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- Point in Time (09/08/2000)
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Version Superseded: 16/11/2000
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Statutory Instruments
MEDICINES
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:
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;
“aerosol” means a product which is dispersed from its container by a propellent gas or liquid;
“appropriate nurse practitioner” means–
a person who–
is registered in Part 1 or 12 of the Register maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of the Nurses, Midwives and Health Visitors Act 1979(3) (referred to below in this definition as “the professional register”), and
has a district nursing qualification additionally recorded in the professional register under rule 11 of the Nurses, Midwives and Health Visitors Rules 1983(4); or
a person who is registered in Part 11 of the professional register as a health visitor;
against whose name (in each case) is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances for patients;
[F1“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;]
[F1“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(5);
“cyanogenetic substances” means preparations which–
are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17, or
contain more than 0.1 per cent by weight of any substance having the formula either α-Cyanobenzyl-6-O-β-d-glucopyranosyl-β-d-glucopyranoside or α-Cyanobenzyl-β-d-glucopy ranosiduronic acid;
“dosage unit” means–
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
where a medicinal product is not in any such form, the unit of measurement which is used as the unit by reference to which the dose of the medicinal product is measured;
“external use” means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal when a local action only is intended and extensive systemic absorption is unlikely to occur; and references to medicinal products for external use shall be read accordingly except that such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;
[F1“Health Authority”—
in relation to England and Wales, has the same meaning as in the National Health Service Act 1977;
in relation to Scotland, means a Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978; and
in relation to Northern Ireland, means a Health and Social Services Board established under Article 16 of the Health and Personal Social Services (Northern Ireland) Order 1972;]
“health prescription” means a prescription issued by a doctor, dentist or nurse prescriber under or by virtue of–
[F1“homoeopathic certificate of registration” means a certificate of registration for the purposes of the Medicines (Homoeopathic Medicinal Products For Human Use) Regulations 1994;]
“inhaler” does not include an aerosol;
[F1“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(9);
“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–
the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product;
the maximum percentage of a substance contained in a medicinal product calculated in any of the following ways–
weight in weight,
weight in volume,
volume in weight, or
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 medicinal product which is a veterinary drug as defined in section 132(1) of the Act or
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(10) and in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 1986(11);
[F1“NHS trust”—
in relation to England and Wales, has the same meaning as in the National Health Service and Community Care Act 1990;
in relation to Scotland, has the same meaning as in the National Health Service (Scotland) Act 1978; and
in relation to Northern Ireland, means a Health and Social Services trust established under article 10 of the Health and Social Services (Northern Ireland) Order 1991;]
“occupational health scheme” means a scheme in which a person, in the course of a business carried on by him, provides facilities for his employees for the treatment or prevention of disease;
“offshore installation” means an offshore installation within the meaning of the Mineral Workings (Offshore Installations) Act 1971(12) which is within–
tidal waters and parts of the sea in or adjacent to the United Kingdom up to the seaward limits of territorial waters;
waters in any area designated under section 1(7) of the Continental Shelf Act 1964(13);
“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;
[F1“Patient Group Direction” means—
in connection with the supply of a prescription only medicine as referred to in article 12A(2), 12B or 12C, a written direction relating to the supply and administration of a description or class of prescription only medicine; or
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)—
is signed by a doctor or dentist, and by a pharmacist; and
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;
[F1“Primary Care Trust” has the same meaning as in the National Health Service Act 1977;]
“prolonged release” in relation to a medicinal product means a formulation of that product which–
is used to reduce the rate at which the active ingredient in that product is released after administration, and
is sold or supplied as a prolonged, controlled or sustained release medicinal product;
“registered midwife” means a person who is registered in Part 10 of the Register maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of the Nurses, Midwives and Health Visitors Act 1979;
“registered nurse” means a person who is registered in the Register maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of the Nurses, Midwives and Health Visitors Act 1979;
“registered ophthalmic optician” means a person who is registered in either of the Registers of ophthalmic opticians maintained under section 7(a) of the Opticians Act 1989(14);
“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;
[F1“Special Health Authority”—
in relation to England and Wales, has the same meaning as in the National Health Service Act 1977;
in relation to Scotland, means a Special Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978; and
in relation to Northern Ireland, means a Special Health and Social Services Agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990;]
“state registered chiropodist” means a person who is registered in the Register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960(15) by the Chiropodists Board;
[F1“state registered paramedic” means a person who is registered in the register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960 by the Paramedics Board;]
“supply” means supply in circumstances corresponding to retail sale as defined in section 131 of the Act;
“unit preparation” means a preparation, including a mother tincture, prepared by a process of solution, extraction or trituration with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert diluent, and then used either in this diluted form or, where applicable, by impregnating tablets, granules, powders or other inert substances.
[F1“United Kingdom marketing authorization” means a marketing authorization granted by the licensing authority under the Medicines For Human Use (Marketing Authorisations Etc.) Regulations 1994 (including a product licence having effect as such an authorization by virtue of Schedule 6 to those Regulations).]
(3) For the purposes of this Order, the equivalence of a substance to a reference material shall be determined by calculating the amount of that reference material which is contained in that substance either by weight or, where the amount of the reference material is specified in terms of international units of activity, those units.
(4) In this Order, unless the context otherwise requires, a reference–
(a)to a numbered section is to the section of the Act which bears that number,
(b)to a numbered article or Schedule is to the article of, or Schedule to, this Order which bears that number,
(c)in an article or in a Part of a Schedule to a numbered paragraph is to the paragraph of that article or Part of that Schedule which bears that number, and
(d)in a paragraph to a lettered sub-paragraph is to the sub-paragraph of that paragraph which bears that letter.
(5) In Schedules 1 to 3–
(a)entries specified in columns 2 to 5 relate to the substances listed in column 1 against which they appear and where, in relation to a particular substance listed in column 1, an entry in columns 2 to 5 bears a number or letter it relates only to such entries in the other of those columns as bear the same number or letter;
(b)the following abbreviations are used:
“g” for gram,
“iu” for international unit of activity,
“mcg” for microgram,
“mg” for milligram,
“ml” for millilitre.
(6) In Schedule 3, the abbreviation “NPF” means the Nurse Prescribers' Formulary Appendix in the British National Formulary.
[F2(7) In articles 12 to 12C, a reference to a prescription only medicine being sold or supplied for the purpose of being administered in accordance with the written directions of a doctor or dentist relating to a particular person, or in accordance with a Patient Group Direction, includes a reference to it being sold or supplied in accordance with such directions or such a Direction.
(8) In articles 12A and 12C, a reference to an arrangement for the supply or adminstration of prescription only medicines includes a reference to an arrangement which covers such supply or administration and other matters.
(9) In Schedule 7, Part I, a reference to treatment of a clinical situation includes a reference to any form of management of that situation.]
Textual Amendments
F1Words in art. 1(2) inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(a)
F2Words in art. 1(7)-(9) inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(b)
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, veterinary surgeons and veterinary practitioners;
(b)in relation to the descriptions and classes of medicinal products specified in Schedule 3, appropriate nurse practitioners.
3. Subject to article 6, the following descriptions and classes of medicinal products are specified for the purposes of section 58, namely–
(a)medicinal products consisting of or containing a substance listed in column 1 of Schedule 1;
(b)medicinal products that are controlled drugs;
(c)medicinal products that are for parenteral administrationF3...;
(d)cyanogenetic substances, other than preparations for external use;
(e)medicinal products that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used;
(f)medicinal products for human use which are classified as subject to medical prescription in marketing authorizations granted under Council Regulation 2309/93(16);
(g)medicinal products–
(i)which are not of a description and do not fall within a class specified in subparagraphs (a) to (f),
(ii)which are of a description in respect of which the conditions specified in section 59(1) are satisfied, and
(iii)in respect of which a product licence or marketing authorization has been granted which contains a provision to the effect that the method of sale or supply of the medicinal product is to be only in accordance with a prescription given by an appropriate practitioner.
Textual Amendments
F3Words in art. 3(c) omitted (13.8.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 2
4. The duration specified for the purposes of section 59(2)(a) (duration of restrictions for certain new products) shall be a period of 5 years.
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.
(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.
6.—(1) A medicinal product shall not be a prescription only medicine by reason that it is a controlled drug listed in Schedule 2 to the Misuse of Drugs Act 1971 where, it–
(a)contains not more than one of the substances listed in column 1 of Schedule 2 to this Order and no other controlled drug;
(b)contains that substance at a strength that does not exceed the maximum strength specified in column 2 of that Schedule; and
(c)is sold or supplied–
(i)in such pharmaceutical form as may be specified in column 3 of that Schedule, and
(ii)for use at a maximum dose which does not exceed that specified in column 4 of that Schedule.
(2) A medicinal product for human use in respect of which a marketing authorization has been granted under Council Regulation 2309/93/EEC(17) shall not be a prescription only medicine where that authorization does not classify the medicinal product as subject to medical prescription.
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
Chlorpheniramine Injection
Cobalt Edetate Injection
Dextrose Injection Strong B.P.C.
Diphenhydramine Injection
Glucagon Injection
Hydrocortisone Injection
Mepyramine Injection
Promethazine Hydrochloride Injection
Snake Venom Antiserum
Sodium Nitrite Injection
Sodium Thiosulphate Injection
Sterile Pralidoxime
where the administration is for the purpose of saving life in an emergency.
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 who by reason of an emergency is unable to furnish a prescription immediately;
(b)that the doctor has undertaken to furnish the person lawfully conducting a retail pharmacy business with a prescription within 72 hours of the sale or supply;
(c)that the prescription only medicine is sold or supplied in accordance with the directions of the doctor requesting it;
(d)subject to paragraph (5), that the prescription only medicine is not a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations;
(e)that an entry is made in the record kept under regulation 6 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980(18) within the time specified in that regulation stating the particulars required under paragraph 1 of Schedule 2 to those Regulations.
(3) The restrictions imposed by section 58(2)(a) shall not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business where the conditions specified in paragraph (4) are satisfied.
(4) The conditions referred to in paragraph (3) are–
(a)that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied has interviewed the person requesting a prescription only medicine and has satisfied himself–
(i)that there is an immediate need for the prescription only medicine requested to be sold or supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay,
(ii)that treatment with the prescription only medicine requested has on a previous occasion been prescribed by a doctor for the person requesting it, and
(iii)as to the dose which in the circumstances it would be appropriate for that person to take;
(b)that no greater quantity of the prescription only medicine than will provide 5 days' treatment is sold or supplied except that where the prescription only medicine–
(i)is [F4a 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
F4Words in art. 8(4)(b)(i) inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 2
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.
10. 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).
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.
12. The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine in the course of the business of a hospital where the medicine is sold or supplied for the purpose of being administered (whether in the hospital or elsewhere) to a particular person in accordance with the written directions of a doctor or dentist relating to that person notwithstanding that those directions do not satisfy the conditions specified in article 15(2).]
Textual Amendments
F5Art. 12 substituted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(c)
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 Health Authority or Special Health Authority;
(c)an NHS trust;
(d)a Primary Care Trust; or
(e)where sub-paragraphs (a) to (d) do not apply, a person other than an excepted person, pursuant to an arrangement made with one of the persons specified in those sub-paragraphs for the supply of prescription only medicines,
where the medicine is supplied for the purpose of being administered to a particular person in accordance with the written directions of a doctor or dentist relating to that person notwithstanding that those directions do not satisfy the conditions specified in article 15(2).
(2) The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by—
(a)the Common Services Agency;
(b)a Health Authority or Special Health Authority;
(c)an NHS trust;
(d)a Primary Care Trust; or
(e)where sub-paragraphs (a) to (d) do not apply, a person other than an excepted person, pursuant to an arrangement made with one of the persons specified in those sub-paragraphs for the supply or, as the case may be, the administration of prescription only medicines,
where the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, to a particular person in accordance with a Patient Group Direction and where the conditions specified in paragraph (3) are satisfied.
(3) The conditions referred to are that—
(a)the Patient Group Direction relates to the supply or, as the case may be, the administration, by the person who supplies or administers the medicine, of a description or class of prescription only medicine, and the Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;
(b)the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);
(c)the Patient Group Direction is signed on behalf of the person specified in column 2 of the Table in Part II of Schedule 7 to this Order (“the authorising person”) against the entry in column 1 of that Table for the class of person by whom the medicine is supplied or administered;
(d)the individual who supplies or, as the case may be, administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is designated in writing, on behalf of the authorising person, for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction; and
(e)at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.
