Over the Counter, Prescription only Medicines and Benzodiazepines.
The Prescription Only Medicines (Human Use) Order 1997
Transcript of The Prescription Only Medicines (Human Use) Order 1997
Status: This is the original version (as it was originally made).
STATUTORY INSTRUMENTS
1997 No. 1830
MEDICINES
The Prescription Only Medicines (Human Use) Order 1997
Made - - - - 25th July 1997
Laid before Parliament 28th July 1997
Coming into force - - 18th August 1997
The Secretary of State concerned with health in England, the Secretaries of State concerned withhealth 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 theDepartment of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred onthem by sections 58(1), (4) and (5), 59(1) and 129(4) of the Medicines Act 1968(1) or, as the case maybe, those conferred by the said provisions and now vested in them(2), and of all other powers enablingthem in that behalf, after consulting such organisations as appear to them to be representative ofinterests 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 tosections 58(6) and 129(7) of that Act, hereby make the following Order:
Citation, commencement and interpretation
1.—(1) This Order may be cited as the Prescription Only Medicines (Human Use) Order 1997and 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) a person who–
(i) is registered in Part 1 or 12 of the Register maintained by the United KingdomCentral Council for Nursing, Midwifery and Health Visiting under section 10 of
(1) 1968 c. 67. Section 58 has been amended by the Prescription by Nurses Etc. Act 1992 (c. 28), section 1. The expression “theappropriate Ministers” is defined in section 1(2) of the Medicines Act 1968.
(2) In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, andSchedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388); in the case of the Secretary of State concernedwith Agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order1978 (S.I. 1978/272) and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, theNorthern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the NorthernIreland Act 1974 (c. 28).
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the Nurses, Midwives and Health Visitors Act 1979(3) (referred to below in thisdefinition as “the professional register”), and
(ii) has a district nursing qualification additionally recorded in the professional registerunder rule 11 of the Nurses, Midwives and Health Visitors Rules 1983(4); or
(b) a person who is registered in Part 11 of the professional register as a health visitor;against whose name (in each case) is recorded in the professional register an annotationsignifying that he is qualified to order drugs, medicines and appliances for patients;“controlled drug” has the meaning assigned to it by section 2 of the Misuse of Drugs Act1971(5);“cyanogenetic substances” means preparations which–(a) are presented for sale or supply under the name of, or as containing, amygdalin, laetrile
or vitamin B17, or(b) contain more than 0.1 per cent by weight of any substance having the formula
either α-Cyanobenzyl-6-O-β-d-glucopyranosyl-β-d-glucopyranoside or α-Cyanobenzyl-β-d-glucopy ranosiduronic acid;
“dosage unit” means–(a) where a medicinal product is in the form of a tablet or capsule or is an article in some
other similar pharmaceutical form, that tablet, capsule or other article, or(b) where a medicinal product is not in any such form, the unit of measurement which is
used as the unit by reference to which the dose of the medicinal product is measured;“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 absorptionis unlikely to occur; and references to medicinal products for external use shall be readaccordingly except that such references shall not include throat sprays, throat pastilles, throatlozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;“health prescription” means a prescription issued by a doctor, dentist or nurse prescriber underor by virtue of–(a) in England and Wales, the National Health Service Act 1977(6),(b) in Scotland, the National Health Service (Scotland) Act 1978(7), and(c) in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order
1972(8);“inhaler” does not include an aerosol;“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 inthe amount of a medicinal product which it is recommended should be taken or administeredin a period of 24 hours;“maximum dose” or “MD” means the maximum quantity of a substance contained in theamount of a medicinal product which it is recommended should be taken or administered atany one time;“maximum strength” means–
(3) 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.(4) Approved by S.I. 1983/873, to which there are amendments not relevant to this Order.(5) 1971 c. 38.(6) 1977 c. 49.(7) 1978 c. 29.(8) S.I. 1972/1265 (N.I. 14).(9) 1995 c. 21.
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(a) the maximum quantity of a substance by weight or volume contained in a dosage unitof a medicinal product;
(b) the maximum percentage of a substance contained in a medicinal product calculated inany of the following ways–(i) weight in weight,(ii) weight in volume,(iii) volume in weight, or(iv) volume in volume,and if the maximum percentage calculated in those ways differs, the higher or highestsuch percentage;
“medicinal product” includes any article or substance in respect of which section 58 of the Acthas effect by virtue of an order made under section 104 of the Act, but does not include–(a) a medicinal product which is a veterinary drug as defined in section 132(1) of the Act or(b) an article or substance in respect of which section 58 has such effect where that article
or substance is only to be administered to animals;“the Misuse of Drugs Regulations” means, in relation to England, Wales and Scotland, theMisuse of Drugs Regulations 1985(10) and in relation to Northern Ireland, the Misuse of Drugs(Northern Ireland) Regulations 1986(11);“occupational health scheme” means a scheme in which a person, in the course of a businesscarried on by him, provides facilities for his employees for the treatment or prevention ofdisease;“offshore installation” means an offshore installation within the meaning of the MineralWorkings (Offshore Installations) Act 1971(12) which is within–(a) tidal waters and parts of the sea in or adjacent to the United Kingdom up to the seaward
limits of territorial waters;(b) waters in any area designated under section 1(7) of the Continental Shelf Act 1964(13);“operator”, in relation to an aircraft, means the person for the time being having themanagement of the aircraft;“parenteral administration” means administration by breach of the skin or mucous membrane;“prescription only medicine” means a medicinal product of a description or falling within aclass specified in article 3 of this Order;“prolonged release” in relation to a medicinal product means a formulation of that productwhich–(a) is used to reduce the rate at which the active ingredient in that product is released after
administration, and(b) is sold or supplied as a prolonged, controlled or sustained release medicinal product;“registered midwife” means a person who is registered in Part 10 of the Register maintainedby the United Kingdom Central Council for Nursing, Midwifery and Health Visiting undersection 10 of the Nurses, Midwives and Health Visitors Act 1979;
(10) S.I. 1985/2066.(11) SR 1986 No. 52.(12) 1971 c. 61; section 1 was substituted by section 24 of the Oil and Gas (Enterprise) Act 1982 (c. 23).(13) 1964 c. 29.
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“registered nurse” means a person who is registered in the Register maintained by the UnitedKingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of theNurses, Midwives and Health Visitors Act 1979;“registered ophthalmic optician” means a person who is registered in either of the Registers ofophthalmic opticians maintained under section 7(a) of the Opticians Act 1989(14);“repeatable prescription” means a prescription which contains a direction that it may bedispensed more than once;“sell” means sell by retail as defined in section 131 of the Act and “sale” has a correspondingmeaning;“soap” means any compound of a fatty acid with an alkali or amine;“state registered chiropodist” means a person who is registered in the Register established andmaintained under section 2(1) of the Professions Supplementary to Medicine Act 1960(15) bythe Chiropodists Board;“supply” means supply in circumstances corresponding to retail sale as defined in section 131of the Act;“unit preparation” means a preparation, including a mother tincture, prepared by a processof 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, whereapplicable, by impregnating tablets, granules, powders or other inert substances.
(3) For the purposes of this Order, the equivalence of a substance to a reference material shall bedetermined by calculating the amount of that reference material which is contained in that substanceeither by weight or, where the amount of the reference material is specified in terms of internationalunits 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 whichthey appear and where, in relation to a particular substance listed in column 1, an entry incolumns 2 to 5 bears a number or letter it relates only to such entries in the other of thosecolumns 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.
