The Prescription Only Medicines (Human Use) Order 1997

Statutory Instruments

1997 No. 1830

MEDICINES

The Prescription Only Medicines (Human Use) Order 1997

Made

25th July 1997

Laid before Parliament

28th July 1997

Coming into force

18th August 1997

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 1968(1) or, as the case may be, those conferred by the said provisions and now vested in them(2), 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 interpretation

1.—(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;

[F1“additional supply optometrist” means a person who is registered as an optometrist, and against whose name particulars of the additional supply speciality have been entered in the relevant register;]

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

[F2“clinical management plan” means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—

(a)

the patient to whom the plan relates,

(b)

the doctor or dentist who is a party to the plan, and

(c)

any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan;]

[F3“clinical trial” has the meaning given by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2003;]

F4...

[F5“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;]

[F5“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 1971(3);

“cyanogenetic substances” means preparations which–

(a)

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

(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;

[F6“district nurse/health visitor prescriber” means a first level nurse, or a registered midwife, against whose name in the professional register there is an annotation that he is qualified to order drugs, medicines and appliances from the Nurse Prescriber’s Formulary for District Nurses and Health Visitors Appendix in the current edition of the British National Formulary];

“dosage unit” means–

(a)

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

(b)

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

[F7“Extended Formulary” means the Nurse Prescribers’ Extended Formulary Appendix in the current edition of the British National Formulary;]

[F7“extended formulary nurse prescriber” means a person—

(a)

[F8who is a first level nurse [F9or registered midwife], and]

(b)

against whose name is recorded in [F10the professional register] an annotation signifying that he is qualified to order drugs, medicines and appliances from the Extended Formulary;]

“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;

[F11“first level nurse” means a person registered in Sub-Part 1 of the Nurses' Part of the professional register;]

[F5“Health Authority”—

(a)

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

(b)

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

(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;]

[F12“health care” means services for or in connection with the prevention, diagnosis or treatment of disease;]

“health prescription” means a prescription issued by a doctor, dentist [F13, supplementary prescriber] [F14, a district nurse/health visitor prescriber or an extended formulary nurse prescriber] under or by virtue of–

(a)

in England and Wales, the National Health Service Act 1977(4),

(b)

in Scotland, the National Health Service (Scotland) Act 1978(5), and

(c)

in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 1972(6);

[F15“health record” has the meaning given by section 68(2) of the Data Protection Act 1998(6);]

[F5“homoeopathic certificate of registration” means a certificate of registration for the purposes of the Medicines (Homoeopathic Medicinal Products For Human Use) Regulations 1994;]

[F16“independent clinic”—

(a)

in relation to England and Wales, has the meaning given by section 2(4) of the Care Standards Act 2000(8), and

(b)

in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001;]

[F16“independent hospital”—

(a)

in relation to England and Wales, shall be construed in accordance with section 2(2), (3) and (6) of the Care Standards Act 2000, and

(b)

in relation to Scotland, means—

(i)

an independent hospital, or

(ii)

a private psychiatric hospital,

as defined by section 77(1) of the Regulation of Care (Scotland) Act 2001;]

[F16“independent medical agency”—

(a)

in relation to England and Wales, has the meaning given by section 2(5) of the Care Standards Act 2000, and

(b)

in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001;]

“inhaler” does not include an aerosol;

[F17“Local Health Board” has the same meaning as in the National Health Service Act 1977;]

[F5“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 1995(7);

“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–

(a)

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

(b)

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

(i)

weight in weight,

(ii)

weight in volume,

(iii)

volume in weight, or

(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–

(a)

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

(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 1985(8) and in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 1986(9);

[F5“NHS trust”—

(a)

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

(b)

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

(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;]

[F18“NHS foundation trust” has the same meaning as in section 1(1) of the Health and Social Care (Community Health and Standards) Act 2003;]

[F19“nursing home” has the meaning given by article 16 of the Registered Homes (Northern Ireland) Order 1992;]

“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 1971(10) which is within–

(a)

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

(b)

waters in any area designated under section 1(7) of the Continental Shelf Act 1964(11);

“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;

[F5“Patient Group Direction” means—

(a)

in connection with the supply of a prescription only medicine as referred to in article 12A(2), [F2012B, 12C, 12D or 12E], a written direction relating to the supply and administration of a description or class of prescription only medicine; or

(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)—

    (i)

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

    (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;

[F5“Primary Care Trust” has the same meaning as in the National Health Service Act 1977;]

[F21“prison service” means—

(a)

in relation to England and Wales, a Minister of the Crown exercising functions in relation to prisons (within the meaning of the Prison Act 1952),

(b)

in relation to Scotland, the Scottish Ministers exercising functions in relation to prisons (within the meaning of the Prisons (Scotland) Act 1989), and

(c)

in relation to Northern Ireland, the Northern Ireland Department exercising functions in relation to prisons (within the meaning of the Prison Act (Northern Ireland) 1953);]

[F22“professional register” means the register maintained by the Nursing and Midwifery Council [F23under article 5 of] the Nursing and Midwifery Order 2001;]

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

(a)

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

(b)

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

[F24“registered chiropodist” means a person who is registered in Part 2 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;];

[F25“registered dietitian” means a person who is registered in Part 4 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F26“registered midwife” means a person registered in the Midwives' Part of the professional register;]

[F27“registered nurse” means a person registered in the Nurses' Part of the professional register;]

[F25“registered occupational therapist” means a person who is registered in Part 6 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F28“registered optometrist” means a person whose name is registered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989;]

[F24“registered orthoptist” means a person who is registered in Part 7 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;];

[F25“registered orthotist and prosthetist” means a person who is registered in Part 10 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F24“registered paramedic” means a person who is registered in Part 8 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F24“registered physiotherapist” means a person who is registered in Part 9 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F29“registered provider” means—

(a)

in relation to an independent hospital, an independent clinic or an independent medical agency—

(i)

in relation to England and Wales, the person who is registered under Part II of the Care Standards Act 2000 as the person carrying on the establishment or agency,

(ii)

in relation to Scotland, the person who is registered under Part 1 of the Regulation of Care (Scotland) Act 2001 as the person providing the establishment or agency, and

(b)

in relation to a nursing home, the person registered under Part III of the Registered Homes (Northern Ireland) Order 1992 as the person carrying on the nursing home, other than a manager who is to be treated as carrying on the home by virtue of article 17(2) of that order;]

[F24“registered radiographer” means a person who is registered in Part 11 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F25“registered speech and language therapist” means a person who is registered in Part 12 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F29“relevant manager” means—

(a)

in relation to an independent hospital, an independent clinic or an independent medical agency—

(i)

in relation to England and Wales—

(aa)

a person who is registered under Part II of the Care Standards Act 2000 as the manager of the establishment or agency, but who is not the registered provider for that establishment or agency, or

(bb)

if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person,

(ii)

in relation to Scotland, a person, other than the registered provider, who was identified as an individual who is to manage the establishment or agency on the application for registration of that establishment or agency under Part 1 of Regulation of Care (Scotland) Act 2001, and

(b)

in relation to a nursing home, the manager of the nursing home, unless they are the registered provider for that home;]

[F29“relevant register” means—

(a)

in relation to a first level nurse [F30or registered midwife], the professional register, F31...

(b)

in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954 or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976; F32...

(c)

[F33in relation to a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

(i)

chiropodists and podiatrists;

(ii)

physiotherapists; or

(iii)

radiographers diagnostic or therapeutic

that register [F34; and]

(d)

[F35in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989;]]

“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;

[F5“Special Health Authority”—

(a)

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

(b)

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

(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;]

F36...

F36...

[F37“Strategic Health Authority” means a Strategic Health Authority established under section 8 of the National Health Service Act 1977;]

[F38“supplementary prescriber” means—

(a)

a first level nurse, F39...

(b)

a pharmacist, F40[F41...

(c)

a registered midwife,] F42...

(d)

[F43a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

(i)

chiropodists and podiatrists;

(ii)

physiotherapists; or

(iii)

radiographers diagnostic or therapeutic [F44or]]

(e)

[F45a registered optometrist, ]

against whose name is recorded in the relevant register an annotation [F46or entry] signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber; ]

“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.

[F5“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 [F47Schedules 1, 2, 3A and 5]–

(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.

[F48(7) In articles 12 to [F4912E] , 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.]]

Textual Amendments

F28Words in reg. 1(2) substituted (30.6.2005 as notified in the London Gazette dated 3.6.2005) by The Opticians Act 1989 (Amendment) Order 2005 (S.I. 2005/848), Sch. 1 para. 27(a)

Appropriate practitioners

2.  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 [F50, supplementary prescribers], veterinary surgeons and veterinary practitioners;

[F51(b)in relation to the descriptions and classes of medicinal products specified in Schedule 3, district nurse/health visitor prescribers;

(c)in relation to the descriptions and classes of medicinal products specified in article 3A(1), extended formulary nurse prescribers.]

Textual Amendments

[F52Medicinal products on prescription only

3.  The following descriptions and classes of medicinal products are specified for the purposes of section 58, namely—

(a)medicinal products in respect of which a marketing authorization has been granted, which in the marketing authorization are classified as being prescription only medicines;

(b)medicinal products in respect of which no marketing authorization has been granted consisting of or containing a substance listed in column 1 of Schedule 1;

(c)medicinal products that are for parenteral administration;

(d)medicinal products that are controlled drugs unless a marketing authorization has been granted in respect of that medicinal product in which the product is classified as being a pharmacy only or on general sale list medicine;

(e)cyanogenetic substances, other than preparations for external use;

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

[F53(g)medicinal products in respect of which a marketing authorization has been granted consisting of or containing aloxiprin, aspirin or paracetamol in the form of non-effervescent tablets or capsules which in the marketing authorization are classified as being pharmacy only or general sale list medicines.]]

Textual Amendments

[F54Prescribing by extended formulary nurse prescribers

3A.—(1) Subject to paragraph (2), the description and classes of medicinal products in relation to which extended formulary nurse prescribers are appropriate practitioners are those prescription only medicines which consist of, or contain, one or more of the substances specified in column 1 of Schedule 3A, but which do not contain any other substance or combination of substances which is a prescription only medicine not included in Schedule 3A.

