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

SECOND SCHEDULE

Other medicinal products excluded from prescription control

THIRD SCHEDULE

Substances which when contained in certain non prescription medicinal products may be supplied in non pharmacy outlets.

FOURTH SCHEDULE

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

FIFTH SCHEDULE

Substances not to be contained in a medicinal product supplied under the exemption conferred by Article 8(2).

SIXTH SCHEDULE

Cautionary and warning notices for dispensed medicinal products.

SEVENTH SCHEDULE

Certificate stating results of test, examination or analysis.

S.I. No. 256 of 1996.

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

In exercise of the powers conferred on the Minister for Health by section 32 of the Irish Medicines Board Act, 1995 (No. 29 of 1995), which said powers are delegated to me by the Health (Delegation of Ministerial Functions) Order, 1996 ( S.I. No. 24 of 1996 ), I, Brian O'Shea, Minister of State at the Department of Health, hereby make the following Regulations:--

CITATION 1

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

COMMENCEMENT

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

REVOCATIONS

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

INTERPRETATION

4. (1) In these Regulations:--

"the Act" means the Irish Medicines Board Act, 1995 ;

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

"authorised person" has the meaning assigned to it by section 2 of the Pharmacy Act, 1962 (No. 14 of 1962) as amended by section 34 of the Misuse of Drugs Act, 1977 and by article 4 of the European Communities (Recognition of Qualifications in Pharmacy) Regulations, 1991 ( S.I. No. 330 of 1991 );

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

"dosage unit" means --

(a) where a medicinal product is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other article, or

(b) where a medicinal product is not in any such form, that quantity of the product which is used as the unit by reference to which the dose is measured;

"external use" means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal when a local action only is intended and extensive systemic absorption is unlikely to occur and references to medicinal products for external use shall be read accordingly except that such references shall not include transdermal delivery systems, throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething products;

"health prescription" means a prescription issued in connection with arrangements made under section 59 of the Health Act, 1970 (No. 1 of 1970), on a form supplied by or on behalf of a health board;

"hospital" includes a clinic, nursing home or similar institution;

"inhaler" does not include an aerosol;

"maximum daily dose" or "MDD" means the maximum quantity of a substance contained in the amount of a medicinal product for internal use which it is recommended should be taken or administered in any period of 24 hours;

"maximum dose" or "MD" means the maximum quantity of a substance contained in the amount of a medicinal product for internal use which it is recommended should be taken or administered at any one time;

"maximum pack size" or "MPS" means the maximum quantity of a medicinal product by weight, volume or number of dosage units contained in the pack presentation for supply;

"maximum period of treatment" or "MPT" means the maximum period specified in days in respect of the amount of a medicinal product which it is recommended should be taken or administered during the period so specified;

"maximum strength" or "MS" means such of the following as may be specified--

( a ) the maximum quantity of a substance by mass or volume contained in a dosage unit of a medicinal product, and

( b ) the maximum percentage of a substance contained in a medicinal product calculated in terms of mass in mass (m/m), mass in volume (m/v), volume in mass (v/m) or volume in volume (v/v), as appropriate;

"the Minister" means the Minister for Health;

"new chemical molecule" means a substance, not being a substance specified in any of the Schedules to these Regulations, which was not contained in a medicinal product, as one of its active ingredients, which was lawfully on the market in the State on, or immediately before, the 19th day of January 1987;

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

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

"premises" includes any aircraft, hovercraft, ship, stall or vehicle;

"product authorisation" means an authorisation granted in pursuance of the Medical Preparations (Licensing and Sale) Regulations, 1996 ( S.I. No. 43 of 1996 );

"registered dentist" means a person registered in the register established under the Dentists Act, 1985 (No. 9 of 1985) and includes any person entitled to be so registered by virtue of section 27(2)(c) of the said Act;

"registered medical practitioner" means a person registered in the register established under the Medical Practitioners Act, 1978 (No. 4 of 1978) and includes any person entitled to be so registered by virtue of section 27(2)(c) of the said Act;

"registered nurse" means a person registered in the register established under the Nurses Act, 1985 (No. 18 of 1985);

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

"supply" includes sell, distribute or offer or keep for sale or distribution notwithstanding that the person supplied may be in another Member State of the European Community and cognate words shall be construed accordingly;

"supply by mail order" means any supply made, after solicitation of custom by the supplier, without the supplier and the customer being simultaneously present and using a means of communication at a distance, whether written or electronic, to convey the custom solicitation and the order for supply;

"supply by way of wholesale dealing" means the supply of a medicinal product to a person who obtains the product for one or more of the following purposes --

( a ) supply in the course of a pharmaceutical business, or

( b ) administration in the course of a professional practice, or

( c ) for or in connection with a service provided by a hospital;

"sampling officer" means a person authorised by a health board to take samples for the purposes of the Sale of Food and Drugs Acts, 1875 to 1936 or in connection with any arrangements made for testing the quality or amount of the drugs, medicines and appliances supplied for the purpose of section 59 of the Health Act, 1970 ;

(2) In these Regulations, unless the context otherwise indicates, any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations

or, as the case may be, to a Schedule thereto; any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article, and any reference in a sub-article to a paragraph shall be construed as a reference to a paragraph of that sub-article.

MEDICINAL PRODUCTS ON PRESCRIPTION ONLY

5. (1) Subject to the provisions of these Regulations a person shall not supply a medicinal product of any of the following classes except in accordance with a prescription, namely--

( a ) any medicinal product which is or which contains a substance specified in column 1 of the First Schedule;

( b ) any medicinal product which is intended for parenteral administration;

( c ) any medicinal product which is or which contains a new chemical molecule.

(2) Sub-article (1)(a) shall not apply as respects a medicinal product where there is an entry in relation to a substance in the medicinal product in one or more of columns 3, 4 and 5 of the First Schedule; and

( a ) where the maximum strength of the substance does not exceed that, if any, specified in column 3 of the said Schedule opposite the mention of that substance in column 1 thereof; and

( b ) where the maximum pack size of the medicinal product does not exceed that, if any, specified in column 3 of the said Schedule opposite the mention in column 1 thereof of a substance contained in the said product; and

( c ) where a pharmaceutical form is specified in column 4 of the said Schedule opposite the mention of the substance, contained in a medicinal product, in column 1 thereof, the medicinal product is supplied in such form; and

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

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

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

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

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

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

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

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

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

(a) is the subject of a product authorisation,

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

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

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

RESTRICTIONS ON MEDICINAL PRODUCTS EXEMPTED FROM PRESCRIPTION CONTROL

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

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

RESTRICTIONS ON DISPENSING OF PRESCRIPTIONS

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

EXEMPTIONS FOR EMERGENCY SUPPLY

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

LABELLING OF DISPENSED MEDICINAL PRODUCTS

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

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

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

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

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

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

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

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

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

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

(i) directions for use of the product, and

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

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

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

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

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

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

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

PHARMACY RECORDS

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

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

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

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

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

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

(v) the date of the prescription; and

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(d) the supply is to a sampling officer.

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

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

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

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

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

(b) in relation to paragraphs (b) and (c) --

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

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

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

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

KEEPING OF RECORDS IN THE CASE OF CERTAIN MEDICINAL PRODUCTS

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

(a) the date of such supply or administration,

(b) the name and address of the recipient,

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

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

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

PROHIBITION OF SUPPLY AFTER EXPIRY DATE

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

Prohibition of mail order supply

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

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

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

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

(a) an officer of the Minister,

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

(d) an officer of the Irish Medicines Board,

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

EXEMPTIONS

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

(a) the supply of a medicinal product to--

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

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

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

(iv) a person employed or engaged in connection with any arrangements made for testing the quality or amount of the drugs, medicines and appliances supplied for the purpose of section 59 of the Health Act, 1970 .

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

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

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

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

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

ENFORCEMENT AND EXECUTION

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

(a) officers of the Minister,

(b) officers of the Pharmaceutical Society of Ireland,

(d) officers of the Irish Medicines Board.

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

(a) enter premises of any class or description,

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

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

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

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

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

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

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

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

(a) a hospital;

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

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

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

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

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

EVIDENCE OF RESULT OF TEST, EXAMINATION OR ANALYSIS

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

(a) the State Chemist, or

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

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

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

TRANSITIONAL PROVISIONS

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

(Articles 5. 6 and 7)

FIRST SCHEDULE

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

In this Schedule:--

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

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

(d ) the following abbreviations are used:

"g",for gram,	"mg" for milligram,	"mcg" for microgram,
"ml" for millilitre.	"%" for per cent