(14) 1989 c. 44.(15) 1960 c. 66.
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(6) In Schedule 3, the abbreviation “NPF” means the Nurse Prescribers' Formulary Appendix inthe British National Formulary.
Appropriate practitioners
2. For the purposes of section 58 (medicinal products on prescription only), the following shallbe appropriate practitioners–
(a) in relation to the descriptions and classes of medicinal products specified in article 3,doctors, dentists, veterinary surgeons and veterinary practitioners;
(b) in relation to the descriptions and classes of medicinal products specified in Schedule 3,appropriate nurse practitioners.
Medicinal products on prescription only
3. Subject to article 6, the following descriptions and classes of medicinal products are specifiedfor the purposes of section 58, namely–
(a) medicinal products consisting of or containing a substance listed in column 1 ofSchedule 1;
(b) medicinal products that are controlled drugs;(c) medicinal products that are for parenteral administration, other than preparations of insulin
for parenteral administration;(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 insubparagraphs (a) to (f),
(ii) which are of a description in respect of which the conditions specified insection 59(1) are satisfied, and
(iii) in respect of which a product licence or marketing authorization has been grantedwhich contains a provision to the effect that the method of sale or supply of themedicinal product is to be only in accordance with a prescription given by anappropriate practitioner.
Duration of special provisions in relation to new medicinal products
4. The duration specified for the purposes of section 59(2)(a) (duration of restrictions for certainnew products) shall be a period of 5 years.
Exempt medicinal products
5.—(1) A medicinal product shall be exempt from the restrictions imposed by section 58(2)(a)(restrictions on sale or supply) if it, or a substance in it, is listed in column 1 of Schedule 1 and there–
(a) is an entry in column 2, 3, 4 or 5 of that Schedule which contains a condition and thatcondition is satisfied in accordance with the following provisions of this article; or
(16) OJ No. L214, 24.8.93, p. 1.5
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(b) there is more than one such condition which applies where that substance is used in thatproduct and each of those conditions is so satisfied.
(2) Where a maximum strength is specified in column 2 in relation to a substance, a medicinalproduct which consists of or contains that substance satisfies the condition where the maximumstrength of that substance in that medicinal product, or where specified in that column the maximumstrength of a medicinal product which contains that substance, does not exceed that specifiedmaximum or, where the medicinal product consists of more than one of the substances sodiumfluoride, sodium monofluorophosphate or stannous fluoride combined in a dentifrice, where themaximum strength of that combination of substances in a product does not exceed the equivalentof 0.15 per cent of fluorine.
(3) Where a route of administration is specified in column 3 in relation to a substance, a medicinalproduct which consists of or contains that substance satisfies the condition where it is sold or suppliedfor administration only by that route.
(4) Where a use is specified in column 3 in relation to a substance, a medicinal product whichconsists of or contains that substance satisfies the condition in respect of use where it is sold orsupplied 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 medicinalproduct which consists of or contains that substance satisfies the condition where it is sold or suppliedin that pharmaceutical form.
(6) Where a maximum dose is specified in column 4 in relation to a substance, a medicinal productwhich consists of or contains that substance satisfies the condition where it is sold or supplied foruse 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 toa substance, a medicinal product which consists of or contains that substance satisfies the conditionwhere it is sold or supplied for use at a maximum daily dose which does not exceed that specifiedmaximum daily dose.
(8) A medicinal product which contains more than one of the substances–AtropineAtropine MethobromideAtropine MethonitrateAtropine Oxide HydrochlorideAtropine SulphateHyoscineHyoscine ButylbromideHyoscine HydrobromideHyoscine MethobromideHyoscine MethonitrateHyoscyamineHyoscyamine HydrobromideHyoscyamine Sulphate,
satisfies the condition only where it is sold or supplied for use at a maximum daily dose which doesnot exceed 1 milligram in total of the alkaloids derived from belladonna, hyoscyamus, stramoniumor other solanaceous plant which are contained in that medicinal product.
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(9) Where a maximum period of use or a maximum frequency of use is specified in column 4in relation to a substance, a medicinal product which consists of or contains that substance satisfiesthe condition where it is sold or supplied for use for a maximum period or frequency, as the casemay be, which does not exceed the maximum period of use or the maximum frequency of use whichis so specified.
(10) Where a maximum quantity is specified in column 5 in relation to a substance, a medicinalproduct which consists of or contains that substance satisfies the condition where it, or where sospecified in that column, the medicinal product which contains that substance is sold or supplied ina 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 referenceto the column bearing that number in Schedule 1.
Circumstances in which controlled drugs and medicinal products authorized by theEuropean Community are not prescription only medicines
6.—(1) A medicinal product shall not be a prescription only medicine by reason that it is acontrolled 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 Orderand no other controlled drug;
(b) contains that substance at a strength that does not exceed the maximum strength specifiedin 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 thatSchedule.
(2) A medicinal product for human use in respect of which a marketing authorization has beengranted under Council Regulation 2309/93/EEC(17) shall not be a prescription only medicine wherethat authorization does not classify the medicinal product as subject to medical prescription.
Exemption for parenteral administration in an emergency to human beings of certainprescription only medicines
7. The restriction imposed by section 58(2)(b) (restriction on administration) shall not applyto the administration to human beings of any of the following medicinal products for parenteraladministration–
Adrenaline Injection 1 in 1000 (1 mg in 1 ml)Atropine Sulphate InjectionChlorpheniramine InjectionCobalt Edetate InjectionDextrose Injection Strong B.P.C.Diphenhydramine InjectionGlucagon InjectionHydrocortisone InjectionMepyramine InjectionPromethazine Hydrochloride Injection
(17) OJ No. L214, 24.8.93, p. 1.7
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Snake Venom AntiserumSodium Nitrite InjectionSodium Thiosulphate InjectionSterile Pralidoxime
where the administration is for the purpose of saving life in an emergency.
Exemptions for emergency sale or supply
8.—(1) The restrictions imposed by section 58(2)(a) (restriction on sale and supply) shall notapply to the sale or supply of a prescription only medicine by a person lawfully conducting a retailpharmacy 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 byreason of an emergency is unable to furnish a prescription immediately;
(b) that the doctor has undertaken to furnish the person lawfully conducting a retail pharmacybusiness 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 directionsof the doctor requesting it;
(d) subject to paragraph (5), that the prescription only medicine is not a controlled drugspecified 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 orSupply) (Miscellaneous Provisions) Regulations 1980(18) within the time specified inthat regulation stating the particulars required under paragraph 1 of Schedule 2 to thoseRegulations.
(3) The restrictions imposed by section 58(2)(a) shall not apply to the sale or supply of aprescription only medicine by a person lawfully conducting a retail pharmacy business where theconditions 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 andhas satisfied himself–
(i) that there is an immediate need for the prescription only medicine requested tobe sold or supplied and that it is impracticable in the circumstances to obtain aprescription without undue delay,
(ii) that treatment with the prescription only medicine requested has on a previousoccasion 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 personto 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 an aerosol for the relief of asthma, an ointment or cream, and has been made upfor sale in a container elsewhere than at the place of sale or supply, the smallest packthat the pharmacist has available for sale or supply may be sold or supplied,
(18) S.I. 1980/1923, amended by S.I. 1997/1831.8
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(ii) is an oral contraceptive, a quantity sufficient for a full treatment cycle may be soldor supplied,
(iii) is an antibiotic for oral administration in liquid form, the smallest quantity that willprovide 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 containa substance specified in Schedule 4 to this Order and is not a controlled drug specified inSchedule 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 regulationstating 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, thepharmaceutical 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 prescriptiononly medicine consists of or contains phenobarbitone or phenobarbitone sodium (but no othersubstance specified in Schedule 4 to this Order or Schedule 1, 2 or 3 to the Misuse of DrugsRegulations) and is sold or supplied for use in the treatment of epilepsy.