(2) [F55Subject to paragraph (4),] an extended formulary nurse prescriber may—

(a)give a prescription for a medicinal product referred to in paragraph (1); or

(b)if that medicinal product is for parenteral administration—

(i)administer that medicinal product, or

(ii)give directions for the administration of that medicinal product,

only where he complies with any condition as to the cases or circumstances in which he may do so that is specified by virtue of paragraph (3).

(3) If the entry in column 2 of Schedule 3A relating to a substance specifies one or more requirements as to use, route of administration or pharmaceutical form, it is a condition for the purposes of paragraph (2) that a medicinal product which consists of, or contains, that substance is administered, or is prescribed or directed for administration, in accordance with the specified requirements.

[F56(4) An extended formulary nurse prescriber may prescribe or administer a medicinal product referred to in paragraph (1), or give directions for administration of such a product, without complying with any condition specified by virtue of paragraph (3) if—

(a)he is a supplementary prescriber; and

(b)he complies with the applicable conditions set out in article 3B(3).]]

Textual Amendments

[F57Prescribing and administration by supplementary prescribers

3B.—(1) Subject to paragraph (2), a supplementary prescriber may—

(a)give a prescription for a medicinal product referred to in article 3; or

(b)if that medicinal product is for parenteral administration—

(i)administer that medicinal product, or

(ii)give directions for the administration of that medicinal product,

only where he complies with the conditions as to the cases or circumstances in which he may do so specified in paragraph (3).

(2) Paragraph (1) does not apply if—

(a)the supplementary prescriber is a district nurse/health visitor prescriber and the medicinal product prescribed or administered, or in respect of which he gives directions for administration, falls within a description or class of medicinal products specified in Schedule 3; or

(b)the supplementary prescriber is an extended formulary nurse prescriber and—

(i)the medicinal product prescribed or administered, or in respect of which he gives directions for administration, falls within a description or class of medicinal products specified in article 3A(1), and

(ii)he satisfies any applicable condition specified by virtue of article 3A(3).

(3) The conditions referred to in paragraph (1) are that—

(a)the supplementary prescriber is acting in accordance with the terms of a clinical management plan which—

(i)relates to the patient for whom the product is prescribed or to whom it is, or is to be, administered,

(ii)is in effect at the time the prescription or direction is given or, as the case may be, the product is administered, and

(iii)includes the particulars specified in Schedule 3B;

F58(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)the supplementary prescriber has access to the health records of the patient to whom the plan relates which are used by any doctor or dentist who is a party to the plan.

Textual Amendments

Exemptions from conditions in respect of the cases or circumstances in which an extended formulary nurse prescriber or supplementary prescriber may administer a medicinal product

3C.  The conditions specified by virtue of article 3A(3) and in article 3B(3) shall not apply in relation to the administration of a medicinal product by an extended formulary nurse prescriber or a supplementary prescriber where—

(a)that person is acting in accordance with the directions of another person who is an appropriate practitioner, or

(b)that administration is exempt from the restriction in section 58(2)(b) (restriction on administration) by virtue of any of the subsequent provisions of this Order.]

Textual Amendments

Duration of special provisions in relation to new medicinal products

F594.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Exempt medicinal products

5.—(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 [F60,

provided that, where the entry in column 3 contains a condition to the effect that the product is to be wholly or mainly for use in a specified class of persons, the product satisfies that condition where it is sold or supplied wholly or mainly for use 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.

Textual Amendments

[F61Exemption for products consisting of or containing aloxiprin, aspirin or paracetamol

5A.  A medicinal product falling within article 3(g) shall be exempt from the restrictions imposed by section 58(2) (restrictions on sale, supply and administration) if the quantity of that product sold or supplied to a person at any one time does not exceed 100 tablets or capsules.]

Textual Amendments

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

F626.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

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

7.  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

  • [F63Atropine sulphate and obidoxime chloride injection]

  • [F63Atropine sulphate and pralidoxime chloride injection]

  • [F63Atropine sulphate, pralidoxime mesilate and avizafone injection]

  • [F64Chlorphenamine Injection]

  • [F65Dicobalt Edetate Injection]

  • F66...

  • F66...

  • Glucagon Injection

  • [F67Glucose Injection 50%]

  • Hydrocortisone Injection

  • [F68Naloxone Hydrochloride]

  • [F63Pralidoxime chloride injection]

  • [F63Pralidoxime mesilate 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.

Textual Amendments

[F69Exemptions for administration of smallpox vaccine

7A.—(1) The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration to human beings of smallpox vaccine where the conditions specified in paragraph (2) or (3) are satisfied.

(2) The conditions referred to in this paragraph are—

(a)the vaccine has been supplied by, or on behalf of, or under arrangements made by—

(i)the Secretary of State,

(ii)the Scottish Ministers,

(iii)the National Assembly for Wales,

(iv)the Department of Health, Social Services and Public Safety,

(v)an NHS body; and

(b)the vaccine is administered for the purpose of providing protection against smallpox virus in the event of a suspected or confirmed case of smallpox in the United Kingdom.

(3) The conditions referred to in this paragraph are—

(a)the vaccine has been supplied by, or on behalf of, or under arrangements made by Her Majesty’s Forces;

(b)the vaccine is administered for the purpose of providing protection against smallpox virus to—

(i)members of Her Majesty’s Forces; or

(ii)other persons employed or engaged by those Forces.

(4) For the purposes of this regulation, “NHS body” means—

(a)the Common Services Agency,

(b)a Strategic Health Authority, Health Authority or Special Health Authority,

(c)a Primary Care Trust,

(d)a Local Health Board, or

(e)an NHS trust or NHS foundation trust]

Textual Amendments

Exemptions for emergency sale or supply

8.—(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 [F70, a supplementary prescriber] [F71, a district nurse/health visitor prescriber or an extended formulary nurse prescriber] who by reason of an emergency is unable to furnish a prescription immediately;

(b)that the doctor [F72, supplementary prescriber] [F73, district nurse/health visitor prescriber or extended formulary nurse prescriber] 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 [F74, supplementary prescriber] [F75, district nurse/health visitor prescriber or extended formulary nurse prescriber] 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 1980(12) 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 [F76, supplementary prescriber] [F77, district nurse/health visitor prescriber or extended formulary nurse prescriber] 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 [F78a 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.

Textual Amendments

Exemption for non-parenteral administration to human beings

9.  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 dilutions

10.—[F79(1)]  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).

[F80(2) 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 solely one or more unit preparations of the following substances—

  • Aconite

  • Arsenic Trioxide

  • Belladonna Herb

  • Ignatia Bean

  • Nux Vomica Seed,

if each such unit preparation has been diluted to at least one part in a million (6x)]

Textual Amendments

Exemptions for certain persons

11.—(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.

[F81Exemption for sale or supply in hospitals

12.—(1) Subject to paragraph (3), 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 directions satisfying the conditions specified in paragraph (2).

(2) The conditions specified in paragraph (1) are that the directions—

(a)are in writing;

(b)relate to the particular person to whom the medicine is to be administered; and

(c)are given by a person (other than a veterinary surgeon or veterinary practitioner) who is an appropriate practitioner in relation to that medicine.

(3) Such directions may be given by an extended formulary nurse prescriber or a supplementary prescriber only where he complies with any condition as to the cases or circumstances in which he may give a prescription for that medicine specified by virtue of article 3A or 3B, as if the directions are a prescription.

(4) The exemption in paragraph (1) applies notwithstanding that the directions do not satisfy the conditions specified in article 15(2).]

Textual Amendments

[F82Exemptions for the supply and administration of prescription only medicines by national health service bodies

12A.—(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 [F83Strategic Health Authority,] Health Authority or Special Health Authority;

(c)an NHS trust [F84or NHS foundation 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 [F85Strategic Health Authority,] Health Authority or Special Health Authority;

(c)an NHS trust [F86or NHS foundation 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.

Textual Amendments

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 services

12B.—(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 [F87or Primary Care Trust]—

(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—

[F88(i)in relation to England and Wales, the provision of primary medical services under Part I of the National Health Service Act 1977;]

[F89(ii)in relation to Scotland, the provision of primary medical services under Part I of the National Health Service (Scotland) Act 1978; and]

[F90(iii)in relation to Northern Ireland, the provision of primary medical services under Article 15B or Part VI of the Health and Personal Social Services (Northern Ireland) Order 1972.]

Textual Amendments

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

12C.—(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—

[F91(a)the medicine is supplied, or as the case may be, is administered by such a person pursuant to an arrangement made with—

(i)a body referred to in article 12A(a) to (d),

(ii)an authority or person carrying on the business of an establishment or agency referred to in article 12D(1),

(iii)a force or service referred to in article 12E(1)(a)(i) to (iii), or

(iv)Her Majesty’s Forces,

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);

[F92(c)the Patient Group Direction is signed—

(i)in the case of an arrangement with a body referred to in article 12A(a) to (d), on behalf of that body,

(ii)in the case of an arrangement with an authority or person carrying on the business of an establishment or agency referred to in article 12D(1), by or on behalf of the relevant provider and, if there is a relevant manager for the establishment or agency, that manager,

(iii)in the case of an arrangement with a prison service, by or on behalf of the person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for that service,

(iv)in the case of an arrangement with a police force or the Police Service of Northern Ireland—

(a)by or on behalf of the person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for that force or service, and

(b)a doctor who is not employed or engaged by, and who does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland, and

(v)in the case of an arrangement with Her Majesty’s Forces, by or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for Her Majesty’s Forces;]

[F93(cc)where the prescription only medicine is administered by the person lawfully conducting a retail pharmacy business within the meaning of section 69, the individual who administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is [F94designated in writing—

(i)in the case of an arrangement with a body referred to in article 12A(a) to (d), on behalf of that body,

(ii)in the case of an arrangement with an authority or person carrying on the business of an establishment or agency referred to in article 12D(1), by or on behalf of the relevant provider or, if there is a relevant manager for the establishment or agency, that relevant manager,

(iii)in the case of an arrangement with a force or service referred to in article 12E(1)(a)(i) to (iii), by or on behalf of the person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for that force or service, or

(iv)in the case of an arrangement with Her Majesty’s Forces, by or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for Her Majesty’s Forces,

for the purpose of the administration of prescription only medicines under the Patient Group Direction; 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.]