		CIRCUMSTANCES EXCLUDING MEDICINAL PRODUCTS FROM PRESCRIPTION CONTROL
COLUMN 1	COLUMN 2	COLUMN 3	COLUMN 4	COLUMN 5
SUBSTANCE	PART IN SCHEDULE	MAXIMUM STRENGTH, PACK SIZE, OR PERIOD OF TREATMENT	USE, PHARMACEUTICAL FORM OR MANNER OF ADMINISTRATION	MAXIMUM DOSE AND MAXIMUM DAILY DOSE
Acarbose	B
Acebutolol Hydrochloride	B
Acecarbromal	B
Aceclofenac	B
Acemetacin	B
Acepromazine Maleate	B
Acetanilide	B
Acetarsol	A
Acetazolamide	B
Acetazolamide Sodium	B
Acetohexamide	B
Acetophenazine Maleate	B
Acetrizoate Sodium	C
Acetrizoic Acid	C
Acetylcholine Chloride	B	0.2% (MS)	External
Acetylcysteine	A		Any use (except local ophthalmic use)
Acipimox	B
Acitretin	A
Aclarubicin	A
Aclarubicin Hydrochloride	A
Aconite	B	1.3% (MS)	External
Acrivastine	B
Acrosoxacin	A
Actaplanin	A
Actinomycin C.	A
Actinomycin D.	A
Acyclovir	A	5.0% (MS) 2.0g (MPS)	External (except local ophthalmic use): Cold sores
Adapalene	A
Adenosine	A
Adrenaline Acid Tartrate	B		External
Adrenaline	B		External
Adrenaline Hydrochloride	B		External
Adrenocortical Extract	A
Albendazole	B
Alclofenac	B
Alclomethasone Dipropionate	A
Alcuronium Chloride	A
Aldesleukin	A
Aldosterone	A
Alendronate Sodium	B
Alendronic Acid	B
Alfacalcidol	B
Alfentanil Hydrochloride	A
Alfuzosin	B
Alfuzosin Hydrochloride	B
Allergen Extracts	B
Allopurinol	B
Allyloestrenol	A
Almitrine	B
Aloxiprim	B			800mg (MD) 3.6g (MDD)
Alphadolone Acetate	A
Alphaxalone	A
Alprazolam	A
Alprenolol	B
Alprenolol Hydrochloride	B
Alprostadil	A
Alseroxylon	B
Alverine Citrate	B
Amantadine Hydrochloride	B
Ambenonium Chloride	A
Ambutonium Bromide	A			5 mg (MD) 20 mg (MDD)
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
Aminophylline	B
Aminopterin Sodium	A
Amiodarone Hydrochloride	B
Amiphenazole Hydrochloride	B
Amitriptyline	A
Amitriptyline Embonate	A
Amitriptyline Hydrochloride	A
Amlodipine Besylate	B
Amlodipine Maleate	B
Ammonium Bromide	B
Amodiaquine Hydrochloride	B		Prophylaxis of malaria
Amorolfine Hydrochloride	B
Amoxapine	A
Amoxycillin	A
Amoxycillin Trihydrate	A
Amphetamine Sulphate	A
Amphomycin Calcium	A
Amphotericin	A
Ampicillin Sodium	A
Ampicillin Trihydrate	A
Amrinone	B
Amsacrine	A
Amygdalin	A
Amyl Nitrite	A
Amylobarbitone	A
Amylobarbitone Sodium	A
Amylocaine Hydrochloride	A		Any use except local ophthalmic use
Anastrozole	A
Ancrod	A
Androsterone	A
Angiotensin Amide	B
Anistreplase	A
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
Apraclonidine	B
Aprotinin	A
Arbaprostil	A
Arbutamine Hydrochloride	C
Arbutamine	C
Arecoline Hydrobromide	B
Argipressin	A
Arsenic	A
Arsenic Triiodide	A
Arsenic Trioxide	A
Arsphenamine	A
Aspirin	B		(1) Internal: any use (except for children under 12 years of age) (2) External	(1) 650 mg (MD) 4.0 g (MDD)
Atamestane	A
Astemizole	B	10mg (MS) 10 (MPS)	10mg (MDD)
Atenolol	B
Atracurium Besylate	A
Atropine	B		1) Internal: (a) by inhaler (b) otherwise than by inhaler (2) External (except local ophthalmic use)	(b) 300mcg(MD) 1.0mg (MDD)
Atropine Methobromide	B		1) Internal: (a) by inhaler (b) otherwise than by inhaler (2) External (except local ophthalmic use)	(b) 400mcg(MD) 1.3mg (MDD)
Atropine Methonitrate	B		(1) Internal: (a) by inhaler (b) otherwise than by inhaler	(b) 400mcg(MD) 1.3mg (MDD)
Atropine Oxide Hydrochloride	B		(1) Internal: (a) by inhaler (b) otherwise than by inhaler (2) External (except local ophthalmic use)	(b) 360mcg(MD) 1.2mg (MDD)
Atropine Sulphate	B		(1) Internal: (a) by inhaler (b) otherwise than by inhaler (2) External (except local ophthalmic use)	(b) 360mcg(MD) 1.2mg (MDD)
Auranofin	B
Azapropazone	B
Azathioprine	A
Azathioprine Sodium	A
Azelaic Acid	B
Azelastine Hydrochloride	B
Azelastine	B
Azidocillin Potassium	A
Azitromycin	A
Azlocillin Sodium	A
Aztreonam	A
Bacampicillin Hydrochloride	A
Bacitracin	A
Bacitracin Methylene Disalicylate	A
Bacitracin Zinc	A
Baclofen	B
Bambuterol	B
Bambuterol Hydrochloride	B
Barbexaclone	A
Barbitone	A
Barbitone Sodium	A
Barium Carbonate	B
Barium Chloride	B
Barium Sulphate	C
Barium Sulphide	B
Beclamide	B
Beclomethasone	A
Beclomethasone Dipropionate	A
Belladonna Herb	B		(1) Internal (2) External	(1) lmg of the alkaloids (MDD)
Belladonna Root	B		(1) Internal (2) External	(1) lmg of the alkaloids (MDD)
Bemegride	B
Bemegride Sodium	B
Benapryzine Hydrochloride	B
Benzquinamide	B
Benazepril Hydrochloride	B
Bendrofluazide	B
Benethamine Penicillin	A
Benorylate	B			1.2g (MD) 7.0g (MDD)
Benoxaprofen	B
Benperidol	A
Benserazide Hydrochloride	B
Bentiromide	A
Benzathine Penicillin	A
Benzbromarone	B
Benzhexol Hydrochloride	B
Benzilonium Bromide	B
Benzocaine	A		Any use except local ophthalmic use
Benzoctamine Hydrochloride	B
Benzquimamide	B
Benzquinamide Hydrochloride	B
Benzthiazide	B
Benztropine Mesylate	B
Benzydamine Hydrochloride	B	(1) 3% (MS) (2)0.15% (MS) 30ml (MPS)	(1)External (2) Throat spray
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
Bethanechol Chloride	B
Bethanidine Sulphate	B
Bezafibrate	B
Bicalutamide	A
Bifonazole	B
Biperiden Hydrochloride	B
Biperiden Lactate	B
Bismuth Glycollylarsanilate	A
Bisoprolol Fumarate	B
Bleomycin	A
Bleomycin Sulphate	A
Bolandiol	A
Bolasterone	A
Bolazine	A
Boldenone	A
Boldenone Undecanoate	A
Bolmantalate	A
Bornaprine Hydrochloride	B
Botulinum Toxins	A
Bretylium Tosylate	B
Bromazepam	A
Bromhexine Hydrochloride	B		Internal
Bromocriptine Mesylate	B
Bromvaletone	B
Broom (Cytisus Scoparium Species)	A
Brotizolam	A
Budesonide	A
Bufexamac	B	5.0% (MS)	External
Buflomedil Hydrochloride	B
Bufuralol Hydrochloride	B
Bumetanide	B
Bunolol Hydrochloride	B
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
Buserelin Acetate	A
Buspirone Hydrochloride	A
Busulphan	A
Butacaine Sulphate	A		Any use except local ophthalmic use
Butobarbitone	A
Butobarbitone Sodium	A
Butorphanol Tartrate	A
Butriptyline Hydrochloride	A
Butyl Nitrite	A
Cabergoline	A
Calcifediol	B
Calcipotriol	A
Calcitonin	B
Calcitriol	B
Calcium Benzamidosalicylate	B
Calcium Bromide	B
Calcium Bromidolactobionate	B
Calcium Carbimide	B
Caldiamide Sodium	C
Calusterone	A
Camazepam	A
Candicidin	A
Canrenoate Potassium	A
Canrenoic Acid	A
Cantharidin	B	0.01% (MS)	External
Canthaxanthin	A
Capreomycin Sulphate	A
Capsaicin	B
Captopril	B
Carbachol	B
Carbamazepine	B
Carbasalate Calcium	B		(1) Internal; Any use (except for children under 12 years of age)	Equivalent of 650mg of Aspirin (MD) Equivalent of 4.0g of Aspirin (MDD)
Carbenicillin Sodium	A
Carbenoxolone Sodium	B	(2) 2.0 per cent (MS)	(1) Pellet (2) Gel	(1) 5mg(MD) 25mg (MDD)
Carbidopa	B
Carbimazole	B
Carbocisteine	B		Internal
Carbon Tetrachloride	B
Carboplatin	A
Carboprost Tromethamol	A
Carbromal	B
Carbuterol Hydrochloride	B
Carfecillin Sodium	A
Carindacillin Sodium	A
Carisoprodol	B
Carmustine	A
Carperidine	A
Carteolol	B
Carteolol Hydrochloride	B
Carvedilol	B
Cefaclor	A
Cefadroxil	A
Cefapirin Sodium	A
Cefazedone Sodium	A
Cefepime Dihydrochloride	A
Cefepime	A
Cefixime	A
Cefodizime	A
Cefonicid Sodium	A
Cefoperazone Sodium	A
Cefotaxime Sodium	A
Cefotiam Hydrochloride	A
Cefoxitin Sodium	A
Cefpodoxime	A
Cefpodoxime Proxetil	A
Cefsulodin Sodium	A
Ceftazidime	A
Ceftibuten	A
Ceftibuten Dihydrate	A
Ceftizoxime Sodium	A
Ceftriaxone Sodium	A
Cefuroxime Axetil	A
Cefuroxime Pivoxetil	A
Cefuroxime Sodium	A
Celiprolol Hydrochloride	B
Cephalexin	A
Cephalexin Sodium	A
Cephaloridine	A
Cephalothin Sodium	A
Cephamandole Nafate	A
Cephazolin Sodium	A
Cephradine	A
Cerium Oxalate	B
Ceruletide	A
Ceruletide Diethylamine	A
Cetirizine	B	10mg (MS) 10 (MPS)		10mg (MDD)
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% (MS)	(1) Internal (2) External
4--Chloromethandienone	A
Chloroquine Phosphate	B		Prophylaxis of malaria
Chloroquine Sulphate	B		Prophylaxis of malaria
Chlorothiazide	B
Chlorotrianisene	A
Chlorphenoxamine Hydrochloride '	B		External
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) 0.075 mg (equivalent to 3000iu Vitamin D) (MDD)
Cholestyramine	B
Choline Magnesium Trisalicylate	B
Ciclacillin	A
Ciclobendazole	B
Ciclopirox	B		External (except vaginal use)
Cilastatin Sodium	A
Cilastatin	A
Cilazapril Cimetidine	B B
Cimetidine Hydrochloride	B
Cinchocaine	B	3.0% (MS)	Any use except local ophthalmic use
Cinchocaine Hydrochloride	B	Equivalent of 3.0% of Cinchocaine (MS)	Any use except local ophthalmic use
Cinchophen	B
Cinnarizine	B	15 (MPS)		30mg (MD) 60mg (MDD)
Cinoxacin	A
Ciprofibrate	B
Ciprofloxacin	A
Ciprofloxacin Hydrochloride	A
Ciprofloxacin Lactate	A
Cisapride	B
Cisplatin	A
Citalopram	A
Citalopram Hydrobromide	A
Clarithromycin	A
Clavulanate Potassium	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 (MS)	(1) Treatment of mouth ulcers (2) External (other than treatment of mouth ulcers)	(1) 280mg (MDD)
Clobazam	A
Clobetasol Propionate	A
Clobetasone Butyrate	A
Clodronate Sodium	B
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
Clorazepate Potassium	A
Clorexolone	B
Clostebol	A
Clostebol Acetate	A

