1997 No. 1830

MEDICINES

The Prescription Only Medicines (Human Use) Order 1997

Made

Laid before Parliament

Coming into force

The Secretary of State concerned with health in England, the Secretaries of State concerned with health and with agriculture in Wales and in Scotland respectively, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred on them by sections 58(1), (4) and (5), 59(1) and 129(4) of the Medicines Act 19681 or, as the case may be, those conferred by the said provisions and now vested in them2, and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by this Order, pursuant to section 129(6) of that Act, and after consulting and taking into account the advice of the Medicines Commission pursuant to sections 58(6) and 129(7) of that Act, hereby make the following Order:

Citation, commencement and interpretation1

1

This Order may be cited as the Prescription Only Medicines (Human Use) Order 1997 and shall come into force on 18th August 1997.

2

In this Order, unless the context otherwise requires–

  • “the Act” means the Medicines Act 1968;

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

  • “appropriate nurse practitioner” means–

    1. a

      a person who–

      1. i

        is registered in Part 1 or 12 of the Register maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of the Nurses, Midwives and Health Visitors Act 19793 (referred to below in this definition as “the professional register”), and

      2. ii

        has a district nursing qualification additionally recorded in the professional register under rule 11 of the Nurses, Midwives and Health Visitors Rules 19834; or

    2. b

      a person who is registered in Part 11 of the professional register as a health visitor;

    against whose name (in each case) is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances for patients;

  • F54“Common Services Agency” means the Common Services Agency for the Scottish Health Service established under section 10 of the National Health Service (Scotland) Act 1978;

  • F54“Community marketing authorization” means a marketing authorization granted by the European Community under Council Regulation (EEC) No. 2309/93;

  • “controlled drug” has the meaning assigned to it by section 2 of the Misuse of Drugs Act 19715;

  • “cyanogenetic substances” means preparations which–

    1. a

      are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17, or

    2. b

      contain more than 0.1 per cent by weight of any substance having the formula either α-Cyanobenzyl-6-O-β-d-glucopyranosyl-β-d-glucopyranoside or α-Cyanobenzyl-β-d-glucopy ranosiduronic acid;

  • “dosage unit” means–

    1. 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

    2. b

      where a medicinal product is not in any such form, the unit of measurement which is used as the unit by reference to which the dose of the medicinal product is measured;

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

  • F54“Health Authority”—

    1. a

      in relation to England and Wales, has the same meaning as in the National Health Service Act 1977;

    2. b

      in relation to Scotland, means a Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978; and

    3. c

      in relation to Northern Ireland, means a Health and Social Services Board established under Article 16 of the Health and Personal Social Services (Northern Ireland) Order 1972;

  • “health prescription” means a prescription issued by a doctor, dentist or nurse prescriber under or by virtue of–

    1. a

      in England and Wales, the National Health Service Act 19776,

    2. b

      in Scotland, the National Health Service (Scotland) Act 19787, and

    3. c

      in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 19728;

  • F54“homoeopathic certificate of registration” means a certificate of registration for the purposes of the Medicines (Homoeopathic Medicinal Products For Human Use) Regulations 1994;

  • “inhaler” does not include an aerosol;

  • F54“marketing authorization” includes a reference both to a United Kingdom marketing authorization and to a Community marketing authorization;

  • “master” has the same meaning as in section 313(1) of the Merchant Shipping Act 19959;

  • “maximum daily dose” or “MDD” means the maximum quantity of a substance contained in the amount of a medicinal product which it is recommended should be taken or administered in a period of 24 hours;

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

  • “maximum strength” means–

    1. a

      the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product;

    2. b

      the maximum percentage of a substance contained in a medicinal product calculated in any of the following ways–

      1. i

        weight in weight,

      2. ii

        weight in volume,

      3. iii

        volume in weight, or

      4. iv

        volume in volume,

      and if the maximum percentage calculated in those ways differs, the higher or highest such percentage;

  • “medicinal product” includes any article or substance in respect of which section 58 of the Act has effect by virtue of an order made under section 104 of the Act, but does not include–

    1. a

      a medicinal product which is a veterinary drug as defined in section 132(1) of the Act or

    2. b

      an article or substance in respect of which section 58 has such effect where that article or substance is only to be administered to animals;

  • “the Misuse of Drugs Regulations” means, in relation to England, Wales and Scotland, the Misuse of Drugs Regulations 198510 and in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 198611;

  • F54“NHS trust”—

    1. a

      in relation to England and Wales, has the same meaning as in the National Health Service and Community Care Act 1990;

    2. b

      in relation to Scotland, has the same meaning as in the National Health Service (Scotland) Act 1978; and

    3. c

      in relation to Northern Ireland, means a Health and Social Services trust established under article 10 of the Health and Social Services (Northern Ireland) Order 1991;

  • “occupational health scheme” means a scheme in which a person, in the course of a business carried on by him, provides facilities for his employees for the treatment or prevention of disease;

  • “offshore installation” means an offshore installation within the meaning of the Mineral Workings (Offshore Installations) Act 197112 which is within–

    1. a

      tidal waters and parts of the sea in or adjacent to the United Kingdom up to the seaward limits of territorial waters;

    2. b

      waters in any area designated under section 1(7) of the Continental Shelf Act 196413;

  • “operator”, in relation to an aircraft, means the person for the time being having the management of the aircraft;

  • “parenteral administration” means administration by breach of the skin or mucous membrane;

  • F54“Patient Group Direction” means—

    1. a

      in connection with the supply of a prescription only medicine as referred to in article 12A(2), 12B or 12C, a written direction relating to the supply and administration of a description or class of prescription only medicine; or

    2. b

      in connection with the administration of a prescription only medicine as referred to in article 12A(2), 12B or 12C, a written direction relating to the administration of a description or class of prescription only medicine,

    • and which, in the case of either (a) or (b)—

      1. i

        is signed by a doctor or dentist, and by a pharmacist; and

      2. ii

        relates to supply and administration, or to administration, to persons generally (subject to any exclusions which may be set out in the Direction);

  • “prescription only medicine” means a medicinal product of a description or falling within a class specified in article 3 of this Order;

  • F54“Primary Care Trust” has the same meaning as in the National Health Service Act 1977;

  • “prolonged release” in relation to a medicinal product means a formulation of that product which–

    1. a

      is used to reduce the rate at which the active ingredient in that product is released after administration, and

    2. b

      is sold or supplied as a prolonged, controlled or sustained release medicinal product;

  • “registered midwife” means a person who is registered in Part 10 of the Register maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of the Nurses, Midwives and Health Visitors Act 1979;

  • “registered nurse” means a person who is registered in the Register maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of the Nurses, Midwives and Health Visitors Act 1979;

  • “registered ophthalmic optician” means a person who is registered in either of the Registers of ophthalmic opticians maintained under section 7(a) of the Opticians Act 198914;

  • “repeatable prescription” means a prescription which contains a direction that it may be dispensed more than once;

  • “sell” means sell by retail as defined in section 131 of the Act and “sale” has a corresponding meaning;

  • “soap” means any compound of a fatty acid with an alkali or amine;

  • F54“Special Health Authority”—

    1. a

      in relation to England and Wales, has the same meaning as in the National Health Service Act 1977;

    2. b

      in relation to Scotland, means a Special Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978; and

    3. c

      in relation to Northern Ireland, means a Special Health and Social Services Agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990;

  • “state registered chiropodist” means a person who is registered in the Register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 196015 by the Chiropodists Board;

  • F54“state registered paramedic” means a person who is registered in the register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960 by the Paramedics Board;

  • “supply” means supply in circumstances corresponding to retail sale as defined in section 131 of the Act;

  • “unit preparation” means a preparation, including a mother tincture, prepared by a process of solution, extraction or trituration with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert diluent, and then used either in this diluted form or, where applicable, by impregnating tablets, granules, powders or other inert substances.

  • F54“United Kingdom marketing authorization” means a marketing authorization granted by the licensing authority under the Medicines For Human Use (Marketing Authorisations Etc.) Regulations 1994 (including a product licence having effect as such an authorization by virtue of Schedule 6 to those Regulations).

3

For the purposes of this Order, the equivalence of a substance to a reference material shall be determined by calculating the amount of that reference material which is contained in that substance either by weight or, where the amount of the reference material is specified in terms of international units of activity, those units.

4

In this Order, unless the context otherwise requires, a reference–

a

to a numbered section is to the section of the Act which bears that number,

b

to a numbered article or Schedule is to the article of, or Schedule to, this Order which bears that number,

c

in an article or in a Part of a Schedule to a numbered paragraph is to the paragraph of that article or Part of that Schedule which bears that number, and

d

in a paragraph to a lettered sub-paragraph is to the sub-paragraph of that paragraph which bears that letter.

5

In Schedules 1 to 3–

a

entries specified in columns 2 to 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 columns 2 to 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;

b

the following abbreviations are used:

  • “g” for gram,

  • “iu” for international unit of activity,

  • “mcg” for microgram,

  • “mg” for milligram,

  • “ml” for millilitre.

6

In Schedule 3, the abbreviation “NPF” means the Nurse Prescribers' Formulary Appendix in the British National Formulary.

F557

In articles 12 to 12C, a reference to a prescription only medicine being sold or supplied for the purpose of being administered in accordance with the written directions of a doctor or dentist relating to a particular person, or in accordance with a Patient Group Direction, includes a reference to it being sold or supplied in accordance with such directions or such a Direction.

8

In articles 12A and 12C, a reference to an arrangement for the supply or adminstration of prescription only medicines includes a reference to an arrangement which covers such supply or administration and other matters.

9

In Schedule 7, Part I, a reference to treatment of a clinical situation includes a reference to any form of management of that situation.

Appropriate practitioners2

For the purposes of section 58 (medicinal products on prescription only), the following shall be appropriate practitioners–

a

in relation to the descriptions and classes of medicinal products specified in article 3, doctors, dentists, veterinary surgeons and veterinary practitioners;

b

in relation to the descriptions and classes of medicinal products specified in Schedule 3, appropriate nurse practitioners.

Medicinal products on prescription only3

Subject to article 6, the following descriptions and classes of medicinal products are specified for the purposes of section 58, namely–

a

medicinal products consisting of or containing a substance listed in column 1 of Schedule 1;

b

medicinal products that are controlled drugs;

c

medicinal products that are for parenteral administrationF19...;

d

cyanogenetic substances, other than preparations for external use;

e

medicinal products that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used;

f

medicinal products for human use which are classified as subject to medical prescription in marketing authorizations granted under Council Regulation 2309/9316;

g

medicinal products–

i

which are not of a description and do not fall within a class specified in subparagraphs (a) to (f),

ii

which are of a description in respect of which the conditions specified in section 59(1) are satisfied, and

iii

in respect of which a product licence or marketing authorization has been granted which contains a provision to the effect that the method of sale or supply of the medicinal product is to be only in accordance with a prescription given by an appropriate practitioner.

Duration of special provisions in relation to new medicinal products4

The duration specified for the purposes of section 59(2)(a) (duration of restrictions for certain new products) shall be a period of 5 years.

Exempt medicinal products5

1

A medicinal product shall be exempt from the restrictions imposed by section 58(2)(a) (restrictions on sale or supply) if it, or a substance in it, is listed in column 1 of Schedule 1 and there–

a

is an entry in column 2, 3, 4 or 5 of that Schedule which contains a condition and that condition is satisfied in accordance with the following provisions of this article; or

b

there is more than one such condition which applies where that substance is used in that product and each of those conditions is so satisfied.

2

Where a maximum strength is specified in column 2 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where the maximum strength of that substance in that medicinal product, or where specified in that column the maximum strength of a medicinal product which contains that substance, does not exceed that specified maximum or, where the medicinal product consists of more than one of the substances sodium fluoride, sodium monofluorophosphate or stannous fluoride combined in a dentifrice, where the maximum strength of that combination of substances in a product does not exceed the equivalent of 0.15 per cent of fluorine.

3

Where a route of administration is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for administration only by that route.

4

Where a use is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition in respect of use where it is sold or supplied only for use–

a

where a purpose for which it may be used is so specified, for that purpose;

b

where the class of persons in whom it may be used is so specified, in persons of that class.

5

Where a pharmaceutical form is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied in that pharmaceutical form.

6

Where a maximum dose is specified in column 4 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for use at a maximum dose which does not exceed that specified maximum dose.

7

Subject to paragraph (8), where a maximum daily dose is specified in column 4 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for use at a maximum daily dose which does not exceed that specified maximum daily dose.

8

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

  • Hyoscyamine Sulphate,

satisfies the condition only where it is sold or supplied for use at a maximum daily dose which does not exceed 1 milligram in total of the alkaloids derived from belladonna, hyoscyamus, stramonium or other solanaceous plant which are contained in that medicinal product.

9

Where a maximum period of use or a maximum frequency of use is specified in column 4 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for use for a maximum period or frequency, as the case may be, which does not exceed the maximum period of use or the maximum frequency of use which is so specified.

10

Where a maximum quantity is specified in column 5 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it, or where so specified in that column, the medicinal product which contains that substance is sold or supplied in a quantity which does not exceed that specified maximum quantity.