Textual Amendments

[F95Exemption for the supply and administration of prescription only medicines by independent hospitals, clinics and agencies

12D.—(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 in the course of the business of—

(a)in England, Wales or Scotland—

(i)an independent hospital,

(ii)an independent clinic, or

(iii)an independent medical agency; or

(b)in Northern Ireland, a nursing home,

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 (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, 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—

(i)by or on behalf of the registered provider, and

(ii)if there is a relevant manager for the independent hospital, clinic or agency, or nursing home, by that manager;

(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—

(i)by or on behalf of the registered provider, or

(ii)if there is a relevant manager for the independent hospital, clinic or agency, or nursing home, by that manager,

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.

Textual Amendments

Exemption for health professionals who supply or administer prescription only medicines under a Patient Group Direction in order to assist the provision of health care by or on behalf of the police, the prison services or the armed forces

12E.—(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 the provision of health care by, on behalf of, or under arrangements made by—

(i)a police force in England, Wales or Scotland,

(ii)the Police Service of Northern Ireland,

(iii)a prison service, or

(iv)Her Majesty’s Forces;

(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 provision of health care by, or on behalf of, or under arrangements made by the police force or service, the prison service or, as the case may be, Her Majesty’s Forces;

(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 or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order (“the authorising person”) against the entry in column 1 of that Table for the police force or service, the prison service or Her Majesty’s Forces by whom, or on whose behalf, the health care is provided, or with whom arrangements are made for the provision of such care; and

(ii)in the case of a police force or the Police Service of Northern Ireland, by a doctor who is not employed or engaged by, and who does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland;

(e)the individual referred to in paragraph (1) is designated in writing, by or 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

(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.]

Textual Amendments

Exemption in cases involving another’s default

13.  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.

[F96Exemptions relating to prescriptions given by nurses

13A.—[F97(1) The restrictions imposed by section 58(2)(a) (restrictions in sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by—

(a)another pharmacist,

(b)a registered nurse, F98...

(c)a registered midwife, F99...

[F100(d)a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

(i)chiropodists and podiatrists;

(ii)physiotherapists; or

(iii)radiographers: diagnostic or therapeutic, [F101or]]

[F102(e)a registered optometrist,]

who is not an appropriate practitioner in relation to that medicine where the pharmacist selling or supplying the medicine, having exercised all due diligence, believes on reasonable grounds that the person is such a practitioner.]

(2) 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 prescription given by an extended formulary nurse prescriber [F103or supplementary prescriber] where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the extended formulary nurse prescriber [F103or supplementary prescriber] has complied with any condition with which he is required to comply by virtue of [F104articles 3A(2) and (3) or 3B].]

Textual Amendments

Exemption in the case of a forged prescription

14.  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.

Prescriptions

[F10515.—(1) For the purposes of section 58(2)(a), and subject to paragraph (3), 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, a supplementary prescriber, a district nurse/health visitor prescriber,an extended formulary nurse prescriber, a veterinary surgeon or a veterinary practitioner,

(iv)where the appropriate practitioner giving it is a doctor, dentist, a supplementary prescriber, a district nurse/health visitor prescriber, or an extended formulary nurse prescriber, 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 the 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) For the purposes of paragraph (1) the prescription may, as an alternative to fulfilling the conditions specified in paragraph (2)(a) and (b), fulfil instead the conditions specified in paragraph (4), unless the prescription is a health prescription for a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations or is given by a veterinary surgeon or a veterinary practitioner.

(4) The conditions referred to in paragraph (3) are that the prescription shall be created in electronic form and signed with an advanced electronic signature and transferred to the person by whom it is dispensed as an electronic communication (including where it is so transferred through one or more intermediaries).

(5) The prohibition on sale or supply imposed by section 58(2)(a) shall not apply where a prescription only medicine is sold or supplied other than in accordance with a prescription given by an appropriate practitioner and –

(a)the reason the sale or supply is not in accordance with such a prescription is that a condition specified in paragraph (2) or (4) is not fulfilled; and

(b)the person selling or supplying the prescription only medicine has exercised all due diligence and believes on reasonable grounds that the condition is fulfilled.

(6) In paragraph (2) “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 the 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.

(7) In this Article—

“advanced electronic signature” means an electronic signature which is—

(a)

uniquely linked to the signatory,

(b)

capable of identifying the signatory,

(c)

created using means that the signatory can maintain under his sole control, and

(d)

which is linked to the data to which it relates in such a manner that any subsequent change of data is detectable;

“electronic communication” means a communication transmitted (whether from one person to another, from one device to another or from a person to a device or vice versa)—

(a)

by means of a telecommunication system (within the meaning of the Telecommunications Act 1984, or

(b)

by other means but while in an electronic form; and

“signatory” means the appropriate practitioner giving the prescription.]

Textual Amendments

Revocations

16.—(1) The Orders specified in Schedule 6 are revoked.

(2) In the Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order 1989(13) articles 2 to 6 and Schedules 1 and 2 are revoked.

Signed by authority of the Secretary of State for Health

Baroness Jay

Minister of State,

Department of Health

Win Griffiths

Parliamentary Under Secretary of State, Welsh Office

Sam Galbraith

Parliamentary Under Secretary of State, The Scottish Office

Jeff Rooker

Minister 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.

Legal seal

D. C. Gowdy

Permanent Secretary

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

Legal seal

P. Small

Permanent Secretary

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

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

Exemptions from the restrictions on the sale and supply of prescription only medicines
Column 1Column 2Column 3Column 4Column 5
SubstanceMaximum strengthRoute of administration, use or pharmaceutical formTreatment limitationsMaximum quantity
[F106Acamprosate]
Acarbose
Acebutolol Hydrochloride
[F106Aceclofenac]
Acemetacin
Acetarsol
Acetazolamide
Acetazolamide Sodium
Acetohexamide
Acetylcholine Chloride0.2 per centExternal
Acetylcysteine
Acipimox
Aciclovir5.0 per centExternalContainer 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
Aconite1.3 per centExternal
Acrivastine24 mg (MDD)Container or package containing not more than 240mg of Acrivastine
Acrosoxacin
Actinomycin C
Actinomycin D
[F107Adapalene]
Adenosine
Adrenaline(1) By inhaler
(2) External [F108(except ophthalmic)]
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
[F106Alendronate Sodium]
Alfacalcidol
Alfuzosin Hydrochloride
Allergen Extracts
Allopurinol
Allyloestrenol
[F109Aloxiprin(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
[F107Altretamine]
Amantadine Hydrochloride
Ambenonium Chloride
Ambutonium Bromide
Amcinonide
Ametazole Hydrochloride
AmethocaineNon-ophthalmic use
Amethocaine GentisateNon-ophthalmic use
Amethocaine HydrochlorideNon-ophthalmic use
Amikacin Sulphate
Amiloride Hydrochloride
Aminocaproic Acid
Aminoglutethimide
Aminopterin Sodium
Amiodarone Hydrochloride
Amiphenazole Hydrochloride
[F110Amisulpride]
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 HydrochlorideNon-ophthalmic use
[F106Anastrozole]
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
[F107Apraclonidine 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
[F111Aspirin

[F112(1) 75mg]

[F112(1) Non-effervescent tablets and capsules]

[F112(1) 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]

[F113[F114(2)] 500 mg]

[F114(2)] Non-effervescent tablets and capsules

[F114(2)] The quantity sold or supplied in one container or package shall not exceed 32

[F114(3)] 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]