		CIRCUMSTANCES EXCLUDING MEDICINAL PRODUCTS FROM PRESCRIPTION CONTROL
COLUMN 1	COLUMN 2	COLUMN 3	COLUMN 4	COLUMN 5
SUBSTANCE	PART IN SCHEDULE	MAXIMUM STRENGTH, PACK SIZE, OR PERIOD OF TREATMENT	USE, PHARMACEUTICAL FORM OR MANNER OF ADMINISTRATION	MAXIMUM DOSE AND MAXIMUM DAILY DOSE
Clotiazepam	A
Clotrimazole	B		External: but, in the case of vaginal use, only external use for the treatment of vaginal candidiasis
Clovoxamine	A
Cloxacillin Benzathine	A
Cloxacillin Sodium	A
Cloxazolam	A
Clozapine	A
Co-dergocrine Mesylate	B
Co-tetroxazine	A
Co-trimoxazole	A
Cocaine	A
Cocaine Hydrochloride	A
Cocculus Indicus	A
Codeine Phosphate	A	Equivalent of 1.5% of Codeine (MS)		Equivalent of 20mg of Codeine (MD)
Colaspase	A
Colchicine	A
Colestipol Hydrochloride	B
Colfosceril Palmitate	A
Colistin Sulphate	A
Colistin Sulphomethate	A
Colistin Sulphomethate Sodium	A
Comfrey (Symphytum Species)	A		External
Coniine	B
Conium Leaf	B	7.0% (MS)	External
Corticotrophin	A
Cortisone	A
Cortisone Acetate	A
Cromoglycate Sodium	B		(1) Administration through the nose (2) Eye Drops
Cropropamide	B
Crotethamide	B
Croton Oil	A
Croton Seed	A
Curare	A
α-Cyanobenzyl-β-D-glucopyr anosiduronic Acid	B	0.1% (MS)
α-Cyanobenzyl-β-D-glucopyranosiduronic Acid	B	0.1% (MS)
Cyanocobalamin	B	25mcg(MS)		25mcg (MDD)
Cyclandelate	B
Cyclobarbitone	A
Cyclobarbitone Calcium	A
Cyclofenil	A
Cyclopenthiazide	B
Cyclopentolate Hydrochloride	B
Cyclophosphamide	A
Cycloserine	A
Cyclosporin	B
Cyclothiazide	B
Cyproterone Acetate	A
Cytarabine	A
Cytarabine Hydrochloride	A
Dacarbazine	A
Dalteparin Sodium	A
Danaparoid Sodium	A
Danazol	B
Danthron	B
Dantrolene Sodium	B
Dapsone	A
Dapsone Ethane Ortho Sulphonate	A
Daunorubicin Hydrochloride	A
Deanol Bitartrate	B			26mg (MDD)
Debrisoquine Sulphate	B
Deflazacort	A
Dehydroepiandrosterone	A
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(MS) (2) 1.0 per cent (MS)	(1) Internal: Throat lozenges or throat pastilles (2) External: Paint
Deserpidine	B
Desferrioxamine Mesylate	B
Desfluorotriamcinolone	A
Desflurane	A
Desipramine Hydrochloride	A
Deslanoside	B
Desmopressin	B
Desogestrel	A
Desonide	A
Desoxymethasone	A
Dexamethasone	A
Dexamethasone Acetate	A
Dexamethasone Isonicotinate	A
Dexamethasone Phenylpropionate	A
Dexamethasone Pivalate	A
Dexamethasone Sodium m-Sulphobenzoate	A
Dexamethasone Sodium Phosphate	A
Dexamethasone Troxundate	A
Dexamphetamine Sulphate	A
Dexfenfluramine Hydrochloride	A
Dexrazoxane	A
Dexrazoxane Hydrochloride	A
Dextromethorphan Hydrobromide	B	Internal	(a) In the case of controlled release preparations: Equivalent of 30mg of Dextromethorphan (MD) Equivalent of 75mg of Dextromethorphan (MDD) (b) In any other case: 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
Diatrizoate Meglumine	C
Diatrizoate Sodium	C
Diatrizoic Acid	C
Diazepam	A
Diazoxide	A
Dibenzepin Hydrochloride	A
Dichloralphenazone	B
Dichlorphenamide	B
Diclofenac Potassium	B
Diclofenac Diethylammonium	B	Equivalent of 1.0% of diclofenac (MS) 30g (MPS)	External: Rheumatic and muscular pain
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
Digitalis Leaf	B
Digitalis Prepared	B
Digitoxin	B
Digoxin	B
Dihydralazine Sulphate	B
Dihydrocodeine Tartrate	A	Equivalent of 1.5% of Dihydrocodeine (MS)		Equivalent of 10mg of Dihydrocodeine (MD)
Dihydroergotamine Mesylate	B
Dihydrostreptomycin	A
Dihydrostreptomycin Sulphate	A
Dihydrotachysterol	B			0.075mg (MDD)
Diiodohydroxyquinoline	B
Diloxanide Furoate	B
Diltiazem Hydrochloride	B
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	C
Dinoprost Trometamol	C
Dinoprostone	C
Diodone	C
Diphenoxylate Hydrochloride	B
Dipipanone Hydrochloride	A
Dipivefrine	A
Dipivefrine Hydrochloride	A
Diprophylline	B
Dipyridamole	B
Disopyramide	B
Disopyramide Phosphate	B
Distigmine Bromide	B
Disulfiram	B
Dithranol	B	0.1% (MS)
Dithranol Triacetate	B	0.1% (MS)
Dobutamine Hydrochloride	B
Docetaxel	A
Domperidone	B		Oral solid unit dosage forms
Domperidone Maleate	B		Oral solid unit dosage forms
Dopamine Hydrochloride	A
Dopexamine Hydrochloride	B
Dornase Alfa	B
Dorzolamide Hydrochloride	B
Dorzolamide	B
Dothiepin	A
Dothiepin Hydrochloride	A
Doxapram Hydrochloride	A
Doxazosin Mesylate	B
Doxazosin	B
Doxepin Hydrochloride	A
Doxorubicin	A
Doxycycline	A
Doxycycline 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 Nitrate	B		External: but, in the case of vaginal use, only external use for the treatment of vaginal candidiasis
Econazole	B		External: but, in the case of vaginal use, only external use for the treatment of vaginal candidiasis
Ecothiopate Iodide	A
Edrophonium Chloride	A
Eflornithine Hydrochloride	A
Eflornithine	A
Embutramide	A
Emepronium Bromide	B
Emetine	B	1.0% (MS)
Emetine Bismuth Iodide	B
Emetine Hydrochloride	B	Equivalent of 1.0% of Emetine (MS)
Enalapril	B
Enalapril Maleate	B
Encainide	B
Endralazine	B
Enestebol	A
Enflurane	A
Enoxaparin Sodium	A
Enoxacin	A
Enoximone	A
Enprostil	A
Ephedra Herb (Including Ma-Huang)	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
Epirubicin Hydrochloride	A
Epirubicin	A
Epitiostanol	A
Epithiazide	B
Epoetin Alfa	A
Epoetin Beta	A
Epoprostenol Sodium	A
Eptacog Alfa	A
Ergocalciferol	B			0.075 mg (equivalent to 3000iu 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
Erythromycin Phosphate	A
Erythromycin Stearate	A
Erythromycin Thiocyanate	A
Esmolol Hydrochloride	B
Estazolam	A
Estradiol Valerate	A
Estramustine Phosphate	A
Etafedrine Hydrochloride	B
Ethacrynate Sodium	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
Ethyl Moniodostearate	C
Ethylmorphine Hydrochloride	A	Equivalent of 0.2% of Ethylmorphine (MS)		Equivalent of 7.5mg 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	A
Famciclovir	A
Famotidine	B	14 days (MPT)	Internal: short term, symptomatic relief of heartburn, dyspepsia and hyperacidity (except in children under 16 years of age)	10mg (MD) 20mg (MDD)
Fazadinium Bromide	A
Felbinac	B	3.17% (MS) 30 (MPS)	External: Rheumatic and muscular pain
Felodipine	A
Felypressin	A
Fenbufen	B
Fencamfamin Hydrochloride	A
Fenclofenac	B
Fenfluramine Hydrochloride	A
Fenofibrate	B
Fenoprofen	B
Fenoprofen Calcium	B
Fenoterol Hydrobromide	B
Fentanyl Citrate	A
Feprazone	B
Ferrous Arsenate	B
Filgrastim	A
Finasteride	A
Flavoxate Hydrochloride	B
Flecainide Acetate	B
Floctafenine	B
Flosequinan	A
Fluanisone	A
Flubendazole	B
Fluclorolone Acetonide	A
Flucloxacillin Sodium	A
Fluconazole	B
Flucytosine	A
Fludarabine Phosphate	A
Fludiazepam	A
Fludrocortisone Acetate	A
Flufenamic Acid	B
Flumazenil	A
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
Fluorescein Dilaurate	A
Fluorescein Sodium	A
Fluorometholone	A
Fluorometholone Acetate	A
Fluorouracil	A
Fluorouracil Trometamol	A
Fluoxetine	A
Fluoxetine Hydrochloride	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
Flutamide	A
Fluticasone Propionate	A
Fluvoxamine Maleate	A
Folic Acid	B			500mcg (MDD)
Folinate Calcium	B
Follitropin Alpha	A
Follitropin Beta	A
Formebolone	A
Formestane	A
Formocortal	A
Formoterol	B
Formoterol Fumarate	B
Foscarnet Sodium	A
Fosfestrol Sodium	A
Fosfomycin Trometamol	A
Fosfomycin	A
Fosinopril	B
Fosinopril Sodium	B
Framycetin Sulphate	A
Frusemide	B
Furazabol	A
Furazolidone	B
Fusafungine	A
Fusidic Acid	A
Gabapentin	B
Gadopentetate Meglumine	C
Gadopentetic Acid	C
Gadoteridol	C
Gallamine Triethiodide	A
Ganciclovir	A
Ganciclovir Sodium	A
Gelsemine	B	0.1% (MS)
Gelsemium	B			25mg (MD) 75mg (MDD)