Exemption for non-parenteral administration to human beings
9. The restriction imposed by section 58(2)(b) (restriction on administration) shall not applyto the administration to human beings of a prescription only medicine which is not for parenteraladministration.
Exemption for medicinal products at high dilutions
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 parenteraladministration and which consists of or contains, any of the substances listed in column 1 ofSchedule 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 theperson selling, supplying or administering the medicinal product has been requested byor on behalf of a particular person and in that person’s presence to use his own judgmentas to the treatment required; or
(b) each such unit preparation has been diluted to at least one part in a million million (6c).
Exemptions for certain persons
11.—(1) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall notapply–
(a) to the sale or supply by a person listed in column 1 of Part I of Schedule 5 of the prescriptiononly medicines listed in relation to that person in column 2 of that Part where the conditionsspecified in the corresponding paragraphs in column 3 of that Part are satisfied;
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(b) to the supply by a person listed in column 1 of Part II of Schedule 5 of the prescription onlymedicines listed in relation to that person in column 2 of that Part where the conditionsspecified 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 applyto the administration by a person listed in column 1 of Part III of Schedule 5 of the prescriptiononly medicines for parenteral administration listed in relation to that person in column 2 of that Partwhere the conditions specified in the corresponding paragraphs in column 3 of that Part are satisfied.
Exemption for sale or supply in hospitals
12. The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not applyto the sale or supply of any prescription only medicine in the course of the business of a hospitalwhere the prescription only medicine is sold or supplied in accordance with the written directionsof a doctor or dentist notwithstanding that those directions do not satisfy the conditions specifiedin article 15(2).
Exemption in cases involving another’s default
13. The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not applyto the sale or supply of a prescription only medicine by a person who, having exercised all duediligence, believes on reasonable grounds that the product sold or supplied is not a prescription onlymedicine.
Exemption in the case of a forged prescription
14. The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall notapply to the sale or supply of a prescription only medicine by a pharmacist in accordance with aforged prescription where the pharmacist, having exercised all due diligence, believes on reasonablegrounds that the prescription is genuine.
Prescriptions
15.—(1) For the purposes of section 58(2)(a) a prescription only medicine shall not be taken tobe sold or supplied in accordance with a prescription given by an appropriate practitioner unless theconditions 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 inSchedule 1, 2 or 3 to the Misuse of Drugs Regulations, in which case it may be writtenby 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 veterinarypractitioner,
(iv) where the appropriate practitioner giving it is a doctor, dentist or appropriate nursepractitioner, the name, address and the age, if under 12, of the person for whosetreatment it is given, and
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(v) where the appropriate practitioner giving it is a veterinary surgeon or a veterinarypractitioner, the name and address of the person to whom the prescription onlymedicine is to be delivered and a declaration by the veterinary surgeon or veterinarypractitioner giving it that the prescription only medicine is prescribed for an animalor 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 timeafter the end of that period nor otherwise than in accordance with the directions containedin the repeatable prescription;
(e) in the case of a repeatable prescription which does not specify the number of times it maybe dispensed, shall not be dispensed on more than two occasions unless it is a prescriptionfor an oral contraceptive in which case it may be dispensed 6 times before the end of theperiod of 6 months from the appropriate date.
(3) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not applyto a sale or supply of a prescription only medicine which is not in accordance with a prescriptiongiven by an appropriate practitioner by reason only that a condition specified in paragraph (2) isnot satisfied where the person selling or supplying the prescription only medicine, having exercisedall due diligence, believes on reasonable grounds that that condition is satisfied in relation to thatsale 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 notbe dispensed; and
(b) in every other case, the date on which the prescription was signed by the appropriatepractitioner giving it;
and, for the purposes of sub-paragraphs (d) and (e) of that paragraph, where a health prescriptionbears both the date on which it was signed and a date indicated as being that before which it shallnot be dispensed, the appropriate date is the later of those dates.
Revocations
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
21st July 1997
Baroness JayMinister of State,
Department of Health
(19) S.I. 1989/1852.11
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25th July 1997
Win GriffithsParliamentary Under Secretary of State, Welsh
Office
23rd July 1997
Sam GalbraithParliamentary Under Secretary of State, The
Scottish Office
25th July 1997
Jeff RookerMinister of State, Ministry of Agriculture,
Fisheries and Food
Sealed with the Official Seal of the Department of Health and Social Services for Northern Irelandon 22nd July 1997.
D. C. GowdyPermanent Secretary
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 18th July1997.
P. SmallPermanent Secretary
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SCHEDULE 1 Articles 3(a), 5(1) and 10
SUBSTANCES WHICH IF INCLUDED IN MEDICINAL PRODUCTS MAKE THOSEPRODUCTS PRESCRIPTION ONLY MEDICINES AND EXEMP TIONS FROM
RESTRICTIONS ON THE SALE AND SUPPLY OF PRESCRIPTION ONLY MEDICINES
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Acarbose
AcebutololHydrochloride
Acemetacin
Acetarsol
Acetazolamide
AcetazolamideSodium
Acetohexamide
