Medicinal Products (Prescription and Control of Supply) Regulations 2003

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STATUTORY INSTRUMENTS

S.I. No. 540 of 2003

Medicinal Products (Prescription and Control of Supply)

Regulations 2003

Dublin

Published by the Stationery Office

Prn : 1201 Price €12.19

S.I. No. 540 of 2003

Medicinal Products (Prescription and Control of Supply) Regulations 2003

ARRANGEMENT OF REGULATIONS

REGULATION

1. Citation

2. Commencement

3. Revocations

4. Interpretation

5. Medicinal products subject to prescription control

6. Restrictions on medicinal products exempted from prescription control

7. Restrictions on dispensing of prescriptions

8. Exemptions for emergency supply

9. Labelling of dispensed medicinal products

10. Pharmacy records

11. Keeping of records in the case of certain medicinal products

12. Control of paracetamol products

13. Control of paracetamol as it relates to pharmacy supplies

14. Control of paracetamol as it relates to non-pharmacy supplies

15. Requirement for solid unit dosage forms of paracetamol to be in blister packs

16. Statements to appear on labelling and in package leaflets of paracetamol products

17. Prohibition of supply of medicinal products from vending machines

18. Prohibition of supply of medicinal products after expiry date

19. Prohibition of mail order supply of medicinal products

20. Exemptions for supply in certain circumstances 21. Enforcement and execution

22. Evidence of result of test, examination or analysis

23. Transitional provisions

FIRST SCHEDULE

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

SECOND SCHEDULE (PART 1)

Substances when contained in certain non-prescription medicinal products may only be supplied in the manufacturer’s original container showing the legal classification for supply.

SECOND SCHEDULE (PART 2)

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

SECOND SCHEDULE (PART 3)

Substances which when contained in certain homeopathic medicinal products may be supplied without a prescription and in non-pharmacy outlets.

SECOND SCHEDULE (PART 4)

Herbal substances which when contained in extemporaneously prepared medicinal products may be supplied without a prescription in certain limited circumstances.

THIRD 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.

FOURTH SCHEDULE

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

FIFTH SCHEDULE

Cautionary and warning notices for dispensed medicinal products.

SIXTH SCHEDULE

Certificate stating results of test, examination or analysis.

S.I. No. 540 of 2003

Medicinal Products (Prescription and Control of Supply) Regulations 2003

I, Micheál Martin, Minister for Health and Children, in exercise of the powers conferred on me by section 32 of the Irish Medicines Board Act, 1995 (No. 29 of 1995), as adapted by the Health (Alteration of Name of Department and Title of Minister) Order, 1997 (S.I. No.308 of 1997), hereby make the following Regulations:-

CITATION

1. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) Regulations 2003.

COMMENCEMENT

2. These Regulations shall come into operation on the 11th day of November 2003.

REVOCATIONS

3. The Medicinal Products (Prescription and Control of Supply) Regulations 1996 (S.I. No. 256 of 1996), the Medicinal Products (Prescription and Control of Supply)(Amendment) Regulations 1996 (S.I. No 309 of 1996), the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 1999 (S.I. No. 271 of 1999), the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2000 (S.I. No. 116 of 2000), the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2002 (S.I. No. 627 of 2002) and the Medicinal Products (Control of Paracetamol) Regulations 2001 (S.I. No.150 of 2001) are hereby revoked.

INTERPRETATION

4. (1) In these Regulations: -

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

"active substance", in respect of a medicinal product, means a substance which contributes to the pharmacological action of the medicinal product and cognate expressions shall be construed accordingly;

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

“authorised officer” means an authorised officer appointed for the purposes of these Regulations under regulation 21;

"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 regulation 4 of the European Communities (Recognition of Qualifications in Pharmacy) Regulations 1991 (S.I. No. 330 of 1991);

"Board" means the Irish Medicines Board;

"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;

“European Pharmacopoeia” means the Pharmacopoeia referred to in subsection (3) of section 4 of the Pharmacopoeia Act, 1931 (No 22 of 1931) (as inserted by section 35 of the Misuse of Drugs Act, 1977 (No 12 of 1977)) and which is for the time being in force.

"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 board" means a board established under section 4 of the Health Act, 1970 (No. 1 of 1970), and the Eastern Regional Health Authority established by section 7 of the Health (Eastern Regional Health Authority) Act, 1999 (No. 13 of 1999);

"health prescription" means a prescription issued in connection with arrangements made under section 59 or section 67 of the Health Act, 1970 (No. 1 of 1970), on a form supplied by or on behalf of a health board;

“homeopathic medicinal product” means any medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeia currently used officially in the Member States;

"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 and Children;

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

"package leaflet" means a leaflet containing information for the user which accompanies the medicinal product;

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

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

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

"prescription" means a prescription issued by a registered medical practitioner, or registered dentist or by a practitioner of equivalent status practising in another Member State with the address of the practitioner in that Member State, as the person issuing the prescription, shown on the prescription, and the practitioner concerned is not connected with any practice of medicine or dentistry in the State and the

prescription has not been issued with a view to enabling the supply of a medicinal product by mail order;

"product authorisation" means an authorisation granted and in force in pursuance of the Medicinal Products (Licensing and Sale) Regulations 1998 (S.I. No. 142 of 1998);

"registered dentist" means a person registered in the register established under the Dentists Act, 1985 (No. 9 of 1985);

"registered medical practitioner" means a person registered in the register established under the Medical Practitioners Act, 1978 (No. 4 of 1978);

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

“registered optometrist” means a person registered in the Register of Optometrists established under the Opticians Acts, 1956 to 2003;

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

"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 or by officers of the Board in the enforcement and execution of Regulations made under the Act;

"supply" includes sell, distribute or offer or keep for sale, supply 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, or by another person in the chain of supply whether inside or outside of the State, 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

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

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

MEDICINAL PRODUCTS SUBJECT TO PRESCRIPTION CONTROL

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;

(2) Paragraph (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) Paragraph (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"

(4) Paragraph (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.

(5) Paragraph (2) shall not apply in the case of a medicinal product containing a substance specified in Part 1 of the Second 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.

(6) The container and outer package of a medicinal product, which by reason of sub- paragraphs (f) or (g) of paragraph (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 paragraph (2), a person shall not supply a medicinal product which, by reason of paragraph (2) of regulation 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) Paragraph (1) shall not apply to the supply of a medicinal product which contains a substance specified in Part 2 of the Second 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 -

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

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

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

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

(2) Subject to paragraphs (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 regulation 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 regulation 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 paragraph applies may be dispensed in accordance with this regulation 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 paragraph applies are -

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

(ii) any product intended for parenteral administration containing insulin,

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

(iv) 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 regulation 5(1)(b) or (c) applies shall be dispensed in accordance with this regulation 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;

(b) except in the case of a health prescription that is a repeatable prescription upon which a second or subsequent supply of a medicinal product is being made, be an original as issued by the registered medical practitioner or registered dentist;

(c) 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 regulation applies, where a prescription is not in accordance with paragraph (1) by reason only that one of the conditions specified in paragraph (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 paragraphs (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 regulation 5(1) or regulation 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 paragraph (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 regulation 5(1) or regulation 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 paragraph (3), the product does not consist of or contain a substance specified in the Fourth 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 sub-paragraph (d) of paragraph (1) and in sub-paragraph (c) of paragraph 2 shall not apply where the product consists of or contains methylphenobarbitone, phenobarbitone or phenobarbitone sodium (but no other substance specified in the Fourth 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 regulation "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 paragraph (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 Fifth Schedule as are in the opinion of the authorised person, deemed to be appropriate.

(3) It shall be sufficient compliance with sub-paragraphs (d), (g), (h), and (i) of paragraph (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 paragraphs (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 regulation 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 regulation 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 paragraph (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 regulation 14(1)(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 paragraph (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 regulation 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 paragraph (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 paragraph (3) "the relevant date" means -

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

(b) in relation to sub-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 paragraph (1) shall be satisfied in the case of computerised records provided that the information required to be kept by virtue of the said paragraph 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 regulation to a register shall include the computerised records and daily print-out referred to in paragraph (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,

(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 paragraph (1) shall be preserved for a period of two years from the date on which the last entry was made therein.

CONTROL OF PARACETAMOL PRODUCTS

12. The provisions of Regulations 13 to 16 shall apply to medicinal products that consists of or contain paracetamol.

CONTROL OF PARACETAMOL AS IT RELATES TO PHARMACY SUPPLIES

13. (1) Subject to paragraphs (2) and (3) and to Regulation 14, a person shall not supply a medicinal product except in accordance with a prescription and the requirements of these Regulations as they apply to medicinal products specified in Part B of the First Schedule.

(2) Notwithstanding paragraph (1), a person keeping open shop for the dispensing or compounding of medical prescriptions under the Pharmacy Acts, 1875 to 1977 may, otherwise than in accordance with a prescription, supply a medicinal product provided that -

(a) in the case of dosage units each of which contains more that 120mg of paracetamol but not more than 500mg of paracetamol, the pack size does not exceed 24 such units;

(b) in the case of dosage units each of which contains more than 500mg of paracetamol but not more than 600mg of paracetamol, the pack size does not exceed 20 such units;

(c) in the case of dosage units each of which contains more than 600mg of paracetamol but not more than 1000mg of paracetamol, the pack size does not exceed 12 such units;

(d) in the case of a medicinal product intended for use in children under six years of age and each dosage unit of which contains not more than 120mg of paracetamol, the pack size does not exceed 24 such units, or in the case of a liquid form of the said product in which the said quantity of paracetamol is contained in 5 millilitres, the pack size does not exceed 140 millilitres; or

(e) in the case of a medicinal product in liquid form in which each 5 millilitre dosage unit contains not more than 250mg of paracetamol other than a product to which sub-paragraph (d) applies, the pack size does not exceed 70 millilitres;

and provided that such supply is effected by, or under the personal supervision, of an authorised person.

(3) Notwithstanding paragraph (1), a person keeping open shop for the dispensing or compounding of medical prescriptions under the Pharmacy Acts, 1875 to 1977 may supply a medicinal product provided that -

(a) an authorised person at such shop has interviewed the person requesting the product and has satisfied himself or herself that it is safe in the circumstances to supply the product, and

(b) the total quantity supplied does not exceed fifty dosage units or, in the case of a medicinal product which is not in the form of a tablet or capsule or is not an article in some other similar pharmaceutical form, two packs.

CONTROL OF PARACETAMOL AS IT RELATES TO NON-PHARMACY SUPPLIES

14. (1) Notwithstanding Regulation 13, a person, who is not a person keeping open shop for the dispensing or compounding of medical prescriptions under the Pharmacy Acts, 1875 to 1977, may supply a medicinal product which is intended for oral use, provided that -

(a) in the case of dosage units each of which contains more than 120mg of paracetamol but not more than 500mg of paracetamol, the pack size does not exceed 12 such units;

(b) in the case of dosage units each of which contains more than 500mg of paracetamol but not more than 600mg of paracetamol, the pack size does not exceed 10 such units;

(c) in the case of dosage units each of which contains more than 600mg of paracetamol but not more than 1000mg of paracetamol, the pack size does not exceed 6 such units; or

(d) in the case of a medicinal product intended for use in children under six years of age and each dosage unit of which contains not more than 120mg of paracetamol, the pack size does not exceed 12 such units, or in the case of a liquid form of the said product in which the said quantity of

paracetamol is contained in 5 millilitres, the pack size does not exceed 60 millilitres.

(2) Where a supply of a medicinal product is effected under this Regulation, the product concerned shall contain paracetamol as its only active analgesic substance and the supply shall be made in the circumstances that no more than one pack of a medicinal product shall be supplied in the course of any one retail transaction.

REQUIREMENT FOR SOLID UNIT DOSAGE FORMS OF PARACETAMOL TO BE IN BLISTER PACKS

15. (1) A person shall not supply a medicinal product that contains paracetamol in solid unit dosage form unless each such unit dosage form is individually contained in a blister pack or in other such equivalent form of packaging as may be specified in the relevant product authorisation.

(2) This regulation shall not apply in the case of a medicinal product which is intended for supply solely on foot of a prescription.