(4) In this article, “excepted person” means—
(a)a doctor or dentist; or
(b)a person lawfully conducting a retail pharmacy business within the meaning of section 69.
Textual Amendments
F6Arts. 12A-12C inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(d)
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—
(a)in the case of the provision of general medical services or general dental services, with which an arrangement has been made for the provision of those services; or
(b)in the case of the performance of personal medical services or personal dental services, which is a party to the pilot scheme under which those services are provided;
(e)the individual referred to in paragraph (1) is designated in writing for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction, by the doctor or dentist in question, or, alternatively, where the Direction also relates to supply or administration in order to assist one or more other doctors or dentists, as referred to in sub-paragraph (a), by one of those other doctors or dentists; and
(f)at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.
(3) In this article—
(a)a reference to the provision of NHS primary dental services shall be construed as a reference to—
(i)in relation to England and Wales, the provision of general dental services under Part II of the National Health Service Act 1977, or the performance of personal dental services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997;
(ii)in relation to Scotland, the provision of general dental services under Part II of the National Health Service (Scotland) Act 1978, or the performance of personal dental services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997; and
(iii)in relation to Northern Ireland, the provision of general dental services under the Health and Personal Social Services (Northern Ireland) Order 1972, or the performance of personal dental services in connection with a pilot scheme under the Health Services (Primary Care) (Northern Ireland) Order 1997;
(b)a reference to the provision of NHS primary medical services shall be construed as a reference to—
(i)in relation to England and Wales, the provision of general medical services under Part II of the National Health Service Act 1977, or the performance of personal medical services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997;
(ii)in relation to Scotland, the provision of general medical services under Part II of the National Health Service (Scotland) Act 1978, or the performance of personal medical services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997; and
(iii)in relation to Northern Ireland, the provision of general medical services under the Health and Personal Social Services (Northern Ireland) Order 1972, or the performance of personal medical services in connection with a pilot scheme under the Health Services (Primary Care) (Northern Ireland) Order 1997.
Textual Amendments
F6Arts. 12A-12C inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(d)
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—
(a)the medicine is supplied or, as the case may be, is administered by such a person pursuant to an arrangement made with the Common Services Agency, a Health Authority, a Special Health Authority, an NHS trust or a Primary Care Trust for the supply or, as the case may be, the administration of prescription only medicines;
(b)the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, to a particular person in accordance with a Patient Group Direction; and
(c)the conditions specified in paragraph (2) are satisfied.
(2) The conditions referred to are that—
(a)the Patient Group Direction relates to the supply or, as the case may be, the administration of a description or class of prescription only medicine by the person lawfully conducting a retail pharmacy business who supplies or, as the case may be, administers the prescription only medicine, and the Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;
(b)the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);
(c)the Patient Group Direction is signed on behalf of the body with which an arrangement has been made as referred to in paragraph (1)(a); and
(d)at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.]
Textual Amendments
F6Arts. 12A-12C inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(d)
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.
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.
15.—(1) For the purposes of section 58(2)(a) a prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless the conditions specified in paragraph (2) are fulfilled.
(2) The conditions referred to in paragraph (1) are that the prescription–
(a)shall be signed in ink with his own name by the appropriate practitioner giving it;
(b)shall, without prejudice to sub-paragraph (a), be written in ink or otherwise so as to be indelible, unless it is a health prescription which is not for a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations, in which case it may be written by means of carbon paper or similar material;
(c)shall contain the following particulars–
(i)the address of the appropriate practitioner giving it,
(ii)the appropriate date,
(iii)such particulars as indicate whether the appropriate practitioner giving it is a doctor, a dentist, an appropriate nurse practitioner, a veterinary surgeon or a veterinary practitioner,
(iv)where the appropriate practitioner giving it is a doctor, dentist or appropriate nurse practitioner, the name, address and the age, if under 12, of the person for whose treatment it is given, and
(v)where the appropriate practitioner giving it is a veterinary surgeon or a veterinary practitioner, the name and address of the person to whom the prescription only medicine is to be delivered and a declaration by the veterinary surgeon or veterinary practitioner giving it that the prescription only medicine is prescribed for an animal or herd under his care;
(d)shall not be dispensed after the end of the period of 6 months from the appropriate date, unless it is a repeatable prescription in which case it shall not be dispensed for the first time after the end of that period nor otherwise than in accordance with the directions contained in the repeatable prescription;
(e)in the case of a repeatable prescription which does not specify the number of times it may be dispensed, shall not be dispensed on more than two occasions unless it is a prescription for an oral contraceptive in which case it may be dispensed 6 times before the end of the period of 6 months from the appropriate date.
(3) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to a sale or supply of a prescription only medicine which is not in accordance with a prescription given by an appropriate practitioner by reason only that a condition specified in paragraph (2) is not satisfied where the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that that condition is satisfied in relation to that sale or supply.
(4) In paragraph (2) “the appropriate date” means–
(a)in the case of a health prescription, the date on which it was signed by the appropriate practitioner giving it or a date indicated by him as being the date before which it shall not be dispensed; and
(b)in every other case, the date on which the prescription was signed by the appropriate practitioner giving it;
and, for the purposes of sub-paragraphs (d) and (e) of that paragraph, where a health prescription bears both the date on which it was signed and a date indicated as being that before which it shall not be dispensed, the appropriate date is the later of those dates.
16.—(1) The Orders specified in Schedule 6 are revoked.
(2) In the Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order 1989(19) 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.
Articles 3(a), 5(1) and 10
Exemptions from the restrictions on the sale and supply of prescription only medicines | |||||
---|---|---|---|---|---|
Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | |
Substance | Maximum strength | Route of administration, use or pharmaceutical form | Treatment limitations | Maximum quantity | |
[F7Acamprosate] | |||||
Acarbose | |||||
Acebutolol Hydrochloride | |||||
[F7Aceclofenac] | |||||
Acemetacin | |||||
Acetarsol | |||||
Acetazolamide | |||||
Acetazolamide Sodium | |||||
Acetohexamide | |||||
Acetylcholine Chloride | 0.2 per cent | External | |||
Acetylcysteine | |||||
Acipimox | |||||
Aciclovir | 5.0 per cent | External | Container or package containing not more than 2g of medicinal product | ||
For treatment of herpes simplex virus infections of the lips and face (Herpes labialis) | |||||
Acitretin | |||||
Aclarubicin Hydrochloride | |||||
Aconite | 1.3 per cent | External | |||
Acrivastine | 24 mg (MDD) | Container or package containing not more than 240mg of Acrivastine | |||
Acrosoxacin | |||||
Actinomycin C | |||||
Actinomycin D | |||||
[F8Adapalene] | |||||
Adenosine | |||||
Adrenaline | (1) By inhaler | ||||
(2) External | |||||
Adrenaline Acid Tartrate | (1) By inhaler | ||||
(2) External | |||||
Adrenaline Hydrochloride | (1) By inhaler | ||||
(2) External | |||||
Adrenocortical Extract | |||||
Albendazole | |||||
Alclofenac | |||||
Alclometasone Dipropionate | |||||
Alcuronium Chloride | |||||
Aldesleukin | |||||
Aldosterone | |||||
[F7Alendronate Sodium] | |||||
Alfacalcidol | |||||
Alfuzosin Hydrochloride | |||||
Allergen Extracts | |||||
Allopurinol | |||||
Allyloestrenol | |||||
[F9Aloxiprin | (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 | |||||
[F8Altretamine] | |||||
Amantadine Hydrochloride | |||||
Ambenonium Chloride | |||||
Ambutonium Bromide | |||||
Amcinonide | |||||
Ametazole Hydrochloride | |||||
Amethocaine | Non-ophthalmic use | ||||
Amethocaine Gentisate | Non-ophthalmic use | ||||
Amethocaine Hydrochloride | Non-ophthalmic use | ||||
Amikacin Sulphate | |||||
Amiloride Hydrochloride | |||||
Aminocaproic Acid | |||||
Aminoglutethimide | |||||
Aminopterin Sodium | |||||
Amiodarone Hydrochloride | |||||
Amiphenazole Hydrochloride | |||||
Amitriptyline | |||||
Amitriptyline Embonate | |||||
Amitriptyline Hydrochloride | |||||
Amlodipine Besylate | |||||
Ammonium Bromide | |||||
Amodiaquine Hydrochloride | |||||
Amorolfine Hydrochloride | |||||
Amoxapine | |||||
Amoxycillin | |||||
Amoxycillin Sodium | |||||
Amoxycillin Trihydrate | |||||
Amphomycin Calcium | |||||
Amphotericin | |||||
Ampicillin | |||||
Ampicillin Sodium | |||||
Ampicillin Trihydrate | |||||