AcetylcholineChloride
0.2 per cent External
Acetylcysteine
Acipimox
ExternalAciclovir 5.0 per cent
For treatmentof herpessimplex virusinfections ofthe lips andface (Herpeslabialis)
Containeror packagecontaining notmore than 2gof medicinalproduct
Acitretin
AclarubicinHydrochloride
Aconite 1.3 per cent External
Acrivastine 24 mg (MDD) Containeror packagecontainingnot more than240mg ofAcrivastine
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Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Acrosoxacin
ActinomycinC
ActinomycinD
Adenosine
(1) By inhalerAdrenaline
(2) External
(1) By inhalerAdrenalineAcid Tartrate
(2) External
(1 )By inhalerAdrenalineHydrochloride
(2) External
AdrenocorticalExtract
Albendazole
Alclofenac
AlclometasoneDipropionate
AlcuroniumChloride
Aldesleukin
Aldosterone
Alfacalcidol
AlfuzosinHydrochloride
AllergenExtracts
Allopurinol
Allyloestrenol
AlphadoloneAcetate
Alphaxalone
14
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Alprenolol
AlprenololHydrochloride
Alprostadil
Alseroxylon
AmantadineHydrochloride
AmbenoniumChloride
AmbutoniumBromide
Amcinonide
AmetazoleHydrochloride
Amethocaine Non-ophthalmicuse
AmethocaineGentisate
Non-ophthalmicuse
AmethocaineHydrochloride
Non-ophthalmicuse
AmikacinSulphate
AmilorideHydrochloride
AminocaproicAcid
Aminoglutethimide
AminopterinSodium
AmiodaroneHydrochloride
15
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
AmiphenazoleHydrochloride
Amitriptyline
AmitriptylineEmbonate
AmitriptylineHydrochloride
AmlodipineBesylate
AmmoniumBromide
AmodiaquineHydrochloride
AmorolfineHydrochloride
Amoxapine
Amoxycillin
AmoxycillinSodium
AmoxycillinTrihydrate
AmphomycinCalcium
Amphotericin
Ampicillin
AmpicillinSodium
AmpicillinTrihydrate
Amsacrine
Amygdalin
Amyl Nitrite
16
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
AmylocaineHydrochloride
Non-ophthalmicuse
Ancrod
Androsterone
AngiotensinAmide
Anistreplase
AnteriorPituitaryExtract
AntimonyBariumTartrate
AntimonyDimercaptosuccinate
AntimonyLithiumThiomalate
AntimonyPentasulphide
AntimonyPotassiumTartrate
AntimonySodiumTartrate
AntimonySodiumThioglycollate
AntimonySulphate
AntimonyTrichloride
AntimonyTrioxide
17
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
AntimonyTrisulphide
Apiol
Apomorphine
ApomorphineHydrochloride
Aprotinin
ArecolineHydrobromide
Argipressin
Aristolochia
AristolochiaClematitis
AristolochiaContorta
AristolochiaDebelis
AristolochiaFang-chi
AristolochiaManshuriensis
AristolochiaSerpentaria
Arsenic
ArsenicTriiodide
ArsenicTrioxide
Arsphenamine
OralAstemizole
For treatmentof hayfeverin adults andchildren not
10mg (MDD) Containeror packagecontainingnot more than100mg ofAstemizole
18
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
less than 12years
Not aprolongedreleasepreparation
Atenolol
AtracuriumBesylate
(1) Internal
(a) by inhaler
(b) otherwisethan by inhaler
(b) 300mcg(MD)
1mg (MDD)
Atropine
(2) External(exceptophthalmic)
(1) Internal
(a) by inhaler
(b) otherwisethan by inhaler
(b) 400mcg(MD)
1.3mg (MDD)
AtropineMethobromide
(2) External(exceptophthalmic)
Internal
(a) by inhaler
(b) otherwisethan by inhaler
(b) 400mcg(MD)
AtropineMethonitrate
1.3mg (MDD)
(1) Internal
(a) by inhaler
AtropineOxideHydrochloride
(b) otherwisethan by inhaler
(b) 360mcg(MD)
19
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
1.2mg (MDD)3
(2) External(exceptophthalmic)
(1) Internal
(a) by inhaler
(b) otherwisethan by inhaler
(b) 360mcg(MD)
1.2mg (MDD)
AtropineSulphate
(2) External(exceptophthalmic)
Auranofin
Azapropazone
Azathioprine
AzathioprineSodium
Azelaic Acid
For nasaladministration
140mcg pernostril (MD)
For thetreatmentof seasonalallergicrhinitis
280mcg pernostril (MDD)
For use inadults andchildren notless than 12years
AzelastineHydrochloride
As a non-aerosol,aqueous form
Containeror packagecontainingnot more than5,040mcg ofAzelastineHydrochloride
AzidocillinPotassium
20
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Azithromycin
AzlocillinSodium
Aztreonam
BacampicillinHydrochloride
Bacitracin
BacitracinMethyleneDisalicylate
BacitracinZinc
Baclofen
BambuterolHydrochloride
BariumCarbonate
BariumChloride
BariumSulphide
Beclamide
Beclomethasone
For nasaladministration(non-aerosol)
100mcg pernostril (MD)
200mcg pernostril (MDD)
BeclomethasoneDipropionate
For thepreventionand treatmentof allergicrhinitis
Containeror packagecontainingnot more than5,600mcg ofBeclomethasoneDipropionate
For use inadults andchildren not
21
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
less than 12years
(1) Internal (1) 1mg ofthe alkaloids(MDD)
BelladonnaHerb
(2) External
(1) Internal (1) 1mg ofthe alkaloids(MDD)
BelladonnaRoot
(2) External
Bemegride
BemegrideSodium
BenapryzineHydrochloride
Bendrofluazide
BenethaminePenicillin
Benoxaprofen
Benperidol
BenserazideHydrochloride
Bentiromide
BenzathinePenicillin
Benzbromarone
BenzhexolHydrochloride
BenziloniumBromide
Benzocaine Any useexceptophthalmicuse
22
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
BenzoctamineHydrochloride
BenzoylPeroxide
10.0 per cent External
N-BenzoylSulphanilamide
Benzquinamide
BenzquinamideHydrochloride
Benzthiazide
BenztropineMesylate
BenzylpenicillinCalcium
BenzylpenicillinPotassium
BenzylpenicillinSodium
Beractant
BetahistineHydrochloride
Betamethasone
BetamethasoneAdamantoate
BetamethasoneBenzoate
BetamethasoneDipropionate
BetamethasoneSodiumPhosphate
BetamethasoneValerate
BetaxololHydrochloride
23
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
BethanecholChloride
BethanidineSulphate
Bezafibrate
BiperidenHydrochloride
BiperidenLactate
BismuthGlycollylarsanilate
BisoprololFumarate
Bleomycin
BleomycinSulphate
BretyliumTosylate
BromhexineHydrochloride
BromocriptineMesylate
Bromperidol
Bromvaletone
Brotizolam
For nasaladministration
200mcg pernostril (MD)
For thepreventionor treatmentof seasonalallergicrhinitis
200mcg pernostril (MDD)
Budesonide
For use inadults and inchildren not
Containeror packagecontainingnot morethan 10mg ofBudesonide
24
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
less than 12years
As a non-aerosol,aqueous form
Bufexamac
Bumetanide
6mg (MD)BuphenineHydrochloride
18mg (MDD)
Bupivacaine Any useexceptophthalmicuse
BupivacaineHydrochloride
Any useexceptophthalmicuse
BuserelinAcetate
BuspironeHydrochloride
Busulphan
ButacaineSulphate
Any useexceptophthalmicuse
ButorphanolTartrate
ButriptylineHydrochloride
Calcipotriol
Calcitonin
Calcitriol
CalciumAmphomycin
25
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
CalciumBenzamidosalicylate
CalciumBromide
CalciumBromidolactobionate