Gemeprost	C
Gemfibrozil	B
Gentamicin	A
Gentamicin Sulphate	A
Gestodene	A
Gestrinone	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
Gonadotrophin	A
Gonadotrophin Chorionic	A
Gonadotrophin Serum	A
Goserelin Acetate	A
Gramicidin	A	0.2 % (MS)	External
Granisetron	A
Granisetron Hydrochloride	A
Griseofulvin	A
Growth Hormone	A
Guanacline Sulphate	B
Guanethidine Monosulphate	B
Guanfacine Hydrochloride	B
Guanoclor Sulphate	B
Guanoxan Sulphate	B
Halazepam	A
Halcinonide	A
Halofantrine Hydrochloride	B
Halofantrine	B
Haloperidol	A
Halothane	A
Haloperidol Decanoate	A
Haloxazolam	A
Harmine	A
Heparin	A		External
Heparin Calcium	A		External
Heparin Sodium	A		External
Heptabarbitone	A
Hexachlorophane	B	(a) 2.0% (MS) (b) 0.1% (MS) (c) 0.75% (MS)	External: (a) soaps (b) aerosols (c) preparations other than soaps and aerosols
Hexamethonium Bromide	A
Hexamethonium Iodide	A
Hexamethonium Tartrate	A
Hexamine Phenylcinchoninate	B
Hexamine Hippurate	B
Hexobarbitone	A
Hexobarbitone Sodium	A
Hexoestrol	A
Hexoestrol Dipropionate	A
L-Histidine Hydrochloride	B
Homatropine	B		(1) Internal (2) External (Except local ophthalmic use)	(1) 0.15 mg (MD) 0.45mg (MDD)
Homatropine Hydrobromide	B			0.2mg (MD) 0.6mg (MDD)
Homatropine Methylbromide	B			2mg (MD) 6mg (MDD)
Hyaluronate Sodium	B
Hyaluronidase	A
Hydralazine Hydrochloride	B
Hydrargaphen	B		Local application to skin
Hydrobromic Acid	B
Hydrochlorothiazide	B
Hydrocodone Resinate	A
Hydrocodone Tartrate	A
Hydrocortisone	A	1.0% (MS) 15.0g (MPS)	External: Contact dermatitis, irritant dermatitis, insect bite reactions and mild to moderate eczema
Hydrocortisone Acetate	A	1.0% (MS) 15.0g (MPS)	External: Contact dermatitis, irritant dermatitis, insect bite reactions and mild to moderate eczema
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 (MS)		25mcg (MDD)
Hydroxyapatite	B
Hydroxychloroquine Sulphate	B		Prophlaxis of malaria
Hydroxyprogesterone	A
Hydroxyprogesterone Enanthate	A
Hydroxyprogesterone Hexanoate	A
Hydroxyurea	A
Hydroxyzine Embonate	B
Hydroxyzine Hydrochloride	B
Hyoscine	B	(1) 0.15% (MS)	(1) Internal (2) External (except local ophthalmic use)
Hyoscine Butylbromide	B		(1) Internal: (a) By inhaler (b) Otherwise than by inhaler (2) External	(b) 3mg (MD) 9mg (MDD)
Hyoscine Hydrobromide	B		(1) Internal: (a) By inhaler (b) Otherwise than by inhaler (2) External (except local ophthalmic use)	(b) 300mcg (MD) 900mcg (MDD)
Hyoscine Methobromide	B		(1) Internal: (a) By inhaler (b) Otherwise than by inhaler (2) External	(b) 2.5mg (MD) 7.5mg (MDD)
Hyoscine Methonitrate	B		(1) Internal: (a) By inhaler (b) Otherwise than by inhaler (2) External	(b) 2.5mg (MD) 7.5mg (MDD)
Hyoscyamine	B		(1) Internal: (a) By inhaler (b) Otherwise than by inhaler (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	(b) 300mcg (MD) 1mg (MDD)
Hyoscyamine Hydrobromide	B		(1) Internal: (a) By inhaler (b) Otherwise than by inhaler (2) External	(b) Equivalent of 300mcg of Hyoscyamine (MD) Equivalent to lmg Hyoscyamine (MDD)
Hyoscyamine Sulphate	B		(1) Internal: (a) By inhaler (b) Otherwise than by inhaler (2) External	(b) Equivalent of 300mcg of Hyoscyamine(MD) Equivalent to 1mg Hyoscyamine(MDD)
Ibuprofen	B	(2) 5.0% (MS) 30g (MPS)	(1) Internal: Rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, feverishness, dysmenorrhoea, symptoms of cold and influenza. (2) External: Rheumatic and muscular pain	(1) 400mg (MD) 1200mg(MDD)
Idarubicin Hydrochloride	A
Idoxuridine	A	0.1% (MS)	External (except local ophthalmic use): Cold sores
Ifosfamide	A
Ignatius Bean	B
Imipenem Hydrochloride	A
Imipenem	A
Imipramine	A
Imipramine Hydrochloride	A
Imipramine Resinate	A
Immunoglobulins	A
Impromidine Hydrochloride	A
Indapamide Hemihydrate	B
Indium (111 In) Satumomab Pendetide	C
Indomethacin	B
Indoprofen	B
Indoramin Hydrochloride	B
Inosine Pranobex	A
Insulin Lispro	B
Insulins	B
Interferon Alfa	A
Interferon Beta	A
Interferon Gamma	A
Iobenamic Acid	C
Iocarmate Meglumine	C
Iocarmic Acid	C
Iocetamic Acid	C
Iodamide	C
Iodamide Meglumine	C
Iodamide Sodium	C
Iodipamide	C
Iodipamide Meglumine	C
Iodised Oil	C
Iodixanol	C
Iodohippurate Sodium	C
Iodoxamate Meglumine	C
Iodoxamic Acid	C
Ioglicate Meglumine	C
Ioglicate sodium	C
Ioglicic Acid	C
Ioglycamate Meglumine	C
Ioglycamate Sodium	C
Ioglycamic Acid	C
Iohexol	C
Iomeprol	C
Iopamidol	C
Iopanoic Acid,	C
Iopentol	C
Iophendylate	C
Iopromide	C
Iopronic acid	C
Ioseric Acid	C
Iosimide	C
Iotasul	C
Iothalamate Meglumine	C
Iothalamate Sodium	C
Iothalamic Acid	C
Iotrolan	C
Iotroxate Meglumine	C
Iotroxic Acid	C
Ioversol	C
Ioxaglate Meglumine	C
Ioxaglate Sodium	C
Ioxaglic Acid	C
Ioxitalamate Meglumine	C
Ioxitalamate Sodium	C
Ioxitalamic Acid	C
Ipodate Calcium	C
Ipodate Sodium	C
Ipratropium Bromide	B
Iprindole Hydrochloride	A
Iproniazid Phosphate	A
Isoaminile	B
Isoaminile Citrate	B
Isoamyl Nitrite	A
Isobutyl Nitrite	A
Isocarboxazid,	A
Isoconazole Nitrate	B		External: but, in the case of vaginal use, only external use for the treatment of vaginal candidiasis
Isoetharine Hydrochloride	B
Isoetharine Mesylate	B
Isoetharine	B
Isoflurane	A
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)
Isopropyl Nitrite	A
Isosorbide Dinitrate	B
Isosorbide Mononitrate	B
Isotretinoin	A
Isoxicam	B
Isoxsuprine Hydrochloride	B
Isradipine	B
Itraconazole	B
Jaborandi	B		External
Kanamycin Sulphate	A
Ketamine Hydrochloride	A
Ketazolam	A
Ketoconazole	B		External: but in the case of vaginal use, only external use for the treatment of vaginal candidiasis
Ketoprofen	B	2.5% (MS) 30.0g (MPS)	External: Rheumatic and muscular pain
Ketorolac	B
Ketorolac Trometamol	B
Ketotifen Fumarate	B
Labetolol Hydrochloride	B
Lacidipine	B
Lamotrigine	B
Lanatoside C	B
Lanatoside Complex A, B and C	B
Lansoprazole	B
Latamoxef Disodium	A
Lenograstim	A
Leuprorelin Acetate	A
Levallorphan Tartrate	B
Levamisole Hydrochloride	B		Anthelmintic
Levamisole	A
Levobunolol Hydrochloride	B
Levodopa	B
Levorphanol Tartrate	A
Lidoflazine	A
Lignocaine Hydrochloride	A		Any use except local ophthalmic use
Lignocaine	A		Any use except local ophthalmic use
Lincomycin Hydrochloride	A
Lincomycin	A
Liothyronine Sodium	B
Lisinopril	B
Lisuride Maleate	B
Lithium Succinate	B
Lithium Sulphate	A			Equivalent of 5mg of Lithium (MD) Equivalent of 15mg of Lithium (MDD)
Lithium Carbonate	A			Equivalent of 5mg of Lithium (MD) Equivalent of 15mg of Lithium (MDD)
Lithium Citrate	A
Lobeline Hydrochloride	B		(1) Internal (2) External	(1) Equivalent of 3mg of Lobeline (MD) Equivalent of 9mg of Lobeline (MDD)
Lobeline	B		(1) Internal (2) External	(1) 3mg (MD) 9mg (MDD)
Lobeline Sulphate	B		(1) Internal (2) External	(1) Equivalent of 3mg of Lobeline (MD) Equivalent of 9mg of Lobeline (MDD)
Lodoxamide Tromethamine	B
Lodoxamide	B
Lodoxamide Tromethamol	B
Lodoxamide Ethyl	B
Lofepramine	A
Lofexidine Hydrochloride	B
Lomefloxacin Hydrochloride	A
Lomustine	A
Loperamide Hydrochloride	B		Treatment of acute diarrhoea
Loprazolam Mesylate	A
Loratadine	B	10mg (MS) 10 (MPS)		l0mg (MDD)
Lorazepam	A
Lormetazepam	A
Losartan	B
Losartan Potassium	B
Loxapine	B
Loxapine Succinate	B
Luteinising Hormone	A
Lymecycline	A
Lynoestrenol	A
Lypressin	A
Lysuride Maleate	B
Mafenide Hydrochloride	A
Mafenide Propionate	A	5.0% (MS)	Eye drops
Mafenide	A
Mafenide Acetate	A
Magnesium Metrizoate	B
Magnesium Fluoride	B
Mandragora Autumnalis	B
Mannomustine Hydrochloride	A
Maprotiline Hydrochloride	B
Mazindol	A