Amsacrine | |||||
Amygdalin | |||||
Amyl Nitrite | |||||
Amylocaine Hydrochloride | Non-ophthalmic use | ||||
[F7Anastrozole] | |||||
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 | |||||
[F8Apraclonidine 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 | |||||
[F10Aspirin | [F11(1) 75mg] | [F11(1) Non-effervescent tablets and capsules] | [F11(1) The quantity sold or supplied in one container or package shall not exceed 100
| ||
[F13(2)] Non-effervescent tablets and capsules | [F13(2)] The quantity sold or supplied in one container or package shall not exceed 32 | ||||
[F13(3)] All preparations other than non-effervescent tablets or capsules |
| ||||
Astemizole | F14. . . | F14. . . | F14. . . | ||
F14. . . | |||||
F14. . . | |||||
Atenolol | |||||
Atracurium Besylate | |||||
Atropine | (1) Internal | ||||
(a) by inhaler | |||||
(b) otherwise than by inhaler | (b) 300mcg (MD) | ||||
1mg (MDD) | |||||
(2) External (except ophthalmic) | |||||
Atropine Methobromide | (1) Internal | ||||
(a) by inhaler | |||||
(b) otherwise than by inhaler | (b) 400mcg (MD) | ||||
1.3mg (MDD) | |||||
(2) External (except ophthalmic) | |||||
Atropine Methonitrate | Internal | ||||
(a) by inhaler | |||||
(b) otherwise than by inhaler | (b) 400mcg (MD) | ||||
1.3mg (MDD) | |||||
Atropine Oxide Hydrochloride | (1) Internal | ||||
(a) by inhaler | |||||
(b) otherwise than by inhaler | (b) 360mcg (MD) | ||||
1.2mg (MDD) 3 | |||||
(2) External (except ophthalmic) | |||||
Atropine Sulphate | (1) Internal | ||||
(a) by inhaler | |||||
(b) otherwise than by inhaler | (b) 360mcg (MD) | ||||
1.2mg (MDD) | |||||
(2) External (except ophthalmic) | |||||
Auranofin | |||||
Azapropazone | |||||
Azathioprine | |||||
Azathioprine Sodium | |||||
Azelaic Acid | |||||
Azelastine Hydrochloride | For nasal administration | 140mcg per nostril (MD) | Container or package containing not more than 5,040mcg of Azelastine Hydrochloride | ||
For the treatment of seasonal allergic rhinitis | 280mcg per nostril (MDD) | ||||
For use in adults and children not less than 12 years | |||||
As a non-aerosol, aqueous form | |||||
Azidocillin Potassium | |||||
Azithromycin | |||||
Azlocillin Sodium | |||||
Aztreonam | |||||
Bacampicillin Hydrochloride | |||||
Bacitracin | |||||
Bacitracin Methylene Disalicylate | |||||
Bacitracin Zinc | |||||
Baclofen | |||||
Bambuterol Hydrochloride | |||||
Barium Carbonate | |||||
Barium Chloride | |||||
Barium Sulphide | |||||
Beclamide | |||||
Beclomethasone | |||||
Beclomethasone Dipropionate | For nasal administration (non-aerosol) | 100mcg per nostril (MD) | Container or package containing not more than [F1520,000 mcg] of Beclomethasone Dipropionate | ||
For the prevention and treatment of allergic rhinitis | 200 mcg per nostril (MDD)[F16For a maximum period of 3 months] | ||||
[F17For use in persons aged 18 years and over] | |||||
Belladonna Herb | (1) Internal | (1) 1mg of the alkaloids (MDD) | |||
(2) External | |||||
Belladonna Root | (1) Internal | (1) 1mg of the alkaloids (MDD) | |||
(2) External | |||||
Bemegride | |||||
Bemegride Sodium | |||||
Benapryzine Hydrochloride | |||||
Bendrofluazide | |||||
Benethamine Penicillin | |||||
Benoxaprofen | |||||
Benperidol | |||||
Benserazide Hydrochloride | |||||
Bentiromide | |||||
Benzathine Penicillin | |||||
Benzbromarone | |||||
Benzhexol Hydrochloride | |||||
Benzilonium Bromide | |||||
Benzocaine | Any use except ophthalmic use | ||||
Benzoctamine Hydrochloride | |||||
Benzoyl Peroxide | 10.0 per cent | External | |||
N-Benzoyl Sulphanilamide | |||||
Benzquinamide | |||||
Benzquinamide Hydrochloride | |||||
Benzthiazide | |||||
Benztropine Mesylate | |||||
Benzylpenicillin Calcium | |||||
Benzylpenicillin Potassium | |||||
Benzylpenicillin Sodium | |||||
Beractant | |||||
Betahistine Hydrochloride | |||||
Betamethasone | |||||
Betamethasone Adamantoate | |||||
Betamethasone Benzoate | |||||
Betamethasone Dipropionate | |||||
Betamethasone Sodium Phosphate | |||||
Betamethasone Valerate | |||||
Betaxolol Hydrochloride | |||||
Bethanechol Chloride | |||||
Bethanidine Sulphate | |||||
Bezafibrate | |||||
[F8Bicalutamide] | |||||
Biperiden Hydrochloride | |||||
Biperiden Lactate | |||||
Bismuth Glycollylarsanilate | |||||
Bisoprolol Fumarate | |||||
Bleomycin | |||||
Bleomycin Sulphate | |||||
Bretylium Tosylate | |||||
Bromhexine Hydrochloride | |||||
Bromocriptine Mesylate | |||||
Bromperidol | |||||
Bromvaletone | |||||
Brotizolam | |||||
Budesonide | For nasal administration | 200mcg per nostril (MD) | Container or package containing not more than 10mg of Budesonide | ||
For the prevention or treatment of seasonal allergic rhinitis | [F16For a maximum period of 3 months] | ||||
200 mcg per nostril (MDD) | |||||
[F17For use in persons aged 18 years and over] | |||||
As a non-aerosol, aqueous form | |||||
Bufexamac | |||||
Bumetanide | |||||
Buphenine Hydrochloride | 6mg (MD) | ||||
18mg (MDD) | |||||
Bupivacaine | Any use except ophthalmic use | ||||
Bupivacaine Hydrochloride | Any use except ophthalmic use | ||||
Buserelin Acetate | |||||
Buspirone Hydrochloride | |||||
Busulphan | |||||
Butacaine Sulphate | Any use except ophthalmic use | ||||
Butorphanol Tartrate | |||||
Butriptyline Hydrochloride | |||||
Calcipotriol | |||||
[F8Calcipotriol Hydrate] | |||||
Calcitonin | |||||
Calcitriol | |||||
Calcium Amphomycin | |||||
Calcium Benzamidosalicylate | |||||
Calcium Bromide | |||||
Calcium Bromidolactobionate | |||||
Calcium Carbimide | |||||
Calcium Folinate | |||||
Calcium Metrizoate | |||||
Calcium Sulphaloxate | |||||
[F18Candesartan Cilexetil] | |||||
Candicidin | |||||
Canrenoic Acid | |||||
Cantharidin | 0.01 per cent | External | |||
Capreomycin Sulphate | |||||
Captopril | |||||
Carbachol | |||||
Carbamazepine | |||||
Carbaryl | |||||
Carbenicillin Sodium | |||||
Carbenoxolone Sodium | (1) Pellet | (1) 5mg (MD) | |||
25mg (MDD) | |||||
(2) 2.0 per cent | (2) Gel | ||||
(3) 1.0 per cent | (3) Granules for mouthwash in adults and children not less than 12 years | (3) 20mg (MD) | (3) Container or package containing not more than [F19560mg] of Carbenoxolone Sodium | ||
80mg (MDD) | |||||
Carbidopa | |||||
Carbimazole | |||||
Carbocisteine | |||||
Carbon Tetrachloride | |||||
Carboplatin | |||||
Carboprost Trometamol | |||||
Carbuterol Hydrochloride | |||||
Carfecillin Sodium | |||||
Carindacillin Sodium | |||||
Carisoprodol | |||||
Carmustine | |||||
Carperidine | |||||
Carteolol Hydrochloride | |||||
Cefaclor | |||||
Cefadroxil | |||||
Cefazedone Sodium | |||||
Cefixime | |||||
Cefodizime Sodium | |||||
Cefotaxime Sodium | |||||
Cefoxitin Sodium | |||||
Cefpodoxime Proxetil | |||||
Cefsulodin Sodium | |||||
Ceftazidime | |||||
Ceftizoxime Sodium | |||||
Ceftriaxone Sodium | |||||
Cefuroxime Axetil | |||||
Cefuroxime Sodium | |||||
Celiprolol Hydrochloride | |||||
Cephalexin | |||||
Cephalexin Sodium | |||||
Cephaloridine | |||||
Cephalothin Sodium | |||||
Cephamandole Nafate | |||||
Cephazolin Sodium | |||||
Cephradine | |||||
Cerium Oxalate | |||||
Cerivastatin | |||||
Ceruletide Diethylamine | |||||
Cetirizine Hydrochloride | 10mg (MDD) | Container or package containing not more than 100mg of Cetirizine Hydrochloride | |||
Chenodeoxycholic Acid | |||||
Chloral Hydrate | External | ||||
Chlorambucil | |||||
Chloramphenicol | |||||
Chloramphenicol Cinnamate | |||||
Chloramphenicol Palmitate | |||||
Chloramphenicol Sodium Succinate | |||||
Chlorhexadol | |||||
Chlormadinone Acetate | |||||
Chlormerodrin | |||||
Chlormethiazole | |||||
Chlormethiazole Edisylate | |||||
Chlormezanone | |||||
Chloroform(20) | (1) 5.0 per cent | (1) Internal | |||
(2) External | |||||
Chloroquine Phosphate | Prophylaxis of malaria | ||||
Chloroquine Sulphate | Prophylaxis of malaria | ||||
Chlorothiazide | |||||
Chlorotrianisene | |||||
Chlorphenoxamine Hydrochloride | |||||
Chlorpromazine | |||||
Chlorpromazine Embonate | |||||
Chlorpromazine Hydrochloride | |||||
Chlorpropamide | |||||
Chlorprothixene | |||||
Chlorprothixene Hydrochloride | |||||
Chlortetracycline | |||||
Chlortetracycline Calcium | |||||
Chlortetracycline Hydrochloride | |||||
Chlorthalidone | |||||
Chlorzoxazone | |||||
Cholestyramine | |||||
Ciclacillin | |||||
Ciclobendazole | |||||
Cilastatin Sodium | |||||
Cilazapril | |||||
Cimetidine | (a) For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity and for the prophylaxis of meal-induced heartburn | (a) 200mg (MD) | |||
800mg (MDD) | |||||
For a maximum period of 14 days | |||||
(b) For the prophylactic management of nocturnal heartburn by a single dose taken at night | (b) 100mg (MD) to be taken as a single dose at night | ||||
For a maximum period of 14 days | |||||
Cimetidine Hydrochloride | |||||
Cinchocaine | 3.0 per cent | Non-ophthalmic use | |||
Cinchocaine Hydrochloride | Equivalent of 3.0 per cent of Cinchocaine | Non-ophthalmic use | |||
Cinchophen | |||||
Cinoxacin | |||||
Ciprofibrate | |||||
Ciprofloxacin | |||||
Ciprofloxacin Hydrochloride | |||||
Cisapride | |||||
Cisplatin | |||||
[F8Citalopram Hydrobromide] | |||||
Clarithromycin | |||||
Clavulanic Acid | |||||
Clidinium Bromide | |||||
Clindamycin | |||||
Clindamycin Hydrochloride | |||||
Clindamycin Palmitate Hydrochloride | |||||
Clindamycin Phosphate | |||||
Clioquinol | (1) External (other than treatment of mouth ulcers) | ||||
(2) 35mg | (2) Treatment of mouth ulcers | (2) 350mg (MDD) | |||
Clobetasol Propionate | |||||
Clobetasone Butyrate | |||||
Clofazimine | |||||
Clofibrate | |||||
Clomiphene Citrate | |||||
Clomipramine | |||||
Clomipramine Hydrochloride | |||||
Clomocycline | |||||
Clomocycline Sodium | |||||
Clonidine | |||||
Clonidine Hydrochloride | |||||
Clopamide | |||||
Clopenthixol Decanoate | |||||
Clopenthixol Hydrochloride | |||||
Clorexolone | |||||
Clotrimazole | External but in the case of vaginal use only external use for the treatment of vaginal candidiasis | ||||
Cloxacillin Benzathine | |||||
Cloxacillin Sodium | |||||
Clozapine | |||||
Cocculus Indicus | |||||
Co-dergocrine Mesylate | |||||
Colaspase | |||||
Colchicine | |||||
Colestipol Hydrochloride | |||||
Colfosceril Palmitate | |||||
Colistin Sulphate | |||||
Colistin Sulphomethate | |||||
Colistin Sulphomethate Sodium | |||||
Coniine | |||||
Conium Leaf | 7.0 per cent | External | |||
Corticotrophin | |||||
Cortisone | |||||
Cortisone Acetate | |||||
Co-tetroxazine | |||||
Co-trimoxazole | |||||
Cropropamide | |||||
Crotethamide | |||||
Croton Oil | |||||
Croton Seed | |||||
Curare | |||||
Cyclofenil | |||||