STATEMENTS TO APPEAR ON LABELLING AND IN PACKAGE LEAFLETS OF PARACETAMOL PRODUCTS

16. (1) The following statements shall appear clearly on the outer packaging of a medicinal product or, if there is no outer packaging, on its immediate packaging :-

(a) "Contains Paracetamol",

(b) "Do not take any other paracetamol-containing products.",

(d) "Immediate medical advice should be sought in the event of overdosage, even if you feel well. Please read the enclosed leaflet carefully." in cases where a package leaflet is supplied with the product and the product is intended mainly for use in adults,

(e) "Immediate medical advice should be sought in the event of overdosage, even if the child seems well. Please read the enclosed leaflet carefully." in cases where a package leaflet is supplied with the product and the product is intended mainly for use in children not over 12 years of age,

(f) "Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage." in cases where no package leaflet is supplied with the product.

(2) The following statements shall appear clearly on the package leaflet of a medicinal product :-

(a) "Contains Paracetamol",

(b) "Do not take any other paracetamol-containing products.",

(d) "Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage.".

(3) The statements specified in paragraphs (1) and (2) as they apply to any particular medicinal product, may be varied with the prior written approval of the Board. Any such varied statement as may be approved by the Board shall not alter the effect of the information that was to have been conveyed by the original statement.

PROHIBITION OF SUPPLY OF MEDICINAL PRODUCTS FROM VENDING MACHINES

17. A person shall not supply a medicinal product from an automatic vending machine or by means of any other mechanically or electronically controlled device of a self-service nature.

PROHIBITION OF SUPPLY OF MEDICINAL PRODUCTS AFTER EXPIRY DATE

18. 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 OF MEDICINAL PRODUCTS

19. (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 paragraph (2) is not identifiable due to the use of a post office box, telephone number or an electronic mail address, any person making available facilities for such use shall be deemed to be the occupier of premises being used for or in connection with the supply by mail order of medicinal products.

EXEMPTIONS FOR SUPPLY IN CERTAIN CIRCUMSTANCES

20. (1) The provisions of regulations 5, 6, 13, 14 and 19 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) subject to paragraph (2), the supply of a medicinal product by way of wholesale dealing.

(2) (a) The exemption provided for in paragraph (1)(b) shall not apply to the supply of a medicinal product to a registered optometrist except where the medicinal product concerned is one to which this paragraph applies and in respect of which a signed order has been given by the optometrist to the supplier for the purpose of each such supply.

(b) The provisions of Regulation (5) shall not apply as respects the administration only of a medicinal product, to which this paragraph applies, to a patient of his by a registered optometrist in the course of his professional practice.

(c) The medicinal products to which this paragraph applies are those medicinal products which are not intended for parenteral administration and which are prescription-only under these Regulations by reason only that they contain any of the following substances: -

Cyclopentolate hydrochloride, Oxybuprocaine hydrochloride, and Tropicamide.

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

(a) the supply of a medicinal product by an authorised person or 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 regulation 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 regulation 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.

(4) The provisions of Regulations 5 and 6 shall not apply to a homeopathic medicinal product which contains a substance specified in Part 3 of the Second Schedule at a level not exceeding one part per million, and which is the subject of an authorisation granted under regulation 7 of the Medicinal Products (Licensing and Sale) Regulations 1998 (S.I. No. 142 of 1998) or a certificate of registration granted under regulation 8 of the said Regulations.

(5) The provisions of Regulations 5 and 6 shall not apply to the supply of a medicinal product which consists of or contains one or more of the herbal substances specified in Part 4 of the Second Schedule, where the person making the supply is the occupier of the premises, not being a shop or other such retail outlet, on which the said medicinal product has been extemporaneously prepared and which the said person is able to close so as to exclude the public and the supply of the medicinal product concerned is made on those premises for administration to a particular person after being requested by or on behalf of that person and in that persons presence to use his or her own professional judgement as to the treatment required.

(6) The provisions of Regulations 5 and 6 shall not apply to the supply of a medicinal product in the form of a free medical sample of such product to a registered medical practitioner or registered dentist in compliance with the conditions specified in Regulation 14(2) of the Medical Preparations (Advertising) Regulations 1993 (S.I. No. 76 of 1993) (as amended).

ENFORCEMENT AND EXECUTION

21. (1) (a) The Minister may appoint such and so many officers as he thinks fit to be authorised officers for the purposes of these Regulations.

(b) The Pharmaceutical Society of Ireland may appoint such and so many officers as it thinks fit to be authorised officers for the purposes of these Regulations.

(c) The Chief Executive Officer of each health board may appoint such and so many officers as it thinks fit to be authorised officers for the purposes of these Regulations.

(d) The Irish Medicines Board may appoint such and so many officers as it thinks fit to be authorised officers for the purposes of these Regulations.

(2) (a) An authorised officer shall be furnished with a warrant of his appointment.

(b) When exercising a power conferred on him under this regulation, an authorised officer shall, if required by a person thereby affected, produce the warrant to that person for inspection.

(3) Subject to paragraphs (4) and (5) an authorised officer may for the purpose ensuring that these Regulations are being complied with -

(a) at all reasonable times, enter and search a 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, inspect and, if he thinks fit, take copies of any prescription, book, invoice, order, record, register, or other document or of any entry in any such book, invoice, order, record, register, or other document at such premises,

(d) inspect and copy or extract information from any data within the meaning of the Data Protection Act, 1988 (No 25 of 1988),

(e) 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,

(f) seize and detain any medicinal product, substance or article,

(g) take any document which he has reasonable cause to believe to be a document which may be required as evidence in proceedings under the Act.

(4) An authorised officer shall not other than with the consent of the occupier enter a private dwelling or such part of any premises (not being a shop) as is used by a registered medical practitioner or registered dentist for carrying on his professional practice unless he or she has obtained a warrant from the District Court under paragraph (8) authorising such entry.

(5) So much of paragraph (3) 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.

(6) A person, who makes available facilities such as post office boxes, telecommunication or electronic mail address facilities as referred to in paragraph (3) of regulation 19 to a person who may be acting in contravention of these regulations, shall on demand made by an authorised officer furnish such particulars as may be requested by such officer.

(7) An authorised officer, for the purpose of exercising any of the powers conferred on him by paragraph (3), may require any other 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.

(8) Where an authorised officer seizes any medicinal product, substance, article or document in the exercise of a power conferred on him by paragraph (3), 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, of that fact.

(9) If a judge of the District Court is satisfied, on the sworn information of an authorised officer, that there are reasonable grounds to authorise entry into any of those premises set out at paragraph (4) herein, the judge may issue a warrant authorising such an authorised officer, accompanied, if appropriate, by other authorised officers and/or by a member or members of the Garda Síochána, at any time or times within one month from the date of issue of the warrant, on production of the warrant requested, to enter those premises or part thereof and to exercise any of the powers conferred on such an authorised officer under these Regulations.

(10) A person shall not wilfully obstruct or interfere with the exercise of a power by an authorised officer pursuant to these Regulations.

(11) A person shall not, without reasonable excuse, fail to comply with any request made by an authorised officer under these Regulations.”.

EVIDENCE OF RESULT OF TEST, EXAMINATION OR ANALYSIS

22. (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 a person authorised by the State Chemist, or

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

- 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 paragraph (1) shall be in the form set out in the Sixth Schedule.

TRANSITIONAL PROVISIONS

23. Any register, prescription, order or invoice required to be retained under Regulations 10(3) and 11(2) of the Medicinal Products (Prescription and Control of Supply) Regulations 1996 shall, for the purposes of regulation 21 herein, be regarded as being retained under Regulation 10(3) and 11(2) herein respectively.

(Regulations 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;

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

(b) the following abbreviations are used: “g” for gram, “mcg” for microgram, “%” for per cent, “mg” for milligram, “ml” for milliliter

23 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Abacavir Sulphate A Acamprosate B Acarbose B Acebutolol Hydrochloride B Acecarbromal B Aceclofenac B Acemetacin B Acenocoumarol (Nicoumalone) B Acepromazine Maleate B Acetanilide B Acetarsol A Acetazolamide B Acetazolamide Sodium B Acetohexamide B Acetophenazine Maleate B Acetriozic Acid C Acetrizoate Sodium C Acetylcholine Chloride B 0.2% (MS) External (except local ophthalmic use) Acetylcysteine A Any use (except local ophthalmic use) Acipimox B Acitretin A Aclarubicin A Aclarubicin Hydrochloride A Aconitum napellus L. B 1.3% (MS) External Acrivastine B Actaplanin A Actinomycin C A Actinomycin D A Acyclovir A 5.0% (MS) 2.0g External (except local (MPS) ophthalmic use): Cold sores Adapalene A Adenosine A Adefovir A Adefovir Dipivoxil A Adipiodone (Iodipamide) C Adipiodone Meglumine C Adrenocortical Extract A Agalsidase Alfa A Agalsidase Beta A Alatrofloxacin A Albendazole B Alclofenac B

24 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Alclomethasone Dipropionate A Alcuronium Chloride A Aldesleukin A Aldosterone A Alefacept A Alemtuzumab A Alendronate Sodium B Alendronic Acid B Alfacalcidol B Alfadolone Acetate A Alfaxalone A Alfentanil Hydrochloride A Alfuzosin B Alfuzosin Hydrochloride B Alimemazine (Trimeprazine) B Alimemazine Tartrate B Alitretinoin A Allergen Extracts B Allopurinol B Allylestrenol (Allyloestrenol) A Almitrine B Almotriptan B Almotriptan Maleate B Aloxiprim B 800mg (MD) 3.6g (MDD) Alprazolam A Alprenolol B Alprenolol Hydrochloride B Alprostadil A Alseroxylon B Alteplase A Alverine Citrate B Amantadine Hydrochloride B Ambenonium Chloride A Ambutonium Bromide A 5 mg (MD) 20 mg (MDD) Amcinonide B Ametazole Hydrochloride B Amfebutamone Hydrochloride A Amfetamine Sulphate A Amfomycin Calcium A (Amphomycin Calcium) Amidotrizoate Meglumine C (Diatrizoate Meglumine)

25 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Amidotrizoate Sodium C (Diatrizoate Sodium) Amidotrizoic acid (Diatrizoic C acid) Amikacin Sulphate A Amiloride Hydrochloride B Aminocaproic Acid B Aminoglutethimide B Aminophylline B Aminopterin Sodium A Amiodarone Hydrochloride B Amiphenazole Hydrochloride B Amisulpride B Amitriptyline A Amitriptyline Embonate A Amitriptyline Hydrochloride A Amlodipine Besylate B Amlopidine Maleate B Ammonium Bromide B Amobarbital (Amylobarbitone) A Amobarbital sodium A Amodiaquine Hydrochloride B Prophylaxis of malaria Amorolfine Hydrochloride B Amoxapine A Amoxicillin A Amoxicillin Trihydrate A Amphotericin A Ampicillin Sodium A Ampicillin Trihydrate A Amprenavir A Amrinone B Amsacrine A Amygdalin A Amyl Nitrite A Amylocaine Hydrochloride A Any use except local ophthalmic use Anakinra A Anamirta cocculus (L.) Wight & A Arn. Anastrozole A Ancrod A Androstanolone (Stanolone) A

26 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Androstenediol in its various A isomeric forms 19-nor-Androstenediol in its A various isomeric forms Androstenedione in its various A isomeric forms 19-nor-Androstenedione in its A various isomeric forms Androsterone A Angiotensin Amide B Anistreplase A Anterior Pituitary Extract A Anti-Melanoma Antibody C Antimony Barium Tartrate B Antimony Dimercaptosuccinate B Antimony Lithium Thiomalate B Antimony Pentasulphide B Antimony Potassium Tartrate B Antimony Sodium Tartrate B Antimony Sodium B Thioglycollate Antimony Sulphate B Antimony Trichloride B Antimony Trioxide B Antimony Trisulphide B Apiol A Apomorphine B Apomorphine Hydrochloride B Apraclonidine B Apraclonidine Hydrochloride B Aprotinin A Arbaprostil A Arbutamine C Arbutamine Hydrochloride C Arcitumomab A Arecoline Hydrobromide B Argipressin A Aristolochia species A Arsenic A Arsenic Triiodide A Arsenic Trioxide A Arsphenamine A

27 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Aspirin B (1) Internal: Any (1) 650mg (MD) use (except for 4.0g (MDD) children under 12 years of age) (2) External Astemizole B Atamestane A Atenolol B Atorvastatin Calcium B Atosiban A Atosiban Acetate A Atracurium Besylate A Atropa belladonna L. – the herb B (1) Internal (1) 1mg of the and root thereof alkaloids (MDD) (2) External Atropine B (1) Internal: (a) by inhaler (b) otherwise (b) 300 mcg (MD) than by inhaler 1mg (MDD)