AstemizoleF115. . .F115. . .F115. . .
F115. . .
F115. . .
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 MethonitrateInternal
(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 HydrochlorideFor nasal administration140mcg per nostril (MD)Container or package containing not more than 5,040mcg of Azelastine Hydrochloride
For the treatment of seasonal allergic rhinitis [F116or perennial allergic rhinitis]280mcg per nostril (MDD)
For use in adults and children not less than [F1175 years]
As a non-aerosol, aqueous form
Azidocillin Potassium
Azithromycin
Azlocillin Sodium
Aztreonam
Bacampicillin Hydrochloride
Bacitracin
Bacitracin Methylene Disalicylate
Bacitracin Zinc
Baclofen
[F110Balsalazide Sodium]
Bambuterol Hydrochloride
Barium Carbonate
Barium Chloride
Barium Sulphide
Beclamide
Beclomethasone
Beclomethasone DipropionateFor nasal administration (non-aerosol)100mcg per nostril (MD)Container or package containing not more than [F11820,000 mcg] of Beclomethasone Dipropionate
For the prevention and treatment of allergic rhinitis200 mcg per nostril (MDD)
[F119For a maximum period of 3 months]
[F120For 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
[F110Benserazide]
Benserazide Hydrochloride
Bentiromide
Benzathine Penicillin
Benzbromarone
Benzhexol Hydrochloride
Benzilonium Bromide
BenzocaineAny use except ophthalmic use
Benzoctamine Hydrochloride
Benzoyl Peroxide10.0 per centExternal
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
[F107Bicalutamide]
Biperiden Hydrochloride
Biperiden Lactate
Bismuth Glycollylarsanilate
Bisoprolol Fumarate
Bleomycin
Bleomycin Sulphate
Bretylium Tosylate
[F110Brimonidine Tartrate]
Bromhexine Hydrochloride
Bromocriptine Mesylate
Bromperidol
Bromvaletone
Brotizolam
BudesonideFor nasal administration200mcg per nostril (MD)Container or package containing not more than 10mg of Budesonide
For the prevention or treatment of seasonal allergic rhinitis [F119For a maximum period of 3 months]
200 mcg per nostril (MDD)
[F120For use in persons aged 18 years and over]
As a non-aerosol, aqueous form
Bufexamac
Bumetanide
Buphenine Hydrochloride6mg (MD)
18mg (MDD)
BupivacaineAny use except ophthalmic use
Bupivacaine HydrochlorideAny use except ophthalmic use
Buserelin Acetate
Buspirone Hydrochloride
Busulphan
Butacaine SulphateAny use except ophthalmic use
Butorphanol Tartrate
Butriptyline Hydrochloride
[F121Cabergoline]
Calcipotriol
[F107Calcipotriol Hydrate]
Calcitonin
Calcitriol
Calcium Amphomycin
Calcium Benzamidosalicylate
Calcium Bromide
Calcium Bromidolactobionate
Calcium Carbimide
Calcium Folinate
Calcium Metrizoate
Calcium Sulphaloxate
[F122Candesartan Cilexetil]
Candicidin
Canrenoic Acid
Cantharidin0.01 per centExternal
Capreomycin Sulphate
Captopril
Carbachol
Carbamazepine
Carbaryl
[F110Carbasalate Calcium]
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 [F123560mg] 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
[F110Cefdinir]
Cefixime
Cefodizime Sodium
Cefotaxime Sodium
Cefoxitin Sodium
Cefpodoxime Proxetil
[F121Cefprozil]
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
[F110Cerivastatin Sodium]
Ceruletide Diethylamine
Cetirizine Hydrochloride10mg (MDD)F124. . .
Chenodeoxycholic Acid
Chloral HydrateExternal
Chlorambucil
Chloramphenicol
Chloramphenicol Cinnamate
Chloramphenicol Palmitate
Chloramphenicol Sodium Succinate
Chlorhexadol
Chlormadinone Acetate
Chlormerodrin
Chlormethiazole
Chlormethiazole Edisylate
Chlormezanone
Chloroform(14)(1) 5.0 per cent(1) Internal
(2) External
Chloroquine PhosphateProphylaxis of malaria
Chloroquine SulphateProphylaxis 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
Cinchocaine3.0 per centNon-ophthalmic use
Cinchocaine HydrochlorideEquivalent of 3.0 per cent of CinchocaineNon-ophthalmic use
Cinchophen
Cinoxacin
Ciprofibrate
Ciprofloxacin
Ciprofloxacin Hydrochloride
Cisapride
Cisplatin
[F107Citalopram 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 [F1250.05 per cent] [F125Cream for use in adults and in children aged 12 years and over, for external use for the short term symptomatic treatment and control of patches of eczema and dermatitis (excluding seborrhoeic dermatitis)] [F125Container or package containing not more than 15g of medicinal product]
Clofazimine
Clofibrate
Clomiphene Citrate
Clomipramine
Clomipramine Hydrochloride
Clomocycline
Clomocycline Sodium
Clonidine
Clonidine Hydrochloride
Clopamide
Clopenthixol Decanoate
Clopenthixol Hydrochloride
Clorexolone
ClotrimazoleExternal 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 Leaf7.0 per centExternal
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 Bitartrate26mg (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 HydrobromideInternal(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 Diethylammonium1.16 per centExternalFor maximum period of 7 daysContainer 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 Hydrochloride10mg (MD)
60mg (MDD)
[F106Didanosine]
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 HydrochlorideNon-ophthalmic use
Dimethisterone
Dimethothiazine Mesylate
Dimethyl Sulphoxide
Dimethyltubocurarine Bromide
Dimethyltubocurarine Chloride
Dimethyltubocurarine Iodide
Dinoprost
Dinoprost Trometamol
Dinoprostone
[F109Diphenhydramine Hydrochloride All preparations except liquid-filled capsules]
[F126Diphenoxylate Hydrochloride] [F1262.5 mg] [F126In combination with Atropine Sulphate for short term use as an adjunctive therapy to appropriate rehydration in acute diarrhoea [F12625 mg (MDD)] [F126Container or package containing not more than 20 tablets]
For use in persons aged 16 years and over
Tablets]
Dipivefrin Hydrochloride
Dipyridamole
Disodium Etidronate
Disodium Pamidronate
Disopyramide
Disopyramide Phosphate
Distigmine Bromide
Disulfiram
Dithranol1.0 per cent
Dobutamine Hydrochloride
[F126Dolasetron Mesilate]
Domperidone [F127For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn] [F12710mg of Domperidone (MD)] [F127Container or package containing not more than 200mg of Domperidone]
[F12740mg of Domperidone (MDD)]
Domperidone Maleate [F128For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn,] [F12910 mg of Domperidone as Domperidone Maleate (MD)] [F128Container or package containing not more than [F130200mg] of Domperidone as Domperidone Maleate;]
[F12940 mg of Domperidone as Domperidone Maleate (MDD)]
[F110Donepezil Hydrochloride]
Dopamine Hydrochloride
Dopexamine Hydrochloride
[F107Dorzolamide Hydrochloride]
Dothiepin
Dothiepin Hydrochloride
Doxapram Hydrochloride
Doxazosin Mesylate
Doxepin Hydrochloride
Doxorubicin
Doxorubicin Hydrochloride
Doxycycline
Doxycycline Calcium Chelate
Doxycycline Hydrochloride
Droperidol
Dydrogesterone
Dyflos
EconazoleExternal but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Econazole NitrateExternal but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Ecothiopate Iodide
Edrophonium Chloride
Eflornithine Hydrochloride
[F106Eformoterol Fumarate]
Embutramide
Emepronium Bromide
Emetine1.0 per cent
Emetine Bismuth Iodide
Emetine HydrochlorideEquivalent 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
[F131Estramustine 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
[F107Exemestane]
Famciclovir
FamotidineFor 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 symptoms10mg (MD)
20mg (MDD)
For maximum period of 14 days
Fazadinium Bromide
Felbinac3.17 per centExternalFor maximum period of 7 daysContainer or package containing not more than [F13250g] of medicinal product
[F133For 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 [F125External use (but in the case of vaginal use, only for the treatment of vaginal candidiasis)]
Feprazone
Ferrous Arsenate
[F107Ferumoxsil]
[F110Fexofenadine Hydrochloride]
Filgrastim
Finasteride
Flavoxate Hydrochloride
Flecainide Acetate
Flosequinan
Fluanisone
Flubendazole
Fluclorolone Acetonide
Flucloxacillin Magnesium
Flucloxacillin Sodium
FluconazoleFor oral administration for the treatment of vaginal candidiasis [F134or associated candidal balanitis] in persons aged not less than 16 but less than 60 years150mg (MD)Container or package containing not more than 150mg of Fluconazole
Flucytosine
Fludrocortisone Acetate
Flufenamic Acid
Flumazenil
Flumethasone
Flumethasone Pivalate
Flunisolide0.025 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)
[F135For use in persons aged 18 years and over] [F136For a maximum period of 3 months]
In the form of a non-pressurised nasal spray
F137...F137... F137...
F137. . .
F137. . .
F137. . .
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 [F1388.75 mg] [F139Throat lozenges] [F14043.75 mg (MDD)] [F141Container or package containing not more than 140 mg of Flurbiprofen]
Flurbiprofen Sodium
Fluspirilene
Flutamide
Fluticasone Propionate
[F110Flutrimazole]
Fluvastatin Sodium
Fluvoxamine Maleate
Folic Acic500mcg (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
Gelsemine0.1 per cent
Gelsemium25mg (MD)
75mg (MDD)
Gemeprost
Gemfibrozil
Gentamicin
Gentamicin Sulphate
Gestodene
Gestrinone
Gestronol
Gestronol Hexanoate
Glibenclamide
Glibornuride
Gliclazide
Glipizide
Gliquidone
Glisoxepide
Glucagon
Glycopyrronium Bromide1mg (MD)
2mg (MDD)
Glymidine
Gonadorelin
Goserelin Acetate
Gramicidin0.2 per centExternal
Granisetron Hydrochloride
Griseofulvin
Growth Hormone
Guanethidine Monosulphate
Guanfacine Hydrochloride
Guanoclor Sulphate
Guanoxan Sulphate
Halcinonide
Halofantrine Hydrochloride
Haloperidol
Haloperidol Decanoate
HeparinExternal
Heparin CalciumExternal
Heparin Sodium
HexachlorophaneExternal
(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 HydrochlorideDietary supplementation
Homatropine(1) Internal(1) 0.15mg (MD)
0.45mg (MDD)
(2) External (except ophthalmic)
Homatropine Hydrobromide0.2mg (MD)
0.6mg (MDD)
Homatropine Methylbromide2mg (MD)
6mg (MDD)
Hydralazine Hydrochloride
HydrargaphenLocal application to skin
Hydrobromic Acid
Hydrochlorothiazide
Hydrocortisone

[F142(1) 0.5 per cent]

[F142(1) External

(a)

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

(b)

For use in adults and children not less than 10 years]

[F142(1) Container or package containing not more than 15g of medicinal product]

[F143(2)] 1.0 per cent

[F143(2)] External

(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 [F144or Miconazole Nitrate] for athlete’s foot and candidal intertrigo or in combination with lignocaine for anal and perianal itch associated with haemorrhoids

(b)

For use in adults and children not less than 10 years

(c)

Cream ointment or spray

[F143(2)] Container or package containing not more than 15g of medicinal product (cream or ointment) or 30ml (spray)