Cyclopenthiazide | |||||
Cyclopentolate Hydrochloride | |||||
Cyclophosphamide | |||||
Cycloserine | |||||
Cyclosporin | |||||
Cyclothiazide | |||||
Cyproterone Acetate | |||||
Cytarabine | |||||
Cytarabine Hydrochloride | |||||
Dacarbazine | |||||
Dalteparin Sodium | |||||
Danazol | |||||
Danthron | |||||
Dantrolene Sodium | |||||
Dapsone | |||||
Dapsone Ethane Ortho Sulphonate | |||||
Daunorubicin Hydrochloride | |||||
Deanol Bitartrate | 26mg (MDD) | ||||
Debrisoquine Sulphate | |||||
Demecarium Bromide | |||||
Demeclocycline | |||||
Demeclocycline Calcium | |||||
Demeclocycline Hydrochloride | |||||
Deoxycortone Acetate | |||||
Deoxycortone Pivalate | |||||
Deptropine Citrate | |||||
Dequalinium Chloride | (1) 0.25mg | (1) Internal: throat lozenges or throat pastilles | |||
(2) 1.0 per cent | (2) External: paint | ||||
Deserpidine | |||||
Desferrioxamine Mesylate | |||||
Desflurane | |||||
Desipramine Hydrochloride | |||||
Deslanoside | |||||
Desmopressin | |||||
Desmopressin Acetate | |||||
Desogestrel | |||||
Desonide | |||||
Desoxymethasone | |||||
Dexamethasone | |||||
Dexamethasone Acetate | |||||
Dexamethasone Isonicotinate | |||||
Dexamethasone Phenylpropionate | |||||
Dexamethasone Pivalate | |||||
Dexamethasone Sodium Metasulphobenzoate | |||||
Dexamethasone Sodium Phosphate | |||||
Dexamethasone Troxundate | |||||
Dexfenfluramine Hydrochloride | |||||
Dextromethorphan Hydrobromide | Internal | (a) In the case of a prolonged release preparation: equivalent of 30mg of Dextromethorphan (MD) | |||
equivalent of 75mg of Dextromethorphan (MDD) | |||||
(b) in any other case: equivalent of 15mg of Dextromethorphan (MD) | |||||
equivalent of 75mg of Dextromethorphan (MDD) | |||||
Dextrothyroxine Sodium | |||||
Diazoxide | |||||
Dibenzepin Hydrochloride | |||||
Dichloralphenazone | |||||
Dichlorphenamide | |||||
Diclofenac Diethylammonium | 1.16 per cent | External | For maximum period of 7 days | Container or package containing not more than 30g of medicinal product | |
For local symptomatic relief of pain and inflammation in trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism | |||||
For use in adults and children not less than 12 years | |||||
Diclofenac Potassium | |||||
Diclofenac Sodium | |||||
Dicyclomine Hydrochloride | 10mg (MD) | ||||
60mg (MDD) | |||||
[F7Didanosine] | |||||
Dienoestrol | |||||
Diethanolamine Fusidate | |||||
Diflucortolone Valerate | |||||
Diflunisal | |||||
Digitalin | |||||
Digitalis Leaf | |||||
Digitalis Prepared | |||||
Digitoxin | |||||
Digoxin | |||||
Dihydralazine Sulphate | |||||
Dihydroergotamine Mesylate | |||||
Dihydrostreptomycin | |||||
Dihydrostreptomycin Sulphate | |||||
Diloxanide Furoate | |||||
Diltiazem Hydrochloride | |||||
Dimercaprol | |||||
Dimethisoquin Hydrochloride | Non-ophthalmic use | ||||
Dimethisterone | |||||
Dimethothiazine Mesylate | |||||
Dimethyl Sulphoxide | |||||
Dimethyltubocurarine Bromide | |||||
Dimethyltubocurarine Chloride | |||||
Dimethyltubocurarine Iodide | |||||
Dinoprost | |||||
Dinoprost Trometamol | |||||
Dinoprostone | |||||
[F9Diphenhydramine Hydrochloride | All preparations except liquid-filled capsules] | ||||
Dipivefrin Hydrochloride | |||||
Dipyridamole | |||||
Disodium Etidronate | |||||
Disodium Pamidronate | |||||
Disopyramide | |||||
Disopyramide Phosphate | |||||
Distigmine Bromide | |||||
Disulfiram | |||||
Dithranol | 1.0 per cent | ||||
Dobutamine Hydrochloride | |||||
Domperidone | |||||
Domperidone Maleate | [F20For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn,] | [F2110 mg of Domperidone as Domperidone Maleate (MD)] | [F20Container or package containing not more than 100mg of Domperidone as Domperidone Maleate;] | ||
[F2140 mg of Domperidone as Domperidone Maleate (MDD)] | |||||
Dopamine Hydrochloride | |||||
Dopexamine Hydrochloride | |||||
[F8Dorzolamide Hydrochloride] | |||||
Dothiepin | |||||
Dothiepin Hydrochloride | |||||
Doxapram Hydrochloride | |||||
Doxazosin Mesylate | |||||
Doxepin Hydrochloride | |||||
Doxorubicin | |||||
Doxorubicin Hydrochloride | |||||
Doxycycline | |||||
Doxycycline Calcium Chelate | |||||
Doxycycline Hydrochloride | |||||
Droperidol | |||||
Dydrogesterone | |||||
Dyflos | |||||
Econazole | External but in the case of vaginal use only external use for the treatment of vaginal candidiasis | ||||
Econazole Nitrate | External but in the case of vaginal use only external use for the treatment of vaginal candidiasis | ||||
Ecothiopate Iodide | |||||
Edrophonium Chloride | |||||
Eflornithine Hydrochloride | |||||
[F7Eformoterol Fumarate] | |||||
Embutramide | |||||
Emepronium Bromide | |||||
Emetine | 1.0 per cent | ||||
Emetine Bismuth Iodide | |||||
Emetine Hydrochloride | Equivalent of 1.0 per cent of Emetine | ||||
Enalapril Maleate | |||||
Encephalitis Virus, Tick-borne, Cent Eur | |||||
Enoxacin | |||||
Enoxaparin Sodium | |||||
Enoximone | |||||
Ephedrine | (1) Internal (other than nasal sprays or nasal drops) | (1) 30mg (MD) | |||
60mg (MDD) | |||||
(2) 2.0 per cent | (2) Nasal sprays or nasal drops | ||||
(3) External | |||||
Ephedrine Hydrochloride | (1) Internal (other than nasal sprays or nasal drops) | (1) Equivalent of 30mg of Ephedrine (MD) | |||
Equivalent of 60mg of Ephedrine (MDD) | |||||
(2) Equivalent of 2.0 per cent of Ephedrine | (2) Nasal sprays or nasal drops | ||||
(3) External | |||||
Ephedrine Sulphate | (1) Internal (other than nasal sprays or nasal drops) | (1) Equivalent of 30mg of Ephedrine (MD) | |||
Equivalent of 60mg of Ephedrine (MDD) | |||||
(2) Equivalent of 2.0 per cent of Ephedrine | (2) Nasal sprays or nasal drops | ||||
(3) External | |||||
Epicillin | |||||
Epirubicin | |||||
Epirubicin Hydrochloride | |||||
Epithiazide | |||||
Epoetin Alfa | |||||
Epoetin Beta | |||||
Epoprostenol Sodium | |||||
Ergometrine Maleate | |||||
Ergometrine Tartrate | |||||
Ergot, Prepared | |||||
Ergotamine Tartrate | |||||
Erythromycin | |||||
Erythromycin Estolate | |||||
Erythromycin Ethylcarbonate | |||||
Erythromycin Ethyl Succinate | |||||
Erythromycin Lactobionate | |||||
Erythromycin Phosphate | |||||
Erythromycin Stearate | |||||
Erythromycin Thiocyanate | |||||
Esmolol Hydrochloride | |||||
Estramustine Phosphate | |||||
[F22Estramustine 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 | |||||
[F8Exemestane] | |||||
Famciclovir | |||||
Famotidine | For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity, and prevention of these symptoms when associated with food and drink, including nocturnal symptoms | 10mg (MD) | |||
20mg (MDD) | |||||
For maximum period of 14 days | |||||
Fazadinium Bromide | |||||
Felbinac | 3.17 per cent | External | For maximum period of 7 days | Container or package containing not more than [F2350g] of medicinal product | |
[F24For the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries such as sprains, strains and contusions] | |||||
For use in adults and children not less than 12 years | |||||
Felodipine | |||||
Felypressin | |||||
Fenbufen | |||||
Fenclofenac | |||||
Fenfluramine Hydrochloride | |||||
Fenofibrate | |||||
Fenoprofen | |||||
Fenoprofen Calcium | |||||
Fenoterol Hydrobromide | |||||
Fenticonazole Nitrate | |||||
Feprazone | |||||
Ferrous Arsenate | |||||
[F8Ferumoxsil] | |||||
Filgrastim | |||||
Finasteride | |||||
Flavoxate Hydrochloride | |||||
Flecainide Acetate | |||||
Flosequinan | |||||
Fluanisone | |||||
Flubendazole | |||||
Fluclorolone Acetonide | |||||
Flucloxacillin Magnesium | |||||
Flucloxacillin Sodium | |||||
Fluconazole | For oral administration for the treatment of vaginal candidiasis in persons aged not less than 16 but less than 60 years | 150mg (MD) | Container or package containing not more than 150mg of Fluconazole | ||
Flucytosine | |||||
Fludrocortisone Acetate | |||||
Flufenamic Acid | |||||
Flumazenil | |||||
Flumethasone | |||||
Flumethasone Pivalate | |||||
Flunisolide | 0.025 per cent | (a) For the prevention and treatment of seasonal allergic rhinitis, including hay fever | (a) 50mcg per nostril (MD) | (a) Container or package containing not more than 6,000mcg of Flunisolide | |
100mcg per nostril (MDD) | |||||
[F25For use in persons aged 18 years and over] | [F26For a maximum period of 3 months] | ||||
In the form of a non-pressurised nasal spray | |||||
F27... | F27... | F27... | |||
F27. . . | |||||
F27. . . | |||||
F27. . . | |||||
Fluocinolone Acetonide | |||||
Fluocinonide | |||||
Fluocortin Butyl | |||||
Fluocortolone | |||||
Fluocortolone Hexanoate | |||||
Fluocortolone Pivalate | |||||
Fluorescein Dilaurate | |||||
Fluorometholone | |||||
Fluorouracil | |||||
Fluorouracil Trometamol | |||||
Fluoxetine Hydrochloride | |||||
Flupenthixol Decanoate | |||||
Flupenthixol Hydrochloride | |||||
Fluperolone Acetate | |||||
Fluphenazine Decanoate | |||||
Fluphenazine Enanthate | |||||
Fluphenazine Hydrochloride | |||||
Fluprednidene Acetate | |||||
Fluprednisolone | |||||
Fluprostenol Sodium | |||||
Flurandrenolone | |||||
Flurbiprofen | |||||
Flurbiprofen Sodium | |||||
Fluspirilene | |||||
Flutamide | |||||
Fluticasone Propionate | |||||
Fluvastatin Sodium | |||||
Fluvoxamine Maleate | |||||
Folic Acic | 500mcg (MDD) | ||||
Formestane | |||||
Formocortal | |||||
Foscarnet Sodium | |||||
Fosfestrol Sodium | |||||
Fosfomycin Trometamol | |||||
Fosinopril Sodium | |||||
Framycetin Sulphate | |||||
Frusemide | |||||
Furazolidone | |||||
Fusafungine | |||||
Fusidic Acid | |||||
Gabapentin | |||||
Gadoteridol | |||||
Gallamine Triethiodide | |||||
Ganciclovir | |||||
Ganciclovir Sodium | |||||
Gelsemine | 0.1 per cent | ||||
Gelsemium | 25mg (MD) | ||||
75mg (MDD) | |||||
Gemeprost | |||||
Gemfibrozil | |||||
Gentamicin | |||||
Gentamicin Sulphate | |||||
Gestodene | |||||
Gestrinone | |||||
Gestronol | |||||
Gestronol Hexanoate | |||||
Glibenclamide | |||||
Glibornuride | |||||
Gliclazide | |||||
Glipizide | |||||
Gliquidone | |||||
Glisoxepide | |||||
Glucagon | |||||
Glycopyrronium Bromide | 1mg (MD) | ||||
2mg (MDD) | |||||
Glymidine | |||||
Gonadorelin | |||||
Goserelin Acetate | |||||
Gramicidin | 0.2 per cent | External | |||
Granisetron Hydrochloride | |||||
Griseofulvin | |||||
Growth Hormone | |||||
Guanethidine Monosulphate | |||||
Guanfacine Hydrochloride | |||||
Guanoclor Sulphate | |||||
Guanoxan Sulphate | |||||
Halcinonide | |||||
Halofantrine Hydrochloride | |||||
Haloperidol | |||||
Haloperidol Decanoate | |||||
Heparin | External | ||||
Heparin Calcium | External | ||||
Heparin Sodium | |||||
Hexachlorophane | External | ||||