(2) External (except local ophthalmic use) Atropine Methobromide B (1) Internal: (a) by inhaler (b) otherwise (b) 400 mcg (MD) than by inhaler 1.3 mg (MDD) (2) External (except local ophthalmic use) Atropine Methonitrate B Internal: (a) by inhaler (b) otherwise (b) 400 mcg (MD) than by inhaler 1.3 mg (MDD)

Atropine Oxide Hydrochloride B (1) Internal: (a) by inhaler (b) otherwise (b) 360 mcg (MD) than by inhaler 1.2mg (MDD) (2) External (except local ophthalmic use) Atropine Sulphate B (1) Internal: (a) by inhaler (b) otherwise (b) 360 mcg (MD) than by inhaler 1.2mg (MDD) (2) External (except local ophthalmic use)

28 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Auranofin B Azapropazone B Azathioprine A Azathioprine A Sodium Azelaic Acid B Azelastine B Azelastine Hydrochloride B Container or For nasal 140mcg per nostril package containing administration in a (MD) not more than non-aerosol, aqueous 5,040mcg of form 280mcg per nostril Azelastine (MDD) Hydrochloride For the treatment of seasonal allergic rhinitis

For use in adults and children not less than 12 years Azidocillin Potassium A Azitromycin A Azlocillin Sodium A Aztreonam A Bacampicillin Hydrochloride A Bacitracin A Bacitracin Methylene A Disalicylate Bacitracin Zinc A Baclofen B Balsalazide B Balsalazide Disodium B Bambuterol B Bambuterol Hydrochloride B Barbexaclone A Barbital A Barbital Sodium A Barium Carbonate B Barium Chloride B Barium Sulphate C Barium Sulphide B Basiliximab C Becaplermin A Beclamide B Beclometasone A

29 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Beclometasone Dipropionate B Container or For the prevention 100mcg per nostril package containing and treatment of (MD) not more than seasonal allergic 9,000 mcg of rhinitis 200mcg per nostril Beclometasone (MDD) Dipropionate In the form of a non- pressurised nasal spray

3 months (MPT) For use in persons aged 18 years and over Bemegride B Bemegride Sodium B Bemiparin Sodium A Benapryzine Hydrochloride B Benazepril B Benazepril Hydrochloride B Bendroflumethizide B (Bendrofluazide) Benethamine Penicillin A Benorilate (Benorylate) B 1.2g (MD) 7.0g (MDD) Benoxaprofen B Benperidol A Benserazide Hydrochloride B Bentiromide A Benzathine Benzylpenicillin A Benzbromarone B Benzilonium Bromide B Benzocaine A Any use except local ophthalmic use Benzoctamine B Hydrochloride Benzquinamide B Benzquinamide B Hydrochloride Benzthiazide B Benztropine Mesylate B Benzydamine Hydrochloride B (1) 3.0% (MS) (1) External

(2) 0.15% (MS) (2) Throat spray 30 ml (MPS) Benzylpenicillin Calcium A Benzylpenicillin Potassium A Benzylpenicillin Sodium A Bepridil Hydrochloride B

30 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Betahistine Hydrochloride B Betamethasone A Betamethasone Adamantoate A Betamethasone Benzoate A Betamethasone Dipropionate A Betamethasone Sodium A Phosphate Betamethasone Valerate A Betanidine Sulphate B Betaxolol Hydrochloride B Bethanechol Chloride B Bexarotene A Bezafibrate B Bicalutamide A Bifonazole B Bimatoprost A 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 Bosentan A Botulinum Toxins A Bretylium Tosylate B Brimonidine Tartrate B Brinzolamide B Bromazepam A Bromhexine Hydrochloride B Internal Bromocriptine Mesylate B Bromvaletone B Brotizolam A Budesonide A Bufexamac B 5.0% (MS) External Buflomedil Hydrochloride B Bufuralol Hydrochloride B Bumetanide B

31 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration 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 Busulfan A Butacaine Sulphate A Any use except local ophthalmic use Butobarbital A Butobarbital Sodium A Butorphanol Tartrate A Butriptyline Hydrochloride A Butyl Nitrite A Cabergoline A Calcifediol B Calcipotriol A Calcitonin (salmon) B (Salcatonin) Calcitonin (salmon) Hydrated B Polyacetate Calcitriol B Calcium Levofolinate B Calcium Benzamidosalicylate B Calcium Bromide B Calcium Bromidolactobionate B Calcium Carbimide B Calcium Folinate B (Calcium Leucovorin)

32 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Caldiamide Sodium C Calusterone A Camazepam A Candesartan Cilexetil B Candicidin A Canrenoate Potassium A Canrenoic Acid A Cantharidin B 0.01% (MS) External Canthaxanthin A Capecitabine A Capreomycin Sulphate A Capsaicin B Captopril B Carbachol B Carbamazepine B Carbasalate Calcium B (1) Internal: Any Equivalent of 650 mg of use (except for Aspirin (MD), children under Equivalent of 4.0g of 12 years of age) Asprin (MDD) Carbenicillin Sodium A Carbenoxolone Sodium B (1) Pellet (1) 5mg (MD), 25mg (MDD) (2) 2.0% (2) Gel (MS) 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 Caspofungin A Caspofungin Acetate A Caulophyllum thalictroides (L.) A Mich. - the root thereof Cefaclor A

33 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Cefadroxil A Cefalexin (Cephalexin) A Cefalexin Sodium A Cefaloridine A Cefalotin Sodium A Cefamandole Nafate A Cefapirin Sodium A Cefazedone Sodium A Cefazolin Sodium A Cefdinir A Cefepime A Cefepime Dihydrochloride A

Cefixime A Cefodizime A Cefonicid Sodium A Cefoperazone Sodium A Cefotaxime Sodium A Cefotiam Hydrochloride A Cefoxitin Sodium A Cefpirome Sulphate A Cefpodoxime A Cefpodoxime Proxetil A Cefprozil A Cefradine 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 Celecoxib B Celiprolol Hydrochloride B Cerium Oxalate B Cerivastatin Sodium B Certoparin Sodium A Ceruletide A Ceruletide Diethylamine A Cetirizine B 10mg (MS) 10mg (MDD) 10 (MPS) Cetrorelix Acetate A

34 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Chenodeoxycholic Acid B Chloral Hydrate B External Chloralodol B Chlorambucil A Chloramphenicol A Chloramphenicol Cinnamate A Chloramphenicol Palmitate A Chloramphenicol Sodium A Succinate Chlordiazepoxide A Chlordiazepoxide Hydrochloride A Chlormadinone Acetate A Chlormerodrin B Chlormethine Hydrochloride A (Mustine Hydrochloride) Chlormezanone B Chloroform B (1) 5.0% (1) Internal (MS) (2) External 4-Chloromethandienone A Chloroquine Phosphate B Prophylaxis of malaria Chloroquine Sulphate B Prophylaxis of malaria Chlorothiazide B Chlorotrianisene A Chlorphenoxamine B External Hydrochloride Chlorpromazine B Chlorpromazine B Hydrochloride Chlorpromazine Embonate B Chlorpropamide B Chlorprothixene B Chlorprothixene B Hydrochloride Chlortalidone B Chlortetracycline A Chlortetracycline A Hydrochloride Chlortetracycline Calcium A Chlorzoxazone B Cholestyramine B Choline Magnesium B Trisalicylate

35 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Choriogonadotropin Alfa A Chymopapain A Ciclacillin A Ciclobendazole B Ciclopirox B External (except vaginal use) Ciclopirox Olamine B Ciclosporin (Cyclosporin) B Cidofovir A Cilastatin A Cilastatin Sodium A Cilazapril B Cilostazol B Cimetidine B Cimetidine Hydrochloride B Cinchocaine B 3.0% Any use except local (MS) ophthalmic use Cinchocaine B Equivalent of 3.0% Any use except local Hydrochloride of Cinchocaine ophthalmic use (MS) Cinchophen B Cinnarizine B 15 (MPS) 30mg (MD) 60mg (MDD) Cinoxacin A Ciprofibrate B Ciprofloxacin A Ciprofloxacin Hydrochloride A Ciprofloxacin Lactate A Cisapride B Cisatracurium A Cisatracurium Besilate A 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 A Hydrochloride Clindamycin Phosphate A

36 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Clioquinol B (1) 35mg (MS) (1) Treatment of (1) 280mg (MDD) mouth ulcers (2) External (other than treatment of mouth ulcers) Clobazam A Clobetasol Propionate A Clobetasone Butyrate A Clodronate Sodium B Clofazimine B Clofibrate B Clomacran Phosphate B Clomethiazole A Clomethiazole Edisilate A Clomifene 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 Clopidogrel Hydrogen Sulphate B Clorazepate Potassium A Clorexolone B Clostebol A Clostebol Acetate A 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 Cocaine A Cocaine Hydrochloride A Codeine Phosphate A Equivalent of 1.5% Equivalent of 20mg of of Codeine (MS) Codeine (MD)

37 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Co-dergocrine Mesylate B Colaspase A Colchicine A Colecalciferol (Cholecalciferol) B (1) Internal (1) 0.075mg (equivalent to 3,000 iu Vitamin D) (MDD) (2) External Colestipol Hydrochloride B Colfosceril Palmitate A Colistimethate A Colistimethate Sodium A Colistin Sulphate A Collagenase B (Clostridiopeptidase A)

38 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Coniine B Conium maculatum L. – the leaf B 7.0% (MS) External thereof Corticotropin A Cortisone A Cortisone Acetate A Co-tetroxazine A Co-trimoxazole A Crisantaspase A Cromoglicate, Sodium B (1) Administration through the nose (2) Eye Drops Cropropamide B Crotethamide B Croton tiglium L. – the oil from A the seeds thereof Croton tiglium L. – the seeds A thereof Curare A α -Cyanobenzyl-6-O-β-D-gluco B 0.1% (MS) pyranosyl-β-D-glucopyranoside α -Cyanobenzyl-β-D-glucopyran B 0.1% (MS) osiduronic Acid Cyanocobalamin B 25mcg (MS) 25mcg (MDD) Cyclandelate B Cyclobarbital A Cyclobarbital calcium A Cyclofenil A Cyclopenthiazide B Cyclopentolate Hydrochloride B Cyclophosphamide A Cycloserine A Cyclothiazide B Cyproterone Acetate A Cytarabine A Cytarabine Hydrochloride A Cytisus scoparium L. Link A (Broom) Dacarbazine A Daclizumab A Dactomycin A Dalfopristin A Dalfopristin Mesylate A Dalteparin Sodium A

39 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Danaparoid Sodium A Danazol B Dantrolene Sodium B Dantron B Dapsone A Dapsone Ethane Ortho A Sulphonate Darbepoetin Alfa A Daunorubicin Hydrochloride A Deanol Aceglumate B Deanol Acetamidobenzoate B Deanol Bitartrate B 26mg (MDD) Debrisoquine Sulphate B Deferiprone B Deflazacort A Dehydroepiandrosterone A Delorazepam A Demecarium Bromide B Demeclocycline A Demeclocycline A Hydrochloride Demeclocycline Calcium A Depreotide Trifluoroacetate C Deptropine Citrate B Dequalinium Chloride B (1) 0.25mg (MS) (1) Internal: throat lozenges or throat pastilles

(2) 1.0% (MS) (2) External: paint Deserpidine B Desferrioxamine Mesylate B Desfluorotriamcinolone A Desflurane A Desipramine Hydrochloride A Desirudin A Deslanoside B Desloratadine B Deslorelin A Desmopressin B Desogestrel A Desonide A Desoxycortone Acetate A Desoxycortone Pivalate A Desoxymethasone A Dexamethasone A

40 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Dexamethasone Isonicotinate A Dexamethasone A Phenylpropionate Dexamethasone Acetate A Dexamethasone Pivalate A Dexamethasone Sodium m- A Sulphobenzoate Dexamethasone Sodium A Phosphate Dexamethasone Troxundate A Dexamfetamine Sulphate A Dexfenfluramine Hydrochloride A Dexketoprofen B Dexketoprofen Trometamol B Dexrazoxane A Dexrazoxane Hydrochloride A Dextromethorphan B Internal (a) In the case of Hydrobromide controlled release products: 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 B Hydrochloride Dextropropoxyphene Napsylate B

41 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Dextrothyroxine Sodium B Diazepam A Diazoxide A Dibenzepin Hydrochloride A Dibotermin alfa A Dichloralphenazone B Diclofenac Diethylammonium B Equivalent of 1.0% External: of Diclofenac (MS) For local symptomatic relief of 30.0g (MPS) pain and inflammation in the 7 days (MPT) trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism.