11

In paragraphs (2) to (7) and (9) and (10) a reference to a numbered column is a reference to the column bearing that number in Schedule 1.

Circumstances in which controlled drugs and medicinal products authorized by the European Community are not prescription only medicines6

1

A medicinal product shall not be a prescription only medicine by reason that it is a controlled drug listed in Schedule 2 to the Misuse of Drugs Act 1971 where, it–

a

contains not more than one of the substances listed in column 1 of Schedule 2 to this Order and no other controlled drug;

b

contains that substance at a strength that does not exceed the maximum strength specified in column 2 of that Schedule; and

c

is sold or supplied–

i

in such pharmaceutical form as may be specified in column 3 of that Schedule, and

ii

for use at a maximum dose which does not exceed that specified in column 4 of that Schedule.

2

A medicinal product for human use in respect of which a marketing authorization has been granted under Council Regulation 2309/93/EEC17 shall not be a prescription only medicine where that authorization does not classify the medicinal product as subject to medical prescription.

Exemption for parenteral administration in an emergency to human beings of certain prescription only medicines7

The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration to human beings of any of the following medicinal products for parenteral administration–

  • Adrenaline Injection 1 in 1000 (1 mg in 1 ml)

  • Atropine Sulphate Injection

  • Chlorpheniramine Injection

  • Cobalt Edetate Injection

  • Dextrose Injection Strong B.P.C.

  • Diphenhydramine Injection

  • Glucagon Injection

  • Hydrocortisone Injection

  • Mepyramine Injection

  • Promethazine Hydrochloride Injection

  • Snake Venom Antiserum

  • Sodium Nitrite Injection

  • Sodium Thiosulphate Injection

  • Sterile Pralidoxime

where the administration is for the purpose of saving life in an emergency.

Exemptions for emergency sale or supply8

1

The restrictions imposed by section 58(2)(a) (restriction on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business where the conditions specified in paragraph (2) are satisfied.

2

The conditions referred to in paragraph (1) are–

a

that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied is satisfied that the sale or supply has been requested by a doctor who by reason of an emergency is unable to furnish a prescription immediately;

b

that the doctor has undertaken to furnish the person lawfully conducting a retail pharmacy business with a prescription within 72 hours of the sale or supply;

c

that the prescription only medicine is sold or supplied in accordance with the directions of the doctor requesting it;

d

subject to paragraph (5), that the prescription only medicine is not a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations;

e

that an entry is made in the record kept under regulation 6 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 198018 within the time specified in that regulation stating the particulars required under paragraph 1 of Schedule 2 to those Regulations.

3

The restrictions imposed by section 58(2)(a) shall not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business where the conditions specified in paragraph (4) are satisfied.

4

The conditions referred to in paragraph (3) are–

a

that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied has interviewed the person requesting a prescription only medicine and has satisfied himself–

i

that there is an immediate need for the prescription only medicine requested to be sold or supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay,

ii

that treatment with the prescription only medicine requested has on a previous occasion been prescribed by a doctor for the person requesting it, and

iii

as to the dose which in the circumstances it would be appropriate for that person to take;

b

that no greater quantity of the prescription only medicine than will provide 5 days' treatment is sold or supplied except that where the prescription only medicine–

i

is F36a preparation of insulin, an aerosol for the relief of asthma, an ointment or cream, and has been made up for sale in a container elsewhere than at the place of sale or supply, the smallest pack that the pharmacist has available for sale or supply may be sold or supplied,

ii

is an oral contraceptive, a quantity sufficient for a full treatment cycle may be sold or supplied,

iii

is an antibiotic for oral administration in liquid form, the smallest quantity that will provide a full course of treatment may be sold or supplied;

c

subject to paragraph (5), that the prescription only medicine does not consist of or contain a substance specified in Schedule 4 to this Order and is not a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations;

d

that an entry is made in the record kept under regulation 6 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 within the time specified in that regulation stating the particulars required under paragraph 3 of Schedule 2 to those Regulations;

e

that the container or package of the prescription only medicine is labelled so as to show–

i

the date on which the prescription only medicine is sold or supplied,

ii

the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine,

iii

the name of the person requesting the prescription only medicine,

iv

the name and address of the registered pharmacy from which the prescription only medicine is sold or supplied, and

v

the words “Emergency Supply”.

5

The conditions specified in paragraphs (2)(d) and (4)(c) shall not apply where the prescription only medicine consists of or contains phenobarbitone or phenobarbitone sodium (but no other substance specified in Schedule 4 to this Order or Schedule 1, 2 or 3 to the Misuse of Drugs Regulations) and is sold or supplied for use in the treatment of epilepsy.

Exemption for non-parenteral administration to human beings9

The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration to human beings of a prescription only medicine which is not for parenteral administration.

Exemption for medicinal products at high dilutions10

The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the sale, supply or administration of a medicinal product which is not for parenteral administration and which consists of or contains, any of the substances listed in column 1 of Schedule 1 or 2, only one or more unit preparation of such substances, if–

a

each such unit preparation has been diluted to at least one part in a million (6x), and the person selling, supplying or administering the medicinal product has been requested by or on behalf of a particular person and in that person’s presence to use his own judgment as to the treatment required; or

b

each such unit preparation has been diluted to at least one part in a million million (6c).

Exemptions for certain persons11

1

The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply–

a

to the sale or supply by a person listed in column 1 of Part I of Schedule 5 of the prescription only medicines listed in relation to that person in column 2 of that Part where the conditions specified in the corresponding paragraphs in column 3 of that Part are satisfied;

b

to the supply by a person listed in column 1 of Part II of Schedule 5 of the prescription only medicines listed in relation to that person in column 2 of that Part where the conditions specified in the corresponding paragraphs in column 3 of that Part are satisfied.

2

The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration by a person listed in column 1 of Part III of Schedule 5 of the prescription only medicines for parenteral administration listed in relation to that person in column 2 of that Part where the conditions specified in the corresponding paragraphs in column 3 of that Part are satisfied.

F56Exemption for sale or supply in hospitals12

The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine in the course of the business of a hospital where the medicine is sold or supplied for the purpose of being administered (whether in the hospital or elsewhere) to a particular person in accordance with the written directions of a doctor or dentist relating to that person notwithstanding that those directions do not satisfy the conditions specified in article 15(2).

F49Exemptions for the supply and administration of prescription only medicines by national health service bodies12A

1

The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the supply of a prescription only medicine by—

a

the Common Services Agency;

b

a Health Authority or Special Health Authority;

c

an NHS trust;

d

a Primary Care Trust; or

e

where sub-paragraphs (a) to (d) do not apply, a person other than an excepted person, pursuant to an arrangement made with one of the persons specified in those sub-paragraphs for the supply of prescription only medicines,

where the medicine is supplied for the purpose of being administered to a particular person in accordance with the written directions of a doctor or dentist relating to that person notwithstanding that those directions do not satisfy the conditions specified in article 15(2).

2

The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by—

a

the Common Services Agency;

b

a Health Authority or Special Health Authority;

c

an NHS trust;

d

a Primary Care Trust; or

e

where sub-paragraphs (a) to (d) do not apply, a person other than an excepted person, pursuant to an arrangement made with one of the persons specified in those sub-paragraphs for the supply or, as the case may be, the administration of prescription only medicines,

where the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, to a particular person in accordance with a Patient Group Direction and where the conditions specified in paragraph (3) are satisfied.

3

The conditions referred to are that—

a

the Patient Group Direction relates to the supply or, as the case may be, the administration, by the person who supplies or administers the medicine, of a description or class of prescription only medicine, and the Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;

b

the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

c

the Patient Group Direction is signed on behalf of the person specified in column 2 of the Table in Part II of Schedule 7 to this Order (“the authorising person”) against the entry in column 1 of that Table for the class of person by whom the medicine is supplied or administered;

d

the individual who supplies or, as the case may be, administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is designated in writing, on behalf of the authorising person, for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction; and

e

at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.

4

In this article, “excepted person” means—

a

a doctor or dentist; or

b

a person lawfully conducting a retail pharmacy business within the meaning of section 69.

Exemption for health professionals who supply or administer prescription only medicines under a Patient Group Direction in order to assist doctors or dentists in providing national health services12B

1

The restrictions imposed by section 58(2) (sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by an individual belonging to one of the classes specified in Part III of Schedule 7 to this Order where—

a

the individual supplies or, as the case may be, administers the medicine in order to assist a doctor or dentist in the provision of, respectively, NHS primary medical services or NHS primary dental services;

b

the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, in accordance with a Patient Group Direction; and

c

the conditions specified in paragraph (2) are satisfied.

2

The conditions referred to are that—

a

the Patient Group Direction relates to the supply or, as the case may be, the administration of a description or class of prescription only medicine in order to assist the doctor or dentist in question in providing the services referred to in paragraph (1)(a) (whether or not it also relates to such supply or administration in order to assist any other doctor or dentist);

b

the Patient Group Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;

c

the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

d

the Patient Group Direction is signed—

i

by the doctor or dentist in question or, alternatively, where the Direction also relates to supply or administration in order to assist one or more other doctors or dentists, as referred to in sub-paragraph (a), by one of those other doctors or dentists; and

ii

on behalf of the health authority—

a

in the case of the provision of general medical services or general dental services, with which an arrangement has been made for the provision of those services; or

b

in the case of the performance of personal medical services or personal dental services, which is a party to the pilot scheme under which those services are provided;

e

the individual referred to in paragraph (1) is designated in writing for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction, by the doctor or dentist in question, or, alternatively, where the Direction also relates to supply or administration in order to assist one or more other doctors or dentists, as referred to in sub-paragraph (a), by one of those other doctors or dentists; and

f

at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.

3

In this article—

a

a reference to the provision of NHS primary dental services shall be construed as a reference to—

i

in relation to England and Wales, the provision of general dental services under Part II of the National Health Service Act 1977, or the performance of personal dental services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997;

ii

in relation to Scotland, the provision of general dental services under Part II of the National Health Service (Scotland) Act 1978, or the performance of personal dental services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997; and

iii

in relation to Northern Ireland, the provision of general dental services under the Health and Personal Social Services (Northern Ireland) Order 1972, or the performance of personal dental services in connection with a pilot scheme under the Health Services (Primary Care) (Northern Ireland) Order 1997;

b

a reference to the provision of NHS primary medical services shall be construed as a reference to—

i

in relation to England and Wales, the provision of general medical services under Part II of the National Health Service Act 1977, or the performance of personal medical services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997;

ii

in relation to Scotland, the provision of general medical services under Part II of the National Health Service (Scotland) Act 1978, or the performance of personal medical services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997; and

iii

in relation to Northern Ireland, the provision of general medical services under the Health and Personal Social Services (Northern Ireland) Order 1972, or the performance of personal medical services in connection with a pilot scheme under the Health Services (Primary Care) (Northern Ireland) Order 1997.

Exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction12C

1

The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by a person lawfully conducting a retail pharmacy business within the meaning of section 69 where—

a

the medicine is supplied or, as the case may be, is administered by such a person pursuant to an arrangement made with the Common Services Agency, a Health Authority, a Special Health Authority, an NHS trust or a Primary Care Trust for the supply or, as the case may be, the administration of prescription only medicines;

b

the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, to a particular person in accordance with a Patient Group Direction; and

c

the conditions specified in paragraph (2) are satisfied.

2

The conditions referred to are that—

a

the Patient Group Direction relates to the supply or, as the case may be, the administration of a description or class of prescription only medicine by the person lawfully conducting a retail pharmacy business who supplies or, as the case may be, administers the prescription only medicine, and the Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;

b

the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

c

the Patient Group Direction is signed on behalf of the body with which an arrangement has been made as referred to in paragraph (1)(a); and

d

at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.

Exemption in cases involving another’s default13

The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a person who, having exercised all due diligence, believes on reasonable grounds that the product sold or supplied is not a prescription only medicine.

Exemption in the case of a forged prescription14

The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a forged prescription where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine.

Prescriptions15

1

For the purposes of section 58(2)(a) a prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless the conditions specified in paragraph (2) are fulfilled.

2

The conditions referred to in paragraph (1) are that the prescription–

a

shall be signed in ink with his own name by the appropriate practitioner giving it;

b

shall, without prejudice to sub-paragraph (a), be written in ink or otherwise so as to be indelible, unless it is a health prescription which is not for a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations, in which case it may be written by means of carbon paper or similar material;

c

shall contain the following particulars–

i

the address of the appropriate practitioner giving it,

ii

the appropriate date,

iii

such particulars as indicate whether the appropriate practitioner giving it is a doctor, a dentist, an appropriate nurse practitioner, a veterinary surgeon or a veterinary practitioner,

iv

where the appropriate practitioner giving it is a doctor, dentist or appropriate nurse practitioner, the name, address and the age, if under 12, of the person for whose treatment it is given, and

v

where the appropriate practitioner giving it is a veterinary surgeon or a veterinary practitioner, the name and address of the person to whom the prescription only medicine is to be delivered and a declaration by the veterinary surgeon or veterinary practitioner giving it that the prescription only medicine is prescribed for an animal or herd under his care;

d

shall not be dispensed after the end of the period of 6 months from the appropriate date, unless it is a repeatable prescription in which case it shall not be dispensed for the first time after the end of that period nor otherwise than in accordance with the directions contained in the repeatable prescription;

e

in the case of a repeatable prescription which does not specify the number of times it may be dispensed, shall not be dispensed on more than two occasions unless it is a prescription for an oral contraceptive in which case it may be dispensed 6 times before the end of the period of 6 months from the appropriate date.