CalciumCarbimide
CalciumFolinate
CalciumMetrizoate
CalciumSulphaloxate
Candicidin
CanrenoicAcid
Cantharidin 0.01 per cent External
CapreomycinSulphate
Captopril
Carbachol
Carbamazepine
Carbaryl
CarbenicillinSodium
(1) 5mg (MD) (1) Pellet
25mg (MDD)
(2) 2.0 percent
(2) Gel
(3) 20mg(MD)
CarbenoxoloneSodium
(3) 1.0 percent
(3)Granules formouthwashin adults andchildren not
80mg (MDD)
(3) Containeror packagecontainingnot more than506mg of
26
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
less than 12years
CarbenoxoloneSodium
Carbidopa
Carbimazole
Carbocisteine
CarbonTetrachloride
Carboplatin
CarboprostTrometamol
CarbuterolHydrochloride
CarfecillinSodium
CarindacillinSodium
Carisoprodol
Carmustine
Carperidine
CarteololHydrochloride
Cefaclor
Cefadroxil
CefazedoneSodium
Cefixime
CefodizimeSodium
CefotaximeSodium
CefoxitinSodium
CefpodoximeProxetil
27
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
CefsulodinSodium
Ceftazidime
CeftizoximeSodium
CeftriaxoneSodium
CefuroximeAxetil
CefuroximeSodium
CeliprololHydrochloride
Cephalexin
CephalexinSodium
Cephaloridine
CephalothinSodium
CephamandoleNafate
CephazolinSodium
Cephradine
CeriumOxalate
Cerivastatin
CeruletideDiethylamine
CetirizineHydrochloride
10mg (MDD) Containeror packagecontainingnot more than100mg ofCetirizineHydrochloride
28
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
ChenodeoxycholicAcid
ChloralHydrate
External
Chlorambucil
Chloramphenicol
ChloramphenicolCinnamate
ChloramphenicolPalmitate
ChloramphenicolSodiumSuccinate
Chlorhexadol
ChlormadinoneAcetate
Chlormerodrin
Chlormethiazole
ChlormethiazoleEdisylate
Chlormezanone
(1) 5.0 percent
(1) InternalChloroform(20)
(2) External
ChloroquinePhosphate
Prophylaxis ofmalaria
ChloroquineSulphate
Prophylaxis ofmalaria
Chlorothiazide
Chlorotrianisene
ChlorphenoxamineHydrochloride
(20) SeeS.I. 1979/382 amended by S.I. 1980/263 and S.I. 1989/1124.29
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Chlorpromazine
ChlorpromazineEmbonate
ChlorpromazineHydrochloride
Chlorpropamide
Chlorprothixene
ChlorprothixeneHydrochloride
Chlortetracycline
ChlortetracyclineCalcium
ChlortetracyclineHydrochloride
Chlorthalidone
Chlorzoxazone
Cholestyramine
Ciclacillin
Ciclobendazole
CilastatinSodium
Cilazapril
(a) 200mg(MD)
800mg(MDD)
Cimetidine (a) For theshort-termsymptomaticrelief ofheartburn,dyspepsia,indigestion,acidindigestionandhyperacidityand for theprophylaxis of
For amaximumperiod of 14days
30
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
meal-inducedheartburn
(b) 100mg(MD) to betaken as asingle dose atnight
(b) For theprophylacticmanagementof nocturnalheartburn bya single dosetaken at night For a
maximumperiod of 14days
CimetidineHydrochloride
Cinchocaine 3.0 per cent Non-ophthalmicuse
CinchocaineHydrochloride
Equivalent of3.0 per cent ofCinchocaine
Non-ophthalmicuse
Cinchophen
Cinoxacin
Ciprofibrate
Ciprofloxacin
CiprofloxacinHydrochloride
Cisapride
Cisplatin
Clarithromycin
ClavulanicAcid
ClidiniumBromide
Clindamycin
ClindamycinHydrochloride
31
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
ClindamycinPalmitateHydrochloride
ClindamycinPhosphate
(1) External(other thantreatment ofmouth ulcers)
Clioquinol
(2) 35mg (2) Treatmentof mouthulcers
(2) 350mg(MDD)
ClobetasolPropionate
ClobetasoneButyrate
Clofazimine
Clofibrate
ClomipheneCitrate
Clomipramine
ClomipramineHydrochloride
Clomocycline
ClomocyclineSodium
Clonidine
ClonidineHydrochloride
Clopamide
ClopenthixolDecanoate
ClopenthixolHydrochloride
Clorexolone
32
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Clotrimazole External butin the case ofvaginal useonly externaluse for thetreatmentof vaginalcandidiasis
CloxacillinBenzathine
CloxacillinSodium
Clozapine
CocculusIndicus
Co-dergocrineMesylate
Colaspase
Colchicine
ColestipolHydrochloride
ColfoscerilPalmitate
ColistinSulphate
ColistinSulphomethate
ColistinSulphomethateSodium
Coniine
Conium Leaf 7.0 per cent External
Corticotrophin
Cortisone
CortisoneAcetate
33
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Co-tetroxazine
Co-trimoxazole
Cropropamide
Crotethamide
Croton Oil
Croton Seed
Curare
Cyclofenil
Cyclopenthiazide
CyclopentolateHydrochloride
Cyclophosphamide
Cycloserine
Cyclosporin
Cyclothiazide
CyproteroneAcetate
Cytarabine
CytarabineHydrochloride
Dacarbazine
DalteparinSodium
Danazol
Danthron
DantroleneSodium
Dapsone
DapsoneEthane OrthoSulphonate
34
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
DaunorubicinHydrochloride
DeanolBitartrate
26mg (MDD)
DebrisoquineSulphate
DemecariumBromide
Demeclocycline
DemeclocyclineCalcium
DemeclocyclineHydrochloride
DeoxycortoneAcetate
DeoxycortonePivalate
DeptropineCitrate
(1) 0.25mg (1) Internal:throatlozenges orthroat pastilles
DequaliniumChloride
(2) 1.0 percent
(2) External:paint
Deserpidine
DesferrioxamineMesylate
Desflurane
DesipramineHydrochloride
Deslanoside
Desmopressin
DesmopressinAcetate
35
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Desogestrel
Desonide
Desoxymethasone
Dexamethasone
DexamethasoneAcetate
DexamethasoneIsonicotinate
DexamethasonePhenylpropionate
DexamethasonePivalate
DexamethasoneSodiumMetasulphobenzoate
DexamethasoneSodiumPhosphate
DexamethasoneTroxundate
DexfenfluramineHydrochloride
(a) In the caseof a prolongedreleasepreparation:equivalentof 30mg ofDextromethorphan(MD)
equivalentof 75mg ofDextromethorphan(MDD)
DextromethorphanHydrobromide
Internal
(b) in anyother case:equivalent
36
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
of 15mg ofDextromethorphan(MD)
equivalentof 75mg ofDextromethorphan(MDD)
DextrothyroxineSodium
Diazoxide
DibenzepinHydrochloride
Dichloralphenazone
Dichlorphenamide
External
For localsymptomaticrelief ofpain andinflammationin trauma ofthe tendons,ligaments,muscles andjoints andin localisedforms ofsoft tissuerheumatism
DiclofenacDiethylammonium
1.16 per cent
For use inadults andchildren notless than 12years
For maximumperiod of 7days
Containeror packagecontaining notmore than 30gof medicinalproduct
DiclofenacPotassium
DiclofenacSodium
37
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
10mg (MD)DicyclomineHydrochloride
60mg (MDD)
Dienoestrol
DiethanolamineFusidate
DiflucortoloneValerate
Diflunisal
Digitalin
Digitalis Leaf
DigitalisPrepared
Digitoxin
Digoxin
DihydralazineSulphate
DihydroergotamineMesylate
Dihydrostreptomycin
DihydrostreptomycinSulphate
DiloxanideFuroate
DiltiazemHydrochloride
Dimercaprol
DimethisoquinHydrochloride
Non-ophthalmicuse
Dimethisterone
DimethothiazineMesylate
DimethylSulphoxide
38
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