For use in adults and children not less than 12 years

Diclofenac Epolamine B Diclofenac Potassium B Diclofenac Sodium B Equivalent of 1.0% External: Diclofenac (MS) For the local symptomatic relief of 30g (MPS) pain and inflamation in the trauma of 7 days (MPT) tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism.

For use in adults and children not under 12 years Diclofenamide B (Dichlorphenamide) Dicycloverine Hydrochloride B Internal (other than 10mg (MD) (Dicyclomine Hydrochloride) liquid products 60mg (MDD) intended for infants) Didanosine A Dienestrol A Diethanolamine Fusidate A Diethylcarbamazine B

42 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Diethylcarbamazine Citrate B Diethylpropion Hydrochloride A Diethylstilbestrol A Diethylstilbestrol Propionate A Difenoxin Hydrochloride A Diflorasone Diacetate A Diflucortolone Valerate A Diflunisal B Digitalin B Digitalis Prepared B Digitalis purpurea L. – the B leaves thereof Digitoxin B Digoxin B Dihydralazine Sulphate B Dihydrocodeine Tartrate A Equivalent of 1.5% Equivalent of 10mg of of Dihydrocodeine Dihydrocodeine (MD) (MS) Dihydroergotamine Mesylate B Dihydrostreptomycin A Dihydrostreptomycin Sulphate A Dihydrotachysterol B 0.075mg (MDD) Di-iodohydroxyquinoline B Diloxanide Furoate B Diltiazem Hydrochloride B Dimercaprol B 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

43 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Distigmine Bromide B Disulfiram B Dithranol B 0.1% (MS) Dithranol Triacetate B 0.1% (MS) Dobutamine Hydrochloride B Docetaxel A Docetaxel Trihydrate A Dodecafluoropentane C Dofetilide A Dolasetron Mesylate A Domperidone B Oral solid unit dosage forms Domperidone Maleate B Oral solid unit dosage forms Donepezil A Donepezil Hydrochloride A Dopamine Hydrochloride A Dopexamine Hydrochloride B Dornase Alfa B Dorzolamide B Dorzolamide Hydrochloride B Dosulepin (Dothiepin) A Dosulepin Hydrochloride A Doxapram Hydrochloride A Doxazosin B Doxazosin Mesylate B Doxepin Hydrochloride A Doxorubicin A Doxorubicin Hydrochloride A Doxycycline A Doxycycline Calcium Chelate A Doxycycline Hyclate A Doxycycline Hydrochloride A Doxylamine Succinate B 10mg (MD) 40mg (MDD) Droperidol A Drospirenone A Drostanolone A Drostanolone Propionate A Drotrecogin Alfa C Dydrogesterone A Dyflos B Ebastine B

44 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Econazole B External: but, in the case of vaginal use, only external use for the treatment of vaginal candidiasis

Econazole Nitrate B External: but in the case of vaginal use, only external use for the treatment of vaginal candidiasis Ecothiopate Iodide A Edrophonium Chloride A Efavirenz A Eflornithine A Eflornithine Hydrochloride A Eformoterol B Eletriptan Hydrochloride B Embutramide A Emedastine B Emedastine Difumarate B 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 Enoxacin A Enoxaparin A Enoxaparin Sodium A Enoxaparin Sodium A Enoximone A Enprostil A Entacapone B Ephedra species A Ephedrine B External (except local ophthalmic use) Ephedrine Hydrochloride B External (except local ophthalmic use) Ephedrine Sulphate B External (except local ophthalmic use)

45 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Epicillin A Epinephrine (Adrenaline) B External Epinephrine Acid Tartrate B External Epinephrine Hydrochloride B External Epirubicin A Epirubicin Hydrochloride A Epitiostanol A Epitizide B Epoetin Alfa A Epoetin Beta A Epoetin Delta A Epoprostenol Sodium A Eprosartan Mesylate Dihydrate B Eptacog Alfa A Eptifibatide A Ergocalciferol B 0.075mg (equivalent to 3,000 iu Vitamin D) (MDD) Ergometrine Maleate B Ergometrine Tartrate B Ergot, Prepared B Ergotamine Tartrate B Ertapenem A Ertapenem Sodium A 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 Escitalopram A Escitalopram Oxalate A Esmolol Hydrochloride B Esomeprazole B Esomeprazole Oxalate B Esomeprazole Magnesium B Trihydrate Estazolam A Estradiol (Oestradiol) A Estradiol Benzoate A Estradiol Cipionate A Estradiol Dipropionate A

46 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Estradiol Diundecanoate A Estradiol Enantate A Estradiol Hemihydrate A Estradiol Phenylpropionate A Estradiol Undecanoate A Estradiol Valerate A Estramustine Phosphate A Estriol (Oestriol) A Estriol Dihemisuccinate A Estrone (Oestrone) A Etacrynic acid B Etafedrine Hydrochloride B Etamivan B Etanercept A Ethacrynate Sodium B Ethambutol Hydrochloride B Ethamsylate B Ethchlorvynol B Ethebenecid B Ethiazide B Ethinyl Androstenediol A Ethinylestradiol A Ethionamide B Ethisterone A Ethoglucid A Ethoheptazine Citrate A Ethosuximide B Ethotoin B Ethyl Biscoumacetate B Ethyl Loflazepate A Ethyl Moniodostearate C Ethylestrenol A Ethylmorphine Hydrochloride A Equivalent of 0.2% Equivalent of 7.5mg of of Ethylmorphine Ethylmorphine (MD) (MS) Etidronate Disodium B Etifoxine A Etodolac B Etofenamate B Etomidate A Etonogestrel A Etoposide A Etoposide Phosphate A Etoricoxib B

47 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Etorphine Hydrochloride A Etretinate A Etynodiol Diacetate A Exemestane A Falecalcitriol B Famciclovir A Famotidine B 14 days (MPT) Internal: 10 mg (MD)

For the short term, 20 mg (MDD) symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion, and hyperacidity, and the prevention of these symptoms when associated with food and drink, including nocturnal symptoms.

For use in adults and children not less than 16 years Fazadinium Bromide A Felbinac B 3.17% (MS) External:

30g (MPS) For local symptomatic relief of 7 days (MPT) pain and inflammation in the trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism.

For use in adults and children not under 12 years Felodipine A Felypressin A Fenbufen B Fenbutrazate Hydrochloride A (Phenbutrazate Hydrochloride) Fencamfamin Hydrochloride A Fenclofenac B Fenfluramine Hydrochloride A

48 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Fenofibrate B Fenoldopan Mesylate A Fenoprofen B Fenoprofen Calcium B Fenoterol Hydrobromide B Fentanyl Citrate A Fenticonazole Nitrate B Feprazone B Ferristene C Ferrous Arsenate B Ferucarbotran A Ferumoxides C Fexofenadine Hydrochloride 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 Fludroxycortide A (Flurandrenolone) Flufenamic Acid B Flumazenil A Flumethasone A Flumethasone Pivalate A Flunarizine Hydrochloride B

49 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Flunisolide A 0. 025% (MS) For the prevention 50mcg per nostril (MD) and treatment of Container or seasonal allergic 100mcg per nostril package containing rhinitis, including (MDD) not more than hay fever. 6000mcg of Flunisolide (MPS) In the form of a non- pressurised nasal spray.

For use in persons aged 18 years and over 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 Flurazepam Hydrochloride A Flurazepam Monohydrochloride A Flurbiprofen B 8.75mg (MS) Throat lozenges 43.75mg (MDD) 140mg(MPS) For use in adults and children not under 12 years. Fluspirilene A

50 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Flutamide A Fluticasone Propionate B Container or For the prevention 100mcg per nostril package containing and treatment of (MD) not more than allergic rhinitis, 200mcg per nostril 3000mcg of including hay fever (MDD) Fluticasone Propionate In the form of a non- pressurised nasal 6 months (MPT) spray.

For use in adults and children not under 12 years. Flutrimazole B Fluvastatin Sodium B Fluvoxamine Maleate A Folic Acid B 500mcg (MDD) Folinate Calcium B (Calcium Leucovorin) Folinate Disodium B Follitropin Alpha A Follitropin Beta A Fomivirsen A Fomivirsen Sodium A Fondaparinux Sodium A Formebolone A Formestane A Formocortal A Formoterol B Formoterol Fumarate B Foscarnet Sodium A Fosfestrol Sodium A Fosfomycin A Fosfomycin Trometamol A Fosinopril B Fosinopril Sodium B Fosphenytoin B Fosphenytoin Sodium B Framycetin Sulphate A Frovatriptan B Frovatriptan Succinate B Monohydrate Furazabol A Furazolidone B Furosemide (Frusemide) B Fusafungine A

51 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Fusidic Acid A Gabapentin B Gadobenic Acid C Gadobentate Meglumine C Gadobutrol C Gadopentetate Meglumine C Gadopentetic Acid C Gadoteric Acid C Gadoteridol C Galantamine A Galantamine Hydrobromide A Gallamine Triethiodide A Ganciclovir A Ganciclovir Sodium A Ganirelix A Gelsemine B 0.1% (MS) Gelsemium nitidum L. B 25mg (MD) 75mg (MDD) Gemcitabine Hydrochloride A Gemeprost C Gemfibrozil B Gentamicin A Gentamicin Sulphate A Gestodene A Gestrinone A Gestronol A Gestronol Hexanoate A Ginkgo biloba L. 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

52 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Goserelin Acetate A Gramicidin A 0.2% (MS) External Granisetron A Granisetron Hydrochloride A Grepafloxacin Hydrochloride A Sesqihydrate 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 B Halofantrine Hydrochloride B Haloperidol A Haloperidol Decanoate A Halothane A Haloxazolam A Harmine A Hemin, Human A Heparin A External Heparin Calcuim A External Heparin Sodium A External Heptabarbitone A Hexachlorophene B External: (a) 2.0%(MS) (a) soaps

(b) 0.1% (MS) (b) aerosols

(c) 0.75% (MS) (c) products other than soaps and aerosols Hexamethonium Bromide A Hexamethonium Iodide A Hexamethonium Tartrate A Hexamine Phenylcinchoninate B Hexobarbital A Hexobarbital Sodium A Hexoestrol A Hexoestrol Dipropionate A L-Histidine Hydrochloride B

53 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Homatropine B (1) Internal (1) 0.15mg (MD) 0.45mg (MDD) (2) External (except local ophthalmic use) Homatropine Hydrobromide B 0.2mg (MD) 0.6mg (MDD) Homatropine Methylbromide B 2mg (MD), 6mg (MDD) 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), External: Contact 15.0g (MPS) dermatitis, irritant dermatitis, insect bite reactions and mild to moderate eczema. Hydrocortisone Acetate A (1) Equivalent to (1) External: 1.0% of For use in irritant Hydro- dermatitis, contact cortisone alergic dermatitis, (MS) insect bite reactions and mild to moderate 15.0g (MPS) eczema.

For use in adults and children not under 10 years.

54 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration (2) Equivalent to (2) External: 1.0% of In ointments when in Hydro- combination with one cortisone or more of the (MS) following: Benzyl Benzoate, Bismuth 15.0g (MPS) Oxide, Bismuth Subgallate, Peru Balsam, Pramoxine Hydrochloride, Zinc Oxide, for use in haemorrhoids.

For use in adults and children not under 10 years.

(3) 10mg (MS) (3) External: In suppositories 12 (MPS) when in combination with one or more of the following: Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Peru Balsam, Pramoxine Hydrochloride, Zinc Oxide, for use in haemorrhoids.