Mebanazine	A
Mebendazole	B		Internal
Mebeverine Hydrochloride	B		Internal
Mebhydrolin Napadisylate	B
Mebhydrolin	B
Mebolazine	A
Mecamylamine Hydrochloride	B
Mecillinam	A
Meclofenoxate Hydrochloride	B
Medazepam	A
Medicinal Opium	A	(1) Equivalent of 0.02% of anhydrous morphine (MS) (2) Equivalent of 0.04% of anhydrous morphine (MS)	(1) Liquids (2) Solids	(1) Equivalent of 3mg of anhydrous morphine (MD) (2) Equivalent of 3mg of anhydrous morphine (MD)
Medigoxin	B
Medrogestone	A
Medroxyprogesterone Acetate	A
Medrysone	A
Mefenamic Acid	B
Mefloquin Hydrochloride	B		Prophylaxis of malaria
Mefruside	B
Megestrol	A
Megestrol Acetate	A
Meglumine Antimonate	A
Melatonin	A
Melperone	A
Melperone Hydrochloride	A
Melphalan Hydrochloride	A
Melphalan	A
Menotrophin	A
Mepenzolate Bromide	B			25mg (MD) 75mg (MD)
Mephenesin Carbamate	B
Mephenesin	B
Mepindolol	B
Mepitiostane	A
Mepivacaine Hydrochloride	A		Any use except local ophthalmic use
Meprobamate	A
Meptazinol Hydrochloride	A
Mequitazine	B
Mercaptopurine	A
Mercuric Iodide	B
Mercuric Chloride	B
Meropenem	A
Mersalyl	B
Mersalyl Acid	B
Mesabolone	A
Mesalazine	B
Mesna	A
Mestanolone	A
Mesterolone	A
Mestranol	A
Metaraminol Tartrate	B
Meteneprost	C
Metergoline	A
Metformin Hydrochloride	B
Methacycline Calcium	A
Methacycline Hydrochloride	A
Methacycline	A
Methadone Hydrochloride	A
Methallenoestril	A
Methandienone	A
Methandriol	A
Methapyrilene Fumarate	A
Methapyrilene Hydrochloride	A
Methaqualone	A
Methenolone	A
Methenolone Acetate	A
Methenolone Enanthate	A
Methicillin Sodium	A
Methiodal Sodium	C
Methixene	B
Methixene Hydrochloride	B
Methocarbamol	B
Methocidin	A		Throat lozenges and throat pastilles
Methohexitone Sodium	A
Methoin	B
Methoserpidine	B
Methotrexate Sodium	A
Methotrexate	A
Methotrimeprazine	B
Methotrimeprazine Hydrochloride	B
Methotrimeprazine Maleate	B
Methoxamine Hydrochloride	B	0.25% (MS)	Nasal sprays or nasal drops not containing liquid paraffin as a vehicle
Methoxsalen	A
Methsuximide	B
Methyclothiazide	B
Methylamphetamine Hydrochloride	A
Methylcysteine Hydrochloride	B		Internal
Methyldopa	B
Methyldopate Hydrochloride	B
Methylephedrine Hydrochloride	B
Methylphenidate Hydrochloride	A
Methylphenobarbitone	A
Methylprednisolone Sodium Succinate	A
Methylprednisolone	A
Methylprednisolone Acetate	A
Methyltestosterone	A
Methylthiouracil	B
Methyprylone	A
Methysergide Maleate	B
Metipranolol	B
Metirosine	A
Metoclopramide Hydrochloride	B
Metolazone	B
Metoprolol Fumarate	B
Metoprolol Succinate	B
Metoprolol Tartrate	B
Metribolone	A
Metrizamide	C
Metrizoate Sodium	C
Metrizoate Meglumine	C
Metrizoate Calcium	C
Metrizoic Acid	C
Metronidazole	B
Metyrapone	B
Mexiletine Hydrochloride	B
Mezlocillin Sodium	A
Mianserin Hydrochloride	B
Miboletone	A
Miconazole	B		External: but, in the case of vaginal use, only external use for the treatment of vaginal candidiasis
Miconazole Nitrate	B		External: but, in the case of vaginal use, only external use for the treatment of vaginal candidiasis
Midazolam	A
Midodrine Hydrochloride	B
Mifepristone	C
Milrinone	B
Milrinone Lactate	B
Minocycline	A
Minocycline Hydrochloride	A
Minoxidil	B
Misoprostol	A
Mistletoe (Viscum album L)	A
Mithramycin	A
Mitobronitol	A
Mitomycin C	A
Mitozantrone Hydrochloride	A
Mitrizoate Meglumine	C
Mivacurium Chloride	A
Moclobemide	A
Molgramostim	A
Molindone Hydrochloride	B
Molsidomine	B
Mometasone	A
Mometasone Furoate	A
Mopidamol	A
Moracizine	B
Moracizine Hydrochloride	B
Morazone Hydrochloride	B
Morphine Hydrochloride	A	(1) Equivalent of 0,02% of anhydrous morphine (MS) (2) Equivalent of 0.04% of anhydrous morphine; equivalent of 300mcg of anhydrous morphine (MS)	(1) Liquids (2) Solids	(1) Equivalent of 3mg of anhydrous morphine (MD) (2) Equivalent of 3mg of anhydrous morphine (MD)
Morphine Sulphate	A	(1) Equivalent of 0.02 % of anhydrous morphine (MS) (2) Equivalent of 0.04% of anhydrous morphine; equivalent of 300 mcg of anhydrous morphine (MS)	(1) Liquids (2) Solids	(1) Equivalent of 3mg of anhydrous morphine (MD) (2) Equivalent of 3mg of anhydrous morphine (MD)
Mupirocin	A
Mustine Hydrochloride	A
Mycophenolate Mofetil	B
Nabilone	A
Nabumetone	B
Nadolol	B
Nafarelin Acetate	A
Naftidrofuryl Oxalate	B
Naftifine Hydrochloride	B
Naftifine	B
Nalbuphine Hydrochloride	A
Nalidixic Acid	A
Nalorphine Hydrobromide	A
Nalorphine Hydrochloride	A
Naloxone Hydrochloride	A
Naltrexone Hydrochloride	A
Nandrolone	A
Nandrolone Decanoate	A
Nandrolone Laureate	A
Nandrolone Phenylpropionate	A
Nandrolone Laureate	A
Naphazoline Hydrochloride	B	(1) 0.05% (MS) (2) 0.015% (MS)	(1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle (2) Eye drops
Naphazoline Nitrate	B	(1) 0.05% (MS) (2) 0.015% (MS)	(1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle. (2) Eye drops
Naproxen	B	5.0% (MS) 30.0g (MPS)	External: Rheumatic and muscular pain
Naproxen Sodium	B
Natamycin	A
Nedocromil Sodium	B
Nefazodone Hydrochloride	A
Nefazodone	A
Nefopam Hydrochloride	B
Neomycin Oleate	A
Neomycin Palmitate	A
Neomycin Sulphate	A
Neomycin	A
Neomycin Undecanoate	A
Neostigmine Bromide	B
Neostigmine Methylsulphate	B
Netilmicin Sulphate	A
Nialamide	A
Nicardipine Hydrochloride	B
Niclosamide	B
Nicorandil	B
Nicotine	B		Internal: (a)oral dosage forms (b)transdermal patches	(a) 4mg (MD) 60mg (MDD) (b) 22mg expressed as the dose delivered over a 24 hour period(MDD)
Nicotine Resinate	B		Internal: Oral dosage forms	Equivalent of 4 mg of Nicotine (MD) Equivalent of 60 mg of Nicotine (MDD)
Nicotinic Acid	B		Any use, except for the treatment of hyperlipidaemia	600mg (MDD)
Nicotinyl Alcohol Tartrate	B
Nicotinyl Alcohol	B
Nicoumalone	B
Nifedipine	B
Nifenazone	B
Nikethamide	B
Nimesulide	B
Nimetazepam	A
Nimodipine	B
Nimorazole	B
Niridazole	B
Nitrazepam	A
Nitrendipine	B
Nitrofurantoin	B
Nitrofurazone	B
Nizatidine	B
Nomifensine Maleate	A
Noradrenaline	B
Noradrenaline Acid Tartrate	B
Norboletone	A
Norclostebol	A
Nordiazepam	A
Norethandrolone	A
Norethisterone	A
Norethisterone Acetate	A
Norethisterone Heptanoate	A
Norethynodrel	A
Norfloxacin	A
Norgestimate	A
Norgestrel	A
Nortriptyline Hydrochloride	A
Noscapine	B
Noscapine Hydrochloride	B
Novobiocin Calcium	A
Novobiocin Sodium	A
Nux Vomica Seed	B
Nystatin	B		External (except vaginal use)
Octacosactrin	A
Octreoide	A
Octreotide Acetate	A
Oestradiol Cypionate	A
Oestradiol Undecanoate	A
Oestradiol	A
Oestradiol Dipropionate	A
Oestradiol Diundecanoate	A
Oestradiol Phenylpropionate	A
Oestradiol Valerate	A
Oestradiol Enanthate	A
Oestradiol Benzoate	A
Oestriol	A
Oestriol Dihemisuccinate	A
Oestrogenic Substances Conjugated	A
Oestrone	A
Ofloxacin	A
Olsalazine Sodium	B
Omeprazole	B
Ondansetron Hydrochloride	A
Opipramol Hydrochloride	A
Orciprenaline Sulphate	B
Orphenadrine Citrate	B
Orphenadrine Hydrochloride	B
Ouabain	B
Ovandrotone	A
Ovarian Gland Dried	A
Oxabolone	A
Oxamniquine	B
Oxandrolone	A
Oxantel Pamoate	B
Oxaprozin	B
Oxatomide	B
Oxazepam	A
Oxazolam	A
Oxedrine Tartrate	B
Oxethazaine	B		Internal: but only as a constituent in an antacid mixture
Oxiconazole Nitrate	B
Oxidronate Sodium	A
Oxitropium Bromide	B
Oxolinic Acid	B
Oxpentifylline	B
Oxprenolol Hydrochloride	B
Oxybuprocaine Hydrochloride	B		Any use except local ophthalmic use
Oxybutynin Hydrochloride	B
Oxycodone Hydrochloride	A
Oxycodone Pectinate	A
Oxymesterone	A
Oxymetholone	A
Oxypertine	B
Oxypertine Hydrochloride	B
Oxyphenbutazone	B
Oxyphencyclimine Hydrochloride	B