(a) 2.0 per cent | (a) Soaps | ||||
(b) 0.1 per cent | (b) Aerosols | ||||
(c) 0.75 per cent | (c) preparations other than soaps and aerosols | ||||
Hexamine Phenylcinchoninate | |||||
Hexobarbitone | |||||
Hexobarbitone Sodium | |||||
Hexoestrol | |||||
Hexoestrol Dipropionate | |||||
L-Histidine Hydrochloride | Dietary supplementation | ||||
Homatropine | (1) Internal | (1) 0.15mg (MD) | |||
0.45mg (MDD) | |||||
(2) External (except ophthalmic) | |||||
Homatropine Hydrobromide | 0.2mg (MD) | ||||
0.6mg (MDD) | |||||
Homatropine Methylbromide | 2mg (MD) | ||||
6mg (MDD) | |||||
Hydralazine Hydrochloride | |||||
Hydrargaphen | Local application to skin | ||||
Hydrobromic Acid | |||||
Hydrochlorothiazide | |||||
Hydrocortisone | [F28(1) 0.5 per cent] | [F28(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] | [F28(1) Container or package containing not more than 15g of medicinal product] | ||
[F29(2)] 1.0 per cent | [F29(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 [F30or 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 | [F29(2)] Container or package containing not more than 15g of medicinal product (cream or ointment) or 30ml (spray) | |||
Hydrocortisone Acetate | Equivalent to 1.0 per cent Hydrocortisone | External | |||
For use in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and in combination with one or more of the following: Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Peru Balsam, Pramoxine Hydrochloride, Zinc Oxide, for haemorrhoids | Container or package containing not more than 15g of medicinal product | ||||
In the case of suppositories, container or package containing no more than 12 | |||||
For use in adults and children not less than 10 years | |||||
Cream, ointment or suppositories | |||||
Hydrocortisone Butyrate | |||||
Hydrocortisone Caprylate | |||||
Hydrocortisone Hydrogen Succinate | |||||
Hydrocortisone Sodium Phosphate | |||||
Hydrocortisone Sodium Succinate | Equivalent to 2.5mg Hydrocortisone | External | Container or package containing not more than equivalent to 50mg of Hydrocortisone | ||
For aphthous ulceration of the mouth for adults and children not less than 12 years | |||||
In the form of pellets | |||||
[F9Hydrocyanic Acid] | |||||
Hydroflumethiazide | |||||
Hydroxychloroquine Sulphate | Prophylaxis of malaria | ||||
Hydroxyprogesterone | |||||
Hydroxyprogesterone Enanthate | |||||
Hydroxyprogesterone Hexanoate | |||||
Hydroxyurea | |||||
Hydroxyzine Embonate | |||||
Hydroxyzine Hydrochloride | (a) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in adults and in children not less than 12 years | (a) 25mg (MD) | (a) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride | ||
75mg (MDD) | |||||
(b) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in children not less than 6 years but less than 12 years | (b) 25 mg (MD) | (b) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride | |||
50mg (MDD) | |||||
Hyoscine | (1) 0.15 per cent | (1) Internal | |||
(2) External (except ophthalmic) | |||||
Hyoscine Butylbromide | (1) Internal | ||||
(a) by inhaler | |||||
(b) otherwise than by inhaler | (b) 20mg (MD) | (b) Container or package containing not more than 240mg of Hyoscine Butylbromide | |||
80mg (MDD) | |||||
(2) External | |||||
Hyoscine Hydrobromide | (1) Internal | ||||
(a) by inhaler | |||||
(b) otherwise than by inhaler | (b) 300mcg (MD) | ||||
900mcg (MDD) | |||||
(2) External (except ophthalmic) | |||||
Hyoscine Methobromide | (1) Internal | ||||
(a) by inhaler | |||||
(b) otherwise than by inhaler | (b) 2.5mg (MD) | ||||
7.5mg (MDD) | |||||
(2) External | |||||
Hyoscine Methonitrate | (1) Internal | ||||
(a) by inhaler | |||||
(b) otherwise than by inhaler | (b) 2.5mg (MD) | ||||
7.5mg (MDD) | |||||
(2) External | |||||
Hyoscyamine | (1) Internal | ||||
(a) by inhaler | |||||
(b) otherwise than by inhaler | (b) 300mcg (MD) | ||||
1mg (MDD) | |||||
(2) External | |||||
Hyoscyamine Hydrobromide | (1) Internal | ||||
(a) by inhaler | |||||
(b) otherwise than by inhaler | (b) Equivalent of 300mcg of Hyoscyamine (MD) | ||||
Equivalent of 1mg of Hyoscyamine (MDD) | |||||
(2) External | |||||
Hyoscyamine Sulphate | (1) Internal | ||||
(a) by inhaler | |||||
(b) otherwise than by inhaler | (b) Equivalent of 300mcg of Hyoscyamine (MD) | ||||
Equivalent of 1mg of Hyoscyamine (MDD) | |||||
(2) External | |||||
Ibuprofen | Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza | ||||
(1) Internal | (1)(a) In the case of a prolonged release preparation 600mg (MD) | ||||
1,200mg (MDD) | |||||
(b) in any other case 400mg (MD) | |||||
1,200mg (MDD) | |||||
(2) 5.0 per cent | (2) External | ||||
[F31(3) 10.0 per cent] | [F31(3) External] | [F31(3) 125 mg (MD) 500 mg (MDD)] | [F31(3) Container or package containing not more than 100 g of medicinal product] | ||
[F9Ibuprofen 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 | |||||
[F7Imidapril Hydrochloride] | |||||
Imipenem Hydrochloride | |||||
Imipramine | |||||
Imipramine Hydrochloride | |||||
Imipramine Ion Exchange Resin Bound Salt or Complex | |||||
Indapamide Hemihydrate | |||||
Indomethacin | |||||
Indomethacin Sodium | |||||
Indoprofen | |||||
Indoramin Hydrochloride | |||||
Inosine Pranobex | |||||
[F32Insulin] | |||||
Iodamide | |||||
Iodamide Meglumine | |||||
Iodamide Sodium | |||||
Iohexol | |||||
Iomeprol | |||||
Iopamidol | |||||
Iopentol | |||||
Iothalamic Acid | |||||
Ioversol | |||||
Ioxaglic Acid | |||||
Ipratropium Bromide | |||||
Iprindole Hydrochloride | |||||
Iproniazid Phosphate | |||||
Isoaminile | |||||
Isoaminile Citrate | |||||
Isocarboxazid | |||||
Isoconazole Nitrate | External but in the case of vaginal use only external use for the treatment of vaginal candidiasis | ||||
Isoetharine | |||||
Isoetharine Hydrochloride | |||||
Isoetharine Mesylate | |||||
Isoniazid | |||||
Isoprenaline Hydrochloride | |||||
Isoprenaline Sulphate | |||||
Isopropamide Iodide | Equivalent of 2.5mg of Isopropamide ion (MD) | ||||
Equivalent of 5.0mg of Isopropamide ion (MDD) | |||||
Isotretinoin | |||||
Isradipine | |||||
Itraconazole | |||||
Jaborandi | External | ||||
Kanamycin Acid Sulphate | |||||
Kanamycin Sulphate | |||||
Ketamine Hydrochloride | |||||
Ketoconazole | 2.0 per cent | [F33(a)] [F34External] | [F33(a)] Maximum frequency of application of once every 3 days | [F33(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 | |||||
[F35(b) For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo] | |||||
Ketoprofen | 2.5 per cent | External | For maximum period of 7 days | Container or package containing not more than 30g of medicinal product | |
For rheumatic and muscular pain in adults and children not less than 12 | |||||
Ketorolac Trometamol | |||||
Ketotifen Fumarate | |||||
Labetalol Hydrocholoride | |||||
Lachesine Chloride | |||||
Lacidipine | |||||
Lamotrigine | |||||
Lanatoside C | |||||
Lanatoside Complex A, B and C | |||||
Latamoxef Disodium | |||||
Levallorphan Tartrate | |||||
Levobunolol Hydrochloride | |||||
[F9Levocabastine Hydrochloride | Equivalent of 0.05 per cent Levocabastine | (1) Nasal sprays | (1) Container or package containing not more than 10 ml of medicinal product | ||
For the symptomatic treatment of seasonal allergic rhinitis | |||||
(2) Aqueous eye drops | (2) Container or package containing not more than 4 ml of medicinal product] | ||||
For the symptomatic treatment of seasonal allergic conjunctivitis | |||||
[F36Levocarnitine] | [F36For dietary supplementation] | ||||
Levodopa | |||||
Levonorgestrel | |||||
Lidoflazine | |||||
Lignocaine | Non-ophthalmic use | ||||
Lignocaine Hydrochloride | Non-ophthalmic use | ||||
Lincomycin | |||||
Lincomycin Hydrochloride | |||||
Liothyronine Sodium | |||||
Lisinopril | |||||
Lithium Carbonate | Equivalent of 5mg of Lithium (MD) | ||||
Equivalent of 15mg of Lithium (MDD) | |||||
Lithium Citrate | |||||
Lithium Succinate | |||||
Lithium Sulphate | Equivalent of 5mg of Lithium (MD) | ||||
Equivalent of 15mg of Lithium (MDD) | |||||
Lobeline | (1) Internal | (1) 3mg (MD) | |||
9mg (MDD) | |||||
(2) External | |||||
Lobeline Hydrochloride | (1) Internal | (1) Equivalent of 3mg of Lobeline (MD) | |||
Equivalent of 9mg of Lobeline (MDD) | |||||
(2) External | |||||
Lobeline Sulphate | (1) Internal | (1) Equivalent of 3mg of Lobeline (MD) | |||
Equivalent of 9mg of Lobeline (MDD) | |||||
(2) External | |||||
Lodoxamide Trometamol | |||||
Lofepramine | |||||
Lofepramine Hydrochloride | |||||
Lofexidine Hydrochloride | |||||
Lomefloxacin Hydrochloride | |||||
Lomustine | |||||
Loperamide Hydrochloride | Treatment of acute diarrhoea | ||||
Loratidine | 10mg (MDD) | Container or package containing not more than 100mg of Loratidine | |||
[F18Lornoxicam] | |||||
[F18Losartan Potassium] | |||||
Loxapine Succinate | |||||
Lung Surfactant Porcine | |||||
Luteinising Hormone | |||||
Lymecycline | |||||
Lynoestrenol | |||||
Lypressin | |||||
Lysuride Maleate | |||||
Mafenide | |||||
Mafenide Acetate | |||||
Mafenide Hydrochloride | |||||
Mafenide Propionate | 5.0 per cent | Eye drops | |||
Magnesium Fluoride | |||||
Magnesium Metrizoate | |||||
Mandragora Autumnalis | |||||
Mannomustine Hydrochloride | |||||
Maprotiline Hydrochloride | |||||
Mebanazine | |||||
Mebendazole | For oral use in the treatment of enterobiasis in adults and in children not less than 2 years | 100mg (MD) | Container or package containing not more than 800mg of Mebendazole | ||
Mebeverine Hydrochloride | [F37(a) For the symptomatic relief of irritable bowel syndrome | [F37(a) 135 mg (MD) 405 mg (MDD)] | |||
(b) For uses other than the symptomatic relief of irritable bowel syndrome] | [F37(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 | |||||
Melphalan | |||||
Melphalan Hydrochloride | |||||
Menotrophin | |||||
Mepenzolate Bromide | 25mg (MD) | ||||
75mg (MDD) | |||||
Mephenesin | |||||
Mephenesin Carbamate | |||||
Mepivacaine Hydrochloride | Any use except ophthalmic use | ||||
Meptazinol Hydrochloride | |||||
Mequitazine | |||||
Mercaptopurine | |||||
Mersalyl | |||||
Mersalyl Acid | |||||
Mesalazine | |||||
Mesna | |||||
Mestranol | |||||
Metaraminol Tartrate | |||||
Metergoline | |||||
Metformin Hydrochloride | |||||
Methacycline | |||||
Methacycline Calcium | |||||
Methacycline Hydrochloride | |||||
Methallenoestril | |||||
Methicillin Sodium | |||||
Methixene | |||||
Methixene Hydrochloride | |||||
Methocarbamol | |||||
Methocidin | Throat lozenges and throat pastilles | ||||
Methohexitone Sodium | |||||
Methoin | |||||
Methoserpidine | |||||