For use in adults and children not under 10 years. Hydrocortisone Butyrate A Hydrocortisone Caprylate A Hydrocortisone Hydrogen A Succinate Hydrocortisone Sodium A Phosphate Hydrocortisone Sodium A Succinate Hydroflumethiazide B Hydromorphone Hydrochloride A Hydroxocobalamin B 25mcg (MS) 25mcg (MDD) 4-Hydroxybutanoic acid lactone A (GBL) Hydroxycarbamide A Hydroxychloroquine Sulphate B Prophlaxis of malaria

55 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Hydroxypatite B Hydroxyprogesterone A Hydroxyprogesterone Caproate A Hydroxyprogesterone Enanthate 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 (b) 3mg (MD) by inhaler 9mg (MDD)

(2) External Hyoscine Hydrobromide B (1) Internal: (a) By inhaler (b) Otherwise than (b) 300mcg (MD) by inhaler 900mcg (MDD)

(2) External (except local ophthalmic use)

Hyoscine Methobromide B (1) Internal: (a) By inhaler (b) Otherwise than (b) 2.5mg (MD) by inhaler 7.5mg (MDD)

(2) External Hyoscine Methonitrate B (1) Internal: (a) By inhaler (b) Otherwise than (b) 2.5mg (MD) by inhaler 7.5mg (MDD)

(2) External

56 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Hyoscyamine B (1) Internal: (a) By inhaler (b) Otherwise than (b) 300mcg (MD) 1mg by inhaler (MDD)

(2) External

(3) Products for the relief of asthma in the form of cigarettes, smoking mixtures or fumigants which contain Hyoscyamine as an alkaloid of Stramonium Hyoscyamine Sulphate B (1) Internal: (a) By inhaler (b) Otherwise than (b) Equivalent of by inhaler 300mcg of Hyoscyamine (MD) Equivalent to 1mg of (2) External Hyoscyamine (MDD) Hyoscyamine Hydrobromide B (1) Internal: (a) By inhaler (b) Otherwise than (b) Equivalent of by inhaler 300mcg of Hyoscyamine (2) External (MD) Equivalent to 1mg of Hyoscyamine (MDD) Hypericum perforatum L. B External Ibandronic Acid B

57 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Ibuprofen B (1) 200mg (MS) (1)Internal:Rheumati (1) 400mg (MD) 50(MPS) c and muscular pain, 1200mg (MDD) backache, neuralgia, migrane, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.

(2) Internal: (2) 400mg (MS) Muscular pain, (2) 400mg (MD) 25(MPS) backache, dental pain 1200mg (MDD) and dysmenorrhoea.

For use in adults and children not under 12 years.

(3)External: For local symptomatic relief of (3) 5.0% pain and inflamation 30g (MPS) in the trauma of the 7 days (MPT) tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism.

For use in adults and children not under 12 years. Idarubicin Hydrochloride A Idoxuridine A 0.1% (MS) External (except local ophthalmic use): Cold sores Ifosfamide A Igovomab A Imatinib A Imatinib Mesilate A Imidapril B Imidapril Hydrochloride B

58 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Imiglucerase A Imipenem A Imipenem Hydrochloride A Imipramine A Imipramine Hydrochloride A Imipramine Resinate A Imiquimod B Immunoglobulins A Immunoglobulins, A Antilymphocyte Immunoglobulins, A Antithymocyte Impromidine Hydrochloride A Indapamide B Indapamide Hemihydrate B Indinavir A Indinavir Sulphate A Indium (111 In) Satumomab C Pendetide Indometacin (Indomethacin) B Indoprofen B Indoramin Hydrochloride B Infliximab A Inosine Pranobex A Inositol Nicotinate B Insulin Aspart B Insulin Glargine B Insulin Lispro B Insulins B Interferon Alfa A Interferon Alfa-2a A Interferon Alfa-2b A Interferon alfacon-1 A Interferon Beta A Interferon Beta-1a A Interferon Beta-1b A Interferon Gamma A Iobenamic Acid C Iobitridol C

59 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Iocarmate Meglumine C Iocarmic Acid C Iocetamic Acid C Iodamide C Iodamide Sodium C Iodimide Meglumine C Iodised Oil C Iodixanol C Iodohippurate Sodium C Iodoxamate Meglumine C Iodoxamic Acid C Iofendylate (Iophendylate) C Ioflupane (123 I) C

60 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration 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 Iopromide C Iopronic Acid C Ioseric Acid C Iosimide C Iotalamic acid C Iotasul C Iothalamate Meglumine C Iothalamate Sodium 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 Irbesartan B Irinotecan Hydrochloride A

61 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Irinotecan Hydrochloride A Trihydrate 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 of the treatment of vaginal candidiasis Isoetharine B Isoetharine Hydrochloride B Isoetharine Mesylate 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 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

62 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Ketoprofen B 2.5% (MS) External: For local 30.0g (MPS) sympromatic relief of pain and 7 days (MPT) inflammation in the trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism.

For use in adults and children not under 12 years Ketorolac B Ketorolac Trometamol B Ketotifen Fumarate B Labetolol Hydrochloride B Lacidipine B Lamivudine A Lamotrigine B Lanatoside C B Lanatoside Complex A, B and C B Lanreotide Acetate A Lansoprazole B Latamoxef Disodium A Latanoprost A Latanoprost A Leflunomide A Lenograstim A Lepirudin A Lercanidipine B Lercanidipine Hydrochloride B Letrozole A Leuprorelin Acetate A Levacetylmethadol A Levacetylmethadol A Hydrochloride Levallorphan Tartrate B Levamisole A Levamisole Hydrochloride B Anthelmintic Levetiracetam B Levobunolol Hydrochloride B Levobupivacaine A Levobupivacaine Hydrochloride A

63 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Levocabastine B Levocabastine Hydrochloride B Levocabastine Hydrochloride B Levocetirizine B Levocetirizine Hydrochloride B Levodopa B Levofloxacin A Levoleucovorin, Calcium A Levomepromazine B (Methotrimeprazine) Levomepromazine B Hydrochloride Levomepromazine Maleate B Levonorgestrel A Levorphanol Tartrate A Levothyroxine Sodium B (Thyroxine Sodium) Lidocaine (Lignocaine) A Any use except local ophthalmic use Lidocaine Hydrochloride A Any use except local ophthalmic use Lidoflazine A Lincomycin A Lincomycin Hydrochloride A Linezolid A

64 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Liothyronine Sodium B Lisinopril B Lisuride Maleate B Lithium Carbonate A Equivalent of 5mg of Lithium (MD) Equivalent of 15mg of Lithium (MDD) Lithium Citrate A Lithium Succinate B Lithium Sulphate A Equivalent of 5mg of Lithium (MD) Equivalent of 15mg of Lithium (MDD) Lobeline B (1) Internal (1) 3mg (MD) (2) External 9mg (MDD)

Lobeline Hydrochloride B (1) Internal (1) Equivalent of 3mg of Lobeline (MD), Equivalent of 9mg of Lobeline (MDD) (2) External Lobeline Sulphate B (1) Internal (1) Equivalent of 3mg of Lobeline (MD), Equivalent of 9mg of Lobeline (MDD) (2) External Lodoxamide B Lodoxamide Ethyl B Lodoxamide Trometamine B Lodoxamide Trometamol B Equivalent of 0.1% Eye Drops Lodoxamide (MS) For use in adults and children not under 4 years. Lofepramine A Lofepramine Hydrochloride A Lofexidine Hydrochloride B Lomefloxacin Hydrochloride A Lomustine A Loperamide Hydrochloride B Treatment of acute diarrhoea Lopinavir A Loprazolam Mesylate A Loratadine B 10mg (MS) 10mg (MDD) 10 (MPS) Lorazepam A Lormetazepam A Lornoxicam B

65 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Losartan B Losartan Potassium B Loxapine B Loxapine Succinate B L-Tryptophan B External Luteinising Hormone A Lutropin Alfa A Lymecycline A Lynestrenol A Lypressin A Lysuride Maleate B Mafenide A Mafenide Acetate A Mafenide Hydrochloride A Mafenide Propionate A 5.0% (MS) Eye Drops Magafodipir C Magnesium Fluoride B Magnesium Metrizoate B Mandragora autumnalis Bertol. B Mangafodipir Trisodium C

66 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Mannitol Hexanitrate A Mannomustine Hydrochloride A Maprotiline Hydrochloride B Mazindol A Mebanazine A Mebendazole B Internal Mebeverine Hydrochloride B Internal Mebhydrolin B Mebhydrolin Napadisylate B Mebolazine A Mecamylamine Hydrochloride B Mecillinam A Meclofenoxate Hydrochloride B Mecysteine Hydrochloride B Internal Medazepam A Medicinal Opium A (1) Equivalent of (1) Liquids (1) Equivalent of 3mg 0.02% of of anhydrous anhydrous morphine (MD) morphine (MS) (2) Equivalent of (2) Solids (2) Equivalent of 3mg 0.04% of of anhydrous anhydrous morphine (MD) morphine (MS) Medigoxin B Medrogestone A Medroxyprogesterone Acetate A Medrysone A Mefenamic Acid B Mefenorex A Mefloquine Hydrochloride B Mefruside B Megestrol A Megestrol Acetate A Meglumine Antimonate A Melatonin A Meloxicam B Melperone A Melperone Hydrochloride A Melphalan A Melphalan Hydrochloride A Memantine A Memantine Hydrochloride A Menotrophin A Mepenzolate Bromide B 25mg (MD) 75mg (MDD)

67 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Mephenesin B Mephenesin Carbamate B Mephenytoin (Methoin) B Mepindolol B Mepitiostane A Mepivacaine Hydrochloride A Any use except local ophthalmic use Meprobamate A Meptazinol Hydrochloride A Mequitazine B Mercaptamine Bitartrate B Mercaptopurine A Mercuric Chloride B Mercuric Iodide B Meropenem A Mersalyl B Mersalyl Acid B Mesabolone A Mesalazine B Mesna A Mestanolone A Mesterolone A Mestranol A Mesuximide (Methsuximide) B Metataraminol Tartrate B Meteneprost C Metergoline A Metformin Hydrochloride B Methacycline A Methacycline Calcium A Methacycline Hydrochloride A Methadone Hydrochloride A Methallenestrol A Methandienone A Methandriol A Methapyrilene Fumarate A Methapyrilene Hydrochloride A Methaqualone A Methenamine Hippurate B (Hexamine Hippurate) Methenolone A Methenolone Acetate A Methenolone Enanthate A Methicillin Sodium A

68 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Methiodal Sodium C Methixene B Methixene Hydrochloride B Methocarbamol B Methocidin A Throat lozenges and throat pastilles Methohexital Sodium A Methoserpidine B Methotrexate A Methotrexate Sodium A Methoxamine Hydrochloride B 0.25% (MS) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle Methoxsalen A Methyclothiazide B Methyl Aminolevulinate A Hydrochloride Methylamphetamine A Hydrochloride Methyldopa B Methyldopate Hydrochloride B Methylephedrine Hydrochloride B Methylphenidate Hydrochloride A Methylphenobarbital A Methylprednisolone A Methylprednisolone Acetate A Methylprednisolone Sodium A Succinate 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 Calcium C Metrizoate Meglumine C Metrizoate Sodium C

69 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Metrizoic Acid C Metronidazole B Metronidazole Benzoate B Metyrapone B Mexiletine Hydrochloride B Mezlocillin Sodium A Mianserin Hydrochloride B Mibefradil Dihydrochloride B Mibolerone A 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 Miglitol B Miglustat A Milrinone B Milrinone Lactate B Minocycline A Minocycline Hydrochloride A Minoxidil B (1) 2% (1) External: For application to the scalp (2) 5% (2) External: For application to the scalp in the treatment of alopecia androgenetica in persons aged 18 to 65 years

Mirtazapine A

Misoprostol A Mithramycin A Mitobronitol A Mitomycin C A

70 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Mitoxantrone Hydrochloride A Mitrizoate Meglumine C Mivacurium Chloride A Mizolastine B Moclobemide A Modafinil A Moexipril Hydrochloride B Molgramostim A Molindone Hydrochloride B Molsidomine B Mometasone A Mometasone Furoate A Montelukast Sodium B Mopidamol A Moracizine B Moracizine Hydrochloride B Morazone Hydrochloride B Moroctocog Alfa A Morphine Hydrochloride A (1) Equivalent of (1) Liquids (1) Equivalent of 3mg 0.02% of of anhydrous anhydrous morphine (MD) morphine (MS) (2) Equivalent of 3mg (2) Equivalent of (2) Solids of anhydrous 0.04% of morphine (MD) anhydrous morphine; equivalent of 300 mcg of anhydrous morphine (MS) Morphine Sulphate A (1) Equivalent of (1) Liquids (1) Equivalent of 3mg 0.02% of of anhydrous anhydrous morphine (MD) morphine (MS)

(2) Equivalent of 0.04% of anhydrous (2) Solids (2) Equivalent of 3mg morphine; of anhydrous equivalent of 300 morphine (MD) mcg of anhydrous morphine (MS) Moxifloxicin A Moxifloxicin Hydrochloride A Moxisylyte Hydrochloride B (Thymoxamine Hydrochloride) Moxonidine B

71 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Mupirocin A Mycophenolate Mofetil B Nabilone A Nabumetone B Nadolol B Nadroparin Calcium A

72 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Nafarelin Acetate A Naftidrofuryl Oxalate B Naftifine B Naftifine Hydrochloride 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 Laurate A Nandrolone Laureate A Nandrolone Phenylpropionate A Naphazoline Hydrochloride B (1) 0.05% (MS) (1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle (2) 0.015% (MS) (2) Eye drops Naphazoline Nitrate B (1) 0.05% (MS) (1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle (2) 0.015% (MS) (2) Eye drops Naproxen B 5.0% (MS) 30.0g External: Rheumatic (MPS) and muscular pain

Naproxen Sodium B 5.0% (MS) External:

30.0g (MPS) For local sympromatic relief of 7 days (MPT) pain and inflammation in the trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism.