3

The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to a sale or supply of a prescription only medicine which is not in accordance with a prescription given by an appropriate practitioner by reason only that a condition specified in paragraph (2) is not satisfied where the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that that condition is satisfied in relation to that sale or supply.

4

In paragraph (2) “the appropriate date” means–

a

in the case of a health prescription, the date on which it was signed by the appropriate practitioner giving it or a date indicated by him as being the date before which it shall not be dispensed; and

b

in every other case, the date on which the prescription was signed by the appropriate practitioner giving it;

and, for the purposes of sub-paragraphs (d) and (e) of that paragraph, where a health prescription bears both the date on which it was signed and a date indicated as being that before which it shall not be dispensed, the appropriate date is the later of those dates.

Revocations16

1

The Orders specified in Schedule 6 are revoked.

2

In the Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order 198919 articles 2 to 6 and Schedules 1 and 2 are revoked.

Signed by authority of the Secretary of State for Health

Baroness JayMinister of State,Department of Health
Win GriffithsParliamentary Under Secretary of State, Welsh Office
Sam GalbraithParliamentary Under Secretary of State, The Scottish Office
Jeff RookerMinister of State, Ministry of Agriculture, Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 22nd July 1997.

seal_r00001D. C. GowdyPermanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 18th July 1997.

seal_r00001P. SmallPermanent Secretary

SCHEDULE 1SUBSTANCES WHICH IF INCLUDED IN MEDICINAL PRODUCTS MAKE THOSE PRODUCTS PRESCRIPTION ONLY MEDICINES AND EXEMP TIONS FROM RESTRICTIONS ON THE SALE AND SUPPLY OF PRESCRIPTION ONLY MEDICINES

Articles 3(a), 5(1) and 10

Annotations:
Amendments (Textual)

Exemptions from the restrictions on the sale and supply of prescription only medicines

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Maximum strength

Route of administration, use or pharmaceutical form

Treatment limitations

Maximum quantity

F52Acamprosate

Acarbose

Acebutolol Hydrochloride

F52Aceclofenac

Acemetacin

Acetarsol

Acetazolamide

Acetazolamide Sodium

Acetohexamide

Acetylcholine Chloride

0.2 per cent

External

Acetylcysteine

Acipimox

Aciclovir

5.0 per cent

External

Container or package containing not more than 2g of medicinal product

For treatment of herpes simplex virus infections of the lips and face (Herpes labialis)

Acitretin

Aclarubicin Hydrochloride

Aconite

1.3 per cent

External

Acrivastine

24 mg (MDD)

Container or package containing not more than 240mg of Acrivastine

Acrosoxacin

Actinomycin C

Actinomycin D

F48Adapalene

Adenosine

Adrenaline

(1) By inhaler

(2) External

Adrenaline Acid Tartrate

(1) By inhaler

(2) External

Adrenaline Hydrochloride

(1) By inhaler

(2) External

Adrenocortical Extract

Albendazole

Alclofenac

Alclometasone Dipropionate

Alcuronium Chloride

Aldesleukin

Aldosterone

F52Alendronate Sodium

Alfacalcidol

Alfuzosin Hydrochloride

Allergen Extracts

Allopurinol

Allyloestrenol

F35Aloxiprin

(1) 620 mg

(1) Non-effervescent tablets and capsules

(1) The quantity sold or supplied in one container or package shall not exceed 32

The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

(2) All preparations other than non-effervescent tablets or capsules

Alphadolone Acetate

Alphaxalone

Alprenolol

Alprenolol Hydrochloride

Alprostadil

Alseroxylon

F48Altretamine

Amantadine Hydrochloride

Ambenonium Chloride

Ambutonium Bromide

Amcinonide

Ametazole Hydrochloride

Amethocaine

Non-ophthalmic use

Amethocaine Gentisate

Non-ophthalmic use

Amethocaine Hydrochloride

Non-ophthalmic use

Amikacin Sulphate

Amiloride Hydrochloride

Aminocaproic Acid

Aminoglutethimide

Aminopterin Sodium

Amiodarone Hydrochloride

Amiphenazole Hydrochloride

Amitriptyline

Amitriptyline Embonate

Amitriptyline Hydrochloride

Amlodipine Besylate

Ammonium Bromide

Amodiaquine Hydrochloride

Amorolfine Hydrochloride

Amoxapine

Amoxycillin

Amoxycillin Sodium

Amoxycillin Trihydrate

Amphomycin Calcium

Amphotericin

Ampicillin

Ampicillin Sodium

Ampicillin Trihydrate

Amsacrine

Amygdalin

Amyl Nitrite

Amylocaine Hydrochloride

Non-ophthalmic use

F52Anastrozole

Ancrod

Androsterone

Angiotensin Amide

Anistreplase

Anterior Pituitary Extract

Antimony Barium Tartrate

Antimony Dimercaptosuccinate

Antimony Lithium Thiomalate

Antimony Pentasulphide

Antimony Potassium Tartrate

Antimony Sodium Tartrate

Antimony Sodium Thioglycollate

Antimony Sulphate

Antimony Trichloride

Antimony Trioxide

Antimony Trisulphide

Apiol

Apomorphine

Apomorphine Hydrochloride

F48Apraclonidine Hydrochloride

Aprotinin

Arecoline Hydrobromide

Argipressin

Aristolochia

Aristolochia Clematitis

Aristolochia Contorta

Aristolochia Debelis

Aristolochia Fang-chi

Aristolochia Manshuriensis

Aristolochia Serpentaria

Arsenic

Arsenic Triiodide

Arsenic Trioxide

Arsphenamine

F20Aspirin

F401

75mg

F401

Non-effervescent tablets and capsules

F401

The quantity sold or supplied in one container or package shall not exceed 100

  • The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

F22F392

500 mg

F392

Non-effervescent tablets and capsules

F392

The quantity sold or supplied in one container or package shall not exceed 32

F393

All preparations other than non-effervescent tablets or capsules

  • The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

Astemizole

F23. . .

F23. . .

F23. . .

F23. . .

F23. . .

Atenolol

Atracurium Besylate

Atropine

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 300mcg (MD)

1mg (MDD)

(2) External (except ophthalmic)

Atropine Methobromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 400mcg (MD)

1.3mg (MDD)

(2) External (except ophthalmic)

Atropine Methonitrate

Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 400mcg (MD)

1.3mg (MDD)

Atropine Oxide Hydrochloride

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 360mcg (MD)

1.2mg (MDD) 3

(2) External (except ophthalmic)

Atropine Sulphate

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 360mcg (MD)

1.2mg (MDD)

(2) External (except ophthalmic)

Auranofin

Azapropazone

Azathioprine

Azathioprine Sodium

Azelaic Acid

Azelastine Hydrochloride

For nasal administration

140mcg per nostril (MD)

Container or package containing not more than 5,040mcg of Azelastine Hydrochloride

For the treatment of seasonal allergic rhinitis

280mcg per nostril (MDD)

For use in adults and children not less than 12 years

As a non-aerosol, aqueous form

Azidocillin Potassium

Azithromycin

Azlocillin Sodium

Aztreonam

Bacampicillin Hydrochloride

Bacitracin

Bacitracin Methylene Disalicylate

Bacitracin Zinc

Baclofen

Bambuterol Hydrochloride

Barium Carbonate

Barium Chloride

Barium Sulphide

Beclamide

Beclomethasone

Beclomethasone Dipropionate

For nasal administration (non-aerosol)

100mcg per nostril (MD)

Container or package containing not more than F4120,000 mcg of Beclomethasone Dipropionate

For the prevention and treatment of allergic rhinitis

200 mcg per nostril (MDD)F25For a maximum period of 3 months

F24For use in persons aged 18 years and over

Belladonna Herb

(1) Internal

(1) 1mg of the alkaloids (MDD)

(2) External

Belladonna Root

(1) Internal

(1) 1mg of the alkaloids (MDD)

(2) External

Bemegride

Bemegride Sodium

Benapryzine Hydrochloride

Bendrofluazide

Benethamine Penicillin

Benoxaprofen

Benperidol

Benserazide Hydrochloride

Bentiromide

Benzathine Penicillin

Benzbromarone

Benzhexol Hydrochloride

Benzilonium Bromide

Benzocaine

Any use except ophthalmic use

Benzoctamine Hydrochloride

Benzoyl Peroxide

10.0 per cent

External

N-Benzoyl Sulphanilamide

Benzquinamide

Benzquinamide Hydrochloride

Benzthiazide

Benztropine Mesylate

Benzylpenicillin Calcium

Benzylpenicillin Potassium

Benzylpenicillin Sodium

Beractant

Betahistine Hydrochloride

Betamethasone

Betamethasone Adamantoate

Betamethasone Benzoate

Betamethasone Dipropionate

Betamethasone Sodium Phosphate

Betamethasone Valerate

Betaxolol Hydrochloride

Bethanechol Chloride

Bethanidine Sulphate

Bezafibrate

F48Bicalutamide

Biperiden Hydrochloride

Biperiden Lactate

Bismuth Glycollylarsanilate

Bisoprolol Fumarate

Bleomycin

Bleomycin Sulphate

Bretylium Tosylate

Bromhexine Hydrochloride

Bromocriptine Mesylate

Bromperidol

Bromvaletone

Brotizolam

Budesonide

For nasal administration

200mcg per nostril (MD)

Container or package containing not more than 10mg of Budesonide

For the prevention or treatment of seasonal allergic rhinitis

F25For a maximum period of 3 months

200 mcg per nostril (MDD)

F24For use in persons aged 18 years and over

As a non-aerosol, aqueous form

Bufexamac

Bumetanide

Buphenine Hydrochloride

6mg (MD)

18mg (MDD)

Bupivacaine

Any use except ophthalmic use

Bupivacaine Hydrochloride

Any use except ophthalmic use

Buserelin Acetate

Buspirone Hydrochloride

Busulphan

Butacaine Sulphate

Any use except ophthalmic use

Butorphanol Tartrate

Butriptyline Hydrochloride

Calcipotriol

F48Calcipotriol Hydrate

Calcitonin

Calcitriol

Calcium Amphomycin

Calcium Benzamidosalicylate

Calcium Bromide

Calcium Bromidolactobionate

Calcium Carbimide

Calcium Folinate

Calcium Metrizoate

Calcium Sulphaloxate

F45Candesartan Cilexetil

Candicidin

Canrenoic Acid

Cantharidin

0.01 per cent

External

Capreomycin Sulphate

Captopril

Carbachol

Carbamazepine

Carbaryl

Carbenicillin Sodium

Carbenoxolone Sodium

(1) Pellet

(1) 5mg (MD)

25mg (MDD)

(2) 2.0 per cent

(2) Gel

(3) 1.0 per cent

(3) Granules for mouthwash in adults and children not less than 12 years

(3) 20mg (MD)

(3) Container or package containing not more than F1560mg of Carbenoxolone Sodium

80mg (MDD)

Carbidopa

Carbimazole

Carbocisteine

Carbon Tetrachloride

Carboplatin

Carboprost Trometamol

Carbuterol Hydrochloride

Carfecillin Sodium

Carindacillin Sodium

Carisoprodol

Carmustine

Carperidine

Carteolol Hydrochloride

Cefaclor

Cefadroxil

Cefazedone Sodium

Cefixime

Cefodizime Sodium

Cefotaxime Sodium

Cefoxitin Sodium

Cefpodoxime Proxetil

Cefsulodin Sodium

Ceftazidime

Ceftizoxime Sodium

Ceftriaxone Sodium

Cefuroxime Axetil

Cefuroxime Sodium

Celiprolol Hydrochloride

Cephalexin

Cephalexin Sodium

Cephaloridine

Cephalothin Sodium

Cephamandole Nafate

Cephazolin Sodium

Cephradine

Cerium Oxalate

Cerivastatin

Ceruletide Diethylamine

Cetirizine Hydrochloride

10mg (MDD)

Container or package containing not more than 100mg of Cetirizine Hydrochloride

Chenodeoxycholic Acid

Chloral Hydrate

External

Chlorambucil

Chloramphenicol

Chloramphenicol Cinnamate

Chloramphenicol Palmitate

Chloramphenicol Sodium Succinate

Chlorhexadol

Chlormadinone Acetate

Chlormerodrin

Chlormethiazole

Chlormethiazole Edisylate

Chlormezanone

Chloroform20

(1) 5.0 per cent

(1) Internal

(2) External

Chloroquine Phosphate

Prophylaxis of malaria

Chloroquine Sulphate

Prophylaxis of malaria

Chlorothiazide

Chlorotrianisene

Chlorphenoxamine Hydrochloride

Chlorpromazine

Chlorpromazine Embonate

Chlorpromazine Hydrochloride

Chlorpropamide

Chlorprothixene

Chlorprothixene Hydrochloride

Chlortetracycline

Chlortetracycline Calcium

Chlortetracycline Hydrochloride

Chlorthalidone

Chlorzoxazone

Cholestyramine

Ciclacillin

Ciclobendazole

Cilastatin Sodium

Cilazapril

Cimetidine

(a) For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity and for the prophylaxis of meal-induced heartburn