DimethyltubocurarineBromide
DimethyltubocurarineChloride
DimethyltubocurarineIodide
Dinoprost
DinoprostTrometamol
Dinoprostone
DipivefrinHydrochloride
Dipyridamole
DisodiumEtidronate
DisodiumPamidronate
Disopyramide
DisopyramidePhosphate
DistigmineBromide
Disulfiram
Dithranol 1.0 per cent
DobutamineHydrochloride
Domperidone
DomperidoneMaleate
DopamineHydrochloride
DopexamineHydrochloride
Dothiepin
39
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
DothiepinHydrochloride
DoxapramHydrochloride
DoxazosinMesylate
DoxepinHydrochloride
Doxorubicin
DoxorubicinHydrochloride
Doxycycline
DoxycyclineCalciumChelate
DoxycyclineHydrochloride
Droperidol
Dydrogesterone
Dyflos
Econazole External butin the case ofvaginal useonly externaluse for thetreatmentof vaginalcandidiasis
EconazoleNitrate
External butin the case ofvaginal useonly externaluse for thetreatmentof vaginalcandidiasis
40
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
EcothiopateIodide
EdrophoniumChloride
EflornithineHydrochloride
Embutramide
EmeproniumBromide
Emetine 1.0 per cent
EmetineBismuthIodide
EmetineHydrochloride
Equivalent of1.0 per cent ofEmetine
EnalaprilMaleate
EncephalitisVirus, Tick-borne, CentEur
Enoxacin
EnoxaparinSodium
Enoximone
(1) Internal(other thannasal sprays ornasal drops)
(1) 30mg(MD)
60mg (MDD)
(2) 2.0 percent
(2) Nasalsprays or nasaldrops
Ephedrine
(3) External
41
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
(1) Equivalentof 30mg ofEphedrine(MD)
(1) Internal(other thannasal sprays ornasal drops)
Equivalentof 60mg ofEphedrine(MDD)
(2) Equivalentof 2.0 per centof Ephedrine
(2) Nasalsprays or nasaldrops
EphedrineHydrochloride
(3) External
(1) Internal(other thannasal sprays ornasal drops)
(1) Equivalentof 30mg ofEphedrine(MD)
Equivalentof 60mg ofEphedrine(MDD)
(2) Equivalentof 2.0 per centof Ephedrine
(2) Nasalsprays or nasaldrops
EphedrineSulphate
(3) External
Epicillin
Epirubicin
EpirubicinHydrochloride
Epithiazide
Epoetin Alfa
Epoetin Beta
EpoprostenolSodium
ErgometrineMaleate
42
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
ErgometrineTartrate
Ergot,Prepared
ErgotamineTartrate
Erythromycin
ErythromycinEstolate
ErythromycinEthylcarbonate
ErythromycinEthylSuccinate
ErythromycinLactobionate
ErythromycinPhosphate
ErythromycinStearate
ErythromycinThiocyanate
EsmololHydrochloride
EstramustinePhosphate
EtafedrineHydrochloride
EthacrynicAcid
EthambutolHydrochloride
Ethamivan
Ethamsylate
Ethiazide
43
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
EthinylAndrostenediol
Ethinyloestradiol
Ethionamide
Ethisterone
Ethoglucid
EthoheptazineCitrate
EthopropazineHydrochloride
Ethosuximide
Ethotoin
EthylBiscoumacetate
EthynodiolDiacetate
Etodolac
Etomidate
EtomidateHydrochloride
Etoposide
Etretinate
Famciclovir
10mg (MD)
20mg (MDD)
Famotidine For theshort-termsymptomaticrelief ofheartburn,dyspepsia,indigestion,acidindigestionandhyperacidity,and preventionof these
For maximumperiod of 14days
44
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
symptomswhenassociatedwith foodand drink,includingnocturnalsymptoms
FazadiniumBromide
External
For the reliefof symptomsassociatedwith softtissue injurysuch asstrains, sprainsand contusions
Felbinac 3.17 per cent
For use inadults andchildren notless than 12years
For maximumperiod of 7days
Containeror packagecontaining notmore than 30gof medicinalproduct
Felodipine
Felypressin
Fenbufen
Fenclofenac
FenfluramineHydrochloride
Fenofibrate
Fenoprofen
FenoprofenCalcium
FenoterolHydrobromide
45
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
FenticonazoleNitrate
Feprazone
FerrousArsenate
Filgrastim
Finasteride
FlavoxateHydrochloride
FlecainideAcetate
Flosequinan
Fluanisone
Flubendazole
FlucloroloneAcetonide
FlucloxacillinMagnesium
FlucloxacillinSodium
Fluconazole For oraladministrationfor thetreatmentof vaginalcandidiasis inpersons agednot less than16 but lessthan 60 years
150mg (MD) Containeror packagecontainingnot more than150mg ofFluconazole
Flucytosine
FludrocortisoneAcetate
FlufenamicAcid
Flumazenil 46
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Flumethasone
FlumethasonePivalate
(a) 50mcg pernostril (MD)
(a) For thepreventionand treatmentof seasonalallergicrhinitis,including hayfever
100mcg pernostril (MDD)
For use inadults andchildren notless than 16years
In the formof a non-pressurisednasal spray
(a) Containeror packagecontainingnot more than6,000mcg ofFlunisolide
(b) 25mcg pernostril (MD)
(b) For thepreventionand treatmentof seasonalallergicrhinitisincluding hayfever
75mcg pernostril (MDD)
(b) Containeror packagecontainingnot more than6,000mcg ofFlunisolide
For use inchildren notless than 12years but lessthan 16 years
Flunisolide 0.025 per cent
In the formof a non-pressurisednasal spray
FluocinoloneAcetonide
Fluocinonide 47
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
FluocortinButyl
Fluocortolone
FluocortoloneHexanoate
FluocortolonePivalate
FluoresceinDilaurate
Fluorometholone
Fluorouracil
FluorouracilTrometamol
FluoxetineHydrochloride
FlupenthixolDecanoate
FlupenthixolHydrochloride
FluperoloneAcetate
FluphenazineDecanoate
FluphenazineEnanthate
FluphenazineHydrochloride
FluprednideneAcetate
Fluprednisolone
FluprostenolSodium
Flurandrenolone
Flurbiprofen
48
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
FlurbiprofenSodium
Fluspirilene
Flutamide
FluticasonePropionate
FluvastatinSodium
FluvoxamineMaleate
Folic Acic 500mcg(MDD)
Formestane
Formocortal
FoscarnetSodium
FosfestrolSodium
FosfomycinTrometamol
FosinoprilSodium
FramycetinSulphate
Frusemide
Furazolidone
Fusafungine
Fusidic Acid
Gabapentin
Gadoteridol
GallamineTriethiodide
Ganciclovir
49
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
GanciclovirSodium
Gelsemine 0.1 per cent
25mg (MD)Gelsemium
75mg (MDD)
Gemeprost
Gemfibrozil
Gentamicin
GentamicinSulphate
Gestodene
Gestrinone
Gestronol
GestronolHexanoate
Glibenclamide
Glibornuride
Gliclazide
Glipizide
Gliquidone
Glisoxepide
Glucagon
1mg (MD)GlycopyrroniumBromide
2mg (MDD)
Glymidine
Gonadorelin
GoserelinAcetate
Gramicidin 0.2 per cent External
GranisetronHydrochloride
50
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Griseofulvin
GrowthHormone
GuanethidineMonosulphate
GuanfacineHydrochloride
GuanoclorSulphate
GuanoxanSulphate
Halcinonide
HalofantrineHydrochloride
Haloperidol
HaloperidolDecanoate
Heparin External
HeparinCalcium
External
HeparinSodium
External
(a) 2.0 percent
(a) Soaps
(b) 0.1 percent
(b) Aerosols
Hexachlorophane
(c) 0.75 percent
(c)preparationsother thansoaps andaerosols
HexaminePhenylcinchoninate
Hexobarbitone
51