Methotrexate | |||||
Methotrexate Sodium | |||||
Methotrimeprazine | |||||
Methotrimeprazine Hydrochloride | |||||
Methotrimeprazine Maleate | |||||
Methoxamine Hydrochloride | 0.25 per cent | Nasal sprays or nasal drops not containing liquid paraffin as a vehicle | |||
Methsuximide | |||||
Methyclothiazide | |||||
Methyldopa | |||||
Methyldopate Hydrochloride | |||||
Methylephedrine Hydrochloride | 30mg (MD) | ||||
60mg (MDD) | |||||
Methylprednisolone | |||||
Methylprednisolone Acetate | |||||
Methylprednisolone Sodium Succinate | |||||
Methylthiouracil | |||||
Methysergide Maleate | |||||
Metipranolol | |||||
Metirosine | |||||
Metoclopramide Hydrochloride | |||||
Metolazone | |||||
Metoprolol Fumarate | |||||
Metoprolol Succinate | |||||
Metoprolol Tartrate | |||||
Metronidazole | |||||
Metronidazole Benzoate | |||||
Metyrapone | |||||
Mexiletine Hydrochloride | |||||
Mezlocillin Sodium | |||||
Mianserin Hydrochloride | |||||
Miconazole | External but in the case of vaginal use only external use for the treatment of vaginal candidiasis | ||||
Miconazole Nitrate | External but in the case of vaginal use only external use for the treatment of vaginal candidiasis | ||||
Mifepristone | |||||
Miglitol | |||||
Milrinone | |||||
Milrinone Lactate | |||||
Minocycline | |||||
Minocycline Hydrochloride | |||||
Minoxidil | [F38(1) 2.0 per cent] | [F38(1) External | |||
[F38(2) 5.0 per cent | (2) External use for the treatment of alopecia androgenetica, in men aged 18 to 65 (but not in women);] | ||||
[F7Mirtazapine] | |||||
Misoprostol | |||||
Mitobronitol | |||||
Mitomycin | |||||
Mitozantrone Hydrochloride | |||||
Mivacurium Chloride | |||||
[F22Mizolastine] | |||||
Moclobemide | |||||
[F8Moexipril Hydrochloride] | |||||
Molgramostim | |||||
Molindone Hydrochloride | |||||
Mometasone Furoate | |||||
Moracizine Hydrochloride | |||||
Morazone Hydrochloride | |||||
[F7Moxonidine] | |||||
Mupirocin | |||||
Mupirocin Calcium | |||||
Mustine Hydrochloride | |||||
Nabilone | |||||
Nabumetone | |||||
Nadolol | |||||
Nafarelin Acetate | |||||
Naftidrofuryl Oxalate | |||||
Naftifine Hydrochloride | |||||
Nalbuphine Hydrochloride | |||||
Nalidixic Acid | |||||
Nalorphine Hydrobromide | |||||
Naloxone Hydrochloride | |||||
Naltrexone Hydrochloride | |||||
Naphazoline Hydrochloride | (1) 0.05 per cent | (1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle | |||
(2) 0.015 per cent | (2) Eye drops | ||||
Naphazoline Nitrate | 0.05 per cent | Nasal sprays or nasal drops not containing liquid paraffin as a vehicle | |||
Naproxen | |||||
Naproxen Sodium | |||||
Natamycin | |||||
[F18Nebivolol Hydrochloride] | |||||
Nedocromil Sodium | [F392.0 per cent] | [F39For the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis] | [F39Container 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 | |||||
[F22Niceritrol] | |||||
Nicotinic Acid | Any use, except for the treatment of hyperlipidaemia | 600mg (MDD) | |||
Nicoumalone | |||||
Nifedipine | |||||
Nifenazone | |||||
Nikethamide | |||||
[F9Nilutamide] | |||||
Nimodipine | |||||
Niridazole | |||||
[F18Nisoldipine] | |||||
Nitrendipine | |||||
Nitrofurantoin | |||||
Nitrofurazone | |||||
Nizatidine | For the prevention [F40and treatment] of the symptoms of food-related heartburn [F40and meal-induced indigestion] | 75mg (MD) | |||
[F41150mg (MDD)] | |||||
[F42For 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 | [F433.0 per cent] | [F43External | [F43Container 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 | |||||
[F7Omeprazole Magnesium] | |||||
Ondansetron Hydrochloride | |||||
Orciprenaline Sulphate | |||||
Orphenadrine Citrate | |||||
Orphenadrine Hydrochloride | |||||
Ouabain | |||||
Ovarian Gland Dried | |||||
Oxamniquine | |||||
Oxantel Embonate | |||||
Oxaprozin | |||||
Oxatomide | |||||
Oxedrine Tartrate | |||||
Oxethazaine | 10mg (MD) | Container or package containing not more than 400mg of Oxethazaine | |||
30mg (MDD) | |||||
Oxitropium Bromide | |||||
Oxolinic Acid | |||||
Oxpentifylline | |||||
Oxprenolol Hydrochloride | |||||
Oxybuprocaine Hydrochloride | Non-ophthalmic use | ||||
Oxybutynin Hydrochloride | |||||
Oxypertine | |||||
Oxypertine Hydrochloride | |||||
Oxyphenbutazone | |||||
Oxyphencyclimine Hydrochloride | |||||
Oxyphenonium Bromide | 5mg (MD) | ||||
15mg (MDD) | |||||
Oxytetracycline | |||||
Oxytetracycline Calcium | |||||
Oxytetracycline Dihydrate | |||||
Oxytetracycline Hydrochloride | |||||
Oxytocin, natural | |||||
Oxytocin, synthetic | |||||
Pancreatin | (1) 21,000 European Pharmacopoeia units of lipase per capsule | (1) capsules | |||
(2) 25,000 European Pharmacopoeia units of lipase per gram | (2) powder | ||||
Pancuronium Bromide | |||||
Papaverine | (1) By inhaler | ||||
(2) Otherwise than by inhaler | (2) 50mg (MD) | ||||
150mg (MDD) | |||||
Papaverine Hydrochloride | (1) By inhaler | ||||
(2) Otherwise than by inhaler | (2) Equivalent of 50mg of Papaverine (MD) | ||||
Equivalent of 150mg of Papaverine (MDD) | |||||
[F10Paracetamol | (1) 120 mg | (1) Non-effervescent tablets and capsules for use in children aged less than 12 years | (1) The quantity sold or supplied in one container or package shall not exceed 32
| ||
(2) 500 mg | (2) Non-effervescent tablets and capsules for use in adults and children not less than 12 years | ||||
(3) All preparations other than non-effervescent tablets and capsules | (2) The quantity sold or supplied in one container or package shall not exceed 32
| ||||
Paraldehyde | |||||
Paramethadione | |||||
Paramethasone Acetate | |||||
Parathyroid Gland | |||||
Pargyline Hydrochloride | |||||
Paroxetine Hydrochloride | |||||
Pecilocin | |||||
Penamecillin | |||||
Penbutolol Sulphate | |||||
Penicillamine | |||||
Penicillamine Hydrochloride | |||||
Pentamidine Isethionate | |||||
Penthienate Bromide | 5mg (MD) | ||||
15mg (MDD) | |||||
Pentolinium Tartrate | |||||
Perfluamine | |||||
Pergolide Mesylate | |||||
Perhexiline Maleate | |||||
Pericyazine | |||||
Perindopril | |||||
Perindopril Erbumine | |||||
Perphenazine | |||||
Phenacetin | 0.1 per cent | ||||
Phenazone | External | ||||
Phenazone Salicylate | |||||
Phenbutrazate Hydrochloride | |||||
Phenelzine Sulphate | |||||
Phenethicillin Potassium | |||||
Phenformin Hydrochloride | |||||
Phenglutarimide Hydrochloride | |||||
Phenindione | |||||
[F44Phenolphthalein.] | |||||
Phenoxybenzamine Hydrochloride | |||||
Phenoxymethylpenicillin | |||||
Phenoxymethylpenicillin Calcium | |||||
Phenoxymethylpenicillin Potassium | |||||
Phenprocoumon | |||||
Phensuximide | |||||
Phentolamine Hydrochloride | |||||
Phentolamine Mesylate | |||||
Phenylbutazone | |||||
Phenylbutazone Sodium | |||||
Phenylpropanolamine Hydrochloride | Internal | ||||
(1) all preparations except prolonged release capsules, nasal sprays and nasal drops | (1) 25mg (MD) | ||||
100mg (MDD) | |||||
(2) prolonged release capsules | (2) 50mg (MD) | ||||
100mg (MDD) | |||||
(3) 2.0 per cent | (3) nasal sprays and nasal drops | ||||
Phenytoin | |||||
Phenytoin Sodium | |||||
Phthalylsulphathiazole | |||||
Physostigmine | |||||
Physostigmine Aminoxide Salicylate | |||||
Physostigmine Salicylate | |||||
Physostigmine Sulphate | |||||
[F9Phytomenadione | Any use except the prevention or treatment of haemorrhagic disorders] | ||||
Picrotoxin | |||||
Pilocarpine | |||||
Pilocarpine Hydrochloride | |||||
Pilocarpine Nitrate | |||||
Pimozide | |||||
Pindolol | |||||
Pipenzolate Bromide | 5mg (MD) | ||||
15mg (MDD) | |||||
Piperacillin Sodium | |||||
Piperazine Oestrone Sulphate | |||||
Piperidolate Hydrochloride | 50mg (MD) | ||||
150mg (MDD) | |||||
Pipothiazine Palmitate | |||||
Piracetam | |||||
Pirbuterol Acetate | |||||
Pirbuterol Hydrochloride | |||||
[F45Pirenzepine Dihydrochloride Monohydrate] | |||||
Pirenzepine Hydrochloride | |||||
Piretanide | |||||
Piroxicam | 0.5 per cent | External | For maximum period of 7 days | Container or package containing not more than 30g of medicinal product | |
For the relief of rheumatic pain, pain of non-serious arthritic conditions and muscular aches, pains and swellings such as strains, sprains and sports injuries | |||||
For use in adults and children not less than 12 years | |||||
[F22Piroxicam Beta-cyclodextrin] | |||||
Pituitary Gland (Whole Dried) | By inhaler | ||||
Pituitary Powdered (Posterior Lobe) | By inhaler | ||||
Pivampicillin | |||||
Pivampicillin Hydrochloride | |||||
Pivmecillinam | |||||
Pivmecillinam Hydrochloride | |||||
Pizotifen | |||||
Pizotifen Malate | |||||
Plicamycin | |||||
Podophyllotoxin | |||||
Podophyllum | |||||
Podophyllum Indian | |||||
Podophyllum Resin | 20.0 per cent | External | |||
Ointment or impregnated plaster | |||||
Poldine Methylsulphate | 2mg (MD) | ||||
6mg (MDD) | |||||
Polidexide | |||||
Polyestradiol Phosphate | |||||
Polymyxin B Sulphate | |||||
Polythiazide | |||||
Poppy Capsule | |||||
Potassium Arsenite | 0.0127 per cent | ||||
Potassium Bromide | |||||
Potassium Canrenoate | |||||
Potassium Clavulanate | |||||
Potassium Perchlorate | |||||
Practolol | |||||
Pralidoxime Chloride | |||||
Pralidoxime Iodide | |||||
Pralidoxime Mesylate | |||||
Pravastatin Sodium | |||||
Prazosin Hydrochloride | |||||
Prednisolone | |||||
Prednisolone Acetate | |||||
Prednisolone Butylacetate | |||||
Prednisolone Hexanoate | |||||
Prednisolone Metasulphobenzoate | |||||
Prednisolone Metasulphobenzoate Sodium | |||||
Prednisolone Pivalate | |||||
Prednisolone Sodium Phosphate | |||||
Prednisolone Steaglate | |||||
Prednisone | |||||
Prednisone Acetate | |||||
Prenalterol Hydrochloride | |||||
Prenylamine Lactate | |||||
Prilocaine Hydrochloride | Non-ophthalmic use | ||||
Primidone | |||||
Probenecid | |||||
Probucol | |||||
Procainamide Hydrochloride | |||||
Procaine Hydrochloride | Non-ophthalmic use | ||||
Procaine Penicillin | |||||
Procarbazine Hydrochloride | |||||
Prochlorperazine | |||||
Prochlorperazine Edisylate | |||||
Prochlorperazine Maleate | |||||
Prochlorperazine Mesylate | |||||
Procyclidine Hydrochloride | |||||
Progesterone | |||||
Prolactin | |||||
Proligestone | |||||
Prolintane Hydrochloride | |||||
Promazine Embonate | |||||
Promazine Hydrochloride | |||||
Propafenone | |||||
Propafenone Hydrochloride | |||||
Propanidid | |||||
Propantheline Bromide | 15mg (MD) | ||||
45mg (MDD) | |||||
[F18Propiverine Hydrochloride] | |||||
Propofol | |||||
Propranolol Hydrochloride | |||||
Propylthiouracil | |||||
Proquazone | |||||
Protamine Sulphate | |||||
Prothionamide | |||||
Protirelin | |||||