(a) 200mg (MD)

800mg (MDD)

For a maximum period of 14 days

(b) For the prophylactic management of nocturnal heartburn by a single dose taken at night

(b) 100mg (MD) to be taken as a single dose at night

For a maximum period of 14 days

Cimetidine Hydrochloride

Cinchocaine

3.0 per cent

Non-ophthalmic use

Cinchocaine Hydrochloride

Equivalent of 3.0 per cent of Cinchocaine

Non-ophthalmic use

Cinchophen

Cinoxacin

Ciprofibrate

Ciprofloxacin

Ciprofloxacin Hydrochloride

Cisapride

Cisplatin

F48Citalopram Hydrobromide

Clarithromycin

Clavulanic Acid

Clidinium Bromide

Clindamycin

Clindamycin Hydrochloride

Clindamycin Palmitate Hydrochloride

Clindamycin Phosphate

Clioquinol

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

(2) 35mg

(2) Treatment of mouth ulcers

(2) 350mg (MDD)

Clobetasol Propionate

Clobetasone Butyrate

Clofazimine

Clofibrate

Clomiphene Citrate

Clomipramine

Clomipramine Hydrochloride

Clomocycline

Clomocycline Sodium

Clonidine

Clonidine Hydrochloride

Clopamide

Clopenthixol Decanoate

Clopenthixol Hydrochloride

Clorexolone

Clotrimazole

External but in the case of vaginal use only external use for the treatment of vaginal candidiasis

Cloxacillin Benzathine

Cloxacillin Sodium

Clozapine

Cocculus Indicus

Co-dergocrine Mesylate

Colaspase

Colchicine

Colestipol Hydrochloride

Colfosceril Palmitate

Colistin Sulphate

Colistin Sulphomethate

Colistin Sulphomethate Sodium

Coniine

Conium Leaf

7.0 per cent

External

Corticotrophin

Cortisone

Cortisone Acetate

Co-tetroxazine

Co-trimoxazole

Cropropamide

Crotethamide

Croton Oil

Croton Seed

Curare

Cyclofenil

Cyclopenthiazide

Cyclopentolate Hydrochloride

Cyclophosphamide

Cycloserine

Cyclosporin

Cyclothiazide

Cyproterone Acetate

Cytarabine

Cytarabine Hydrochloride

Dacarbazine

Dalteparin Sodium

Danazol

Danthron

Dantrolene Sodium

Dapsone

Dapsone Ethane Ortho Sulphonate

Daunorubicin Hydrochloride

Deanol Bitartrate

26mg (MDD)

Debrisoquine Sulphate

Demecarium Bromide

Demeclocycline

Demeclocycline Calcium

Demeclocycline Hydrochloride

Deoxycortone Acetate

Deoxycortone Pivalate

Deptropine Citrate

Dequalinium Chloride

(1) 0.25mg

(1) Internal: throat lozenges or throat pastilles

(2) 1.0 per cent

(2) External: paint

Deserpidine

Desferrioxamine Mesylate

Desflurane

Desipramine Hydrochloride

Deslanoside

Desmopressin

Desmopressin Acetate

Desogestrel

Desonide

Desoxymethasone

Dexamethasone

Dexamethasone Acetate

Dexamethasone Isonicotinate

Dexamethasone Phenylpropionate

Dexamethasone Pivalate

Dexamethasone Sodium Metasulphobenzoate

Dexamethasone Sodium Phosphate

Dexamethasone Troxundate

Dexfenfluramine Hydrochloride

Dextromethorphan Hydrobromide

Internal

(a) In the case of a prolonged release preparation: 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)

Dextrothyroxine Sodium

Diazoxide

Dibenzepin Hydrochloride

Dichloralphenazone

Dichlorphenamide

Diclofenac Diethylammonium

1.16 per cent

External

For maximum period of 7 days

Container or package containing not more than 30g of medicinal product

For local symptomatic relief of pain and inflammation in 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 Potassium

Diclofenac Sodium

Dicyclomine Hydrochloride

10mg (MD)

60mg (MDD)

F52Didanosine

Dienoestrol

Diethanolamine Fusidate

Diflucortolone Valerate

Diflunisal

Digitalin

Digitalis Leaf

Digitalis Prepared

Digitoxin

Digoxin

Dihydralazine Sulphate

Dihydroergotamine Mesylate

Dihydrostreptomycin

Dihydrostreptomycin Sulphate

Diloxanide Furoate

Diltiazem Hydrochloride

Dimercaprol

Dimethisoquin Hydrochloride

Non-ophthalmic use

Dimethisterone

Dimethothiazine Mesylate

Dimethyl Sulphoxide

Dimethyltubocurarine Bromide

Dimethyltubocurarine Chloride

Dimethyltubocurarine Iodide

Dinoprost

Dinoprost Trometamol

Dinoprostone

F35Diphenhydramine Hydrochloride

All preparations except liquid-filled capsules

Dipivefrin Hydrochloride

Dipyridamole

Disodium Etidronate

Disodium Pamidronate

Disopyramide

Disopyramide Phosphate

Distigmine Bromide

Disulfiram

Dithranol

1.0 per cent

Dobutamine Hydrochloride

Domperidone

Domperidone Maleate

F11For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn,

F2610 mg of Domperidone as Domperidone Maleate (MD)

F11Container or package containing not more than 100mg of Domperidone as Domperidone Maleate;

F2640 mg of Domperidone as Domperidone Maleate (MDD)

Dopamine Hydrochloride

Dopexamine Hydrochloride

F48Dorzolamide Hydrochloride

Dothiepin

Dothiepin Hydrochloride

Doxapram Hydrochloride

Doxazosin Mesylate

Doxepin Hydrochloride

Doxorubicin

Doxorubicin Hydrochloride

Doxycycline

Doxycycline Calcium Chelate

Doxycycline Hydrochloride

Droperidol

Dydrogesterone

Dyflos

Econazole

External but in the case of vaginal use only external use for the treatment of vaginal candidiasis

Econazole Nitrate

External but in the case of vaginal use only external use for the treatment of vaginal candidiasis

Ecothiopate Iodide

Edrophonium Chloride

Eflornithine Hydrochloride

F52Eformoterol Fumarate

Embutramide

Emepronium Bromide

Emetine

1.0 per cent

Emetine Bismuth Iodide

Emetine Hydrochloride

Equivalent of 1.0 per cent of Emetine

Enalapril Maleate

Encephalitis Virus, Tick-borne, Cent Eur

Enoxacin

Enoxaparin Sodium

Enoximone

Ephedrine

(1) Internal (other than nasal sprays or nasal drops)

(1) 30mg (MD)

60mg (MDD)

(2) 2.0 per cent

(2) Nasal sprays or nasal drops

(3) External

Ephedrine Hydrochloride

(1) Internal (other than nasal sprays or nasal drops)

(1) Equivalent of 30mg of Ephedrine (MD)

Equivalent of 60mg of Ephedrine (MDD)

(2) Equivalent of 2.0 per cent of Ephedrine

(2) Nasal sprays or nasal drops

(3) External

Ephedrine Sulphate

(1) Internal (other than nasal sprays or nasal drops)

(1) Equivalent of 30mg of Ephedrine (MD)

Equivalent of 60mg of Ephedrine (MDD)

(2) Equivalent of 2.0 per cent of Ephedrine

(2) Nasal sprays or nasal drops

(3) External

Epicillin

Epirubicin

Epirubicin Hydrochloride

Epithiazide

Epoetin Alfa

Epoetin Beta

Epoprostenol Sodium

Ergometrine Maleate

Ergometrine Tartrate

Ergot, Prepared

Ergotamine Tartrate

Erythromycin

Erythromycin Estolate

Erythromycin Ethylcarbonate

Erythromycin Ethyl Succinate

Erythromycin Lactobionate

Erythromycin Phosphate

Erythromycin Stearate

Erythromycin Thiocyanate

Esmolol Hydrochloride

Estramustine Phosphate

F7Estramustine Sodium Phosphate

Etafedrine Hydrochloride

Ethacrynic Acid

Ethambutol Hydrochloride

Ethamivan

Ethamsylate

Ethiazide

Ethinyl Androstenediol

Ethinyloestradiol

Ethionamide

Ethisterone

Ethoglucid

Ethoheptazine Citrate

Ethopropazine Hydrochloride

Ethosuximide

Ethotoin

Ethyl Biscoumacetate

Ethynodiol Diacetate

Etodolac

Etomidate

Etomidate Hydrochloride

Etoposide

Etretinate

F48Exemestane

Famciclovir

Famotidine

For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity, and prevention of these symptoms when associated with food and drink, including nocturnal symptoms

10mg (MD)

20mg (MDD)

For maximum period of 14 days

Fazadinium Bromide

Felbinac

3.17 per cent

External

For maximum period of 7 days

Container or package containing not more than F4650g of medicinal product

F27For the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries such as sprains, strains and contusions

For use in adults and children not less than 12 years

Felodipine

Felypressin

Fenbufen

Fenclofenac

Fenfluramine Hydrochloride

Fenofibrate

Fenoprofen

Fenoprofen Calcium

Fenoterol Hydrobromide

Fenticonazole Nitrate

Feprazone

Ferrous Arsenate

F48Ferumoxsil

Filgrastim

Finasteride

Flavoxate Hydrochloride

Flecainide Acetate

Flosequinan

Fluanisone

Flubendazole

Fluclorolone Acetonide

Flucloxacillin Magnesium

Flucloxacillin Sodium

Fluconazole

For oral administration for the treatment of vaginal candidiasis in persons aged not less than 16 but less than 60 years

150mg (MD)

Container or package containing not more than 150mg of Fluconazole

Flucytosine

Fludrocortisone Acetate

Flufenamic Acid

Flumazenil

Flumethasone

Flumethasone Pivalate

Flunisolide

0.025 per cent

(a) For the prevention and treatment of seasonal allergic rhinitis, including hay fever

(a) 50mcg per nostril (MD)

(a) Container or package containing not more than 6,000mcg of Flunisolide

100mcg per nostril (MDD)

F28For use in persons aged 18 years and over

F29For a maximum period of 3 months

In the form of a non-pressurised nasal spray

F30...

F30...

F30...

F30. . .

F30. . .

F30. . .

Fluocinolone Acetonide

Fluocinonide

Fluocortin Butyl

Fluocortolone

Fluocortolone Hexanoate

Fluocortolone Pivalate

Fluorescein Dilaurate

Fluorometholone

Fluorouracil

Fluorouracil Trometamol

Fluoxetine Hydrochloride

Flupenthixol Decanoate

Flupenthixol Hydrochloride

Fluperolone Acetate

Fluphenazine Decanoate

Fluphenazine Enanthate

Fluphenazine Hydrochloride

Fluprednidene Acetate

Fluprednisolone

Fluprostenol Sodium

Flurandrenolone

Flurbiprofen

Flurbiprofen Sodium

Fluspirilene

Flutamide

Fluticasone Propionate

Fluvastatin Sodium

Fluvoxamine Maleate

Folic Acic

500mcg (MDD)

Formestane

Formocortal

Foscarnet Sodium

Fosfestrol Sodium

Fosfomycin Trometamol

Fosinopril Sodium

Framycetin Sulphate

Frusemide

Furazolidone

Fusafungine

Fusidic Acid

Gabapentin

Gadoteridol

Gallamine Triethiodide

Ganciclovir

Ganciclovir Sodium

Gelsemine

0.1 per cent

Gelsemium

25mg (MD)

75mg (MDD)

Gemeprost

Gemfibrozil

Gentamicin

Gentamicin Sulphate

Gestodene

Gestrinone

Gestronol

Gestronol Hexanoate

Glibenclamide

Glibornuride

Gliclazide

Glipizide

Gliquidone

Glisoxepide

Glucagon

Glycopyrronium Bromide

1mg (MD)

2mg (MDD)

Glymidine

Gonadorelin

Goserelin Acetate

Gramicidin

0.2 per cent

External

Granisetron Hydrochloride

Griseofulvin

Growth Hormone

Guanethidine Monosulphate

Guanfacine Hydrochloride

Guanoclor Sulphate

Guanoxan Sulphate

Halcinonide

Halofantrine Hydrochloride

Haloperidol

Haloperidol Decanoate

Heparin

External

Heparin Calcium

External

Heparin Sodium

Hexachlorophane

External

(a) 2.0 per cent

(a) Soaps

(b) 0.1 per cent

(b) Aerosols

(c) 0.75 per cent

(c) preparations other than soaps and aerosols

Hexamine Phenylcinchoninate

Hexobarbitone

Hexobarbitone Sodium

Hexoestrol

Hexoestrol Dipropionate

L-Histidine Hydrochloride

Dietary supplementation

Homatropine

(1) Internal

(1) 0.15mg (MD)