For use in adults and children not under 12 years Naratriptan B Naratriptan Hydrochloride B

73 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Natamycin A Nateglinide B Nebivolol Hydrochloride B Nedocromil Sodium B Nefazodone A Nefazodone Hydrochloride A Nefopam Hydrochloride B Nelfinavir Mesylate A Neomycin A Neomycin Oleate A Neomycin Palmitate A Neomycin Sulphate A Neomycin Undecanoate A Neostigmine Bromide B Neostigmine Methylsulphate A Nesiritide A Nesiritide Citrate A

74 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Netilmicin Sulphate A Nevirapine A Nialamide A Nicardipine Hydrochloride B Niclosamide B Nicofuranose B Nicorandil B Nicotine B Internal: (a) Oral dosage forms (a) 4 mg (MD) 60mg (MDD) (b) Transdermal (b) 22mg expressed as patches the dose delivered over a 24 hour period (MDD) Nicotine Resinate B Internal: Oral dosage Equivalnent of 4mg of forms Nicotine (MD), Equivalent of 60mg of Nicotine (MDD) Nicotinic Acid B Any use, except for 600mg (MDD) the treatment of hyperlipidaemia Nicotinyl Alcohol B Nicotinyl Alcohol Tartrate B Nifedipine B Nifenazone B Nikethamide B Nilvadipine B Nimesulide B Nimetazepam A Nimodipine B Nimorazole B Niridazole B Nisoldipine B

75 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Nitrazepam A Nitrendipine B Nitrofurantoin B Nitrofurazone B Nizatidine B 8 (MPS) For the prevention of 75mg (MD) heartburn, indigestion 14 days (MPT) and excess acid. 150mg (MDD)

For use in adults and children not under 16 years. Nomifensine Maleate A Nonacog alpha A Norboletone A Norclostebol A Nordiazepam A Norelgestromin A Norepinephrine B (Noradrenaline) Norepinephrine Acid Tartrate B 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 Noxytiolin A Nystatin B External (except vaginal use) Octafluoropropane C Octafluoropropane C Octocog Alfa A

76 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Octreotide A Octreotide Acetate A Oestradiol Valerate A Oestrogenic Substances A Conjugated Ofloxacin A Olanzapine A Olopatadine Hydrochloride B Olsalazine Sodium B Omeprazole B Omeprazole Magnesium B Ondansetron Hydrochloride A Opipramol Hydrochloride A Orciprenaline Sulphate B Orlistat A Orphenadrine Citrate B Orphenadrine Hydrochloride B Oseltamvir A 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 Oxcarbazepine B

77 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Oxedrine Tartrate B Oxetacaine (Oxethazaine) B Internal: but only as a constituent in an antacid mixture Oxiconazole Nitrate B Oxidronate Sodium A Oxitropium Bromide B Oxolinic Acid B Oxprenolol Hydrochloride B Oxybuprocaine Hydrochloride B Any use except local opthalmic use Oxybutynin Hydrochloride B Oxycodone Hydrochloride A Oxycodone Pectinate A Oxymesterone A Oxymetholone A Oxypertine B Oxypertine Hydrochloride B Oxyphenbutazone B Oxyphencyclimine B Hydrochloride Oxyphenonium Bromide B 5mg (MD) 15mg (MDD) Oxytetracycline A Oxytetracycline Calcium A Oxytetracycline Dihydrate A Oxytetracycline Hydrochloride A Oxytocin, natural B Oxytocin, synthetic B Paclitaxel A Palivizumab A

78 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Pamidronate Disodium A Pancreatin B (1) (1) Capsules 21,000 European Pharmacopoeia units of lipase per capsule (MS) (2) (2) Powder 25,000 European Pharmacopoeia units of lipase per capsule (MS) Pancuronium Bromide A Pantoprazole B Pantoprazole Sodium B Sesquihydrate Papaveretum A Papaverine B (1) By inhaler (2) Otherwise than by (2) 50mg (MD) 150mg inhaler (MDD) Papaverine Hydrochloride B (1) By inhaler (2) Otherwise than by (2) Equivalent of 50mg inhaler of Papaverine (MD) Equivalent of 150mg of Papaverine (MDD) Papaver somniferum L. – the B capsules thereof Paraldehyde B Paramethadione B Paramethasone Acetate A Parathyroid Gland A Parecoxib A Parecoxib Sodium A Pargyline Hydrochloride A Paroxetine Hydrochloride A Pausinystalia yohimba (K. B Schum) Pierre ex Beille. – the bark thereof. (Yohimbine bark) Pecilocin A Pegfilgrastim A Peginterferon Alfa-2a A Peginterferon Alfa-2b A

79 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Pegvisomant A Pemoline A Pempidine Tartrate B Penamecillin A Penbutolol Sulphate B Penciclovir A Penfluridol A Penicillamine B Penicillamine Hydrochloride B Pentaerythritol Tetranitrate B Pentagastrin A Pentamidine A Pentamidine Isethionate A Pentazocaine Hydrochloride A Pentazocine Hydrochloride A Pentazocine Lactate A Pentetreotide C Penthienate Methobromide B 5mg (MD) 15mg (MDD) Pentobarbital A Pentobarbital Sodium A Pentolinium Tartrate B Pentostatin A Pentoxifylline (Oxpentifylline) B Pentyl Nitrite A Perfluamine A Perflutren C Pergolide B Pergolide Mesylate B Perhexiline Maleate B Pericyazine B Perindopril B Permethrin B External Perospirone A

80 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Perphenazine B Pethidine Hydrochloride A Phenacetin A 0.1% (MS) External Phenazone B External Phenazone and Caffeine Citrate B Phenazone Salicylate B Phenelzine Sulphate A Pheneticillin Potassium A Phenformin Hydrochloride B Phenglutarimide Hydrochloride B Phenindione B Phenmetrazine Hydrochloride A Phenobarbital A Phenobarbital Sodium A Phenoperidine Hydrochloride A Phenothrin B External Phenoxybenzamine B Hydrochloride Phenoxymethylpenicillin A Phenoxymethylpenicillin A Calcium Phenoxymethyl-penicillin A Potassium Phenprocoumon B Phensuximide B Phentermine Hydrochloride A Phentermine Resinate 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 40mg of Phenylephrine Hydrochloride (MDD)

81 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Phenylephrine Hydrochloride B (1) Internal (other (1) 10mg (MD), 40mg than controlled (MDD) release capsules and tablets, nasal sprays and nasal drops)

(2) Controlled release capsules (2) 20mg (MD), 40mg and tablets (MDD)

(3) Nasal sprays and nasal drops (3) 0.5% (MS) (4) External (except local opthalmic use) Phenylmethylbarbituric Acid A Phenylpropanolamine B Internal: Hydrochloride (1) All products (1) 25 mg (MD), except controlled 100mg (MDD) release capsules, nasal sprays and nasal drops (2) 50mg (MD), (2) Controlled release 100mg (MDD) (3) 2.0% (MS) capsules (3) Nasal sprays and nasal drops Phenylpropanolamine Resinate B Internal Equivalent of 50mg of Phenylpropanolamine Hydrochloride (MD), Equivalent of 100mg of Phenylpropanolamine Hydrochloride (MDD) Phenytoin B Phenytoin Sodium B Pholcodine A 1.5% (MS) 20mg (MD) Pholcodine Citrate A Equivalent of 1.5% Equivalent of 20mg of of Pholcodine Pholcodine (MD) (MS) Pholcodine Tartrate A Equivalent of 1.5% Equivalent of 20mg of of Pholcodine Pholcodine (MD) (MS)

Phthalylsulfathiazole B Physostigmine B Physostigmine Aminoxide B Salicylate Physostigmine Salicylate B

82 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Physostigmine Sulphate B Phytolacca species A Phytomenadione B Picrotoxin B Pilocarpine B Pilocarpine Hydrochloride B Pilocarpine Nitrate B Pilocarpus jaborandi Holmes B External Pimozide B Pinacidil B Pinazepam A Pindolol B Pioglitazone B Pioglitazone Hydrochloride B

83 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Pipecuronium Bromide A Pipenzolate Bromide B 5mg (MD) 15mg (MDD) Piperacillin Sodium A Piperazine Adipate B Piperazine Citrate B Piperazine Hydrate B Piperazine Oestrone Sulphate A Piperazine Phosphate B Piperidolate Hydrochloride B 50mg (MD) 150mg (MDD) Pipothiazine Palmitate B Pipradrol Hydrochloride A Piracetam B Pirbuterol Acetate B Pirbuterol Hydrochloride B Pirenzepine Hydrochloride A Piretanide B Piritramide A Piromidic Acid A Piroxicam B 0.5% (MS) External:

30.0g (MPS) For local symptomatic relief of 7 days (MPT) pain and inflammation in the trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism.

For use in adults and children not under 12 years Pirprofen B Pituitary Gland (Whole Dried) B Pituitary Gland, Powdered B (Posterior Lobe) Pivampicillin Hydrochloride A Pivmecillinam A Pivmecillinam Hydrochloride A Pizotifen B Pizotifen Maleate B Podophyllotoxin B Podophyllum species B

84 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Podophyllum Resin B 20.0% (MS) External Poldine Methylsulphate B 2mg (MD) 6mg (MDD) Polidexide B Polyestradiol Phosphate A Polymyxin B Sulphate A Polythiazide B Porfimer C Porfimer Sodium C Potassium Arsenite B 0.0127% (MS) Potassium Bromide B Potassium Perchlorate B Practolol B Pralidoxime Chloride B Pralidoxime Iodide B Pralidoxime Mesylate B Pramipexole B Pramipexole Dihydrochloride B Monohydrate

85 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Prasterone A Pravastatin B Pravastatin Sodium B Prazepam A Prazosin Hydrochloride B Prednisolone A Prednisolone 21-Steaglate A Prednisolone Acetate A Prednisolone Butylacetate A Prednisolone Hexanoate A Prednisolone m-Sulphobenzoate A Prednisolone Pivalate A Prednisolone Sodium m- A Sulphobenzoate Prednisolone Sodium Phosphate A Prednisone A Prednisone Acetate A Pregnenolone A Pregnenolone Succinate A Prenalterol Hydrochloride B Prenylamine Lactate B Prilocaine A Any use except local opthalmic use Prilocaine Hydrochloride A Any use except local opthalmic use Primidone B Probenecid B Probucol B Procainamide Hydrochloride B Procaine Benzylpenicillin A Procaine Hydrochloride A Any use except local opthalmic use Procarbazine Hydrochloride A Procaterol Hydrochloride B Prochlorperazine Edisylate B Prochlorperazine Maleate B Prochlorperazine Mesylate B Procyclidine Hydrochloride B Profenamine Hydrochloride A Progesterone A Proguanil Hydrochloride B Prophylaxis of malaria Prolactin A Proligestone A Prolintane Hydrochloride A

86 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Promazine Embonate B Promazine Hydrochloride B Propafenone Hydrochloride B Propanidid B Propantheline Bromide B 15mg (MD) 45mg (MDD) Proparacaine Hydrochloride B Propetandrol A Propiverine B Propiverine Hydrochloride B

87 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration 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 B Proxymetacaine Hydrochloride B Any use except local ophthalmic use Pseudoephedrine Hydrochloride B Internal:

(1) All prolonged (1) 120mg (MD) 240mg release products (MDD)

(2) Any other (2) 60mg (MDD) product 240mg (MDD)

Pseudoephedrine Sulphate B Internal:

(1) All products (1) 60mg (MD), 180mg except (MDD) controlled release capsules and tablets (2) 180mg (MDD) (2) Controlled release capsules and tablets Pyrantel Embonate B Pyrantel Tartrate B Pyrazinamide B Pyridostigmine Bromide B Pyridoxine Hydrochloride B 50mg (MD) Pyrimethamine B Pyritinol B Pyritinol Hydrochloride B Quazepam A Quetiapine A Quetiapine Fumarate A