Protriptyline Hydrochloride | |||||
Proxymetacaine Hydrochloride | Non-ophthalmic use | ||||
Pseudoephedrine Hydrochloride | Internal | (a) In the case of a prolonged release preparation | |||
120mg (MD) | |||||
240mg (MDD) | |||||
(b) in any other case 60mg (MD) | |||||
240mg (MDD) | |||||
Pseudoephedrine Sulphate | 60mg (MD) | ||||
180mg (MDD) | |||||
Pyrantel Embonate | (a) For the treatment of enterobiosis, in adults and children not less than 12 years | (a) 750mg MDD (as a single dose) | (a) Container or package containing not more than 750mg of Pyrantel Embonate | ||
(b) For the treatment of enterobiosis, in children less than 12 years but not less than 6 years | (b) 500mg MDD (as a single dose) | (b) Container or package containing not more than 750mg of Pyrantel Embonate | |||
(c) For the treatment of enterobiosis in children less than 6 years but not less than 2 years | (c) 250mg MDD (as a single dose) | (c) Container or package containing not more than 750mg of Pyrantel Embonate | |||
Pyrantel Tartrate | |||||
Pyrazinamide | |||||
Pyridostigmine Bromide | |||||
Pyrimethamine | |||||
[F18Quetiapine Fumarate] | |||||
[F8Quinagolide Hydrochloride] | |||||
Quinapril | |||||
[F45Quinapril Hydrochloride] | |||||
Quinestradol | |||||
Quinestrol | |||||
Quinethazone | |||||
Quinidine | |||||
Quinidine Bisulphate | |||||
Quinidine Polygalacturonate | |||||
Quinidine Sulphate | |||||
Quinine | 100mg (MD) | ||||
300mg (MDD) | |||||
Quinine Bisulphate | Equivalent of 100mg of Quinine (MD) | ||||
Equivalent of 300mg of Quinine (MDD) | |||||
Quinine Cinchophen | Equivalent of 100mg of Quinine (MD) | ||||
Equivalent of 300mg of Quinine (MDD) | |||||
Quinine Dihydrochloride | Equivalent of 100mg of Quinine (MD) | ||||
Equivalent of 300mg of Quinine (MDD) | |||||
Quinine Ethyl Carbonate | Equivalent of 100mg of Quinine (MD) | ||||
Equivalent of 300mg of Quinine (MDD) | |||||
Quinine Glycerophosphate | Equivalent of 100mg of Quinine (MD) | ||||
Equivalent of 300mg of Quinine (MDD) | |||||
Quinine Hydrobromide | Equivalent of 100mg of Quinine (MD) | ||||
Equivalent of 300mg of Quinine (MDD) | |||||
Quinine Hydrochloride | Equivalent of 100mg of Quinine (MD) | ||||
Equivalent of 300mg of Quinine (MDD) | |||||
Quinine Iodobismuthate | Equivalent of 100mg of Quinine (MD) | ||||
Equivalent of 300mg of Quinine (MDD) | |||||
Quinine Phosphate | Equivalent of 100mg of Quinine (MD) | ||||
Equivalent of 300mg of Quinine (MDD) | |||||
Quinine Salicylate | Equivalent of 100mg of Quinine (MD) | ||||
Equivalent of 300mg of Quinine (MDD) | |||||
Quinine Sulphate | Equivalent of 100mg of Quinine (MD) | ||||
Equivalent of 300mg of Quinine (MDD) | |||||
Quinine Tannate | Equivalent of 100mg of Quinine (MD) | ||||
Equivalent of 300mg of Quinine (MDD) | |||||
Quinine in combination with Urea Hydrochloride | |||||
Ramipril | |||||
[F7Ranitidine Bismuth Citrate] | |||||
Ranitidine Hydrochloride | For the short term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity [F46or the prevention of these symptoms when associated with consuming food and drink] | Equivalent to 75mg of Ranitidine (MD) | |||
Equivalent to 300mg of Ranitidine (MDD) | |||||
For a maximum period of 14 days | |||||
Rauwolfia Serpentina | |||||
Rauwolfia Vomitoria | |||||
Razoxane | |||||
Remoxipride Hydrochloride | |||||
Reproterol Hydrochloride | |||||
Rescinnamine | |||||
Reserpine | |||||
Rifabutin | |||||
Rifampicin | |||||
Rifampicin Sodium | |||||
Rifamycin | |||||
[F7Rimexolone] | |||||
Rimiterol Hydrobromide | |||||
Risperidone | |||||
Ritodrine Hydrochloride | |||||
Rolitetracycline Nitrate | |||||
Sabadilla | |||||
Salbutamol | |||||
Salbutamol Sulphate | |||||
Salcatonin | |||||
Salcatonin Acetate | |||||
Salmefamol | |||||
Salmeterol Xinafoate | |||||
Salsalate | |||||
Saralasin Acetate | |||||
Selegiline Hydrochloride | |||||
Semisodium Valproate | |||||
[F7Sertraline Hydrochloride] | |||||
Serum Gonadotrophin | |||||
[F7Sevoflurane] | |||||
Silver Sulphadiazine | |||||
Simvastatin | |||||
Sissomicin | |||||
Sissomicin Sulphate | |||||
Snake Venoms | |||||
Sodium Acetrizoate | |||||
Sodium Aminosalicylate | |||||
Sodium Antimonylgluconate | |||||
Sodium Arsanilate | |||||
Sodium Arsenate | |||||
Sodium Arsenite | 0.013 per cent | ||||
Sodium Bromide | |||||
Sodium Clodronate | |||||
Sodium Cromoglycate | (a) For nasal admistration | ||||
(b) 2.0 per cent | (b) For the treatment of acute seasonal allergic conjunctivitis [F47or perennial allergic conjunctivitis] | (b) Container or package containing not more than 10ml of medicinal product | |||
In the form of aqueous eye drops | |||||
(c) 4.0 per cent | (c) For the treatment of acute seasonal allergic conjunctivitis | (c) Container or package containing not more than 5g of medicinal product | |||
In the form of an eye ointment | |||||
Sodium Ethacrynate | |||||
Sodium Fluoride | (1) 0.33 per cent | (1) Dentifrices | |||
(2) Other preparations for use in the prevention of dental caries | |||||
In the form of | |||||
(a) tablets or drops | (a) 2.2 mg (MDD) | ||||
(b) 0.2 per cent | (b) mouth rinses other than those for daily use | ||||
(c) 0.05 per cent | (c) mouth rinses for daily use | ||||
Sodium Fusidate | |||||
Sodium Metrizoate | |||||
Sodium Monofluorophosphate | 1.14 per cent | Dentrifrice | |||
Sodium Oxidronate | |||||
Sodium Stibogluconate | |||||
Sodium Valproate | |||||
Somatorelin Acetate | |||||
Sotalol Hydrochloride | |||||
[F8Sparfloxacin] | |||||
Spectinomycin | |||||
Spectinomycin Hydrochloride | |||||
Spiramycin | |||||
Spiramycin Adipate | |||||
Spironolactone | |||||
Stannous Fluoride | 0.62 per cent | Dentifrice | |||
Stilboestrol | |||||
Stilboestrol Dipropionate | |||||
Streptodornase | External | ||||
Streptokinase | External | ||||
Streptomycin | |||||
Streptomycin Sulphate | |||||
Strychnine | |||||
Strychnine Arsenate | |||||
Strychnine Hydrochloride | |||||
[F9Strychnine Nitrate] | |||||
Styramate | |||||
Succinylsulphathiazole | |||||
Sucralfate | |||||
Sulbactam Sodium | |||||
Sulbenicillin | |||||
Sulbenicillin Sodium | |||||
Sulconazole Nitrate | External (except vaginal) | ||||
[F9Sulfabenzamide] | |||||
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 | |||||
[F18Tacalcitol Monohydrate] | |||||
Tacrine Hydrochloride | |||||
Talampicillin | |||||
Talampicillin Hydrochloride | |||||
Talampicillin Napsylate | |||||
Tamoxifen | |||||
Tamoxifen Citrate | |||||
[F7Tazarotene] | |||||
Tazobactam Sodium | |||||
Teicoplanin | |||||
Temocillin Sodium | |||||
Tenoxicam | |||||
Terazosin Hydrochloride | |||||
Terbinafine | |||||
[F48Terbinafine Hydrochloride] | [F481.0 per cent] | [F48External use for the treatment of tinea pedis and tinea cruris] | [F48Container or package containing not more than 15 g of medicinal product.] | ||
Terbutaline | |||||
Terbutaline Sulphate | |||||
Terfenadine | F49. . . | F49... | |||
Terlipressin | |||||
Terodiline Hydrochloride | |||||
Tetrabenazine | |||||
Tetracosactrin | |||||
Tetracosactrin Acetate | |||||
Tetracycline | |||||
Tetracycline Hydrochloride | |||||
Tetracycline Phosphate Complex | |||||
Tetroxoprim | |||||
Thallium Acetate | |||||
Thallous Chloride | |||||
Thiabendazole | |||||
Thiambutosine | |||||
Thiethylperazine Malate | |||||
Thiethylperazine Maleate | |||||
Thiocarlide | |||||
Thioguanine | |||||
Thiopentone Sodium | |||||
Thiopropazate Hydrochloride | |||||
Thioproperazine Mesylate | |||||
Thioridazine | |||||
Thioridazine Hydrochloride | |||||
Thiosinamine | |||||
Thiotepa | |||||
Thiothixene | |||||
Thiouracil | |||||
Thymoxamine Hydrochloride | |||||
Thyroid | |||||
Thyrotrophin | |||||
Thyroxine Sodium | |||||
Tiamulin Fumarate | |||||
Tiaprofenic Acid | |||||
Tibolone | |||||
Ticarcillin Sodium | |||||
Tigloidine Hydrobromide | |||||
Timolol Maleate | |||||
Tinidazole | |||||
Tinzaparin | |||||
Tioconazole | (1) 2.0 per cent | (1) External (except vaginal) | |||
(2) Vaginal for treatment of vaginal candidiasis | |||||
[F8Tizanidine Hydrochloride] | |||||
Tobramycin | |||||
Tobramycin Sulphate | |||||
Tocainide Hydrochloride | |||||
Tofenacin Hydrochloride | |||||
Tolazamide | |||||
Tolazoline Hydrochloride | External | ||||
Tolbutamide | |||||
Tolbutamide Sodium | |||||
Tolfenamic Acid | |||||
Tolmetin Sodium | |||||
[F7Topiramate] | |||||
[F22Torasemide] | |||||
Tramadol Hydrochloride | |||||
Trandolapril | |||||
Tranexamic Acid | |||||
Tranylcypromine Sulphate | |||||
Trazodone Hydrochloride | |||||
Treosulfan | |||||
Tretinoin | |||||
Triamcinolone | |||||
Triamcinolone Acetonide | 0.1 per cent | For the treatment of common mouth ulcers | Container or package containing not more than 5g of medicinal product | ||
Triamcinolone Diacetate | |||||
Triamcinolone Hexacetonide | |||||
Triamterene | |||||
Tribavirin | |||||
Triclofos Sodium | |||||
Trientine Dihydrochloride | |||||
Trifluoperazine | |||||
Trifluoperazine Hydrochloride | |||||
Trifluperidol | |||||
Trifluperidol Hydrochloride | |||||
Trilostane | |||||
Trimeprazine | |||||
Trimeprazine Tartrate | |||||
Trimetaphan Camsylate | |||||
Trimetazidine | |||||
Trimetazidine Hydrochloride | |||||
Trimethoprim | |||||
Trimipramine Maleate | |||||
Trimipramine Mesylate | |||||
Tropicamide | |||||
Tropisetron Hydrochloride | |||||
Troxidone | |||||
L-Tryptophan | (1) Oral | ||||
Dietary supplementation | |||||
(2) External | |||||
Tubocurarine Chloride | |||||
Tulobuterol | |||||
Tulobuterol Hydrochloride | |||||
Tyrothricin | Throat lozenges or throat pastilles | ||||
Uramustine | |||||
Urea Stibamine | |||||
Urethane | |||||
Uridine 5'-triphosphate | |||||
Urofollitrophin | |||||
Urokinase | |||||
Ursodeoxychoic Acid | |||||
Vaccine: Bacillus Salmonella Typhi | |||||
Vaccine: Poliomyelitis (Oral) | |||||
[F8Valaciclovir Hydrochloride] | |||||
Valproic Acid | |||||
Vancomycin Hydrochloride | |||||
Vasopressin | |||||
Vasopressin Tannate | |||||
Vecuronium Bromide | |||||
[F8Venlafaxine 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 | |||||
[F8Zalcitabine] | |||||
Zidovudine | |||||
Zimeldine Hydrochloride | |||||
Zolpidem Tartrate | |||||
Zomepirac Sodium | |||||
Zopiclone | |||||
Zuclopenthixol Acetate | |||||
Zuclopenthixol Decanoate | |||||
Zuclopenthixol Hydrochloride] |
Textual Amendments
F7Words in Sch. 1 inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 3(c)
F8Words in Sch. 1 inserted (19.1.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1999 (S.I. 1999/3463), arts. 1(1), 2(c)
F9Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), art. 1(1), Sch.