Hydrocortisone AcetateEquivalent to 1.0 per cent HydrocortisoneExternal
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 [F145or in combination with Miconazole Nitrate, for athlete’s foot and candidal intertrigo]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 SuccinateEquivalent to 2.5mg HydrocortisoneExternalContainer 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
[F109Hydrocyanic Acid]
Hydroflumethiazide
Hydroxychloroquine SulphateProphylaxis 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
IbuprofenRheumatic 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
[F146(3) 10.0 per cent] [F146(3) External] [F146(3) 125 mg (MD) 500 mg (MDD)] [F146(3) Container or package containing not more than [F14750g] of medicinal product]
[F109Ibuprofen 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
[F106Imidapril Hydrochloride]
Imipenem Hydrochloride
Imipramine
Imipramine Hydrochloride
Imipramine Ion Exchange Resin Bound Salt or Complex
[F121Indapamide]
Indapamide Hemihydrate
Indomethacin
Indomethacin Sodium
Indoprofen
Indoramin Hydrochloride
Inosine Pranobex
[F148Insulin]
Iodamide
Iodamide Meglumine
Iodamide Sodium
Iohexol
Iomeprol
Iopamidol
Iopentol
Iothalamic Acid
Ioversol
Ioxaglic Acid
Ipratropium Bromide
Iprindole Hydrochloride
Iproniazid Phosphate
[F110Irbesartan]
Isoaminile
Isoaminile Citrate
Isocarboxazid
Isoconazole NitrateExternal 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 IodideEquivalent of 2.5mg of Isopropamide ion (MD)
Equivalent of 5.0mg of Isopropamide ion (MDD)
Isotretinoin
Isradipine
Itraconazole
JaborandiExternal
Kanamycin Acid Sulphate
Kanamycin Sulphate
Ketamine Hydrochloride
Ketoconazole2.0 per cent [F149(a)] [F150External] [F149(a)] Maximum frequency of application of once every 3 days [F149(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
[F151(b) For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo]
Ketoprofen2.5 per centExternalFor maximum period of 7 daysContainer 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
[F121Lansoprazole]
Latamoxef Disodium
[F121Lercanidipine Hydrochloride]
Levallorphan Tartrate
Levobunolol Hydrochloride
[F109Levocabastine HydrochlorideEquivalent 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
[F152Levocarnitine] [F152For dietary supplementation]
Levodopa
[F110Levofloxacin]
Levonorgestrel [F1530.75mg] [F153for use as an emergency contraceptive in women aged 16 years and over]
Lidoflazine
LignocaineNon-ophthalmic use
Lignocaine HydrochlorideNon-ophthalmic use
Lincomycin
Lincomycin Hydrochloride
Liothyronine Sodium
Lisinopril
Lithium CarbonateEquivalent of 5mg of Lithium (MD)
Equivalent of 15mg of Lithium (MDD)
Lithium Citrate
Lithium Succinate
Lithium SulphateEquivalent 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 [F154equivalent of 0.1 per cent Lodoxamide] [F155For the treatment of ocular signs and symptoms of allergic conjunctivitis, in adults and in children aged 4 years and over]
Lofepramine
Lofepramine Hydrochloride
Lofexidine Hydrochloride
Lomefloxacin Hydrochloride
Lomustine
Loperamide HydrochlorideTreatment of acute diarrhoea
Loratidine10mg (MDD)F156. . .
[F122Lornoxicam]
[F122Losartan Potassium]
Loxapine Succinate
Lung Surfactant Porcine
Luteinising Hormone
Lymecycline
Lynoestrenol
Lypressin
Lysuride Maleate
Mafenide
Mafenide Acetate
Mafenide Hydrochloride
Mafenide Propionate5.0 per centEye drops
Magnesium Fluoride
Magnesium Metrizoate
Mandragora Autumnalis
Mannomustine Hydrochloride
Maprotiline Hydrochloride
Mebanazine
MebendazoleFor oral use in the treatment of enterobiasis in adults and in children not less than 2 years100mg (MD)Container or package containing not more than 800mg of Mebendazole
Mebeverine Hydrochloride

[F157(a) For the symptomatic relief of irritable bowel syndrome

[F157(a) 135 mg (MD)

405 mg (MDD)]

(b) For uses other than the symptomatic relief of irritable bowel syndrome]

[F157(b) 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
[F121Meloxicam]
Melphalan
Melphalan Hydrochloride
Menotrophin
Mepenzolate Bromide25mg (MD)
75mg (MDD)
Mephenesin
Mephenesin Carbamate
Mepivacaine HydrochlorideAny use except ophthalmic use
Meptazinol Hydrochloride
Mequitazine
[F110Mercaptamine Bitartrate]
Mercaptopurine
Mersalyl
Mersalyl Acid
Mesalazine
Mesna
Mestranol
Metaraminol Tartrate
Metergoline
Metformin Hydrochloride
Methacycline
Methacycline Calcium
Methacycline Hydrochloride
Methallenoestril
Methicillin Sodium
Methixene
Methixene Hydrochloride
Methocarbamol
MethocidinThroat lozenges and throat pastilles
Methohexitone Sodium
Methoin
Methoserpidine
Methotrexate
Methotrexate Sodium
Methotrimeprazine
Methotrimeprazine Hydrochloride
Methotrimeprazine Maleate
Methoxamine Hydrochloride0.25 per centNasal sprays or nasal drops not containing liquid paraffin as a vehicle
Methsuximide
Methyclothiazide
Methyldopa
Methyldopate Hydrochloride
Methylephedrine Hydrochloride30mg (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
MiconazoleExternal but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Miconazole NitrateExternal 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[F158(1) 2.0 per cent][F158(1) External
[F158(2) 5.0 per cent (2) External use for the treatment of alopecia androgenetica, in men aged 18 to 65 (but not in women);]
[F106Mirtazapine]
Misoprostol
Mitobronitol
Mitomycin
Mitozantrone Hydrochloride
Mivacurium Chloride
[F131Mizolastine]
Moclobemide
[F110Modafinil]
[F107Moexipril Hydrochloride]
Molgramostim
Molindone Hydrochloride
Mometasone Furoate
Moracizine Hydrochloride
Morazone Hydrochloride
[F106Moxonidine]
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 Nitrate0.05 per centNasal sprays or nasal drops not containing liquid paraffin as a vehicle
Naproxen
Naproxen Sodium
[F110Naratriptan Hydrochloride]
Natamycin
[F122Nebivolol Hydrochloride]
Nedocromil Sodium [F1592.0 per cent] [F159For the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis] [F159Container 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
[F131Niceritrol]
Nicotinic AcidAny use, except for the treatment of hyperlipidaemia600mg (MDD)
Nicoumalone
Nifedipine
Nifenazone
Nikethamide
[F109Nilutamide]
Nimodipine
Niridazole
[F122Nisoldipine]
Nitrendipine
Nitrofurantoin
Nitrofurazone
NizatidineFor the prevention [F160and treatment] of the symptoms of food-related heartburn [F160and meal-induced indigestion]75mg (MD)
[F161150mg (MDD)]
[F162For 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 [F1633.0 per cent] [F163External [F163Container 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
[F106Omeprazole Magnesium]
Ondansetron Hydrochloride
Orciprenaline Sulphate
Orphenadrine Citrate
Orphenadrine Hydrochloride
Ouabain
Ovarian Gland Dried
Oxamniquine
Oxantel Embonate
Oxaprozin
Oxatomide
Oxedrine Tartrate
Oxethazaine10mg (MD)Container or package containing not more than 400mg of Oxethazaine
30mg (MDD)
Oxitropium Bromide
Oxolinic Acid
Oxpentifylline
Oxprenolol Hydrochloride
Oxybuprocaine HydrochlorideNon-ophthalmic use
Oxybutynin Hydrochloride
Oxypertine
Oxypertine Hydrochloride
Oxyphenbutazone
Oxyphencyclimine Hydrochloride
Oxyphenonium Bromide5mg (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
[F121Pantoprazole Sodium]
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)
[F111Paracetamol

(1) [F164250mg]