0.45mg (MDD)

(2) External (except ophthalmic)

Homatropine Hydrobromide

0.2mg (MD)

0.6mg (MDD)

Homatropine Methylbromide

2mg (MD)

6mg (MDD)

Hydralazine Hydrochloride

Hydrargaphen

Local application to skin

Hydrobromic Acid

Hydrochlorothiazide

Hydrocortisone

F431

0.5 per cent

F431

External

  1. a

    For use in combination with Nystatin of maximum strength 3.0 per cent for intertrigo

  2. b

    For use in adults and children not less than 10 years

F431

Container or package containing not more than 15g of medicinal product

F422

1.0 per cent

F422

External

  1. a

    For use either alone or in conjunction with Crotamiton in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and either in combination with Clotrimazole F3or Miconazole Nitrate for athlete’s foot and candidal intertrigo or in combination with lignocaine for anal and perianal itch associated with haemorrhoids

  2. b

    For use in adults and children not less than 10 years

  3. c

    Cream ointment or spray

F422

Container or package containing not more than 15g of medicinal product (cream or ointment) or 30ml (spray)

Hydrocortisone Acetate

Equivalent to 1.0 per cent Hydrocortisone

External

For use in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and in combination with one or more of the following: Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Peru Balsam, Pramoxine Hydrochloride, Zinc Oxide, for haemorrhoids

Container or package containing not more than 15g of medicinal product

In the case of suppositories, container or package containing no more than 12

For use in adults and children not less than 10 years

Cream, ointment or suppositories

Hydrocortisone Butyrate

Hydrocortisone Caprylate

Hydrocortisone Hydrogen Succinate

Hydrocortisone Sodium Phosphate

Hydrocortisone Sodium Succinate

Equivalent to 2.5mg Hydrocortisone

External

Container or package containing not more than equivalent to 50mg of Hydrocortisone

For aphthous ulceration of the mouth for adults and children not less than 12 years

In the form of pellets

F35Hydrocyanic Acid

Hydroflumethiazide

Hydroxychloroquine Sulphate

Prophylaxis of malaria

Hydroxyprogesterone

Hydroxyprogesterone Enanthate

Hydroxyprogesterone Hexanoate

Hydroxyurea

Hydroxyzine Embonate

Hydroxyzine Hydrochloride

(a) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in adults and in children not less than 12 years

(a) 25mg (MD)

(a) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride

75mg (MDD)

(b) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in children not less than 6 years but less than 12 years

(b) 25 mg (MD)

(b) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride

50mg (MDD)

Hyoscine

(1) 0.15 per cent

(1) Internal

(2) External (except ophthalmic)

Hyoscine Butylbromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 20mg (MD)

(b) Container or package containing not more than 240mg of Hyoscine Butylbromide

80mg (MDD)

(2) External

Hyoscine Hydrobromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 300mcg (MD)

900mcg (MDD)

(2) External (except ophthalmic)

Hyoscine Methobromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 2.5mg (MD)

7.5mg (MDD)

(2) External

Hyoscine Methonitrate

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 2.5mg (MD)

7.5mg (MDD)

(2) External

Hyoscyamine

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 300mcg (MD)

1mg (MDD)

(2) External

Hyoscyamine Hydrobromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) Equivalent of 300mcg of Hyoscyamine (MD)

Equivalent of 1mg of Hyoscyamine (MDD)

(2) External

Hyoscyamine Sulphate

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) Equivalent of 300mcg of Hyoscyamine (MD)

Equivalent of 1mg of Hyoscyamine (MDD)

(2) External

Ibuprofen

Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza

(1) Internal

(1)(a) In the case of a prolonged release preparation 600mg (MD)

1,200mg (MDD)

(b) in any other case 400mg (MD)

1,200mg (MDD)

(2) 5.0 per cent

(2) External

F50(3) 10.0 per cent

F50(3) External

F50(3) 125 mg (MD) 500 mg (MDD)

F50(3) Container or package containing not more than 100 g of medicinal product

F35Ibuprofen Lysine

Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza

(a) in the case of a prolonged release preparation 600 mg (MD) 1,200 mg (MDD)

Internal

(b) in any other case 400 mg (MD) 1,200 mg (MDD)

Idarubicin Hydrochloride

Idoxuridine

Ifosfamide

Ignatius Bean

F52Imidapril Hydrochloride

Imipenem Hydrochloride

Imipramine

Imipramine Hydrochloride

Imipramine Ion Exchange Resin Bound Salt or Complex

Indapamide Hemihydrate

Indomethacin

Indomethacin Sodium

Indoprofen

Indoramin Hydrochloride

Inosine Pranobex

F18Insulin

Iodamide

Iodamide Meglumine

Iodamide Sodium

Iohexol

Iomeprol

Iopamidol

Iopentol

Iothalamic Acid

Ioversol

Ioxaglic Acid

Ipratropium Bromide

Iprindole Hydrochloride

Iproniazid Phosphate

Isoaminile

Isoaminile Citrate

Isocarboxazid

Isoconazole Nitrate

External but in the case of vaginal use only external use for the treatment of vaginal candidiasis

Isoetharine

Isoetharine Hydrochloride

Isoetharine Mesylate

Isoniazid

Isoprenaline Hydrochloride

Isoprenaline Sulphate

Isopropamide Iodide

Equivalent of 2.5mg of Isopropamide ion (MD)

Equivalent of 5.0mg of Isopropamide ion (MDD)

Isotretinoin

Isradipine

Itraconazole

Jaborandi

External

Kanamycin Acid Sulphate

Kanamycin Sulphate

Ketamine Hydrochloride

Ketoconazole

2.0 per cent

F32(a)F31External

F32(a) Maximum frequency of application of once every 3 days

F32(a) Container or package containing not more than 120ml of medicinal product and containing not more than 2,400mg of Ketoconazole

For the prevention and treatment of dandruff and seborrhoeic dermatitis of the scalp

In the form of a shampoo

F33(b) For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo

Ketoprofen

2.5 per cent

External

For maximum period of 7 days

Container or package containing not more than 30g of medicinal product

For rheumatic and muscular pain in adults and children not less than 12

Ketorolac Trometamol

Ketotifen Fumarate

Labetalol Hydrocholoride

Lachesine Chloride

Lacidipine

Lamotrigine

Lanatoside C

Lanatoside Complex A, B and C

Latamoxef Disodium

Levallorphan Tartrate

Levobunolol Hydrochloride

F35Levocabastine Hydrochloride

Equivalent of 0.05 per cent Levocabastine

(1) Nasal sprays

(1) Container or package containing not more than 10 ml of medicinal product

For the symptomatic treatment of seasonal allergic rhinitis

(2) Aqueous eye drops

(2) Container or package containing not more than 4 ml of medicinal product

For the symptomatic treatment of seasonal allergic conjunctivitis

F47Levocarnitine

F47For dietary supplementation

Levodopa

Levonorgestrel

Lidoflazine

Lignocaine

Non-ophthalmic use

Lignocaine Hydrochloride

Non-ophthalmic use

Lincomycin

Lincomycin Hydrochloride

Liothyronine Sodium

Lisinopril

Lithium Carbonate

Equivalent of 5mg of Lithium (MD)

Equivalent of 15mg of Lithium (MDD)

Lithium Citrate

Lithium Succinate

Lithium Sulphate

Equivalent of 5mg of Lithium (MD)

Equivalent of 15mg of Lithium (MDD)

Lobeline

(1) Internal

(1) 3mg (MD)

9mg (MDD)

(2) External

Lobeline Hydrochloride

(1) Internal

(1) Equivalent of 3mg of Lobeline (MD)

Equivalent of 9mg of Lobeline (MDD)

(2) External

Lobeline Sulphate

(1) Internal

(1) Equivalent of 3mg of Lobeline (MD)

Equivalent of 9mg of Lobeline (MDD)

(2) External

Lodoxamide Trometamol

Lofepramine

Lofepramine Hydrochloride

Lofexidine Hydrochloride

Lomefloxacin Hydrochloride

Lomustine

Loperamide Hydrochloride

Treatment of acute diarrhoea

Loratidine

10mg (MDD)

Container or package containing not more than 100mg of Loratidine

F45Lornoxicam

F45Losartan Potassium

Loxapine Succinate

Lung Surfactant Porcine

Luteinising Hormone

Lymecycline

Lynoestrenol

Lypressin

Lysuride Maleate

Mafenide

Mafenide Acetate

Mafenide Hydrochloride

Mafenide Propionate

5.0 per cent

Eye drops

Magnesium Fluoride

Magnesium Metrizoate

Mandragora Autumnalis

Mannomustine Hydrochloride

Maprotiline Hydrochloride

Mebanazine

Mebendazole

For oral use in the treatment of enterobiasis in adults and in children not less than 2 years

100mg (MD)

Container or package containing not more than 800mg of Mebendazole

Mebeverine Hydrochloride

F4a

For the symptomatic relief of irritable bowel syndrome

F4a

135 mg (MD)

405 mg (MDD)

b

For uses other than the symptomatic relief of irritable bowel syndrome

F4b

100 mg (MD)

300 mg (MDD)

Mebeverine Pamoate

Mebhydrolin

Mebhydrolin Napadisylate

Mecamylamine Hydrochloride

Mecillinam

Meclofenoxate Hydrochloride

Medigoxin

Medrogestone

Medroxyprogesterone Acetate

Mefenamic Acid

Mefloquine Hydrochloride

Mefruside

Megestrol

Megestrol Acetate

Meglumine Gadopentetate

Meglumine Iodoxamate

Meglumine Ioglycamate

Meglumine Iothalamate

Meglumine Iotroxate

Meglumine Ioxaglate

Melphalan

Melphalan Hydrochloride

Menotrophin

Mepenzolate Bromide

25mg (MD)

75mg (MDD)

Mephenesin

Mephenesin Carbamate

Mepivacaine Hydrochloride

Any use except ophthalmic use

Meptazinol Hydrochloride

Mequitazine

Mercaptopurine

Mersalyl

Mersalyl Acid

Mesalazine

Mesna

Mestranol

Metaraminol Tartrate

Metergoline

Metformin Hydrochloride

Methacycline

Methacycline Calcium

Methacycline Hydrochloride

Methallenoestril

Methicillin Sodium

Methixene

Methixene Hydrochloride

Methocarbamol

Methocidin

Throat lozenges and throat pastilles

Methohexitone Sodium

Methoin

Methoserpidine

Methotrexate

Methotrexate Sodium

Methotrimeprazine

Methotrimeprazine Hydrochloride

Methotrimeprazine Maleate

Methoxamine Hydrochloride

0.25 per cent

Nasal sprays or nasal drops not containing liquid paraffin as a vehicle

Methsuximide

Methyclothiazide

Methyldopa

Methyldopate Hydrochloride

Methylephedrine Hydrochloride

30mg (MD)

60mg (MDD)

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Sodium Succinate

Methylthiouracil

Methysergide Maleate

Metipranolol

Metirosine

Metoclopramide Hydrochloride

Metolazone

Metoprolol Fumarate

Metoprolol Succinate

Metoprolol Tartrate

Metronidazole

Metronidazole Benzoate

Metyrapone

Mexiletine Hydrochloride

Mezlocillin Sodium

Mianserin Hydrochloride

Miconazole

External but in the case of vaginal use only external use for the treatment of vaginal candidiasis

Miconazole Nitrate

External but in the case of vaginal use only external use for the treatment of vaginal candidiasis

Mifepristone

Miglitol

Milrinone

Milrinone Lactate

Minocycline

Minocycline Hydrochloride

Minoxidil

F12(1) 2.0 per cent

F12(1) External

F12(2) 5.0 per cent

(2) External use for the treatment of alopecia androgenetica, in men aged 18 to 65 (but not in women);

F52Mirtazapine

Misoprostol

Mitobronitol

Mitomycin

Mitozantrone Hydrochloride

Mivacurium Chloride

F7Mizolastine

Moclobemide

F48Moexipril Hydrochloride

Molgramostim

Molindone Hydrochloride

Mometasone Furoate

Moracizine Hydrochloride

Morazone Hydrochloride

F52Moxonidine

Mupirocin

Mupirocin Calcium

Mustine Hydrochloride

Nabilone

Nabumetone

Nadolol

Nafarelin Acetate

Naftidrofuryl Oxalate

Naftifine Hydrochloride

Nalbuphine Hydrochloride

Nalidixic Acid

Nalorphine Hydrobromide

Naloxone Hydrochloride

Naltrexone Hydrochloride

Naphazoline Hydrochloride

(1) 0.05 per cent

(1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle

(2) 0.015 per cent

(2) Eye drops

Naphazoline Nitrate

0.05 per cent

Nasal sprays or nasal drops not containing liquid paraffin as a vehicle

Naproxen

Naproxen Sodium

Natamycin

F45Nebivolol Hydrochloride

Nedocromil Sodium

F342.0 per cent

F34For the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis

F34Container or package containing not more than 3 ml of medicinal product

Nefazodone Hydrochloride

Nefopam Hydrochloride

Neomycin

Neomycin Oleate

Neomycin Palmitate

Neomycin Sulphate

Neomycin Undecanoate

Neostigmine Bromide

Neostigmine Methylsulphate

Netilmicin Sulphate

Nicardipine Hydrochloride

Nicergoline

F7Niceritrol

Nicotinic Acid

Any use, except for the treatment of hyperlipidaemia

600mg (MDD)