F10Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1997 (S.I. 1997/2044), art. 1(1), Sch. 1
F11Words in Sch. 1 inserted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(a)
F12Words in Sch. 1 substituted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(a)
F13Sch. 1: entries renumbered (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(a)
F14Words in Sch. 1 omitted (16.9.1998) by virtue of The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(b)
F15Word in Sch. 1 substituted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(b)
F16Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(c)(ii)
F17Words in Sch. 1 substituted (16.9.1998) by virtue ofThe Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(c)(i)
F18Words in Sch. 1 inserted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(e)
F19Word in Sch. 1 substituted (16.9.1997) by The Prescription Only Medicines (Human Use) Amendment Order 1997 (S.I. 1997/2044), arts. 1(1), 2(a)
F20Words in Sch. 1 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(a)
F21Words in Sch. 1 substituted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(d)
F22Words in Sch. 1 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(e)(i)
F23Word in Sch. 1 substituted (19.1.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1999 (S.I. 1999/3463), arts. 1(1), 2(a)
F24Words in Sch. 1 substituted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(e)
F25Words in Sch. 1 substituted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(f)(i)
F26Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(f)(ii)
F27Words in Sch. 1 omitted (16.9.1998) by virtue of The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(f)(iii)
F28Words in Sch. 1 inserted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(c)
F29Sch. 1: entries renumbered (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(c)
F30Words in Sch. 1 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(a)
F31Words in Sch. 1 inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 3(a)
F32Word in Sch. 1 inserted (13.8.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(e)(ii)
F33Word in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(g)(ii)
F34Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(g)(i)
F35Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(g)(iii)
F36Words in Sch. 1 inserted (19.1.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1999 (S.I. 1999/3463), arts. 1(1), 2(b)
F37Words in Sch. 1 substituted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(b)
F38Words in Sch. 1 substituted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(b)
F39Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(h)
F40Words in Sch. 1 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(c)(i)
F41Words in Sch. 1 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(c)(ii)
F42Words in Sch. 1 substituted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(c)(iii)
F43Words in Sch. 1 inserted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(d)
F44Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(d)(ii)
F45Words in Sch. 1 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(d)(i)
F46Words in Sch. 1 added (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(c)
F47Words in Sch. 1 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(d)
F48Words in Sch. 1 inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 3(b)
F49Words in Sch. 1 omitted (16.9.1997) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 1997 (S.I. 1997/2044), arts. 1(1), 2(b)
Articles 6(1) and 10
Column 1 | Circumstances excluding medicinal products from the class of prescription only medicines | ||
---|---|---|---|
Column 2 | Column 3 | Column 4 | |
Substance | Maximum strength | Pharmaceutical Form | Maximum Dose |
Codeine and its salts | Equivalent of 1.5 per cent of codeine monohydrate | Equivalent of 20 mg of codeine monohydrate | |
Dihydrocodeine and its salts | Equivalent of 1.5 per cent of dihydrocodeine | Equivalent of 10 mg of dihydrocodeine | |
Ethylmorphine andits salts | Equivalent of 0.2 per cent of ethylmorphine | Equivalent of 7.5 mg of ethylmorphine | |
Morphine and its salts | (1) Equivalent of 0.02 per cent anhydrous morphine | (1) Liquid | (1) Equivalent of 3 mg of anhydrous morphine |
(2) Equivalent of 0.04 per cent of anhydrous morphine; equivalent of 300 mcg of anhydrous morphine | (2) Solid | (2) Equivalent of 3 mg of anhydrous morphine | |
Medicinal Opium | (1) Equivalent of 0.02 per cent of anhydrous morphine | (1) Liquid | (1) Equivalent of 3 mg of anhydrous morphine |
(2) Equivalent of 0.04 per cent of anhydrous morphine | (2) Solid | (2) Equivalent of 3 mg of anhydrous morphine | |
Pholcodine and its salts | Equivalent of 1.5 per cent of pholcodine monohydrate | Equivalent of 20 mg of pholcodine monohydrate |
Article 2(b)
[F50Co-danthramer Capsules NPF]
[F50Co-danthramer Capsules, Strong NPF]
Co-danthramer-Oral Suspension NPF
Co-danthramer-Oral Suspension Strong NPF
Co-danthrusate Capsules
[F50Co-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
Textual Amendments
F50Words in Sch. 3 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 4
Article 8(4)(c)
Ammonium Bromide
Calcium Bromide
Calcium Bromidolactobionate
Embutramide
Fencamfamin Hydrochloride
Fluanisone
Hexobarbitone
Hexobarbitone Sodium
Hydrobromic Acid
Meclofenoxate Hydrochloride
Methohexitone Sodium
Pemoline
Piracetam
Potassium Bromide
Prolintane Hydrochloride
Sodium Bromide
Strychnine Hydrochloride
Tacrine Hydrochloride
Thiopentone Sodium
Article 11(1)(a)
Column 1 | Column 2 | Column 3 |
---|---|---|
Persons exempted | Prescription only medicines to which the exemption applies | Conditions |
1. Persons selling or supplying prescription only medicines to universities, other institutions concerned with higher education or institutions concerned with research. | 1. All prescription only medicines | 1. 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(21) or article 36 of the Food (Northern Ireland) Order 1989(22), (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(23), the National Health Service (Scotland) Act 1978(24) and the Health and Personal Social Services (Northern Ireland) Order 1972(25), 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–
| 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 registered ophthalmic optician. |
6. Registered ophthalmic opticians. | 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. |
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(26) 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(27). | 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. |
[F5210. State registered chiropodists who hold a certificate of competence in the use of the medicines specified in Column 2 issued by or with the approval of the Chiropodists Board. | 10. The following prescription only medicines— (a)Co-dydramol 10/500 tablets; (b)Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight; (c)Amorolfine hydrochloride lacquer where the maximum strength of the Amorolfine in the lacquer does not exceed 5 per cent by weight in volume; and (d)Topical hydrocortisone where the maximum strength of the hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight. | 10. The sale or supply shall be only in the course of their professional practice and (a) in the case of Co-dydramol 10/500 tablets the quantity sold or supplied to a person at any one time shall not exceed the amount sufficient for 3 days' treatment to a maximum of 24 tablets.] |
Textual Amendments
F51Word in Sch. 5 Pt. 1 para. 4 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 4(a)
F52Sch. 5 Pt. 1 para. 10 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), art. 1, Sch.
Article 11(1)(b)
Column 1 | Column 2 | Column 3 |
---|---|---|
Persons exempted | Prescription only medicines to which the exemption applies | Conditions |
1. Royal National Lifeboat Institution and certified first aiders of the Institution. | 1. All prescription only medicines. | 1. The supply shall be only so far as is necessary for the the treatment of sick or injured persons in the exercise of the functions of the Institution. |
2. The owner or the master of a ship which does not carry a doctor on board as part of her complement. | 2. All prescription only medicines. | 2. The supply shall be only so far as is necessary for the treatment of persons on the ship. |
3. Persons authorized by licences granted under regulation 5 of the Misuse of Drugs Regulations to supply a controlled drug. | 3. Such prescription only medicines, being controlled drugs, as are specified in the licence. | 3. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence. |
4. Persons requiring prescription only medicines for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees. | 4. Such prescription only medicines as may be specified in the relevant enactment. | 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. |
Article 11(2)
Column 1 | Column 2 | Column 3 |
---|---|---|
Persons exempted | Prescription only medicines to which the exemption applies | Conditions |
1. State registered chiropodists who hold a certificate of competence in the use of analgesics issued by or with the approval of the Chiropodists Board. | 1. Prescription only medicines for parenteral administration that contain,as the sole active ingredient, not more than one of the following substances–
| 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–
| 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. | 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; (c) prescription only medicines containing one or more of the following substances, but no active ingredient–
| 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
F53Words in Sch. 5 Pt. 3 substituted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 5(2)
F54Words in Sch. 5 Pt. 3 para. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 4(b)
F55Words in Sch. 5 Pt. 3 para. 9 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 3
Article 16(1)
Column 1 | Column 2 |
---|---|
Orders | References |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Order 1983 | S.I. 1983/1212 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1984 | S.I. 1984/756 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1986 | S.I. 1986/586 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1987 | S.I. 1987/674 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1987 | S.I. 1987/1250 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1988 | S.I. 1988/2017 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1991 | S.I. 1991/962 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1992 | S.I. 1992/1534 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1992 | S.I. 1992/2937 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1993 | S.I. 1993/1890 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1993 | S.I. 1993/3256 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1994 | S.I. 1994/558 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1994 | S.I. 1994/3016 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 3) Order 1994 | S.I. 1994/3050 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1995 | S.I. 1995/1384 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1995 | S.I. 1995/3174 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1996 | S.I. 1996/1514 |
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1996 | S.I. 1996/3193 |
Articles 12A to 12C
Textual Amendments
F56Sch. 7 inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(e)
(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.
Column 1 | Column 2 |
---|---|
Class of person by whom a prescription only medicine is supplied or administered | Person on whose behalf the Direction must be signed |
Common Services Agency | The Agency |
Health Authority | The Health Authority |
Special Health Authority | The Special Health Authority |
NHS trust | The trust |
Primary Care Trust | The Trust |
A person who supplies or administers a prescription only medicine pursuant to an arrangement made with the Common Services Agency, a Health Authority, a Special Health Authority, an NHS trust or a Primary Care Trust | The Common Services Agency, where the arrangement has been made with the Agency; or the Health Authority, Special Health Authority, NHS trust or Primary Care Trust with which the arrangement has been made |
Individuals who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State, or individuals who are state registered paramedics.
Pharmacists.
Registered health visitors.
Registered midwives.
Registered nurses.
Registered ophthalmic opticians.
State registered chiropodists.
Individuals who are registered in the register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960 by the Orthoptists Board (state registered orthoptists).
Individuals who are registered in the register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960 by the Physiotherapists Board (state registered physiotherapists).
Individuals who are registered in the register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960 by the Radiographers Board (state registered radiographers).]
(This note is not part of the Order)
This Order consolidates with amendments the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983 as amended. That Order and the Orders amending it (“the 1983 Order as amended”) are revoked by article 16 and Schedule 6.
This Order specifies the descriptions and classes of prescription only medicines (i.e. medicinal products which, subject to exemptions, may be sold or supplied by retail only in accordance with a prescription given by an appropriate practitioner and which may be administered only by or in accordance with the directions of such a practitioner). Many medicinal products are included in a class of such medicines by reason of the substances contained in them (seeSchedule 1) but others are included because of other criteria, such as their method of administration (seearticle 3). In many cases the provisions of the Act apply subject to exemptions (seearticles 4 and 5 to 13 and Schedule 1).
The principal amendments relate to those medicines in respect of which marketing authorizations have been granted by the European Community. They include as prescription only medicines those medicines in respect of which such an authorization has been granted which classifies a medicine as being subject to medical prescription (article 3(f)). They exclude from the class of prescription only medicines those medicines in respect of which such an authorization provides for supply which is not subject to medical prescription (article 6(3)).
The differences between this Order and the 1983 Order as amended are in the main technical changes concerning the location of provisions such as the division of material in Schedule 1 to the 1983 Order as amended between the new Schedules 1 and 2. But within the new Schedule 1 there are changes which relate to–
(a)the deletion from Column 1 of substances which are no longer used in those medicinal products which are on the market;
(b)the use of current names for the substances which are specified in that Column where their names have changed;
(c)the incorporation in that Schedule of provisions from article 4 of, and Part IV of Schedule 1 to, the 1983 Order as amended so that they may be found more easily;
(d)a change in the legal base for the entries in Columns 2 to 4 so that those entries now form the criteria for exemptions from the sale or supply requirements of section 58(2) of the Medicines Act 1968 instead of the criteria for excluding medicinal products from the class of prescription only medicines (see alsoarticle 5);
(e)the introduction of a fifth Column which specifies the maximum pack sizes to which exemptions apply.
As this order will impose no additional costs to business a compliance cost assessment has not been prepared.
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.
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).
1979 c. 36; the Parts of the professional register were determined by S.I. 1983/667, amended by S.I. 1989/104 and 1989/1455.
Approved by S.I. 1983/873, to which there are amendments not relevant to this Order.
1971 c. 61; section 1 was substituted by section 24 of the Oil and Gas (Enterprise) Act 1982 (c. 23).
OJ No. L214, 24.8.93, p. 1.
OJ No. L214, 24.8.93, p. 1.
S.I. 1980/1923, amended by S.I. 1997/1831.
See S.I. 1979/382 amended by S.I. 1980/263 and S.I. 1989/1124.
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