(1) Non-effervescent tablets and capsules [F165wholly or mainly] 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 [F166wholly or mainly] 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
[F121Penciclovir]
Penicillamine
Penicillamine Hydrochloride
Pentamidine Isethionate
Penthienate Bromide5mg (MD)
15mg (MDD)
Pentolinium Tartrate
Perfluamine
Pergolide Mesylate
Perhexiline Maleate
Pericyazine
Perindopril
Perindopril Erbumine
Perphenazine
Phenacetin0.1 per cent
PhenazoneExternal
Phenazone Salicylate
Phenbutrazate Hydrochloride
Phenelzine Sulphate
Phenethicillin Potassium
Phenformin Hydrochloride
Phenglutarimide Hydrochloride
Phenindione
[F167Phenolphthalein.]
Phenoxybenzamine Hydrochloride
Phenoxymethylpenicillin
Phenoxymethylpenicillin Calcium
Phenoxymethylpenicillin Potassium
Phenprocoumon
Phensuximide
Phentolamine Hydrochloride
Phentolamine Mesylate
Phenylbutazone
Phenylbutazone Sodium
Phenylpropanolamine HydrochlorideInternal
(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
[F109Phytomenadione Any use except the prevention or treatment of haemorrhagic disorders]
Picrotoxin
Pilocarpine
Pilocarpine Hydrochloride
Pilocarpine Nitrate
Pimozide
Pindolol
Pipenzolate Bromide5mg (MD)
15mg (MDD)
Piperacillin Sodium
Piperazine Oestrone Sulphate
Piperidolate Hydrochloride50mg (MD)
150mg (MDD)
Pipothiazine Palmitate
Piracetam
Pirbuterol Acetate
Pirbuterol Hydrochloride
[F168Pirenzepine Dihydrochloride Monohydrate]
Pirenzepine Hydrochloride
Piretanide
Piroxicam0.5 per centExternalFor maximum period of 7 daysContainer 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
[F131Piroxicam 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 Resin20.0 per centExternal
Ointment or impregnated plaster
Poldine Methylsulphate2mg (MD)
6mg (MDD)
Polidexide
Polyestradiol Phosphate
Polymyxin B Sulphate
Polythiazide
Poppy Capsule
Potassium Arsenite0.0127 per cent
Potassium Bromide
Potassium Canrenoate
Potassium Clavulanate
Potassium Perchlorate
Practolol
Pralidoxime Chloride
Pralidoxime Iodide
Pralidoxime Mesylate
[F110Pramipexole Hydrochloride]
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 HydrochlorideNon-ophthalmic use
Primidone
Probenecid
Probucol
Procainamide Hydrochloride
Procaine HydrochlorideNon-ophthalmic use
Procaine Penicillin
Procarbazine Hydrochloride
Prochlorperazine
Prochlorperazine Edisylate
Prochlorperazine Maleate [F1253mg] [F125Buccal tablets for the treatment of nausea and vomiting in cases of previously diagnosed migraine only. For use in persons aged 18 years and over.] [F12512mg (MDD)] [F125Container or package containing not more than 8 tablets]
Prochlorperazine Mesylate
Procyclidine Hydrochloride
Progesterone
Prolactin
Proligestone
Prolintane Hydrochloride
Promazine Embonate
Promazine Hydrochloride
Propafenone
Propafenone Hydrochloride
Propanidid
Propantheline Bromide15mg (MD)
45mg (MDD)
[F122Propiverine Hydrochloride]
Propofol
Propranolol Hydrochloride
Propylthiouracil
Proquazone
Protamine Sulphate
Prothionamide
Protirelin
Protriptyline Hydrochloride
Proxymetacaine HydrochlorideNon-ophthalmic use
Pseudoephedrine HydrochlorideInternal(a) In the case of a prolonged release preparation
120mg (MD)
240mg (MDD)
(b) in any other case 60mg (MD)
240mg (MDD)
Pseudoephedrine Sulphate60mg (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
[F122Quetiapine Fumarate]
[F107Quinagolide Hydrochloride]
Quinapril
[F168Quinapril Hydrochloride]
Quinestradol
Quinestrol
Quinethazone
Quinidine
Quinidine Bisulphate
Quinidine Polygalacturonate
Quinidine Sulphate
Quinine100mg (MD)
300mg (MDD)
Quinine BisulphateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine CinchophenEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine DihydrochlorideEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine Ethyl CarbonateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine GlycerophosphateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine HydrobromideEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine HydrochlorideEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine IodobismuthateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine PhosphateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine SalicylateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine SulphateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine TannateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine in combination with Urea Hydrochloride
Ramipril
[F106Ranitidine Bismuth Citrate]
Ranitidine HydrochlorideFor the short term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity [F169or 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
[F110Reboxetine Mesilate]
Remoxipride Hydrochloride
Reproterol Hydrochloride
Rescinnamine
Reserpine
Rifabutin
Rifampicin
Rifampicin Sodium
Rifamycin
[F106Rimexolone]
Rimiterol Hydrobromide
Risperidone
Ritodrine Hydrochloride
Rolitetracycline Nitrate
[F126Ropinirole Hydrochloride]
Sabadilla
Salbutamol
Salbutamol Sulphate
Salcatonin
Salcatonin Acetate
Salmefamol
Salmeterol Xinafoate
Salsalate
Saralasin Acetate
Selegiline Hydrochloride
Semisodium Valproate
[F110Sertindole]
[F106Sertraline Hydrochloride]
Serum Gonadotrophin
[F106Sevoflurane]
Silver Sulphadiazine
Simvastatin
Sissomicin
Sissomicin Sulphate
Snake Venoms
Sodium Acetrizoate
Sodium Aminosalicylate
Sodium Antimonylgluconate
Sodium Arsanilate
Sodium Arsenate
Sodium Arsenite0.013 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 [F170or 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 Monofluorophosphate1.14 per centDentrifrice
Sodium Oxidronate
Sodium Stibogluconate
Sodium Valproate
Somatorelin Acetate
Sotalol Hydrochloride
[F107Sparfloxacin]
Spectinomycin
Spectinomycin Hydrochloride
Spiramycin
Spiramycin Adipate
Spironolactone
Stannous Fluoride([F1711]) 0.62 per cent([F1711]) Dentifrice
[F171(2) 0.4 per] [F171(2) Dental gels for use in the prevention and treatment of dental caries and decalcification of the teeth]
Stilboestrol
Stilboestrol Dipropionate
StreptodornaseExternal
StreptokinaseExternal
Streptomycin
Streptomycin Sulphate
Strychnine
Strychnine Arsenate
Strychnine Hydrochloride
[F109Strychnine Nitrate]
Styramate
Succinylsulphathiazole
Sucralfate
Sulbactam Sodium
Sulbenicillin
Sulbenicillin Sodium
Sulconazole NitrateExternal (except vaginal)
[F109Sulfabenzamide]
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
[F122Tacalcitol Monohydrate]
Tacrine Hydrochloride
Talampicillin
Talampicillin Hydrochloride
Talampicillin Napsylate
Tamoxifen
Tamoxifen Citrate
[F121Tamsulosin Hydrochloride]
[F106Tazarotene]
Tazobactam Sodium
Teicoplanin
[F110Temocapril Hydrochloride]
Temocillin Sodium
Tenoxicam
Terazosin Hydrochloride
Terbinafine [F1721.0 per cent] [F173External use for the treatment of tinea pedis, tinea cruris and tinea corporis. In the form of a gel] [F174Container or package containing not more than 30 grams of medicinal product]
[F175Terbinafine Hydrochloride] [F1751.0 per cent] ([F1761]) [F177Preparations, other than spray solutions, for] [F175external use for the treatment of tinea pedis and tinea cruris] ([F1761]) [F175Container or package containing not more than 15 g of medicinal product.]
[F178(2) Spray solutions for external use for the treatment of tinea corporis, tinea cruris and tinea pedis] [F178(2) Container containing not more than 30ml of medicinal product]
Terbutaline
Terbutaline Sulphate
TerfenadineF179. . .F179...
Terlipressin
Terodiline Hydrochloride
[F110Testosterone]
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
[F121Ticlopidine Hydrochloride]
Tigloidine Hydrobromide
[F121Tiludronate Disodium]
Timolol Maleate
Tinidazole
Tinzaparin
Tioconazole(1) 2.0 per cent(1) External (except vaginal)
(2) Vaginal for treatment of vaginal candidiasis
[F107Tizanidine Hydrochloride]
Tobramycin
Tobramycin Sulphate
Tocainide Hydrochloride
Tofenacin Hydrochloride
Tolazamide
Tolazoline HydrochlorideExternal
Tolbutamide
Tolbutamide Sodium
Tolfenamic Acid
Tolmetin Sodium
[F106Topiramate]
[F131Torasemide]
[F121Toremifene]
Tramadol Hydrochloride
Trandolapril
Tranexamic Acid
Tranylcypromine Sulphate
Trazodone Hydrochloride
Treosulfan
Tretinoin
Triamcinolone
Triamcinolone Acetonide [F180(1)] 0.1 per cent [F180(1)] For the treatment of common mouth ulcers [F180(1)] Container or package containing not more than 5g of medicinal product
[F181(2) In the form of a non-pressurised nasal spray, for the treatment of symptoms of seasonal allergic rhinitis in persons aged 18 years and over] [F181(2) 110mcg per nostril (MD) [F181Container or package containing not more than 3.575mg of Triamcinolone Acetonide]
110mcg per nostril (MDD)
For a maximum period of 3 months]
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
TyrothricinThroat lozenges or throat pastilles
Uramustine
Urea Stibamine
Urethane
Uridine 5'-triphosphate
Urofollitrophin
Urokinase
Ursodeoxychoic Acid
Vaccine: Bacillus Salmonella Typhi
Vaccine: Poliomyelitis (Oral)
[F107Valaciclovir Hydrochloride]
Valproic Acid
[F110Valsartan]
Vancomycin Hydrochloride
Vasopressin
Vasopressin Tannate
Vecuronium Bromide
[F107Venlafaxine 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
[F107Zalcitabine]
Zidovudine
Zimeldine Hydrochloride
Zolpidem Tartrate
Zomepirac Sodium
Zopiclone
Zuclopenthixol Acetate
Zuclopenthixol Decanoate
Zuclopenthixol Hydrochloride]

Textual Amendments

Articles 6(1) and 10

SCHEDULE 2

Column 1 Circumstances excluding medicinal products from the class of prescription only medicines
Column 2Column 3Column 4
SubstanceMaximum strengthPharmaceutical FormMaximum Dose
Codeine and its saltsEquivalent of 1.5 per cent of codeine monohydrateEquivalent of 20 mg of codeine monohydrate
Dihydrocodeine and its saltsEquivalent of 1.5 per cent of dihydrocodeineEquivalent of 10 mg of dihydrocodeine
Ethylmorphine andits saltsEquivalent of 0.2 per cent of ethylmorphineEquivalent 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 saltsEquivalent of 1.5 per cent of pholcodine monohydrateEquivalent of 20 mg of pholcodine monohydrate

Article 2(b)

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

  • [F182Co-danthramer Capsules NPF]

  • [F182Co-danthramer Capsules, Strong NPF]

  • Co-danthramer-Oral Suspension NPF

  • Co-danthramer-Oral Suspension Strong NPF

  • Co-danthrusate Capsules

  • [F182Co-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

  • [F183Water for Injections]

Textual Amendments

Article 3A

[F184SCHEDULE 3ASUBSTANCES WHICH MAY BE PRESCRIBED, ADMINISTERED OR DIRECTED FOR ADMINISTRATION BY EXTENDED FORMULARY NURSE PRESCRIBERS AND CONDITIONS FOR SUCH PRESCRIPTION OR ADMINISTRATION