Nicoumalone

Nifedipine

Nifenazone

Nikethamide

F35Nilutamide

Nimodipine

Niridazole

F45Nisoldipine

Nitrendipine

Nitrofurantoin

Nitrofurazone

Nizatidine

For the prevention F13and treatment of the symptoms of food-related heartburn F13and meal-induced indigestion

75mg (MD)

F14150mg (MDD)

F15For a maximum period of 14 days

For use in adults and children not less than 16 years

Nomifensine Maleate

Noradrenaline

Noradrenaline Acid Tartrate

Norethisterone

Norethisterone Acetate

Norethisterone Enanthate

Norethynodrel

Norfloxacin

Norgestimate

Norgestrel

Nortriptyline Hydrochloride

Noscapine

Noscapine Hydrochloride

Novobiocin Calcium

Novobiocin Sodium

Nux Vomica Seed

Nystatin

F443.0 per cent

F44External

F44Container or package containing not more than 15g of medicinal product

For use in combination with Hydrocortisone of maximum strength 0.5 per cent for intertrigo

For use in adults and children not less than 10 years

Octacosactrin

Octreotide

Oestradiol

Oestradiol Benzoate

Oestradiol Cypionate

Oestradiol Dipropionate

Oestradiol Diundecanoate

Oestradiol Enanthate

Oestradiol Phenylpropionate

Oestradiol Undecanoate

Oestradiol Valerate

Oestriol

Oestriol Succinate

Oestrogenic Substances Conjugated

Oestrone

Ofloxacin

Olsalazine Sodium

Omeprazole

F52Omeprazole Magnesium

Ondansetron Hydrochloride

Orciprenaline Sulphate

Orphenadrine Citrate

Orphenadrine Hydrochloride

Ouabain

Ovarian Gland Dried

Oxamniquine

Oxantel Embonate

Oxaprozin

Oxatomide

Oxedrine Tartrate

Oxethazaine

10mg (MD)

Container or package containing not more than 400mg of Oxethazaine

30mg (MDD)

Oxitropium Bromide

Oxolinic Acid

Oxpentifylline

Oxprenolol Hydrochloride

Oxybuprocaine Hydrochloride

Non-ophthalmic use

Oxybutynin Hydrochloride

Oxypertine

Oxypertine Hydrochloride

Oxyphenbutazone

Oxyphencyclimine Hydrochloride

Oxyphenonium Bromide

5mg (MD)

15mg (MDD)

Oxytetracycline

Oxytetracycline Calcium

Oxytetracycline Dihydrate

Oxytetracycline Hydrochloride

Oxytocin, natural

Oxytocin, synthetic

Pancreatin

(1) 21,000 European Pharmacopoeia units of lipase per capsule

(1) capsules

(2) 25,000 European Pharmacopoeia units of lipase per gram

(2) powder

Pancuronium Bromide

Papaverine

(1) By inhaler

(2) Otherwise than by inhaler

(2) 50mg (MD)

150mg (MDD)

Papaverine Hydrochloride

(1) By inhaler

(2) Otherwise than by inhaler

(2) Equivalent of 50mg of Papaverine (MD)

Equivalent of 150mg of Papaverine (MDD)

F20Paracetamol

1

120 mg

1

Non-effervescent tablets and capsules for use in children aged less than 12 years

1

The quantity sold or supplied in one container or package shall not exceed 32

  • The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

2

500 mg

2

Non-effervescent tablets and capsules for use in adults and children not less than 12 years

3

All preparations other than non-effervescent tablets and capsules

2

The quantity sold or supplied in one container or package shall not exceed 32

  • The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

Paraldehyde

Paramethadione

Paramethasone Acetate

Parathyroid Gland

Pargyline Hydrochloride

Paroxetine Hydrochloride

Pecilocin

Penamecillin

Penbutolol Sulphate

Penicillamine

Penicillamine Hydrochloride

Pentamidine Isethionate

Penthienate Bromide

5mg (MD)

15mg (MDD)

Pentolinium Tartrate

Perfluamine

Pergolide Mesylate

Perhexiline Maleate

Pericyazine

Perindopril

Perindopril Erbumine

Perphenazine

Phenacetin

0.1 per cent

Phenazone

External

Phenazone Salicylate

Phenbutrazate Hydrochloride

Phenelzine Sulphate

Phenethicillin Potassium

Phenformin Hydrochloride

Phenglutarimide Hydrochloride

Phenindione

F21Phenolphthalein.

Phenoxybenzamine Hydrochloride

Phenoxymethylpenicillin

Phenoxymethylpenicillin Calcium

Phenoxymethylpenicillin Potassium

Phenprocoumon

Phensuximide

Phentolamine Hydrochloride

Phentolamine Mesylate

Phenylbutazone

Phenylbutazone Sodium

Phenylpropanolamine Hydrochloride

Internal

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

(1) 25mg (MD)

100mg (MDD)

(2) prolonged release capsules

(2) 50mg (MD)

100mg (MDD)

(3) 2.0 per cent

(3) nasal sprays and nasal drops

Phenytoin

Phenytoin Sodium

Phthalylsulphathiazole

Physostigmine

Physostigmine Aminoxide Salicylate

Physostigmine Salicylate

Physostigmine Sulphate

F35Phytomenadione

Any use except the prevention or treatment of haemorrhagic disorders

Picrotoxin

Pilocarpine

Pilocarpine Hydrochloride

Pilocarpine Nitrate

Pimozide

Pindolol

Pipenzolate Bromide

5mg (MD)

15mg (MDD)

Piperacillin Sodium

Piperazine Oestrone Sulphate

Piperidolate Hydrochloride

50mg (MD)

150mg (MDD)

Pipothiazine Palmitate

Piracetam

Pirbuterol Acetate

Pirbuterol Hydrochloride

F16Pirenzepine Dihydrochloride Monohydrate

Pirenzepine Hydrochloride

Piretanide

Piroxicam

0.5 per cent

External

For maximum period of 7 days

Container or package containing not more than 30g of medicinal product

For the relief of rheumatic pain, pain of non-serious arthritic conditions and muscular aches, pains and swellings such as strains, sprains and sports injuries

For use in adults and children not less than 12 years

F7Piroxicam Beta-cyclodextrin

Pituitary Gland (Whole Dried)

By inhaler

Pituitary Powdered (Posterior Lobe)

By inhaler

Pivampicillin

Pivampicillin Hydrochloride

Pivmecillinam

Pivmecillinam Hydrochloride

Pizotifen

Pizotifen Malate

Plicamycin

Podophyllotoxin

Podophyllum

Podophyllum Indian

Podophyllum Resin

20.0 per cent

External

Ointment or impregnated plaster

Poldine Methylsulphate

2mg (MD)

6mg (MDD)

Polidexide

Polyestradiol Phosphate

Polymyxin B Sulphate

Polythiazide

Poppy Capsule

Potassium Arsenite

0.0127 per cent

Potassium Bromide

Potassium Canrenoate

Potassium Clavulanate

Potassium Perchlorate

Practolol

Pralidoxime Chloride

Pralidoxime Iodide

Pralidoxime Mesylate

Pravastatin Sodium

Prazosin Hydrochloride

Prednisolone

Prednisolone Acetate

Prednisolone Butylacetate

Prednisolone Hexanoate

Prednisolone Metasulphobenzoate

Prednisolone Metasulphobenzoate Sodium

Prednisolone Pivalate

Prednisolone Sodium Phosphate

Prednisolone Steaglate

Prednisone

Prednisone Acetate

Prenalterol Hydrochloride

Prenylamine Lactate

Prilocaine Hydrochloride

Non-ophthalmic use

Primidone

Probenecid

Probucol

Procainamide Hydrochloride

Procaine Hydrochloride

Non-ophthalmic use

Procaine Penicillin

Procarbazine Hydrochloride

Prochlorperazine

Prochlorperazine Edisylate

Prochlorperazine Maleate

Prochlorperazine Mesylate

Procyclidine Hydrochloride

Progesterone

Prolactin

Proligestone

Prolintane Hydrochloride

Promazine Embonate

Promazine Hydrochloride

Propafenone

Propafenone Hydrochloride

Propanidid

Propantheline Bromide

15mg (MD)

45mg (MDD)

F45Propiverine Hydrochloride

Propofol

Propranolol Hydrochloride

Propylthiouracil

Proquazone

Protamine Sulphate

Prothionamide

Protirelin

Protriptyline Hydrochloride

Proxymetacaine Hydrochloride

Non-ophthalmic use

Pseudoephedrine Hydrochloride

Internal

(a) In the case of a prolonged release preparation

120mg (MD)

240mg (MDD)

(b) in any other case 60mg (MD)

240mg (MDD)

Pseudoephedrine Sulphate

60mg (MD)

180mg (MDD)

Pyrantel Embonate

(a) For the treatment of enterobiosis, in adults and children not less than 12 years

(a) 750mg MDD (as a single dose)

(a) Container or package containing not more than 750mg of Pyrantel Embonate

(b) For the treatment of enterobiosis, in children less than 12 years but not less than 6 years

(b) 500mg MDD (as a single dose)

(b) Container or package containing not more than 750mg of Pyrantel Embonate

(c) For the treatment of enterobiosis in children less than 6 years but not less than 2 years

(c) 250mg MDD (as a single dose)

(c) Container or package containing not more than 750mg of Pyrantel Embonate

Pyrantel Tartrate

Pyrazinamide

Pyridostigmine Bromide

Pyrimethamine

F45Quetiapine Fumarate

F48Quinagolide Hydrochloride

Quinapril

F16Quinapril Hydrochloride

Quinestradol

Quinestrol

Quinethazone

Quinidine

Quinidine Bisulphate

Quinidine Polygalacturonate

Quinidine Sulphate

Quinine

100mg (MD)

300mg (MDD)

Quinine Bisulphate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Cinchophen

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Dihydrochloride

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Ethyl Carbonate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Glycerophosphate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Hydrobromide

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Hydrochloride

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Iodobismuthate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Phosphate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Salicylate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Sulphate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Tannate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine in combination with Urea Hydrochloride

Ramipril

F52Ranitidine Bismuth Citrate

Ranitidine Hydrochloride

For the short term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity F5or the prevention of these symptoms when associated with consuming food and drink

Equivalent to 75mg of Ranitidine (MD)

Equivalent to 300mg of Ranitidine (MDD)

For a maximum period of 14 days

Rauwolfia Serpentina

Rauwolfia Vomitoria

Razoxane

Remoxipride Hydrochloride

Reproterol Hydrochloride

Rescinnamine

Reserpine

Rifabutin

Rifampicin

Rifampicin Sodium

Rifamycin

F52Rimexolone

Rimiterol Hydrobromide

Risperidone

Ritodrine Hydrochloride

Rolitetracycline Nitrate

Sabadilla

Salbutamol

Salbutamol Sulphate

Salcatonin

Salcatonin Acetate

Salmefamol

Salmeterol Xinafoate

Salsalate

Saralasin Acetate

Selegiline Hydrochloride

Semisodium Valproate

F52Sertraline Hydrochloride

Serum Gonadotrophin

F52Sevoflurane

Silver Sulphadiazine

Simvastatin

Sissomicin

Sissomicin Sulphate

Snake Venoms

Sodium Acetrizoate

Sodium Aminosalicylate

Sodium Antimonylgluconate

Sodium Arsanilate

Sodium Arsenate

Sodium Arsenite

0.013 per cent

Sodium Bromide

Sodium Clodronate

Sodium Cromoglycate

(a) For nasal admistration

(b) 2.0 per cent

(b) For the treatment of acute seasonal allergic conjunctivitis F6or perennial allergic conjunctivitis

(b) Container or package containing not more than 10ml of medicinal product

In the form of aqueous eye drops

(c) 4.0 per cent

(c) For the treatment of acute seasonal allergic conjunctivitis

(c) Container or package containing not more than 5g of medicinal product

In the form of an eye ointment

Sodium Ethacrynate

Sodium Fluoride

(1) 0.33 per cent

(1) Dentifrices

(2) Other preparations for use in the prevention of dental caries

In the form of

(a) tablets or drops

(a) 2.2 mg (MDD)

(b) 0.2 per cent

(b) mouth rinses other than those for daily use

(c) 0.05 per cent

(c) mouth rinses for daily use

Sodium Fusidate

Sodium Metrizoate

Sodium Monofluorophosphate

1.14 per cent

Dentrifrice

Sodium Oxidronate

Sodium Stibogluconate

Sodium Valproate

Somatorelin Acetate

Sotalol Hydrochloride

F48Sparfloxacin

Spectinomycin

Spectinomycin Hydrochloride

Spiramycin

Spiramycin Adipate

Spironolactone

Stannous Fluoride

0.62 per cent

Dentifrice

Stilboestrol

Stilboestrol Dipropionate

Streptodornase

External

Streptokinase

External

Streptomycin

Streptomycin Sulphate

Strychnine

Strychnine Arsenate

Strychnine Hydrochloride

F35Strychnine Nitrate

Styramate

Succinylsulphathiazole

Sucralfate

Sulbactam Sodium

Sulbenicillin

Sulbenicillin Sodium

Sulconazole Nitrate

External (except vaginal)

F35Sulfabenzamide

Sulfacytine

Sulfadoxine

Sulfamerazine

Sulfamerazine Sodium

Sulfametopyrazine

Sulfamonomethoxine

Sulindac

Sulphacetamide

Sulphacetamide Sodium

Sulphadiazine

Sulphadiazine Sodium

Sulphadimethoxine

Sulphadimidine

Sulphadimidine Sodium

Sulphafurazole

Sulphafurazole Diethanolamine

Sulphaguanidine

Sulphaloxic Acid

Sulphamethizole

Sulphamethoxazole

Sulphamethoxydiazine

Sulphamethoxypyridazine

Sulphamethoxypyridazine Sodium

Sulphamoxole

Sulphanilamide

Sulphaphenazole

Sulphapyridine

Sulphapyridine Sodium

Sulphasalazine

Sulphathiazole

Sulphathiazole Sodium

Sulphaurea

Sulphinpyrazone

Sulpiride

Sultamicillin

Sultamicillin Tosylate

Sulthiame

Sumatriptan Succinate

Suprofen

Suxamethonium Bromide

Suxamethonium Chloride

Suxethonium Bromide

F45Tacalcitol Monohydrate

Tacrine Hydrochloride

Talampicillin

Talampicillin Hydrochloride

Talampicillin Napsylate

Tamoxifen

Tamoxifen Citrate

F52Tazarotene

Tazobactam Sodium

Teicoplanin

Temocillin Sodium

Tenoxicam

Terazosin Hydrochloride

Terbinafine

F51Terbinafine Hydrochloride

F511.0 per cent

F51External use for the treatment of tinea pedis and tinea cruris

F51Container or package containing not more than 15 g of medicinal product.