88 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Quinagolide A Quinagolide Hydrochloride A Quinapril B Quinapril Hydrochloride B Quinbolone A Quinestradol A Quinestrol A Quinethazone B Quinidine B Quinidine Bisulphate B Quinidine A Phenylethylbarbiturate Quinidine Polygalacturonate B Quinidine Sulphate B Quinine B 100mg (MD) 300mg (MDD) Quinine and Urea Hydrochloride B Quinine Bisulphate B Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD) Quinine Dihhydrochloride B Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD) Quinine Ethyl Carbonate B Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD) Quinine Glycerophosphate B Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD) Quinine Hydrobromide B Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD) Quinine Hydrochloride B Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD) Quinine Iodobismuthate B Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD)

89 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Quinine Phenylcinchoninate B Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD) Quinine Phosphate B Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD) Quinine Salicylate B Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD) Quinine Sulphate B Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD) Quinine Tannate B Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD) Quinisocaine Hydrochloride B Any use except local ophthalmic use Quinupristin A Quinupristin Mesilate A Rabeprazole B Rabeprazole Sodium B Radionuclide compounds C Radionuclides C Raloxifene Hydrochloride B Raltitrexed A Ramipril B Ranitidine Bismuth Citrate B Ranitidine Bismutrex B Ranitidine Hydrochloride B 14 days (MPT) Internal: Equivalent to 75mg of For the short term Ranitidine (MD) symptomatic relief of acid indigestion and Equivalent to 150mg of heartburn. Ranitidine (MDD)

For use in adults and children not under 16 years. Rasburicase A Rauwolfia serpentina (L.) Benth. B ex Kurtz Rauwolfia vomitoria Afzel. B Razoxane A Reboxetine Mesylate A

90 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Reboxetine Methanesulphonate A Recombinant Human Osteogenic A Protein -1 (BMP-7) Remifentanil Hydrochloride A Remoxipride Hydrochloride A Repaglinide B Reproterol Hydrochloride B Rescinnamine B Reserpine B Reteplase A Retinol (Vitamin A) B (1) Internal (1) 7,500 iu (2,250mcg Retinol equivalent) (MDD)

(2) External Retinol Acetate (Vitamin A B (1) Internal (1) Equivalent to 7,500 Acetate) iu Vitamin A (2,250mcg Retinol Equivalent) (MDD)

(2) External Retinol Palmitate (Vitamin A B (1) Internal (1) Equivalent to 7,500 Palmitate) iu Vitamin A (2,250mcg Retinol Equivalent) (MDD)

(2) External Reviparin Sodium A Ribavirin A Rifabutin A Rifampicin A Rifamycin A Riluzole A Rimexolone B Rimiterol Hydrobromide B Risedronate B Risedronate Sodium B Risperidone A Ritodrine Hydrochloride B Ritonavir A Rituximab A Rivastigmine A Rivastigmine Hydrogen Tartrate A Rizatriptan Benzoate B Rocuronium Bromide A Rofecoxib B

91 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Rolitetracycline Nitrate A Ropinirole Hydrochloride B Ropivacaine Hydrochloride A Rosiglitazone B Rosoxacin A Roxibolone A Safrole A Salbutamol B Salbutamol Sulphate B Salmefamol B Salmeterol B Salmeterol Xinafoate B Salsalate B Samarium (153Sm) Lexidronam C Pentasodium Saquinavir A Saquinavir Mesylate A Saralasin Acetate B Sargramostim A Sassafras species. – the bark, A root and oil thereof Satumomab C Schoenocaulon officinale B (Schlect & Cham) A. Gray Senecio jacobaea L. (Ragworth) A Sera and Antisera:- Botulin Antitoxin A Diptheria Antitoxin A Gas-gangrene Antitoxin A (Oedematiens) Gas-gangrene Antitoxin A (Perfringens) Gas-gangrene Antitoxin A (Septicum) Hepatitis A Immunoglobulins A

92 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Leptospira Antiserum A Mixed Gas-gangrene A Antitoxin Rabies Antiserum A Scorpion Venom Antiserum A Serum Gonadotrophin A Snake Venom Antiserum A Tetanus Antitoxin A Varicella Zoster A Immunoglobulins Secbutobarbital A Secbutobarbital Sodium A Secobarbital (Quinalbarbitone) A Secobarbital Sodium A Secretin B Selegiline Hydrochloride B Sermorelin A Sermorelin Acetate A Sertindole A Sertraline Hydrochloride A Sevelamer A Sevelamer Hydrochloride A Sevoflurane A Sibutramine A Sibutramine Hydrochloride A Silandrone A Sildenafil A Sildenafil Citrate A Simvastatin B Sirolimus A

93 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Sisomicin A Sisomicin 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) (1) Dentrifices

(2) (2) Other products for use in the prevention of dental caries in the form of:- (a) tablets or (a) 2.2mg (MDD) drops (b) 0.2% (MS) (b) mouth rinses other than those for daily use (c) 0.05% (MS) (c) mouth rinses for daily use Sodium Fusidate A Sodium Metrizoate B Sodium Monofluorophosphate B 1.14% (MS) Dentifrice Sodium Nitroprusside Dihydrate A Sodium Oxybate A Sodium Phenylbutyrate A Sodium Stibogluconate B Somatorelin A Somatorelin Acetate A Somatotrophin A Somatrem A Somatropin A Sotalol Hydrochloride B Sparfloxacin A

94 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Spectinomycin A Spectinomycin Hydrochloride A Spiramycin A Spiramycin Adipate A Spironolactone A Spironolactone A Stannous Flouride B 0.62% (MS) Dentifrice Stanolonetanozolol A Stanozolol A Stavudine A Stenbolone A Stenbolone Acetate 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 Strychnos ignatii Berg. A Strychnos nux vomica L. – the A seeds thereof Succimer C (Dimercaptosuccinic Acid)

95 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Succinylsulfathiazole B Sufentanil Citrate A Sulbactam Sodium A Sulbactam Tosylate A Sulbenicillin A Sulbenicillin Sodium A Sulconazole Nitrate B External (except vaginal use) Sulesomab C Sulfacarbamide (Sulphaurea) A Sulfacetamide A Sulfacetamide Sodium A Sulfacytine A Sulfadiazine A Sulfadiazine Silver A Sulfadiazine Sodium A Sulfadimidine A Sulfadimidine Sodium A Sulfadoxine A Sulfafurazole A Sulfafurazole Diethanolamine A Sulfaguanidine B Sulfaloxic acid B Sulfamethizole A Sulfamethoxazole A Sulfametopyrazine A Sulfametoxydiazine A Sulfametoxypyridazine A Sulfametoxypyridazine Sodium A Sulfamonomethoxine A Sulfamoxole A Sulfaphenazole A Sulfasalazine B

96 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Sulfathiazole A Sulfathiazole Sodium A Sulfinpyrazone B Sulindac B Suloctidil B Sulphaloxate Calcuim A Sulphamerazine A Sulphamerazine Sodium A Sulphanilamide A Sulphanilamide, N-Benzoyl A Sulphapyridine A Sulphapyridine Sodium A Sulphur Hexafluoride C 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 Symphytum species (Comfrey) A External Tacalcitol A Tacalcitrol Monohydrate B Tacrine Hydrochloride A Tacrolimus A Tadalafil A Talampicillin A Talampicillin Hydrochloride A Talampicillin Napsylate A Tamoxifen Citrate B Tamsulosin Hydrochloride B Tasonermin A Taurolidine B Tazarotene B Tazobactam Sodium A Tegafur A Tegaserod A Tegaserod Maleate A

97 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Teicoplanin A Telithromycin A Telmisartan B Temafloxacin A Temafloxacin Hydrochloride A Temazepam A Temocillin A Temocillin Sodium A Temoporfin A Temozolomide A Tenecteplase A Teniposide A Tenofovir A Tenofovir Disoproxil Fumarate A

98 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Tenoxicam B Terazosin Hydrochloride B Terbinafine B Terbinafine Hydrochloride B 1.0% (MS) External: Products other than spray 15g (MPS) solutions. For the treatment of 14 days (MPT) tinea cruris (jock or dhobie itch ) and tinea pedis (athlete's foot).

For use in adults and children not under 16 years. Terbutaline B Terbutaline Sulphate B Terfenadine B Terlipressin A Terodiline Hydrochloride B Tertatolol Hydrochloride B Testosterone A 19-nor-Testosterone A Testosterone Cyclohexyl- A propionate Testosterone Phenylpropionate A Testosterone 17β Chloral A Hemiacetal Testosterone Acetate A Testosterone Cypionate A Testosterone Decanoate A Testosterone Enanthate A Testosterone Isocaproate A Testosterone Propionate A Testosterone Undecanoate A Tetrabenazine B Tetracaine (Amethocaine) A Any use except local ophthalmic use Tetracaine Gentisate A Any use except local ophthalmic use Tetracaine Hydrochloride A Any use except local ophthalmic use Tetracosactide (Tetracosactrin) A Tetracosactide Acetate A Tetracycline A Tetracycline Hydrochloride A

99 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Tetracycline Phosphate Complex A Tetrazepam A Tetrofosmin C Thalidomide A Thallium Acetate A Thallous Chloride A Theophylline B Thiambutosine B Thiamphenicol A Thiamphenicol Glycinate A Hydrochloride Thiamphenicol Palmitate A Thiethyleperazine Maleate B Thiethylperazine B Thiethylperazine Malate B Thiocarlide B Thiomesterone A Thiopental Sodium A Thiopropazate Hydrochloride B Thioproperazine Mesylate B Thioridazine B Thioridazine Hydrochloride B Thiosinamine A Thiotepa A Thiothixene B Thiouracil B Thyroid B Thyrotrophin A Thyrotropin Alfa C Tiamulin Fumarate A Tiaprofenic Acid B Tibezonium Iodide A Tibolone A Ticarcillin Sodium A Ticlopidine A Ticlopidine Hydrochloride A

100 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Tienilic Acid B Tigabine B Tigloidine Hydrobromide B Tiludonate Disodium B Tiludronic Acid 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 Tioguanine A Tiotropium Bromide B Tirofiban A Tirofiban Hydrochloride A Tirofiban Hydrochloride A

101 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration 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 Tolcapone B Tolfenamic Acid B Tolmetin Sodium B Tolrestat B Tolterodine L-Tartrate B Topiramate B Topotecan Hydrochloride A Torasemide Sodium B Toremifene B Toremifine Citrate B Tosactide (Octacosactrin) A Tramadol A Tramadol Hydrochloride B Tramazoline Hydrochloride B Trandolapril B Tranexamic Acid B Tranylcypromine Sulphate A Trastuzumab A Travoprost A

102 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration 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 Tribulus terrestris L. B Triclofos Sodium B Trientine Hydrochloride B Trifluoperazine B Trifluoperazine Hydrochloride B Trifluperidol A Trifluperidol Hydrochloride A Trifluridine A Trihexyphenidyl Hydrochloride B Trilostane A Trimazosin Hydrochloride B Trimegestone A Trimetaphan Camsylate B Trimetazidine B Trimetazidine Hydrochloride B Trimethadione (Troxidone) B Trimethoprim A Trimetrexate A Trimetrexate A Trimetrexate Glucuronate A Trimetrexate Glucuronate A Trimipramine Maleate A Trimipramine Mesylate A Tripotassium Dicitrato- B bismuthate Triptorelin A Troglitazone A Tropicamide B Tropisetron Hydrochloride A Trospium Chloride B

103 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Trovafloxacin Mesylate A 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 Urea-C13 A Urethane A Uridine-5-Triphosphoric Acid B Urofollitropin A Urokinase B Ursodeoxycholic Acid B Vaccines: Anthrax Vaccines A Bacillus Calmette-Guerin A Vaccines (BCG) Cholera Vaccines A Diphtheria and Tetanus A Vaccines Diphtheria Tetanus and A Pertussis Vaccines Diphtheria Vaccines A Diphtheria, Tetanus and A Poliomyelitis Vaccines Diphtheria, Tetanus, Pertussis A (Acellular, Component) and Hepatitis B (rDNA) Vaccine (Adsorbed) Diphtheria, Tetanus, Pertussis A and Haemophilus Influenzae Vaccines