Oxyphenonium Bromide	B			5mg (MD) 15mg (MDD)
Oxytetracycline	A
Oxytetracycline Dihydrate	A
Oxytetracycline Hydrochloride	A
Oxytetracycline Calcium	A
Oxytocin, synthetic	B
Oxytocin, natural	B
Paclitaxel	A
Pamidronate Disodium	A
Pancuronium Bromide	A
Pantoprazole	B
Pantoprazole Sodium Sesquihydrate	B
Papaveretum	A
Papaverine	B		(1) By inhaler (2) Otherwise than by inhaler	(2) 50mg (MD) 150mg (MDD)
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			lg(MD) 4g (MDD)
Paraldehyde	B
Paramethadione	B
Paramethasone Acetate	A
Parathyroid Gland	A
Pargyline Hydrochloride	A
Paroxetine Hydrochloride	A
Pecilocin	A
Pemoline	A
Pempidine Tartrate	B
Penamecillin	A
Penbutolol Sulphate	B
Penfluridol	A
Penicillamine	B
Penicillamine Hydrochloride	B
Pentaerythritol Tetranitrate	B
Pentagastrin	A
Pentamidine	A
Pentamidine Isethionate	A
Pentazocine Hydrochloride	A
Pentazocine Lactate	A
Pentetreotide	C
Penthienate Methobromide	B			5mg (MB) 15mg (MDD)
Pentobarbitone	A
Pentobarbitone Sodium	A
Pentolinium Tartrate	B
Pentostatin	A
Pentyl Nitrite	A
Perfluamine	A
Pergolide	B
Pergolide Mesylate	B
Perhexiline Maleate	B
Pericyazine	B
Perindopril	B
Permethrin	B		External
Perphenazine	B
Pethidine Hydrochloride	A
Phenacetin	A	0.1% (MS)	External
Phenazone Salicylate	B
Phenazone and Caffeine Citrate	B
Phenazone	B		External
Phenbutrazate Hydrochloride	A
Phenelzine Sulphate	A
Phenethicillin Potassium	A
Phenformin Hydrochloride	B
Phenglutarimide Hydrochloride	B
Phenindione	B
Phenmetrazine Hydrochloride	A
Phenobarbitone Sodium	A
Phenobarbitone	A
Phenoperidine Hydrochloride	A
Phenothrin	B		External
Phenoxybenzamine Hydrochloride	B
Phenoxymethylpenicillin Potassium	A
Phenoxymethylpenicillin	A
Phenoxymethylpenicillin Calcium	A
Phenprocoumon	B
Phensuximide	B
Phentermine Resinate	A
Phentermine Hydrochloride	A
Phentolamine Hydrochloride	B
Phentolamine Mesylate	B
Phenylbutazone	A
Phenylbutazone Sodium	A
Phenylephrine Bitartrate	B		Internal	Equivalent of 10mg of Phenylephrine Hydrochloride
				(MD) Equivalent of 40 mg of Phenylephrine Hydrochloride(MDD)
Phenylephrine Hydrochloride	B	(3) 0.5% (MS)	(1) Internal (other than controlled release capsules and tablets, nasal sprays and nasal drops) (2) controlled release capsules and tablets (3) nasal sprays and nasal drops (4) External (except local ophthalmic use)	(1) 10mg (MD) 40mg (MDD) (2) 20mg (MD) 40mg (MDD)
Phenylmethylbarbituric Acid	A
Phenylpropanolamine Hydrochloride	B	(3) 2.0% (MS)	Internal: (1) all preparations except controlled release capsules, nasal sprays and nasal drops) (2) controlled release capsules (3) nasal sprays and nasal drops	(1) 25mg (MD) 100mg (MDD) (2) 50mg (MD) 100mg (MDD)
Phenylpropanolamine Resinate	B		Internal	Equivalent of 50mg of Phenylpropanolamine Hydrochloride (MD) Equivalent of 100mg of Phenylpropanolamine Hydrochlomide (MDD)
Phenytoin	B
Phenytoin Sodium	B
Pholcodine	A	1.5% (MS)		20mg (MD)
Pholcodine Tartrate	A	Equivalent to 1.5% of Pholcodine (MS)		Equivalent to 20mg of Pholcodine (MD)
Pholcodine Citrate	A	Equivalent to 1.5% of Pholcodine (MS)		Equivalent to 20mg of Pholcodine (MD)
Phthalylsulphathiazole	B
Physostigmine	B
Physostigmine Sulphate	B
Physostigmine Salicylate	B
Physostigmine Aminoxide Salicylate	B
Phytomenadione	B
Picrotoxin	B
Pilocarpine Nitrate	B
Pilocarpine Hydrochloride	B
Pilocarpine	B
Pimozide	B
Pinacidil	B
Pinazepam	A
Pindolol	B
Pipecuronium Bromide	A
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 Hydrochloride	B
Pirbuterol Acetate	B
Pirenzepine Hydrochloride	A
Piretanide	B
Piritramide	A
Piromidic Acid	A
Piroxicam	B	0.5% (MS) 30.0g (MPS)	External: Rheumatic and muscular pain
Pirprofen	B
Pituitary Gland (Whole Dried)	B
Pituitary Gland, Powdered (Posterior Lobe)	B
Pivampicillin Hydrochloride	A
Pivmecillinam Hydrochloride	A
Pivmecillinam	A
Pizotifen Maleate	B
Pizotifen	B
Podophyllotoxin	B
Podophyllum Resin	B	20.0% (MS)	External
Podophyllum Indian	B
Podophyllum	B
Poke Root (Phytolacca Species)	A
Poldine Methylsulphate	B			2mg (MD) 6mg (MDD)
Polidexide	B
Polyestradiol Phosphate	A
Polymyxin B Sulphate	A
Polythiazide	B
Poppy Capsule	A
Potassium Bromide	B
Potassium Perchlorate	B
Potassium Arsenite	B	0.0127% (MS)
Practolol	B
Pralidoxime Iodide	B
Pralidoxime Mesylate	B
Pralidoxime Chloride	B
Prasterone	A
Pravastatin	B
Pravastatin Sodium	B
Prazepam	A
Prazosin Hydrochloride	B
Prednisolone Sodium Phosphate	A
Prednisolone 21--Steaglate	A
Prednisolone Hexanoate	A
Prednisolone Sodium m-Sulphobenzoate	A
Prednisolone Butylacetate	A
Prednisolone Pivalate	A
Prednisolone m-Sulphobenzoate	A
Prednisolone	A
Prednisolone Acetate	A
Prednisone	A
Prednisone Acetate	A
Prenalterol Hydrochloride	B
Prenylamine Lactate	B
Prilocaine Hydrochloride	A		Any use except local ophthalmic use
Prilocaine	A		Any use except local ophthalmic use
Primidone	B
Probenecid	B
Probucol	B
Procainamide Hydrochloride	B
Procaine Penicillin	A
Procaine Hydrochloride	A		Any use except local ophthalmic use
Procarbazine Hydrochloride	A
Procaterol Hydrochloride	B
Prochlorperazine Maleate	B
Prochlorperazine Edisylate	B
Prochlorperazine Mesylate	B
Procyclidine Hydrochloride	B
Progesterone	A
Proguanil Hydrochloride	B		Prophylaxis of maleria
Prolactin	A
Proligestone	A
Prolintane Hydrochloride	A
Promazine Embonate	B
Promazine Hydrochloride	B
Propafenone Hydrochloride	B
Propanidid	B
Propantheline Bromide	B			15mg (MD) 45mg (MDD)
Propetandrol	A
Propizepine	A
Propofol	A
Propranolol Hydrochloride	B
Propyl Nitrite	A
Propyliodone	C
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 (2) controlled	(1) 60mg (MD) 180mg (MDD) (2)180mg
Pyrantel Embonate	B
Pyrantel Tartrate	B
Pyrazinamide	B
Pyridostigmine Bromide	B
Pyridoxine Hydrochloride	B			50mg (MD) 100mg (MDD)
Pyrimethamine	B
Pyritinol Hydrochloride	B
Pyritinol	B
Quazepam	A
Quinagolide	A
Quinagolide Hydrochloride	A
Quinalbarbitone Sodium	A
Quinalbarbitone	A
Quinapril Hydrochloride	B
Quinapril	B
Quinbolone	A
Quinestradol	A
Quinestrol	A
Quinethazone	B
Quinidine	B
Quinidine Bisulphate	B
Quinidine Phenylethylbarbiturate	A
Quinidine Polygalacturonate	B
Quinidine Sulphate	B
Quinine Glycerophosphate	B			Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD)
Quinine Bisulphate	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 Tannate	B			Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD)
Quinine	B			100mg (MD) 300mg (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 and Urea Hydrochloride	B
Quinine Phosphate	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 Ethyl Carbonate	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 Sulphate	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)
Radionuclide compounds	C
Radionuclides	C
Ragworth (Senecio jacobaea L)	A
Raltitrexed	A
Ramipril	B
Ranitidine Bismuth Citrate	B
Ranitidine Bismutrex	B
Ranitidine Hydrochloride	B
Rauwolfia Serpentina	B
Rauwolfia Vomitoria	B
Razoxane	A
Remoxipride Hdrochloride	A
Reproterol Hydrochloride	B
Rescinnamine	B
Reserpine	B
Rifampicin	A
Rifamycin	A
Rimexolone	B
Rimiterol Hydrobromide	B
Risperidone	A
Ritodrine Hydrochloride	B
Rolitetracycline Nitrate	A
Rosoxacin	A
Roxibolone	A
Sabadilla	A
Safrole	A
Salbutamol	B
Salbutamol Sulphate	B
Salcatonin	B
Salcatonin Hydrated Polyacetate	B
Salmefamol	B
Salmeterol	B
Salmeterol Xinafoate	B
Salsalate	B
Saralasin Acetate	B
Sargramostim	A
Sassafras Bark	A
Sassafras Oil	A
Sassafras Root	A
Satumomab	C
Secbutobarbitone	A