Textual Amendments

Column 1Column 2
SubstanceRequirements as to use, route of administration, or pharmaceutical form
[F185Acetylcysteine Parenteral]
AciclovirExternal use
AcrivastineOral
AdapaleneExternal use
[F185Adrenaline Parenteral]
Alclometasone dipropionateExternal use
Alimemazine tartrate (trimeprazine tartrate)Oral
[F185Alteplase Parenteral]
[F185Amiodarone Parenteral]
[F186Amitriptyline hydrochloride Oral [F187administration in palliative care]]
Amorolfine hydrochlorideExternal use
Amoxycillin trihydrateOral
AspirinOral
Azelaic acidExternal use
Azelastine hydrochlorideOphthalmic use or nasal
[F186Azithromycin dihydrate Oral]
BaclofenOral administration in palliative care
Beclometasone dipropionateExternal use or nasal [F188inhalation]
[F185Bemiparin sodium Parenteral]
[F185Benzatropine mesilate Parenteral]
[F189Benzylpenicillin sodium Parenteral]
Betamethasone dipropionateExternal use
Betamethasone sodium phosphateAural or nasal
Betamethasone valerateExternal use
BudesonideNasal [F190inhalation]
[F185Calcipotriol External]
[F185Calcitriol External]
[F186Carbamazepine Oral or rectal [F191administration in palliative care]]
CarbarylExternal use
Carbenoxolone sodiumMouthwash
[F185Cefotaxime sodium Parenteral]
[F185Ceftriaxone Sodium Parenteral]
[F185Certoparin sodium Parenteral]
Cetirizine hydrochlorideOral
[F185Chlorphenamine maleate Parenteral]
ChloramphenicolOphthalmic use
CimetidineOral
[F185Cimetidine Parenteral]
Cinchocaine hydrochlorideExternal use
[F186Clavulanic acid [F192(as potassium clavulanate)]Oral]
Clindamycin phosphateExternal use
Clobetasone butyrateExternal use
ClotrimazoleExternal use
[F193Codeine Phosphate Oral]
[F186Conjugated oestrogens (equine) External use]
[F193Co-Phenotrope Oral]
F194. . .F194. . .
[F185Cyclizine hydrochloride Oral]
[F185Cyclizine lactate Parenteral]
[F185Dalteparin sodicum Parenteral]
Dantrolene sodiumOral administration in palliative care
DantronOral
DesogestrelOral
Desoximetasone (Desoxymethasone)External use
DexamethasoneAural
Dexamethasone isonicotinateNasal
[F185Dexamethasone sodium phosphate Oral]
[F185Dextran 70 Parenteral]
[F193Diazepam Oral, parenteral or rectal administration F195...]
Diclofenac diethylammoniumExternal use
[F186Diclofenac potassium Oral]
[F186Diclofenac sodium Oral F196... rectal [F197or ophthalmic]]
[F193Dihydrocodeine Tartrate Oral]
[F185Dolesetron mesilate Oral and parenteral]
DomperidoneOral or rectal administration F198...
Domperidone maleateOral administration F199...
Doxycycline [F200hyclate]Oral
[F201Doxycycline monohydrate Oral]
Econazole nitrateExternal use
[F201Emedastine Ophthalmic use]
[F185Enoxaparin Parenteral]
ErythromycinExternal use [F202or oral]
[F186Erythromycin ethyl succinate Oral]
[F186Erythromycin stearate Oral]
[F186Estradiol External use]
[F186Estriol External use]
EthinylestradiolOral
[F186Etonogestrel Implant]
Etynodiol diacetate (ethynodiol diacetate)Oral
FamotidineOral
FelbinacExternal use
Fenticonazole nitrateExternal use
Fexofenadine hydrochlorideOral
[F201Flucloxacillin magnesium Oral]
Flucloxacillin sodiumOral [F203or parenteral]
FluconazoleOral
Fludroxycortide (Flurandrenolone)External use
[F186Flumazenil Parenteral]
Flumetasone pivalateAural
FlunisolideNasal
Fluocinolone acetonideExternal use
FluocinonideExternal use
Fluocortolone hexanoateExternal use
Fluocortolone pivalateExternal use
FlurbiprofenLozenges
Fluticasone propionateExternal use or nasal
[F185Furosemide Oral and parenteral]
Fusidic acid [F204External Use]
[F186Gabapentin Oral [F205administration in palliative care]]
[F185Gelatin 3.5 – 4% Parenteral]
Gentamicin sulphateAural
GestodeneOral
[F186Glucagon hydrochloride Parenteral]
[F186GlucoseParenteral]
[F185Glucose 5% Parenteral]
[F185Glucose 5% with Potassium (K+ 40 mmol/L) ready made infusion bag Parenteral]
[F185Granisetron hydrochloride Parenteral]
[F185Heparin sodium Parenteral for the purpose of cannulae flushing]
[F185Hexastarch Parenteral]
[F185Human soluble insulin Parenteral]
HydrocortisoneExternal use
Hydrocortisone acetateExternal use [F206or aural]
Hydrocortisone butyrateExternal use
Hydrocortisone sodium succinateLozenges [F207or parenteral]
[F185Hydroxyethl starch Parenteral]
[F208Hyoscine Transdermal administration in palliative care]
Hyoscine butylbromideParenteral F209... administration in palliative care
Hyoscine hydrobromide [F210Oral or parenteral administration in palliative care]
IbuprofenExternal use or oral
Ibuprofen lysineOral
[F186Imipramine hydrochloride Oral [F211administration in palliative care]]
Ipratropium bromideNasal [F212inhalation]
IsotretinoinExternal use
KetoconazoleExternal use
KetoprofenExternal use
Levocabastine hydrochlorideOphthalmic use or nasal
[F185Levomepromazine Oral and parenteral]
F213. . .F213. . .
F213. . .F213. . .
LevonorgestrelOral
[F186Lignocaine hydrochloride External use or parenteral]
Lithium succinateExternal use
Lodoxamide trometamolOphthalmic use
Loperamide hydrochlorideOral
LoratadineOral
[F193Lorazepam Oral or parenteral administration F214...]
[F186Lymecycline Oral]
MebendazoleOral
Medroxyprogesterone acetateParenteral
MestranolOral
Metoclopramide hydrochlorideOral or parenteral administration F215...
Metronidazole [F216External use, oral or rectal]
Metronidazole benzoateOral
MiconazoleDental lacquer
Miconazole nitrateExternal use
[F193Midazolam Parenteral administration F217...]
MinocyclineOral
[F201MizolastineOral]
[F201Minocycline hydrochloride Oral]
Mometasone furoateExternal use or nasal
[F185Naloxone Parenteral]
Nedocromil sodiumOphthalmic use
Nefopam hydrochlorideOral
Neomycin sulphateAural
Neomycin undecenoateAural
NitrofurantoinOral
NizatidineOral
Norethisterone 9 Oral
Norethisterone acetateOral
Norethisterone enanthateParenteral
NorgestimateOral
NorgestrelOral
[F186Nortriptyline hydrochloride Oral [F218administration in palliative care]]
NystatinExternal use
[F185Omeprazole Oral]
[F185Omeprazole sodium Parenteral]
[F185Ondansetron Hydrochloride Oral and parenteral]
[F185Oxbuprocaine hydrochloride Ophalmic]
Oxytetracycline dihydrateOral
ParacetamolOral
PenciclovirExternal use
[F185Pentastarch Parenteral]
PiroxicamExternal use
[F186Prednisolone Oral]
Prednisolone hexanoateExternal use
Prednisolone sodium phosphateAural [F219or oral]
[F185Prilocaine External and parenteral]
[F185Prochlorperazine maleate Oral, rectal and buccal]
[F185Prochlorperazine mesilate Oral and rectal]
[F185Proxymetacaine hydrochloride Ophthalmic]
Ranitidine hydrochlorideOral [F220or parenteral]
[F185Reteplase Parenteral]
[F186Salbutamol sulphate Inhalation]
Silver sulphadiazineExternal use
[F185Sodium chloride 0.9% Parental, for reconstitution of injections and for the purpose of cannulae flushing]
[F185Sodium chloride 0.9% & Glucose 5% ready made infusion bag Parenteral]
[F185Sodium chloride 0.45% & Glucose 5% ready made infusion bag ]
[F185Sodium chloride 0.9% with Potassium (K+ 40 mmol/L) ready made infusion bag Parenteral]
[F185Sodium chloride 0.45% and Glucose 5% with Potassium 20mmol per 500 ml ready made infusion bag Parenteral]
Sodium cromoglycateOphthalmic use
[F186Sodium fusidate External use]
StreptodornaseExternal use
StreptokinaseExternal use
[F185Streptokinase Parenteral]
Sulconazole nitrateExternal use
[F185Tacalcitol External]
[F185Tenecteplase Parenteral]
[F185Tetanus immunoglobulin Parenteral]
Terbinafine hydrochlorideExternal use
[F186Terbutaline sulphate Inhalation]
[F185Tetracaine External]
Tetracycline hydrochlorideExternal use or oral
[F185Tinzaparin sodium Parenteral]
TretinoinExternal use
Triamcinolone acetonideExternal use, aural, nasal or oral paste
TrimethoprimOral
[F185Tropicamide Ophthalmic]
[F185Tropisetron hydrochloride Parenteral]
Tuberculin PPDParenteral
[F185Unfractionated Heparin Parenteral]
Vaccine, Adsorbed DiphtheriaParenteral
Vaccine, Adsorbed Diphtheria And TetanusParenteral
Vaccine, Adsorbed Diphtheria And Tetanus For Adults And AdolescentsParenteral
Vaccine, Adsorbed Diphtheria For Adults And AdolescentsParenteral
Vaccine, Adsorbed Diphtheria, Tetanus And PertussisParenteral
Vaccine, Adsorbed Diphtheria, Tetanus And Pertussis (Acellular Component)Parenteral
Vaccine, BCGParenteral
Vaccine, BCG PercutaneousParenteral
[F185Vaccine – Combined Tetanus, diphtheria, [F221acellular pertussis], inactivated poliomyelitis and haemophilus influenza type B Parenteral]
Vaccine, Haemophilus Influenzae Type B (Hib)Parenteral
Vaccine, Haemophilus Influenzae Type B (Hib) with Diphtheria, Tetanus And PertussisParenteral
Vaccine, Haemophilus Influenzae Type B, Diphtheria, Tetanus And Acellular PertussisParenteral
Vaccine, Hepatitis AParenteral
Vaccine, Hepatitis A With TyphoidParenteral
Vaccine, Hepatitis A, Inactivated, With Recombinant (DNA) Hepatitis BParenteral
Vaccine, Hepatitis BParenteral
[F185Vaccine – Inactivated Poliomyelitis Parenteral]
Vaccine, InfluenzaParenteral
Vaccine, Live Measles, Mumps And Rubella (MMR)Parenteral
Vaccine, Meningococcal Group C ConjugateParenteral
Vaccine, Meningococcal Polysaccharide A and CParenteral
[F185Vaccine – Meningococcal Polysaccharide A, C, W135 and Y Parenteral]
Vaccine, PneumococcalParenteral
F222. . .F222. . .
Vaccine, Poliomyelitis, Live (Oral)Oral
Vaccine, Rubella, LiveParenteral
Vaccine, Tetanus, AdsorbedParenteral
Vaccine, Typhoid, Live Attenuated (Oral)Oral
Vaccine, Typhoid, PolysaccharideParenteral
[F201Water for Injections Parenteral]]

Textual Amendments

Regulation 3B(3)(a)(iii)

[F223SCHEDULE 3BPARTICULARS FOR CLINICAL MANAGEMENT PLANS

Textual Amendments

A clinical management plan shall contain the following particulars—

(a)the name of the patient to whom the plan relates;

(b)the illnesses or conditions which may be treated by the supplementary prescriber;

(c)the date on which the plan is to take effect and when it is to be reviewed by the doctor or dentist who is a party to the plan;

(d)reference to the class or description of medicinal product which may be prescribed or administered under the plan;

(e)any restrictions or limitations as to the strength or dose of any product which may be prescribed or administered under the plan, and any period of administration or use of any medicinal product which may be prescribed or administered under the plan;

(f)relevant warnings about the known sensitivities of the patient to, or known difficulties of the patient with, particular medicinal products;

(g)the arrangements for notification of—

(i)suspected or known adverse reactions to any medicinal product which may be prescribed or administered under the plan, and

(ii)suspected or known adverse reactions to any other medicinal product taken at the same time as any medicinal product prescribed or administered under the plan; and

(h)the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the doctor or dentist who is a party to the plan.]