Terbutaline

Terbutaline Sulphate

Terfenadine

F2. . .

F2...

Terlipressin

Terodiline Hydrochloride

Tetrabenazine

Tetracosactrin

Tetracosactrin Acetate

Tetracycline

Tetracycline Hydrochloride

Tetracycline Phosphate Complex

Tetroxoprim

Thallium Acetate

Thallous Chloride

Thiabendazole

Thiambutosine

Thiethylperazine Malate

Thiethylperazine Maleate

Thiocarlide

Thioguanine

Thiopentone Sodium

Thiopropazate Hydrochloride

Thioproperazine Mesylate

Thioridazine

Thioridazine Hydrochloride

Thiosinamine

Thiotepa

Thiothixene

Thiouracil

Thymoxamine Hydrochloride

Thyroid

Thyrotrophin

Thyroxine Sodium

Tiamulin Fumarate

Tiaprofenic Acid

Tibolone

Ticarcillin Sodium

Tigloidine Hydrobromide

Timolol Maleate

Tinidazole

Tinzaparin

Tioconazole

(1) 2.0 per cent

(1) External (except vaginal)

(2) Vaginal for treatment of vaginal candidiasis

F48Tizanidine Hydrochloride

Tobramycin

Tobramycin Sulphate

Tocainide Hydrochloride

Tofenacin Hydrochloride

Tolazamide

Tolazoline Hydrochloride

External

Tolbutamide

Tolbutamide Sodium

Tolfenamic Acid

Tolmetin Sodium

F52Topiramate

F7Torasemide

Tramadol Hydrochloride

Trandolapril

Tranexamic Acid

Tranylcypromine Sulphate

Trazodone Hydrochloride

Treosulfan

Tretinoin

Triamcinolone

Triamcinolone Acetonide

0.1 per cent

For the treatment of common mouth ulcers

Container or package containing not more than 5g of medicinal product

Triamcinolone Diacetate

Triamcinolone Hexacetonide

Triamterene

Tribavirin

Triclofos Sodium

Trientine Dihydrochloride

Trifluoperazine

Trifluoperazine Hydrochloride

Trifluperidol

Trifluperidol Hydrochloride

Trilostane

Trimeprazine

Trimeprazine Tartrate

Trimetaphan Camsylate

Trimetazidine

Trimetazidine Hydrochloride

Trimethoprim

Trimipramine Maleate

Trimipramine Mesylate

Tropicamide

Tropisetron Hydrochloride

Troxidone

L-Tryptophan

(1) Oral

Dietary supplementation

(2) External

Tubocurarine Chloride

Tulobuterol

Tulobuterol Hydrochloride

Tyrothricin

Throat lozenges or throat pastilles

Uramustine

Urea Stibamine

Urethane

Uridine 5'-triphosphate

Urofollitrophin

Urokinase

Ursodeoxychoic Acid

Vaccine: Bacillus Salmonella Typhi

Vaccine: Poliomyelitis (Oral)

F48Valaciclovir Hydrochloride

Valproic Acid

Vancomycin Hydrochloride

Vasopressin

Vasopressin Tannate

Vecuronium Bromide

F48Venlafaxine Hydrochloride

Verapamil Hydrochloride

Veratrine

Veratrum, Green

Veratrum, White

Vidarabine

Vigabatrin

Viloxazine Hydrochloride

Vinblastine Sulphate

Vincristine Sulphate

Vindesine Sulphate

Viomycin Pantothenate

Viomycin Sulphate

Vitamin A

(1) Internal

(1) 7,500iu (2,250mcg Retinol equivalent) (MDD)

(2) External

Vitamin A Acetate

(1) Internal

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

(2) External

Vitamin A Palmitate

(1) Internal

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

(2) External

Warfarin

Warfarin Sodium

Xamoterol Fumarate

Xipamide

Yohimbine Hydrochloride

F48Zalcitabine

Zidovudine

Zimeldine Hydrochloride

Zolpidem Tartrate

Zomepirac Sodium

Zopiclone

Zuclopenthixol Acetate

Zuclopenthixol Decanoate

Zuclopenthixol Hydrochloride

SCHEDULE 2

Articles 6(1) and 10

Column 1

Circumstances excluding medicinal products from the class of prescription only medicines

Column 2

Column 3

Column 4

Substance

Maximum strength

Pharmaceutical Form

Maximum Dose

Codeine and its salts

Equivalent of 1.5 per cent of codeine monohydrate

Equivalent of 20 mg of codeine monohydrate

Dihydrocodeine and its salts

Equivalent of 1.5 per cent of dihydrocodeine

Equivalent of 10 mg of dihydrocodeine

Ethylmorphine andits salts

Equivalent of 0.2 per cent of ethylmorphine

Equivalent of 7.5 mg of ethylmorphine

Morphine and its salts

(1) Equivalent of 0.02 per cent anhydrous morphine

(1) Liquid

(1) Equivalent of 3 mg of anhydrous morphine

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

(2) Solid

(2) Equivalent of 3 mg of anhydrous morphine

Medicinal Opium

(1) Equivalent of 0.02 per cent of anhydrous morphine

(1) Liquid

(1) Equivalent of 3 mg of anhydrous morphine

(2) Equivalent of 0.04 per cent of anhydrous morphine

(2) Solid

(2) Equivalent of 3 mg of anhydrous morphine

Pholcodine and its salts

Equivalent of 1.5 per cent of pholcodine monohydrate

Equivalent of 20 mg of pholcodine monohydrate

SCHEDULE 3DESCRIPTIONS AND CLASSES OF PRESCRIPTION ONLY MEDICINES IN RELATION TO WHICH APPROPRIATE NURSE PRACTITIONERS ARE APPROPRIATE PRACTITIONERS

Article 2(b)

Annotations:
Amendments (Textual)

  • F8Co-danthramer Capsules NPF

  • F8Co-danthramer Capsules, Strong NPF

  • Co-danthramer-Oral Suspension NPF

  • Co-danthramer-Oral Suspension Strong NPF

  • Co-danthrusate Capsules

  • F8Co-danthrusate Oral Suspension NPF

  • Mebendazole Tablets NPF

  • Mebendazole Oral Suspension NPF

  • Miconazole Oral Gel NPF

  • Nystatin Oral Suspension

  • Nystatin Pastilles NPF

  • Streptokinase and Streptodornase Topical Powder NPF

SCHEDULE 4SUBSTANCES NOT TO BE CONTAINED IN A PRESCRIPTION ONLY MEDI CINE SOLD OR SUPPLIED UNDER THE EXEMPTION CONFERRED BY ARTICLE 8(3)

Article 8(4)(c)

  • Ammonium Bromide

  • Calcium Bromide

  • Calcium Bromidolactobionate

  • Embutramide

  • Fencamfamin Hydrochloride

  • Fluanisone

  • Hexobarbitone

  • Hexobarbitone Sodium

  • Hydrobromic Acid

  • Meclofenoxate Hydrochloride

  • Methohexitone Sodium

  • Pemoline

  • Piracetam

  • Potassium Bromide

  • Prolintane Hydrochloride

  • Sodium Bromide

  • Strychnine Hydrochloride

  • Tacrine Hydrochloride

  • Thiopentone Sodium

SCHEDULE 5EXEMPTION FOR CERTAIN PERSONS FROM SECTION 58(2) OF THE ACT

Article 11(1)(a)

PART IEXEMPTION FROM RESTRICTIONS ON SALE OR SUPPLY

Annotations:
Amendments (Textual)

Column 1

Column 2

Column 3

Persons exempted

Prescription only medicines to which the exemption applies

Conditions

1. Persons selling or supplying prescription only medicines to universities, other institutions concerned with higher education or institutions concerned with research.

1. All prescription only medicines

  1. 1

    The sale or supply shall be–

    1. a

      subject to the presentation of an order signed by the principal of the institution concerned with education or research or the appropriate head of department in charge of a specified course of research stating–

      1. i

        the name of the institution for which the prescription only medicine is required,

      2. ii

        the purpose for which the prescription only medicine is required, and

      3. iii

        the total quantity required, and

    2. b

      for the purposes of the education or research with which the institution is concerned.

  1. 1

    Persons selling or supplying prescription only medicines to any of the following–

    1. 1

      a public analyst appointed under section 27 of the Food Safety Act 199021 or article 36 of the Food (Northern Ireland) Order 198922,

    2. 2

      an authorized officer within the meaning of section 5(6) of the Food Safety Act 1990,

    3. 3

      a sampling officer within the meaning of article 38(1) of the Food (Northern Ireland) Order 1989,

    4. 4

      a person duly authorized by an enforcement authority under sections 111 and 112,

    5. 5

      a sampling officer within the meaning of Schedule 3 to the Act.

2. All prescription only medicines.

2. The sale or supply shall be subject to the presentation of an order signed by or on behalf of any person listed in column 1 of this paragraph stating the status of the person signing it and the amount of prescription only medicine required, and shall be only in connection with the exercise by those persons of their statutory functions.

3. Persons selling or supplying prescription only medicines to any person employed or engaged in connection with a scheme for testing the quality and checking the amount of the drugs and appliances supplied under the National Health Service Act 197723, the National Health Service (Scotland) Act 197824 and the Health and Personal Social Services (Northern Ireland) Order 197225, or under any subordinate legislation made under those Acts or that Order.

3. All prescription only medicines.

  1. 1

    The sale or supply shall be–

    1. a

      subject to the presentation of an order signed by or on behalf of the person so employed or engaged stating the status of the person signing it and the amount of prescription only medicine required, and

    2. b

      for the purposes of a scheme referred to in column 1 in this paragraph.

4. Registered midwives.

  1. 1

    Prescription only medicines containing any of the following substances–

    • Chloral hydrate

    • Ergometrine maleate

    • Pentazocine hydrochloride

    • F38Phytomenadione

    • Triclofos sodium.

4. The sale or supply shall be only in the course of their professional practice and in the case of Ergometrine maleate only when contained in a medicinal product which is not for parenteral administration.

5. Persons lawfully conducting a retail pharmacy business within the meaning of section 69.

  1. 1

    Prescription only medicines which are not for parenteral administration and which–

    1. a

      are eyes drops and are prescription only medicines by reason only that they contain not more than 0.5 per cent Chloramphenicol, or

    2. b

      are eye ointments and are prescription only medicines by reason only that they contain not more than 1.0 per cent Chloramphenicol, or

    3. c

      are prescription only medicines by reason only that they contain any of the following substances:

      • Atropine sulphate

      • Bethanecol chloride

      • Carbachol

      • Cyclopentolate hydrochloride

      • Homatropine hydrobromide

      • Naphazoline hydrochloride

      • Naphazoline nitrate

      • Physostigmine salicylate

      • Physostigmine sulphate

      • Pilocarpine hydrochloride

      • Pilocarpine nitrate

      • Tropicamide.

5. The sale or supply shall be subject to the presentation of an order signed by a registered ophthalmic optician.

6. Registered ophthalmic opticians.

6. Prescription only medicines listed in column 2 of paragraph 5.

  1. 1

    The sale or supply shall be only–

    1. a

      in the course of their professional practice and

    2. b

      in an emergency.