Secbutobarbitone Sodium	A
Secretin	B
Selegiline Hydrochloride	B
Sera and Antisera:-
Botulin Antitoxin	A
Diphtheria Antitoxin	A
Gas-gangrene Antitoxin (Perfringens)	A
Gas-gangrene Antitoxin (Septicum)	A
Gas-gangrene' Antitoxin (Oedematiens)	A
Leptospira Antiserum	A
Mixed Gas-gangrene Antitoxin	A
Rabies Antiserum	A
Scorpion Venom Antiserum	A
Serum Gonadotrophin	A
Snake Venom Antiserum	A
Tetanus Antitoxin	A
Sermorelin	A
Sermorelin Acetate	A
Sertraline Hydrochloride	A
Sevoflurane	A
Silandrone	A
Simvastatin	B
Sissomicin	A
Sissomicin Sulphate	A
Snake Venoms	B
Sodium Aminosalicylate	B
Sodium Antimonylgluconate	B
Sodium Arsanilate	B
Sodium Arsenate	B
Sodium Arsenite	B	0.013% (MS)
Sodium Bromide	B
Sodium Fluoride	B	(1) 0.33% (MS) (b) 0.2% (MS) (c) 0.05% (MS)	(1) Dentifrices (2) Other products for use in the prevention of dental caries in the form of:- (a) tablets or drops (b) mouth rinses other than those for daily use (c) mouth rinses for daily use	(a) 2.2mg (MDD)
Sodium Fusidate	A
Sodium Hyaluronate	A
Sodium Metrizoate	B
Sodium Monofluorophosphate	B	1.14% (MS)	Dentifrice
Sodium Stibogluconate	B
Somatorelin	A
Somatorelin Acetate	A
Somatotrophin	A
Somatrem	A
Somatropin	A
Sotalol Hydrochloride	B
Spectinomycin	A
Spectinomycin Hydrochloride	A
Spiramycin	A
Spiramycin Adipate	A
Spironolactone	A
Stannous Fluoride	B	0.62% (MS)	Dentifrice
Stanolone	A
Stanolonetanozolol	A
Stanozolol	A
Stavudine	A
Stenbolone	A
Stenbolone Acetate	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
Succinylsulphathiazole	B
Sufentanil Citrate	A
Sulbactam Sodium	A
Sulbactam Tosylate	A
Sulbenicillin	A
Sulbenicillin Sodium	A
Sulconazole Nitrate	B		External (except vaginal use)
Sulfacytine	A
Sulfadoxine	A
Sulfametopyrazine	A
Sulfamonomethoxine	A
Sulindac	B
Suloctidil	B
Sulphacetamide	A
Sulphacetamide Sodium	A
Sulphadiazine	A
Sulphadiazine Silver	A
Sulphadiazine Sodium	A
Sulphadimidine	A
Sulphadimidine Sodium	A
Sulphafurazole	A
Sulphafurazole Diethanolamine	A
Sulphaguanidine	B
Sulphaloxate Calcium	A
Sulphaloxic Acid	B
Sulphamerazine	A
Sulphamerazine Sodium	A
Sulphamethizole	A
Sulphamethoxazole	A
Sulphamethoxydiazine	A
Sulphamethoxypyridazine	A
Sulphamethoxypyridazine Sodium	A
Sulphamoxole	A
Sulphanilamide	A
Sulphanilamide, N-Benzoyl	A
Sulphaphenazole	A
Sulphaphenazole	A
Sulphapyridine	A
Sulphapyridine Sodium	A
Sulphasalazine	B
Sulphathiazole	A
Sulphathiazole Sodium	A
Sulphaurea	A
Sulphinpyrazone	B
Sulpiride	B
Sulprostone	C
Sultamicillin	A
Sultamicillin Tosylate	A
Sulthiame	B
Sumatriptan	B
Sumatriptan Hemisuccinate	B
Sumatriptan Succinate	B
Sutoprofen	B
Suxamethonium Bromide	A
Suxamethonium Chloride	A
Suxethonium Bromide	A
Tacrine Hydrochloride	A
Talampicillin	A
Talampicillin Hydrochloride	A
Talampicillin Napsylateamoxifen	A
Tamoxifen Citrate	B
Taurolidine	B
Tazobactam Sodium	A
Teicoplanin	A
Temafloxacin	A
Temafloxacin Hydrochloride	A
Temazepam	A
Temocillin	A
Temocillin Sodium	A
Teniposide	A
Tenoxicam	B
Terazosin Hydrochloride	B
Terbinafine	B
Terbinafine Hydrochloride	B
Terbutaline	B
Terbutaline Sulphate	B
Terfenadine	B	120mg (MS) of 1200mg of terfenadine (MPS)		120mg (MDD)
Terlipressin	A
Terodiline Hydrochloride	B
Tertatolol Hydrochloride	B
Testosterone	A
Testosterone 17↓ Chloral Hemiacetal	A
Testosterone Acetate	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
Tetrofosmin	C
Thalidomide	A
Thallium Acetate	A
Thallous Chloride	A
Theophylline	B
Thiambutosine	B
Thiamphenicol	A
Thiamphenicol Glycinate Hydrochloride	A
Thiamphenicol Palmitate	A
Thiethylperazine	B
Thiethylperazine Malate	B
Thiethylperazine Maleate	B
Thiocarlide	B
Thioguanine	A
Thiomesterone	A
Thiopentone Sodium	A
Thiopropazate Hydrochloride	B
Thioproperazine Mesylate	B
Thioridazine	B
Thioridazine Hydrochloride	B
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
Tinzaparin	A
Tinzaparin Sodium	A
Tioconazole	B		External, but, in the case of vaginal use, only external use for the treatment of vaginal candidiasis
Tizanidine Hydrochloride	A
Tobramycin Sulphate	A
Tocainide Hydrochloride	B
Tofenacin Hydrochloride	B
Tofisopam	A
Tolazamide	B
Tolazoline Hydrochloride	B		External
Tolbutamide	B
Tolbutamide Sodium	B
Tolfenamic Acid	B
Tolmetin Sodium	B
Tolrestat	B
Toremifene	B
Toremifine citrate	B
Tramadol	A
Tramadol Hydrochloride	A
Tramazoline Hydrochloride	B
Trandolapril	B
Tranexamic Acid	B
Tranylcypromine Sulphate	A
Trazodone Hydrochloride	B
Trenbolone	A
Trenbolone Acetate	A
Treosulfan	A
Tretinoin	B
Triamcinolone	A
Triamcinolone Acetonide	A
Triamcinolone Diacetate	A
Triamcinolone Hexacetonide	A
Triamterene	B
Triazolam	A
Tribavirin	A
Triclofos Sodium	B
Trientine Hydrochloride	A
Trifluoperazine	B
Trifluoperazine Hydrochloride	B
Trifluperidol	A
Trifluperidol Hydrochloride	A
Trilostane	A
Trimazosin Hydrochloride	B
Trimeprazine	B
Trimeprazine Tartrate	B
Trimetaphan Camsylate	B
Trimetazidine	B
Trimetazidine Hydrochloride	B
Trimethoprim	A
Trimetrexate	A
Trimetrexate Glucuronate	A
Trimipramine Maleate	A
Trimipramine Mesylate	A
Tripotassium Dicitratobismuthate	B
Triptorelin	A
Tropicamide	B
Tropisetron Hydrochloride	A
Troxidone	B
L-Tryptophan	B		External
Tubocurarine Chloride	A
Tulobuterol	B
Tulobuterol Hydrochloride	B
Tyropanoate Sodium	C
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
Bacillus Calmette-Guerin Vaccine (Percutaneous)	A
Cholera Vaccine	A
Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine	A
Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)	A
Diphtheria, Tetanus and Poliomyelitis Vaccine	A
Diphtheria, Tetanus and Pertussis Vaccine	A
Diphtheria and Tetanus Vaccine	A
Diphtheria and Tetanus Vaccine (Adsorbed)	A
Diphtheria Vaccine	A
Diphtheria Vaccine (Adsorbed)	A
Eltor Vaccine	A
Haemophilus Type B Polysaccharide Conjugate Vaccine	A
Hepatitis A Vaccine	A
Vaccines (continued):-
Hepatitis B Vaccine	A
Hepatitis B Virus Vaccine (Inactivated)	A
Influenza Vaccine	A
Measles, Mumps and Rubella Virus Vaccine (Live)	A
Measles Vaccine (Live Attenuated)	A
Meningococcal Polysaccharide Vaccine	A
Old Tuberculin	A
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
Schick Control	A
Schick Test Toxin	A
Smallpox Vaccine	A
Smallpox Vaccine (Dried)	A
Tetanus Vaccine	A
Tetanus Vaccine (Adsorbed)	A
Tuberculin Purified Protein Derivative	A
Vaccines (continued):-
Typhoid - paratyphoid A and B and Cholera Vaccine	A
Typhoid - paratyphoid A and B Vaccine	A
Typhoid - paratyphoid A and B and Tetanus Vaccine	A
Typhoid and Tetanus Vaccine	A
Typhoid Vaccine	A
Typhus Vaccine	A
Yellow Fever Vaccine	A
Valproate Sodium	B
Valproic Acid	B
Vancomycin Hydrochloride	A
Vasopressin	A
Vasopressin Tannate	A
Vecuronium Bromide	A
Venlafaxine	A
Venlafaxine Hydrochloride	A
Veralipride	B
Verapamil Hydrochloride	B
Veratrine	B
Veratrum (Green and White)	B
Vidarabine	A
Vigabatrin	B
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) 7500 iu (2250mcg Retinol equivalent) (MDD)
Vitamin A Acetate	B		(1) Internal (2) External	(1) Equivalent to 7500iu Vitamin A (2250 mcg Retinol equivalent) (MDD)
Vitamin A Palmitate	B		(1) Internal (2) External	(1) Equivalent to 7500 iu Vitamin A (2250mcg Retinol equivalent) (MDD)
Warfarin	B
Warfarin Sodium	B
Xamoterol Fumarate	B
Xipamide	B
Yohimbine Hydrochloride	B
Zafirlukast	B
Zalcitabine	A
Zeranol	A
Zidovudine	A
Zimeldine Hydrochloride	A
Zomepirac Sodium	B
Zopiclone	A
Zuclopenthixol	A
Zuclopenthixol Acetate	A
Zuclopenthixol Decanoate	A
Zuclopenthixol Hydrochloride	A