Article 8(4)(c)

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

  • 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

Article 11(1)(a)

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

PART IEXEMPTION FROM RESTRICTIONS ON SALE OR SUPPLY

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
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.

The sale or supply shall be–

(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–

(i)

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

(ii)

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

(iii)

the total quantity required, and

(b)

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

2.

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

(1)

a public analyst appointed under section 27 of the Food Safety Act 1990(15) or article 36 of the Food (Northern Ireland) Order 1989(16),

(2)

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

(3)

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

(4)

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

(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 1977(17), the National Health Service (Scotland) Act 1978(18) and the Health and Personal Social Services (Northern Ireland) Order 1972(19), or under any subordinate legislation made under those Acts or that Order.3. All prescription only medicines.
3.

The sale or supply shall be–

(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

(b)

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

4. Registered midwives.
4.

Prescription only medicines containing any of the following substances–

  • Chloral hydrate

  • Ergometrine maleate

  • Pentazocine hydrochloride

  • [F224Phytomenadione]

  • 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.
5.

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

(a)

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

(b)

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

(c)

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

5. The sale or supply shall be subject to the presentation of an order signed by a [F229registered optometrist].
6. [F230Registered optometrists]6. Prescription only medicines listed in column 2 of paragraph 5.
6.

The sale or supply shall be only–

(a)

in the course of their professional practice and

(b)

in an emergency.

[F2316A Persons lawfully conducting a retail pharmacy business within the meaning of section 69.

Homotropine hydrobromide

Ketotifen

Levocabastine

Lodoxamide

Nedocromil sodium

Olopatadine

Pilocarpine hydrochloride

Polymyxin B/bacitracin

Polymyxin B/trimethoprim

Sodium cromoglycate.

The sale or supply shall be subject to the presentation of an order signed by an additional supply optometrist.
6B Additional supply optometrists. Prescription only medicines specified in column 2 of paragraph 6A.

The sale or supply shall be only—

(a)

in the course of their professional practice, and

(b)

in an emergency.]

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

The sale or supply shall be–

(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

(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.
8.

The sale or supply shall be only–

(a)

to a pharmacist,

(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

(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 1972(20) 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 1976(21).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.

[F23210.  F233... 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 [F234or the Health Professions Council].

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.]

Textual Amendments

F229Words in Order substituted (30.6.2005 as notified in the London Gazette dated 3.6.2005) by The Opticians Act 1989 (Amendment) Order 2005 (S.I. 2005/848), Sch. 1 para. 27(b)

F230Words in Order substituted (30.6.2005 as notified in the London Gazette dated 3.6.2005) by The Opticians Act 1989 (Amendment) Order 2005 (S.I. 2005/848), Sch. 1 para. 27(b)

Article 11(1)(b)

PART IIEXEMPTIONS FROM THE RESTRICTION ON SUPPLY

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
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.
[F2353A. Persons employed or engaged in the provision of lawful drug treatment services. 3A. Ampoules of sterile water for injection containing not more than 2 ml of sterile water.3A. The supply shall be only in the course of provision of lawful drug treatment services.]
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.
4.

The supply shall be–

(a)

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

(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.
5.

—

(1)

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

(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.

Textual Amendments

Article 11(2)

PART IIIEXEMPTIONS FROM RESTRICTION ON ADMINISTRATION Column 1

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
1. F236... registered chiropodists who hold a certificate of competence in the use of analgesics issued by or with the approval of the Chiropodists Board [F237or the Health Professions Council].
1.

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

  • [F238Bupivacaine 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

  • [F239Mepivacaine hydrochloride]

  • Prilocaine hydrochloride.]

1. The administration shall be only in the course of their professional practice.
2. Registered midwives.
2.

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–

  • [F240Diamorphine]

  • Ergometrine maleate

  • Lignocaine

  • Lignocaine hydrochloride

  • [F240Morphine]

  • 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.
5.

—

(1)

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

(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 [F241or persons who are [F242registered] paramedics].
9.

The following prescription only medicines for parenteral administration–

(a)

Diazepam 5 mg per ml emulsion for injection;

(b)

Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion;

(bb)

[F243medicines containing the substances Ergometrine Maleate 500mcg per ml with Oxytocin 5 iu per ml, but no other active ingredient]

(d)

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

  • Adrenaline Acid Tartrate

  • [F244Amiodarone]

  • Anhydrous Glucose

  • [F245Benzylpenicillin]

  • [F246Bretylium Tosylate]

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

  • Ergometrine Maleate

  • [F245Frusemide]

  • Glucose

  • Heparin Sodium

  • Lignocaine Hydrochloride

  • [F245Metoclopramide]

  • [F245Morphine Sulphate]

  • Nalbuphine Hydrochloride

  • Naloxone Hydrochloride

  • Polygeline

  • [F247Reteplase ]

  • Sodium Bicarbonate

  • Sodium Chloride

  • [F245Streptokinase]

  • [F247Tenecteplase.]

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.

Textual Amendments

Article 16(1)

SCHEDULE 6ORDERS REVOKED

Column 1Column 2
OrdersReferences
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Order 1983S.I. 1983/1212
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1984S.I. 1984/756
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1986S.I. 1986/586
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1987S.I. 1987/674
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1987S.I. 1987/1250
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1988S.I. 1988/2017
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1991S.I. 1991/962
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1992S.I. 1992/1534
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1992S.I. 1992/2937
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1993S.I. 1993/1890
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1993S.I. 1993/3256
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1994S.I. 1994/558
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1994S.I. 1994/3016
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 3) Order 1994S.I. 1994/3050
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1995S.I. 1995/1384
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1995S.I. 1995/3174
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1996S.I. 1996/1514
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1996S.I. 1996/3193

Articles 12A to 12C

[F248SCHEDULE 7

Textual Amendments

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 1Column 2
Class of person by whom a prescription only medicine is supplied or administeredPerson on whose behalf the Direction must be signed
Common Services AgencyThe Agency
[F249Strategic Health Authority] [F249The Strategic Health Authority]
Health AuthorityThe Health Authority
Special Health AuthorityThe Special Health Authority
NHS trust [F250or NHS foundation trust]The trust
Primary Care TrustThe 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, [F251, an NHS foundation 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 [F252or NHS foundation trust] or Primary Care Trust with which the arrangement has been made

Textual Amendments

[F253PART IIAPERSONS BY WHOM OR ON WHOSE BEHALF A PATIENT GROUP DIRECTION USED IN THE PROVISION OF HEALTH CARE BY OR ON BEHALF OF THE POLICE, THE PRISON SERVICES OR THE ARMED FORCES MUST BE SIGNED

Textual Amendments

Column 1

Force or service by whom or on whose behalf the health care is provided

Column 2

Person by whom or on whose behalf the Direction must be signed

A police force in England or WalesThe chief officer of police for that police force (within the meaning of the Police Act 1996)
A police force in ScotlandThe chief constable of that police force (within the meaning of the Police (Scotland) Act 1997)
The Police Service of Northern IrelandThe Chief Constable of the Police Service of Northern Ireland
The prison service in England and WalesThe governor of the prison in relation to which the health care in question is being provided
The prison service in ScotlandThe Scottish Prison Service Management Board
The prison service in Northern IrelandThe Northern Ireland Prison Service Management Board
Her Majesty’s Forces

(i)the Surgeon General,

(ii)a Medical Director General, or

(iii)a chief executive of an executive agency of the Ministry of Defence]

PART IIICLASSES OF INDIVIDUAL [F254BY WHOM PRESCRIPTION ONLY MEDICINES MAY BE SUPPLIED OR ADMINISTERED]

Textual Amendments

  • [F255Registered paramedics or individuals who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State.]

  • Pharmacists.

  • F256...

  • Registered midwives.

  • Registered nurses.

  • [F257Registered optometrists]

  • [F258Registered] chiropodists.

  • [F259Registered orthoptists.

  • Registered physiotherapists.

  • Registered radiographers.]

  • [F260“Registered dietitians.”;]

  • [F260“Registered occupational therapists.”;]

  • [F260“Registered orthotists and prosthetists.”; and]

  • [F260“Registered speech and language therapists.”]]

Textual Amendments

F257Words in Order substituted (30.6.2005 as notified in the London Gazette dated 3.6.2005) by The Opticians Act 1989 (Amendment) Order 2005 (S.I. 2005/848), Sch. 1 para. 27(b)

Explanatory Note

(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.

(1)

1968 c. 67. Section 58 has been amended by the Prescription by Nurses Etc. Act 1992 (c. 28), section 1. The expression “the appropriate Ministers” is defined in section 1(2) of the Medicines Act 1968.

(2)

In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388); in the case of the Secretary of State concerned with Agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272) and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).

(10)

1971 c. 61; section 1 was substituted by section 24 of the Oil and Gas (Enterprise) Act 1982 (c. 23).

(12)

S.I. 1980/1923, amended by S.I. 1997/1831.

(14)

See S.I. 1979/382 amended by S.I. 1980/263 and S.I. 1989/1124.