7. Persons selling or supplying prescription only medicines to the British Standards Institution.

7. All prescription only medicines.

  1. 1

    The sale or supply shall be–

    1. a

      subject to the presentation of an order signed on behalf of the British Standards Institution stating the status of the person signing it and the amount of the prescription only medicine required, and

    2. b

      only for the purpose of testing containers of medicinal products or determining the standards for such containers.

8. Holders of marketing authorizations, product licences or manufacturer’s licences.

8. Prescription only medicines referred to in the authorizations or licences.

  1. 1

    The sale or supply shall be only–

    1. a

      to a pharmacist,

    2. b

      so as to enable that pharmacist to prepare an entry relating to the prescription only medicine in question in a tablet or capsule identification guide or similar publication, and

    3. c

      of no greater quantity than is reasonably necessary for that purpose.

9. Pharmacists selling or supplying to persons to whom cyanide salts may be sold by virtue of section 3 (regulation of poisons) or section 4 (exclusion of sales by wholesale and certain other sales) of the Poisons Act 197226 or by virtue of article 5 (prohibitions and regulations with respect to sale of poisons) or article 6 (exemption with respect to certain sales) of the Poisons (Northern Ireland) Order 197627.

9. Amyl nitrite.

9. The sale or supply shall only be so far as is necessary to enable an antidote to be available to persons at risk of cyanide poisoning.

F910

State registered chiropodists who hold a certificate of competence in the use of the medicines specified in Column 2 issued by or with the approval of the Chiropodists Board.

10

The following prescription only medicines—

a

Co-dydramol 10/500 tablets;

b

Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight;

c

Amorolfine hydrochloride lacquer where the maximum strength of the Amorolfine in the lacquer does not exceed 5 per cent by weight in volume; and

d

Topical hydrocortisone where the maximum strength of the hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight.

10

The sale or supply shall be only in the course of their professional practice and (a) in the case of Co-dydramol 10/500 tablets the quantity sold or supplied to a person at any one time shall not exceed the amount sufficient for 3 days' treatment to a maximum of 24 tablets.

PART IIEXEMPTIONS FROM THE RESTRICTION ON SUPPLY

Article 11(1)(b)

Column 1

Column 2

Column 3

Persons exempted

Prescription only medicines to which the exemption applies

Conditions

1. Royal National Lifeboat Institution and certified first aiders of the Institution.

1. All prescription only medicines.

1. The supply shall be only so far as is necessary for the the treatment of sick or injured persons in the exercise of the functions of the Institution.

2. The owner or the master of a ship which does not carry a doctor on board as part of her complement.

2. All prescription only medicines.

2. The supply shall be only so far as is necessary for the treatment of persons on the ship.

3. Persons authorized by licences granted under regulation 5 of the Misuse of Drugs Regulations to supply a controlled drug.

3. Such prescription only medicines, being controlled drugs, as are specified in the licence.

3. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence.

4. Persons requiring prescription only medicines for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees.

4. Such prescription only medicines as may be specified in the relevant enactment.

  1. 1

    The supply shall be–

    1. a

      for the purpose of enabling them to comply with any requirements made by or in pursuance of any such enactment, and

    2. b

      subject to such conditions and in such circumstances as may be specified in the relevant enactment.

5. Persons operating an occupational health scheme.

5. Prescription only medicines sold or supplied to a person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.

  1. 1

    —

    1. 1

      The supply shall be in the course of an occupational health scheme.

    2. 2

      The individual supplying the prescription only medicine, if not a doctor, shall be a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of the occupational health scheme.

6. The operator or commander of an aircraft.

6. Prescription only medicines which are not for parenteral administration and which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.

6. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.

7. Persons employed as qualified first-aid personnel on offshore installations.

7. All prescription only medicines.

7. The supply shall be only so far as is necessary for the treatment of persons on the installation.

PART IIIEXEMPTIONS FROM RESTRICTION ON ADMINISTRATION Column 1

Article 11(2)

Annotations:
Amendments (Textual)

Column 1

Column 2

Column 3

Persons exempted

Prescription only medicines to which the exemption applies

Conditions

1. State registered chiropodists who hold a certificate of competence in the use of analgesics issued by or with the approval of the Chiropodists Board.

  1. 1

    Prescription only medicines for parenteral administration that contain,as the sole active ingredient, not more than one of the following substances–

    • F10Bupivacaine hydrochloride

    • Bupivacaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of bupivacaine hydrochloride

    • Lignocaine hydrochloride

    • Lignocaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of lignocaine hydrochloride

    • F37Mepivacaine hydrochloride

    • Prilocaine hydrochloride.

1. The administration shall be only in the course of their professional practice.

2. Registered midwives.

  1. 1

    Prescription only medicines for parenteral administration containing any of the following substances but no other substance specified in column 1 of Schedule 1 to this Order–

    • Ergometrine maleate

    • Lignocaine

    • Lignocaine hydrochloride

    • Naloxone hydrochloride

    • Oxytocins, natural and synthetic

    • Pentazocine lactate

    • Pethidine hydrochloride

    • Phytomenadione

    • Promazine hydrochloride.

2. The administration shall be only in the course of their professional practice and in the case of Promazine hydrochloride, Lignocaine and Lignocaine hydrochloride shall be only while attending on a woman in childbirth.

3. Persons who are authorized as members of a group by a group authority granted under regulations 8(3) or 9(3) of the Misuse of Drugs Regulations to supply a controlled drug by way of administration only.

3. Prescription only medicines that are specified in the group authority.

3. The administration shall be subject to such conditions and in such circumstances and to such extent as may be specified in the group authority.

4. The owner or master of a ship which does not carry a doctor on board as part of her complement.

4. All prescription only medicines that are for parenteral administration.

4. The administration shall be only so far as is necessary for the treatment of persons on the ship.

5. Persons operating an occupational health scheme.

5. Prescription only medicines for parenteral administration sold or supplied to the person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.

  1. 1

    —

    1. 1

      The administration shall be in the course of an occupational health scheme.

    2. 2

      The individual administering the prescription only medicine, if neither a doctor nor acting in accordance with the directions of a doctor, shall be a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of the occupational health scheme.

6. The operator or commander of an aircraft.

6. Prescription only medicines for parenteral administration which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.

6. The administration shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.

7. Persons who are, and at 11th February 1982 were, persons customarily administering medicinal products to human beings by parenteral administration in the course of a business in the field of osteopathy, naturopathy, acupuncture or other similar field except chiropody.

7. Medicinal products that are prescription only medicines by reason only that they fall within the class specified in article 3(c) (products for parenteral administration).

7. The person administering the prescription only medicine shall have been requested by or on behalf of the person to whom it is administered and in that person’s presence to use his own judgement as to the treatment required.

8. Persons employed as qualified first-aid personnel on offshore installations.

8. All prescription only medicines that are for parenteral administration.

8. The administration shall be only so far as is necessary for the treatment of persons on the installation.

9. Persons who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State.

  1. 1

    The following prescription only medicines for parenteral administration–

    1. a

      Diazepam 5 mg per ml emulsion for injection;

    2. b

      Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion;

    3. c

      prescription only medicines containing one or more of the following substances, but no active ingredient–

      • Adrenaline Acid Tartrate

      • Anhydrous Glucose

      • F17Bretylium Tosylate

      • Compound Sodium Lactate Intravenous Infusion (Hartmann’s Solution)

      • Ergometrine Maleate

      • Glucose

      • Heparin Sodium

      • Lignocaine Hydrochloride

      • Nalbuphine Hydrochloride

      • Naloxone Hydrochloride

      • Polygeline

      • Sodium Bicarbonate

      • Sodium Chloride

9. The administration shall be only for the immediate, necessary treatment of sick or injured persons and in the case of a prescription only medicine containing Heparin Sodium shall be only for the purpose of cannula flushing.

SCHEDULE 6ORDERS REVOKED

Article 16(1)

Column 1

Column 2

Orders

References

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Order 1983

S.I. 1983/1212

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1984

S.I. 1984/756

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1986

S.I. 1986/586

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1987

S.I. 1987/674

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1987

S.I. 1987/1250

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1988

S.I. 1988/2017

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1991

S.I. 1991/962

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1992

S.I. 1992/1534

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1992

S.I. 1992/2937

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1993

S.I. 1993/1890

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1993

S.I. 1993/3256

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1994

S.I. 1994/558

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1994

S.I. 1994/3016

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 3) Order 1994

S.I. 1994/3050

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1995

S.I. 1995/1384

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1995

S.I. 1995/3174

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1996

S.I. 1996/1514

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1996

S.I. 1996/3193

F53SCHEDULE 7

Articles 12A to 12C

Annotations:
Amendments (Textual)

PART IPARTICULARS TO BE INCLUDED IN A PATIENT GROUP DIRECTION

a

the period during which the Direction shall have effect;

b

the description or class of prescription only medicine to which the Direction relates;

c

whether there are any restrictions on the quantity of medicine which may be supplied on any one occasion, and, if so, what restrictions;

d

the clinical situations which prescription only medicines of that description or class may be used to treat;

e

the clinical criteria under which a person shall be eligible for treatment;

f

whether any class of person is excluded from treatment under the Direction and, if so, what class of person;

g

whether there are circumstances in which further advice should be sought from a doctor or dentist and, if so, what circumstances;

h

the pharmaceutical form or forms in which prescription only medicines of that description or class are to be administered;

i

the strength, or maximum strength, at which prescription only medicines of that description or class are to be administered;

j

the applicable dosage or maximum dosage;

k

the route of administration;

l

the frequency of administration;

m

any minimum or maximum period of administration applicable to prescription only medicines of that description or class;

n

whether there are any relevant warnings to note, and, if so, what warnings;

o

whether there is any follow up action to be taken in any circumstances, and, if so, what action and in what circumstances;

p

arrangements for referral for medical advice;

q

details of the records to be kept of the supply, or the administration, of medicines under the Direction.

PART IIPERSONS ON WHOSE BEHALF A PATIENT GROUP DIRECTION MUST BE SIGNED

Column 1

Column 2

Class of person by whom a prescription only medicine is supplied or administered

Person on whose behalf the Direction must be signed

Common Services Agency

The Agency

Health Authority

The Health Authority

Special Health Authority

The Special Health Authority

NHS trust

The trust

Primary Care Trust

The Trust

A person who supplies or administers a prescription only medicine pursuant to an arrangement made with the Common Services Agency, a Health Authority, a Special Health Authority, an NHS trust or a Primary Care Trust

The Common Services Agency, where the arrangement has been made with the Agency; or the Health Authority, Special Health Authority, NHS trust or Primary Care Trust with which the arrangement has been made

PART IIICLASSES OF INDIVIDUAL BY WHOM SUPPLIES MAY BE MADE

  • Individuals who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State, or individuals who are state registered paramedics.

  • Pharmacists.

  • Registered health visitors.

  • Registered midwives.

  • Registered nurses.

  • Registered ophthalmic opticians.

  • State registered chiropodists.

  • Individuals who are registered in the register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960 by the Orthoptists Board (state registered orthoptists).

  • Individuals who are registered in the register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960 by the Physiotherapists Board (state registered physiotherapists).

  • Individuals who are registered in the register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960 by the Radiographers Board (state registered radiographers).

(This note is not part of the Order)

This Order consolidates with amendments the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983 as amended. That Order and the Orders amending it (“the 1983 Order as amended”) are revoked by article 16 and Schedule 6.

This Order specifies the descriptions and classes of prescription only medicines (i.e. medicinal products which, subject to exemptions, may be sold or supplied by retail only in accordance with a prescription given by an appropriate practitioner and which may be administered only by or in accordance with the directions of such a practitioner). Many medicinal products are included in a class of such medicines by reason of the substances contained in them (seeSchedule 1) but others are included because of other criteria, such as their method of administration (seearticle 3). In many cases the provisions of the Act apply subject to exemptions (seearticles 4 and 5 to 13 and Schedule 1).

The principal amendments relate to those medicines in respect of which marketing authorizations have been granted by the European Community. They include as prescription only medicines those medicines in respect of which such an authorization has been granted which classifies a medicine as being subject to medical prescription (article 3(f)). They exclude from the class of prescription only medicines those medicines in respect of which such an authorization provides for supply which is not subject to medical prescription (article 6(3)).

The differences between this Order and the 1983 Order as amended are in the main technical changes concerning the location of provisions such as the division of material in Schedule 1 to the 1983 Order as amended between the new Schedules 1 and 2. But within the new Schedule 1 there are changes which relate to–

a

the deletion from Column 1 of substances which are no longer used in those medicinal products which are on the market;

b

the use of current names for the substances which are specified in that Column where their names have changed;

c

the incorporation in that Schedule of provisions from article 4 of, and Part IV of Schedule 1 to, the 1983 Order as amended so that they may be found more easily;

d

a change in the legal base for the entries in Columns 2 to 4 so that those entries now form the criteria for exemptions from the sale or supply requirements of section 58(2) of the Medicines Act 1968 instead of the criteria for excluding medicinal products from the class of prescription only medicines (see alsoarticle 5);

e

the introduction of a fifth Column which specifies the maximum pack sizes to which exemptions apply.

As this order will impose no additional costs to business a compliance cost assessment has not been prepared.