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
HexobarbitoneSodium
Hexoestrol
HexoestrolDipropionate
L-HistidineHydrochloride
Dietarysupplementation
(1) 0.15mg(MD)
(1) Internal
0.45mg(MDD)
Homatropine
(2) External(exceptophthalmic)
0.2mg (MD)HomatropineHydrobromide
0.6mg (MDD)
2mg (MD)HomatropineMethylbromide
6mg (MDD)
HydralazineHydrochloride
Hydrargaphen Localapplication toskin
HydrobromicAcid
Hydrochlorothiazide
ExternalHydrocortisone 1.0 per cent
For use eitheralone or inconjunctionwithCrotamitonin irritantdermatitis,contactallergic
Containeror packagecontaining notmore than 15gof medicinalproduct(cream orointment) or30ml (spray)
52
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
dermatitis,insect bitereactions, mildto moderateeczema, andeither incombinationwithClotrimazolefor athlete’sfoot andcandidalintertrigo or incombinationwithlignocainefor anal andperianal itchassociatedwithhaemorrhoids
For use inadults andchildren notless than 10years
Creamointment orspray
External
Containeror packagecontaining notmore than 15gof medicinalproduct
HydrocortisoneAcetate
Equivalent to1.0 per centHydrocortisone For use
in irritantdermatitis,contactallergicdermatitis,insect bitereactions, mildto moderateeczema, and incombinationwith one ormore of the
In the case ofsuppositories,containeror packagecontaining nomore than 12
53
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
following:BenzylBenzoate,BismuthOxide,BismuthSubgallate,Peru Balsam,PramoxineHydrochloride,ZincOxide, forhaemorrhoids
For use inadults andchildren notless than 10years
Cream,ointment orsuppositories
HydrocortisoneButyrate
HydrocortisoneCaprylate
HydrocortisoneHydrogenSuccinate
HydrocortisoneSodiumPhosphate
ExternalHydrocortisoneSodiumSuccinate
Equivalentto 2.5mgHydrocortisone For aphthous
ulceration ofthe mouth foradults andchildren notless than 12years
Containeror packagecontainingnot more thanequivalentto 50mg ofHydrocortisone
54
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
In the form ofpellets
Hydroflumethiazide
HydroxychloroquineSulphate
Prophylaxis ofmalaria
Hydroxyprogesterone
HydroxyprogesteroneEnanthate
HydroxyprogesteroneHexanoate
Hydroxyurea
HydroxyzineEmbonate
(a) 25mg(MD)
(a) For themanagementof pruritisassociatedwith acuteor chronicurticariaor atopicdermatitisor contactdermatitis, inadults and inchildren notless than 12years
75mg (MDD)
(a) Containeror packagecontainingnot more than750mg ofHydroxyzineHydrochloride
(b) 25 mg(MD)
HydroxyzineHydrochloride
(b) For themanagementof pruritisassociatedwith acuteor chronicurticariaor atopicdermatitisor contactdermatitis, inchildren not
50mg (MDD)
(b) Containeror packagecontainingnot more than750mg ofHydroxyzineHydrochloride
55
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
less than 6years but lessthan 12 years
(1) 0.15 percent
(1) InternalHyoscine
(2) External(exceptophthalmic)
(1) Internal
(a) by inhaler
(b) 20mg(MD)
(b) otherwisethan by inhaler
80mg (MDD)
(b) Containeror packagecontainingnot morethan 240mgof HyoscineButylbromide
HyoscineButylbromide
(2) External
(1) Internal
(a) by inhaler
(b) 300mcg(MD)
(b) otherwisethan by inhaler
900mcg(MDD)
HyoscineHydrobromide
(2) External(exceptophthalmic)
(1) Internal
(a) by inhaler
(b) 2.5mg(MD)
(b) otherwisethan by inhaler
7.5mg (MDD)
HyoscineMethobromide
(2) External
(1) InternalHyoscineMethonitrate
(a) by inhaler
56
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
(b) 2.5mg(MD)
(b) otherwisethan by inhaler
7.5mg (MDD)
(2) External
(1) Internal
(a) by inhaler
(b) 300mcg(MD)
(b) otherwisethan by inhaler
1mg (MDD)
Hyoscyamine
(2) External
(1) Internal
(a) by inhaler
(b) Equivalentof 300mcg ofHyoscyamine(MD)
(b) otherwisethan by inhaler
Equivalentof 1mg ofHyoscyamine(MDD)
HyoscyamineHydrobromide
(2) External
(1) Internal
(a) by inhaler
(b) Equivalentof 300mcg ofHyoscyamine(MD)
(b) otherwisethan by inhaler
Equivalentof 1mg ofHyoscyamine(MDD)
HyoscyamineSulphate
(2) External
Ibuprofen Rheumaticand muscularpain, pain of
57
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
non-seriousarthriticconditions,backache,neuralgia,migraine,headache,dental pain,dysmenorrhoea,feverishness,symptomsof colds andinfluenza
(1)(a) In thecase of aprolongedreleasepreparation600mg (MD)
1,200mg(MDD)
(b) in anyother case400mg (MD)
(1) Internal
1,200mg(MDD)
(2) 5.0 percent
(2) External
IdarubicinHydrochloride
Idoxuridine
Ifosfamide
Ignatius Bean
ImipenemHydrochloride
Imipramine
ImipramineHydrochloride
58
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
ImipramineIon ExchangeResin BoundSalt orComplex
IndapamideHemihydrate
Indomethacin
IndomethacinSodium
Indoprofen
IndoraminHydrochloride
InosinePranobex
Iodamide
IodamideMeglumine
IodamideSodium
Iohexol
Iomeprol
Iopamidol
Iopentol
IothalamicAcid
Ioversol
Ioxaglic Acid
IpratropiumBromide
IprindoleHydrochloride
IproniazidPhosphate
59
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Isoaminile
IsoaminileCitrate
Isocarboxazid
IsoconazoleNitrate
External butin the case ofvaginal useonly externaluse for thetreatmentof vaginalcandidiasis
Isoetharine
IsoetharineHydrochloride
IsoetharineMesylate
Isoniazid
IsoprenalineHydrochloride
IsoprenalineSulphate
Equivalentof 2.5mg ofIsopropamideion (MD)
IsopropamideIodide
Equivalentof 5.0mg ofIsopropamideion (MDD)
Isotretinoin
Isradipine
Itraconazole
Jaborandi External
KanamycinAcid Sulphate
60
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
KanamycinSulphate
KetamineHydrochloride
For theprevention andtreatment ofdandruff andseborrhoeicdermatitis ofthe scalp
Ketoconazole 2.0 per cent
In the form ofa shampoo
Maximumfrequency ofapplication ofonce every 3days
Containeror packagecontainingnot morethan 120mlof medicinalproduct andcontainingnot more than2,400mg ofKetoconazole
ExternalKetoprofen 2.5 per cent
For rheumaticand muscularpain in adultsand childrennot less than12
For maximumperiod of 7days
Containeror packagecontaining notmore than 30gof medicinalproduct
KetorolacTrometamol
KetotifenFumarate
LabetalolHydrocholoride
LachesineChloride
Lacidipine
Lamotrigine
Lanatoside C
LanatosideComplex A, Band C
LatamoxefDisodium
61
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
LevallorphanTartrate
LevobunololHydrochloride
Levodopa
Levonorgestrel
Lidoflazine
Lignocaine Non-ophthalmicuse
LignocaineHydrochloride
Non-ophthalmicuse
Lincomycin
LincomycinHydrochloride
LiothyronineSodium
Lisinopril
Equivalentof 5mg ofLithium (MD)
LithiumCarbonate
Equivalentof 15mgof Lithium(MDD)
LithiumCitrate
LithiumSuccinate
Equivalentof 5mg ofLithium (MD)
LithiumSulphate
Equivalentof 15mg