104 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Diphtheria, Tetanus, Pertussis A and Poliomyelitis Vaccine Diptheria, Tetanus, Pertussis A and Hepatitis B Vaccine Eltor Vaccine A Haemophilus b Conjugate A (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine Haemophilus Influenzae A Conjugate Vaccine (Diphtheria CRM 197 Protein Conjugate) Haemophilus Influenzae A Conjugate Vaccine (Diphtheria Toxoid Conjugate) Haemophilus Influenzae A Conjugate Vaccine (Meningococcal Protein Conjugate) Haemophilus Influenzae A Conjugate Vaccine (Tetanus Toxoid Conjugate) Haemophilus Type B A Conjugate Vaccines Hepatitis A (Inactivated) and A Hepatitis B (rDNA) Vaccine (Adsorbed) Hepatitis A Vaccines A Hepatitis A Virus A (Inactivated) and Hepatitis B Vaccine Hepatitis B Vaccines A Influenza Vaccines A Measles Vaccines A Measles, Mumps and Rubella A Virus Vaccine (Live) Melanoma Vaccine A Meningococcal A Polysaccharide Vaccines Mumps Vaccines A

105 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Old Tuberculin A Pertussis Vaccine A Plague Vaccine A Pneumococcal Vaccines A Poliomyelitis Vaccine A (Inactivated) Poliomyelitis Vaccine (Oral) A Rabies Vaccine A Rotavirus Vaccine A Rotavirus Vaccines A Rubella Vaccines A Schick Control A Schick Test Toxin A Smallpox Vaccines A Tetanus Vaccines A Thyphoid Vaccine (Live, Oral, A Strain Ty21a) Tick-borne Encephalitis A Vaccines Tuberculin Purified Protein A Derivative Typhoid and Tetanus Vaccine A Typhoid Polysaccharide A Vaccine Typhoid Vaccine A Typhoid-paratyphoid A and B A and Cholera Vaccine Typhoid-paratyphoid A and B A and Tetanus Vaccine Typhoid-paratyphoid A and B A Vaccine Typhus Vaccine A Varicella Zoster Vaccine A (Live) Yellow Fever Vaccines A Valaciclovir A Valaciclovir Hydrochloride A Valdecoxib B Valganciclovir A Valganciclovir Hydrochloride A

106 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Valproate Sodium B Valproic Acid B Valsartan B Vancomycin Hydrochloride A Vardenafil A Vasopressin A Vasopressin Tannate A Venlafaxine A Venlafaxine Hydrochloride A Veralipride B Verapamil Hydrochloride B Veratrine B Veratrum album L. B Veratrum viride Ait. B Vercuronium Bromide A Verteporfin C Vidarabine A Vigabatrin B Viloxazine Hydrochloride B Vinblastine Sulphate A Vincristine Sulphate A Vindesine Sulphate A Vinorelbine Tartrate A Viomycin Pantothenate A Viomycin Sulphate A Voriconazole A Viscum album L. (Mistletoe) A Votumumab C Warfarin B Warfarin Sodium B Xamoterol Fumarate B Xipamide B Yohimbine Hydrochloride B Zafirlukast B Zalcitabine A Zaleplon A Zanamivir A Zeranol A Zidovudine A Zimeldine Hydrochloride A Zipeprol Hydrochloride A Ziprasidone Hydrochloride A Ziprasidone Mesylate A Zofenopril B

107 Circumstances excluding products from prescription- only control Column Column 1 Column 3 Column 4 Column 5 2 Use, Maximum pharmaceutical Maximum Dose Part in strength, pack Substance form or manner and Maximum Schedule size or period of Daily Dose of treatment administration Zofenopril Calcium B Zoledronic Acid A Zolmitriptan B Zolpidem Tartrate 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).

108

Second Schedule

Part 1 (Regulation 5(5)) 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 Flurbiprofen Hydrocortisone Hydrocortisone Acetate Ibuprofen Ketoprofen Minoxidil Naproxen Nicotine Nicotine Resinate Oxetacaine Piroxicam

Second Schedule

Part 2 (Regulation 6)

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

Aspirin Colecalciferol Cyanocobalamin Ergocalciferol Folic Acid Hypericum perforatum L. Nicotinic acid Pyridoxine Hydrochloride Retinol Retinol Acetate Retinol Palmitate Sodium Fluoride Sodium Monofluorophosphate Stannous Fluoride

109

Second Schedule

Part 3 (Regulation 20(4))

Substances which when contained in certain homeopathic medicinal products may be supplied without a prescription and in non-pharmacy outlets

Aconitum napellus L Anamirta cocculus (L.) Wight & Arn. Arsenic Atropa belladonna L. Caulophyllum thalictroides (L.) Mich. Conium maculatum L. Cytisus scoparium L. Digitalis purpurea L. Ephedra vulgaris Rich. Gelsemium nitidum L. Ginkgo biloba L. Hypericum perforatum L. Mandragora autumnalis Bertol. Phytolacca species Podophyllum species Pilocarpus jaborandi Holmes Rauwolfia serpentina (L.) Benth. ex Kurtz Schoenocaulon officinale (Schlect & Cham) A.Gray Snake Venoms Strychnos ignatii Berg. Strychnos nux vomica L. Symphytum species Veratrum album L. Viscum album L.

Second Schedule

Part 4 (Regulation 20(5))

Herbal substances which when contained in extemporaneously prepared medicinal products may be supplied without a prescription in certain limited circumstances

Ginkgo biloba L. Hypericum perforatum L.

110

Third Schedule

Part 1 (Regulation 7(3))

Substances which, when contained in Medicinal Products intended for external use that 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

Alclomethasone Dipropionate Fluocortolone Beclometasone Dipropionate Fluocortolone Hexanoate Betametasone Fluocortolone Pivalate Betametasone Benzoate Fluorometholone Betametasone Dipropionate Fluprednidene Acetate Betametasone Sodium Phosphate Formocortal Betametasone Valerate Halcinonide Clobetasol Propionate Hydrocortisone Clobetasone Butyrate Hydrocortisone Acetate Desonide Hydrocortisone Butyrate Desoxymethasone Medrysone Dexamethasone Methylprednisolone Acetate Dexamethasone Sodium Phosphate Mometasone Furoate Diflorasone Diacetate Prednisolone Diflucortolone Valerate Prednisolone Acetate Fluclorolone Acetonide Prednisolone Hexanoate Fludroxycortide Prednisolone Sodium Phosphate Flumethasone Pivalate Prednisolone Steaglate Fluocinolone Acetonide Triamcinolone Acetonide Fluocinonide

Third Schedule

Part 2 (Regulation 7(3))

Substances which, when contained in Medicinal Products that are intended for use as an oral contraceptive 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

Cyproterone acetate Levonorgestrel Drospirenone Lynestrenol Desogestrel Mestranol Estradiol valerate Norelgestromin Ethinylestradiol Norethisterone Etynodiol diacetate Norethisterone acetate Gestodene Norgestimate

111

Fourth Schedule

(Regulation 8)

Substances not to be contained in a Medicinal Product supplied under the exemption conferred by Regulation 8

Ammonium Bromide Meclofenoxate Hydrochloride Calcium Bromidolactobionate Mifepristone Calcium Bromide Piracetam Chlomethiazole Edisilate Potassium Bromide Chlomethiazole Sodium Bromide Embutramide Strychnine Hydrochloride Fluanisone Tacrine Hydrochloride Hydrobromic Acid Thiopental Sodium

Fifth Schedule

Cautionary and Warning Notices for Dispensed Medicinal Products

(Regulation 9(2)(i))

Notice Examples of medicinal products for which the notice appearing opposite may be appropriate

1 Warning. May cause drowsiness Products for children containing antihistamines or other products given to children that can cause drowsiness. 2 Warning. May cause drowsiness. If affected do not Products for adults that can cause drowsiness thereby drive or operate machinery. Avoid alcoholic drink. affecting the ability to drive and operate hazardous machinery. 3 Warning. May cause drowsiness. If affected do not Monoamine-oxidase inhibitors when "Treatment Card" is drive or operate machinery supplied. 4 Warning. Causes drowsiness which may continue the Hypnotics and certain other products with sedative effects, next day. If affected do not drive or operate machinery. prescribed to be taken at night Avoid alcoholic drink 5 Warning. Avoid alcoholic drink 6 Do not take indigestion remedies at the same time of Products coated to resist gastric acid (e.g. enteric coated day as this medicine. tablets). This is to avoid the possibility of premature dissolution due to the presence of an alkaline pH. 7 Do not take indigestion remedies or medicines Products containing ciprofloxacin and some other quinolones, containing iron or zinc at the same time of day as this doxycycline, lymecycline, minocycline or penicillamine medicine 8 Do not take milk, indigestion remedies or medicines Products containing norfloxacin, tetracyclines other than containing iron or zinc at the same time of day as this doxycycline and minocycline medicine. 9 Do not stop taking this medicine except on your Products (such as beta- adrenoceptor blocking drugs, anti- doctor's advice 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 or where withdrawal is likely to be a particular hazard (e.g clonidine). 10 Take at regular intervals. Complete the prescribed Antimicrobial drugs given by mouth. course unless otherwise directed

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Notice Examples of medicinal products for which the notice appearing opposite may be appropriate

11 Warning. Follow the printed instructions you have Products (such as anticoagulants, lithium and oral been given with this medicine. corticosteroids) 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 products containing aspirin while taking Products containing salicylate derivatives this medicine. 14 Dissolve or mix with water before taking. 15 This medicine may colour the urine. Products such as levodopa (dark reddish), phenolphthalein (pink), triamterene (blue), and rifampicin (red). 16 Caution flammable: keep away from fire or flames. 17 Allow to dissolve under the tongue. Do not transfer Glyceryl trinitrate Tablets. from this container. Keep tightly closed. Discard eight weeks after opening 18 Not to be used for prolonged periods or at higher levels Sympathomimetics for internal use. than those recommended without medical advice. 19 Do not take more than.....in 24 hours or...... in any one Products containing ergotamine. week 20 Do not take more than...... in 24 hours. Products for the treatment of acute migraine except for ergotamine (see 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 and acid in the stomach. 22 Take half to one hour before food. Products the action of which is thereby improved. 23 To be swallowed whole, not chewed. . Enteric coated or modified release products or in the case of products that taste very unpleasant or may damage the mouth. 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 or which are better absorbed with food. 29 Warning. Do not exceed the stated dose. 30 Caution. It is dangerous to exceed the stated dose. Products that are recommended to be taken on an “as required” basis. 31 Do not take more than 2 at any one time. Do not take Dispensed tablets or capsules containing paracetamol labelled more than 8 in 24 hours. 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 children under three years of age or Products containing hexachlorophane. for application to large areas of skin unless on medical advice. 43 Not to be applied to broken skin and not to be used for Products containing boric acid or borax. 113

Notice Examples of medicinal products for which the notice appearing opposite may be appropriate

children under three years of age. 44 When taking this medicine and for 14 days after your Monoamine-oxidase inhibitors - (Treatment Card Text). 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. 45 If the condition is not improved, consult your doctor. 46 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.

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Sixth Schedule (Regulation 22)

Medicinal Products (Prescription and Control of Supply) Regulations 2003

CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS

This Certificate is issued by me, the undersigned, for the purpose of regulation 22 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003, being -

(1)______

I hereby certify that I received on the ______day of______20______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.

GIVEN under my Official Seal this 11th day of November, 2003. L.S. MICHEÁL MARTIN ______Minister for Health and Children

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Explanatory Note

(This note is not part of the Instrument and does not purport to be a legal interpretation).

The main purpose of these Regulations is to consolidate and to update the controls applicable to the prescription and supply of medicinal products to the public in accordance with the requirements of E.U. Directive 2001/83/EC of 6th November 2001 insofar as that Directive relates to the classification for the supply of medicinal products for human use (OJ No L311, 28.11.2001, p67). The Regulations also set out the classification for supply of medicinal products to the public as required by that Directive.

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-only control are also specified and incorporates a pharmacy-only category into which most such non- prescription products 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" is 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, as is the supply by means of automatic vending machines.

The Regulations also impose particular restrictions on the sale of medicinal products containing paracetamol. In this context they prescribe maximum pack sizes for products when sold in pharmacies and in non-pharmacies. They set out the precautionary and warning statements that must appear on the packs and they prohibit the sale of multiple packs in the course of a single transaction. They also require that all solid unit dosage forms be included in blister packs or other equivalent form on packaging with appropriate exemptions for supplies made on prescription.

Certain exemptions are also provided in respect of certain low strength homeopathic medicinal products, which will be available to the public without a prescription and also in the case of certain extemporaneously prepared herbal medicinal products that are used by medical herbalists who are not medical practitioners.

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.

Copies may be obtained from the Government Publications Sale Office, Sun Alliance House, Molesworth Street, Dublin 2 or by mail order from Government Publications, Postal Trade Section, 51 St Stephen’s Green, Dublin 2, Fax no: 01 6476843, Price €12.19.

Department of Health and Children November, 2003

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