, hypnotics and tricyclic anti-depressants.
2. Warning. May cause drowsiness. Alternative for children's preparations of the examples specified in 1 above.
3. Warning. Avoid alcoholic drink.
4. Do not take indigestion remedies at the same time of day as this medicine. Capsules, tablets or granules incorporating an enteric coat.
5. Do not take iron preparations or indigestion remedies at the same time of day as this medicine. Preparations containing doxycycline, minocycline or penicillamine.
6. Do not take milk, iron preparations or indigestion remedies at the same time of day as this medicine. Preparations containing tetracycline other than doxycycline and minocycline.
7. Do not stop taking this medicine except on your doctor's advice. Preparations (such as beta-adrenoceptor blocking drugs, antihypertensives, those for the treatment or prophylaxis of asthma, or allopurinol) required to be taken over a prolonged period for a benefit to be noticed.
8. Take at regular intervals. Complete the prescribed course unless otherwise directed. Antimicrobial drugs given by mouth.
9. Warning. Follow the printed instructions you have been given with this medicine. Preparations in respect of which a treatment card or other written instructions are given to the patient.
10. Avoid exposure of skin to direct sunlight or sun-lamps. Preparations which may cause phototoxic or photoallergic reactions.
11. Do not take remedies containing aspirin while taking this medicine. Preparations containing salicylate derivatives.
12. Dissolve or mix with water before taking.
12. This medicine may colour the urine or stools.
14. Caution flammable: keep away from naked flames.
15. Allow to dissolve under the tongue. Do not transfer from this container. Keep tightly closed. Discard eight weeks after opening. Glyceryl Trinitrate Tablets.
16. Discard eight weeks after opening. Glyceryl Trinitrate Tablets supplied in manufacturer's original pack.
17. Not more than . . in 24 hours or . . .in any one week. Preparations containing Ergotamine and intended for the treatment of acute migraine.
18. Not more than . . .in 24 hours. Alternative for preparations specified in 17 above.
19. Take an hour before food or on an empty stomach. Certain oral antibiotics the absorption of which may be reduced by the presence of food.
20. Take half to one hour before food. Preparations the action of which is thereby improved.
21. To be swallowed whole, not chewed. Sustained release preparations.
22. Take with plenty of water.
23. To be applied sparingly. Preparations for external use containing a corticosteroid or dithranol.
24. To be dissolved under the tongue. Preparations intended for sublingual use.
25. To be sucked or chewed.
26. Take with or after food. Preparations liable to cause gastric irritation with nausea and vomiting or those that are better absorbed with food.
27. Caution. It is dangerous to exceed the stated dose.
28. Not to be taken.
29. Shake the bottle.
30. Store in a cool place.
31. Do not use after . . .
32. Discard . . . days after opening.
33. Not to be used for babies.
34. Warning. Do not exceed the stated dose.
35. Not to be used for prolonged periods or at higher levels than those recommended without medical advice. Sympathomimetics for internal use.
36. Not to be used for children under three years of age or for application to large areas of skin unless on medical advice. Preparations containing hexachlorophane.
37. Not to be applied to broken skin and not to be used for children under three years of age. Preparations containing boric acid or borax.
38. When taking this medicine and for 14 days after your treatment finishes you must observe the following instructions:— Monoamine-oxidase inhibitors.

1. Do not eat cheese, pickled herrings or broad bean pods.

2. Do not eat or drink bovril, oxo, marmite or any similar meal or yeast extract.

3. Eat only fresh foods and avoid food that you suspect could be stale or going off. This is especially important with meat, fish, poultry or offal. Avoid game.

4. Do not take any other medicines whether purchased by you or previously prescribed for you by your doctor, without first consulting your doctor or your pharmacist.

5. Avoid alcoholic drinks.

Note: Certain of these notices may be incorporated in the directions for use on the label.

Article 14

FIFTH SCHEDULE

Medical Preparations (Control of Sale) Regulations, 1987

( S.I. No. 18 of 1987 )
CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS
This Certificate is issued by me, the undersigned, for the purpose of article 14 of the Medical Preparations (Control of Sale) Regulations, 1987, being 1 ............................................................ ......................................
I hereby certify that I received on the................................ day of............................................................ ..............
19 from2............................................of............................................................ ...............................
a sample of 3............................... for test, examination or analysis; which was undamaged, duly sealed and
marked4 ............................................................ ............................................................ .................................................
I further certify that the said sample has been tested, examined or analysed by me or under my direction and that the results are as follows:—5

Results

Signature............................................................ .............. Date............................................................ ................
Address............................................................ ......................
1 Here insert official title of analyst.
2 Here insert the name of the sampling officer or agent who submitted the sample for analysis.
3 Here insert the name or description of the substance or preparation.
4 Here insert the distinguishing mark on the sample and the date of sampling shown thereon.
5 Here insert the relevant results as appropriate.

GIVEN under the Official Seal of the Minister for Health this 19th day of January, 1987.

BARRY DESMOND,

Minister for Health.

EXPLANATORY NOTE.

The purpose of these Regulations is to apply an up-to-date and comprehensive system of control to those medical preparations which should only be sold or supplied against a prescription issued by a registered medical practitioner or registered dentist. The Regulations specify the classes of medical preparations and the substances, which, when contained in medical preparations, are subjected to prescription control. The circumstances excluding certain preparations from such control are also specified.

In addition, the Regulations include restrictions in relation to the dispensing of prescriptions, conditions under which the emergency sale or supply of "prescription-only" medical preparations may be made by pharmacists, requirements as to the labelling of dispensed medical preparations, pharmacy record-keeping requirements and prohibitions on the advertising to the public of "prescription-only" medical preparations and on the sale of medical preparations after their expiry dates.