NOTE: In relation to a medicinal product 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).

SECOND SCHEDULE

Article 5(3)

OTHER MEDICINAL PRODUCTS EXCLUDED FROM PRESCRIPTION CONTROL
NAME, FORM AND STRENGTH OF PRODUCT	PRODUCT AUTHORISATION NUMBER
Regaine Topical Solution 2%	PA16/41/1.

(Article 5(6))

THIRD SCHEDULE

PART I

SUBSTANCES WHICH WHEN CONTAINED IN CERTAIN NON-PRESCRIPTION MEDICINAL PRODUCTS MAY ONLY BE SUPPLIED IN THE MANUFACTURERS ORIGINAL CONTAINER SHOWING THE LEGAL CLASSIFICATION FOR SUPPLY

Acyclovir

Diclofenac Diethylammonium

Famotidine

Hydrocortisone

Hydrocortisone Acetate

Ibuprofen

Ketoprofen

Naproxen

Nicotine

Nicotine Resinate

Oxethazine

Piroxicam

(Article 6)

THIRD SCHEDULE

PART 2

SUBSTANCES WHICH WHEN CONTAINED IN CERTAIN NON-PRESCRIPTION MEDICINAL PRODUCTS MAY BE SUPPLIED IN NON-PHARMACY OUTLETS

Aspirin

Cholecalciferol

Cyanocobalamin

Ergocalciferol

Folic Acid

Nicotinic acid

Paracetamol

Pyridoxine Hydrochloride

Sodium Fluoride

Sodium Monofluorophosphate

Stannous Fluoride

Vitamin A

Vitamin A Acetate

Vitamin A Palmitate

(Article 7(3))

FOURTH SCHEDULE

SUBSTANCES WHICH, WHEN CONTAINED IN CERTAIN MEDICINAL PRODUCTS MAY BE DISPENSED IN THE MANNER PRESCRIBED FOR A PRODUCT WHICH IS OR WHICH CONTAINS A SUBSTANCE SPECIFIED IN PART B OF THE FIRST SCHEDULE
PART 1
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 Fluocortolone	Triamcinolone Acetonide
PART 2
Desogestrel	Lynoestrenol
Estradiol valerate	Mestranol
Ethinyloestradiol	Norethisterone Acetate
Ethynodiol Diacetate	Norethisterone
Gestodene	Norgestimate
Levonorgestrel

FIFTH SCHEDULE

(Article 8)

SUBSTANCES NOT TO BE CONTAINED IN A MEDICINAL PRODUCTS SUPPLIED UNDER THE EXEMPTION CONFERRED BY ARTICLE 8(2).
Ammonium Bromide	Meclofenoxate Hydrochloride
Calcium Bromidolactobionate	Mifepristone
Calcium Bromide	Piracetam
Chlormethiazole Edisylate	Potassium Bromide
Chlormethiazole	Sodium Bromide
Embutramide	Strychnine Hydrochloride
Fluanisone	Tacrine Hydrochloride
Hydrobromic Acid	Thiopentone Sodium

SIXTH SCHEDULE

(Article 9(2)(i))

Cautionary and Warning Notices for Dispensed Medicinal Products

	NOTICE	EXAMPLES OF MEDICINAL PRODUCTS 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. If affected do not drive or operate machinery.	Monoamine-oxidase inhibitors when "Treatment Card" is supplied.
3.	Warning. May cause drowsiness.	Alternative for Children's products of the examples specified in 1 above.
4	Warning. Causes drowsiness which may continue the next day. If affected do not drive or operate machinery. Avoid alcoholic drink.	Hypnotics and certain other products with sedative effects, prescribed to be taken at night.
5.	Warning. Avoid alcoholic drink.
6.	Do not take indigestion remedies at the same time of day as this medicine.	Capsules, tablets or granules incorporating an enteric coat.
7.	Do not take iron products or indigestion remedies at the same time of day as this medicine.	Products containing doxycycline, minocycline or penicillamine.
8.	Do not take milk, iron products or indigestion remedies at the same time of day as this medicine.	Products containing tetracyclines other than doxycycline and minocycline.
9.	Do not stop taking this medicine except on your doctor's advice.	Products (such as beta- adrenoceptor blocking drugs, anti-hypertensives, those for the treatment or prophylaxis of asthma or allopurinol) required to be taken over a prolonged period for a benefit to be noticed.
10.	Take at regular intervals. Complete the prescribed course unless otherwise directed.	Antimicrobial drugs given by mouth.
11.	Warning. Follow the printed instructions you have been given with this medicine.	Products in respect of which a treatment card or other written instructions are given to the patient.
12	Avoid exposure of skin to direct sunlight or sun-lamps.	Products which may cause photo toxic or photo allergic reactions.
13	Do not take remedies containing aspirin while taking this medicine.	Products containing salicylate derivatives.
14	Dissolve or mix with water before taking.
15	This medicine may colour the urine.	Products such as phenolthalein (pink), triamterene (blue), levodopa (dark reddish) and rifampicin (red).
16	Caution flammable: keep away from fire or flames.
17	Allow to dissolve under the tongue. Do not transfer from this container. Keep tightly closed. Discard eight weeks after opening.	Glyceryl Trinitrate Tablets.
18	Discard eight weeks after opening.	Glyceryl Trinitrate Tablets supplied in manufacturers original pack.
19	Not more than......in 24 hours or......in any one week.	Products containing Ergotamine and intended for the treatment of acute migraine.
20	Not more than......in 24 hours.	Alternative for products specified in 17 above.
21	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.
22	Take half to one hour before food.	Products the act ion of which is thereby improved.
23	To be swallowed whole, not chewed.	Sustained release products.
24	Take with plenty of water.
25	To be applied sparingly.	Products for external use containing a corticosteroid or dithranol.
26	To be dissolved under the tongue.	Products intended for sublingual use.
27	To be sucked or chewed.
28	Take with or after food.	Products liable to cause gastric irritation with nausea and vomiting or those that are better absorbed with food.
29	Caution. It is dangerous to exceed the stated dose.
30	Warning. Do not exceed the stated dose.
31	Do not take more than 2 at any one time. Do not take more than 8 in 24 hours.	Dispensed tablets or capsules containing paracetamol labelled to be taken "as required".
32	Contains paracetamol.	Dispensed products containing paracetamol when the name on the label does not include the word "paracetamol".
33	Contains aspirin and paracetamol.	Dispensed products containing aspirin and paracetamol when the name on the label does not include the words "aspirin" and "paracetamol".
34	Contains aspirin.	Dispensed products containing aspirin when the name on the label does not include the word "aspirin".
35	Contains an aspirin-like medicine.	Dispensed products containing a salicylate derivative.
36	Not to be taken.
37	Shake the bottle.
38	Store in a cool place.
39	Do not use after....
40	Discard.....days after opening.
41	Not to be used for babies.
42	Not to be used for prolonged periods or at higher levels than those recommended without medical advice.	Sympathomimetics for internal use.
43	Not to be used for children under three years of age or for application to large areas of skin unless on medical advice.	Products containing hexachlorophane.
44	Not to be applied to broken skin and not to be used for children under three years of age.	Products containing boric acid or borax.
45	When taking this medicine and for 14 days after your treatment finishes you must observe the following instructions:-- 1. Do not eat cheese, pickled herrings or broad bean pods. 2. Do not eat or drink bovril, oxo, marmite or any similar meat 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.	Monoamine-oxidase inhibitors - (Treatment Card Text).
46	If the condition is not improved, consult your doctor.
47	Do not use in pregnancy without medical advice.

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

(Article 16)

SEVENTH SCHEDULE

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

CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS

This Certificate is issued by me, the undersigned, for the purpose of article 16 of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996, being

⁽¹⁾________________________________________

I hereby certify that I received on the ________day of ______________________ 19____ from⁽²⁾ ____________________ of _______________________________________ a sample of⁽³⁾ _______________________________________________ for test, examination or analysis; which was undamaged, duly sealed and marked⁽⁴⁾ __________________________

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 PRODUCT.

(4) HERE INSERT THE DISTINGUISHING MARK ON THE SAMPLE AND THE DATE OF SAMPLING SHOWN THEREON.

(5) HERE INSERT THE RELEVANT RESULTS AS APPROPRIATE

Dated this 28th day of August, 1996.

Brian O'Shea

Minister of State at the Department of Health.

Explanatory Note

The main purpose of these Regulations is to update the controls applicable to the prescription and supply of medicinal products to the public. The Regulations are also intended to establish the classification for supply of medicinal products with a view to giving effect, on an on-going basis, to E.C. Council Directive 92/26/EEC of 31st March, 1992 concerning the classification for the supply of medicinal products for human use (O.J. No. L 113, 30.4.92, p.5).

The Regulations apply an up-to-date and comprehensive system of control to medicinal products and identify those products which may only be supplied on medical prescription. The circumstances excluding medicinal products from prescription control are also specified and incorporates a pharmacy-only category into which most such non-prescription products now fall.

The Regulations up-date the list of medicinal products subject to prescription control and de-regulate certain other products which were previously subject to prescription control. In recognition of Ireland's position as part of the E.U. Internal Market, the term "supply" has been defined in the broader context, so that the controls apply equally to supplies made to persons in the State and to persons who may at the time be in another Member State of the European Union. In this connection also, the supply of medicinal products by mail order is prohibited.

In addition the Regulations set out the restrictions relating to the dispensing of prescriptions, the conditions for emergency supply of prescription-only medicinal products by pharmacists, the requirements for the labelling of dispensed medicinal products and for pharmacy records and a prohibition on the supply of medicinal products after their expiry dates.

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	Irish Statutory Instruments
You are here: BAILII >> Databases >> Irish Statutory Instruments >> Medicinal Products (Prescription and Control of Supply) Regulations, S.I. No. 256/1996 URL: http://www.bailii.org/ie/legis/num_reg/1996/0256.html

Irish Statutory Instruments

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