62
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
of Lithium(MDD)
(1) 3mg (MD)(1) Internal
9mg (MDD)
Lobeline
(2) External
(1) Equivalentof 3mg ofLobeline(MD)
(1) Internal
Equivalentof 9mg ofLobeline(MDD)
LobelineHydrochloride
(2) External
(1) Equivalentof 3mg ofLobeline(MD)
(1) Internal
Equivalentof 9mg ofLobeline(MDD)
LobelineSulphate
(2) External
LodoxamideTrometamol
Lofepramine
LofepramineHydrochloride
LofexidineHydrochloride
LomefloxacinHydrochloride
Lomustine
LoperamideHydrochloride
Treatmentof acutediarrhoea
63
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Loratidine 10mg (MDD) Containeror packagecontainingnot more than100mg ofLoratidine
LoxapineSuccinate
LungSurfactantPorcine
LuteinisingHormone
Lymecycline
Lynoestrenol
Lypressin
LysurideMaleate
Mafenide
MafenideAcetate
MafenideHydrochloride
MafenidePropionate
5.0 per cent Eye drops
MagnesiumFluoride
MagnesiumMetrizoate
MandragoraAutumnalis
MannomustineHydrochloride
MaprotilineHydrochloride
Mebanazine 64
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Mebendazole For oral use inthe treatmentof enterobiasisin adults andin childrennot less than 2years
100mg (MD) Containeror packagecontainingnot more than800mg ofMebendazole
135mg (MD)MebeverineHydrochloride
For thesymptomaticrelief ofirritable bowelsyndrome
405mg(MDD)
MebeverinePamoate
Mebhydrolin
MebhydrolinNapadisylate
MecamylamineHydrochloride
Mecillinam
MeclofenoxateHydrochloride
Medigoxin
Medrogestone
MedroxyprogesteroneAcetate
MefenamicAcid
MefloquineHydrochloride
Mefruside
Megestrol
MegestrolAcetate
MeglumineGadopentetate
65
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
MeglumineIodoxamate
MeglumineIoglycamate
MeglumineIothalamate
MeglumineIotroxate
MeglumineIoxaglate
Melphalan
MelphalanHydrochloride
Menotrophin
25mg (MD)MepenzolateBromide
75mg (MDD)
Mephenesin
MephenesinCarbamate
MepivacaineHydrochloride
Any useexceptophthalmicuse
MeptazinolHydrochloride
Mequitazine
Mercaptopurine
Mersalyl
Mersalyl Acid
Mesalazine
Mesna
Mestranol
MetaraminolTartrate
66
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Metergoline
MetforminHydrochloride
Methacycline
MethacyclineCalcium
MethacyclineHydrochloride
Methallenoestril
MethicillinSodium
Methixene
MethixeneHydrochloride
Methocarbamol
Methocidin Throatlozenges andthroat pastilles
MethohexitoneSodium
Methoin
Methoserpidine
Methotrexate
MethotrexateSodium
Methotrimeprazine
MethotrimeprazineHydrochloride
MethotrimeprazineMaleate
MethoxamineHydrochloride
0.25 per cent Nasal spraysor nasal dropsnot containingliquid paraffinas a vehicle
67
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Methsuximide
Methyclothiazide
Methyldopa
MethyldopateHydrochloride
30mg (MD)MethylephedrineHydrochloride
60mg (MDD)
Methylprednisolone
MethylprednisoloneAcetate
MethylprednisoloneSodiumSuccinate
Methylthiouracil
MethysergideMaleate
Metipranolol
Metirosine
MetoclopramideHydrochloride
Metolazone
MetoprololFumarate
MetoprololSuccinate
MetoprololTartrate
Metronidazole
MetronidazoleBenzoate
Metyrapone
MexiletineHydrochloride
68
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
MezlocillinSodium
MianserinHydrochloride
Miconazole External butin the case ofvaginal useonly externaluse for thetreatmentof vaginalcandidiasis
MiconazoleNitrate
External butin the case ofvaginal useonly externaluse for thetreatmentof vaginalcandidiasis
Mifepristone
Miglitol
Milrinone
MilrinoneLactate
Minocycline
MinocyclineHydrochloride
Minoxidil 2.0 per cent External
Misoprostol
Mitobronitol
Mitomycin
MitozantroneHydrochloride
MivacuriumChloride
69
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Moclobemide
Molgramostim
MolindoneHydrochloride
MometasoneFuroate
MoracizineHydrochloride
MorazoneHydrochloride
Mupirocin
MupirocinCalcium
MustineHydrochloride
Nabilone
Nabumetone
Nadolol
NafarelinAcetate
NaftidrofurylOxalate
NaftifineHydrochloride
NalbuphineHydrochloride
Nalidixic Acid
NalorphineHydrobromide
NaloxoneHydrochloride
NaltrexoneHydrochloride
70
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
(1) 0.05 percent
(1) Nasalsprays or nasaldrops notcontainingliquid paraffinas a vehicle
NaphazolineHydrochloride
(2) 0.015 percent
(2) Eye drops
NaphazolineNitrate
0.05 per cent Nasal spraysor nasal dropsnot containingliquid paraffinas a vehicle
Naproxen
NaproxenSodium
Natamycin
NedocromilSodium
NefazodoneHydrochloride
NefopamHydrochloride
Neomycin
NeomycinOleate
NeomycinPalmitate
NeomycinSulphate
NeomycinUndecanoate
NeostigmineBromide
NeostigmineMethylsulphate
71
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
NetilmicinSulphate
NicardipineHydrochloride
Nicergoline
Nicotinic Acid Any use,except for thetreatment ofhyperlipidaemia
600mg(MDD)
Nicoumalone
Nifedipine
Nifenazone
Nikethamide
Nimodipine
Niridazole
Nitrendipine
Nitrofurantoin
Nitrofurazone
75mg (MD)For theprevention ofthe symptomsof food-relatedheartburn
Maximum of 4such doses inany period of14 days
Nizatidine
For use inadults andchildren notless than 16years
NomifensineMaleate
Noradrenaline
NoradrenalineAcid Tartrate
Norethisterone
72
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
NorethisteroneAcetate
NorethisteroneEnanthate
Norethynodrel
Norfloxacin
Norgestimate
Norgestrel
NortriptylineHydrochloride
Noscapine
NoscapineHydrochloride
NovobiocinCalcium
NovobiocinSodium
Nux VomicaSeed
Nystatin
Octacosactrin
Octreotide
Oestradiol
OestradiolBenzoate
OestradiolCypionate
OestradiolDipropionate
OestradiolDiundecanoate
OestradiolEnanthate
73
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
OestradiolPhenylpropionate
OestradiolUndecanoate
OestradiolValerate
Oestriol
OestriolSuccinate
OestrogenicSubstancesConjugated
Oestrone
Ofloxacin
OlsalazineSodium
Omeprazole
OndansetronHydrochloride
OrciprenalineSulphate
OrphenadrineCitrate
OrphenadrineHydrochloride
Ouabain
Ovarian GlandDried
Oxamniquine
OxantelEmbonate
Oxaprozin
Oxatomide
74
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
OxedrineTartrate
10mg (MD)Oxethazaine
30mg (MDD)
Containeror packagecontainingnot more than400mg ofOxethazaine
OxitropiumBromide
Oxolinic Acid
Oxpentifylline
OxprenololHydrochloride
OxybuprocaineHydrochloride
Non-ophthalmicuse
OxybutyninHydrochloride
Oxypertine
OxypertineHydrochloride
Oxyphenbutazone
OxyphencyclimineHydrochloride
5mg (MD)OxyphenoniumBromide
15mg (MDD)
Oxytetracycline
OxytetracyclineCalcium
OxytetracyclineDihydrate
OxytetracyclineHydrochloride
75
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Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Oxytocin,natural
Oxytocin,synthetic
(1) 21,000EuropeanPharmacopoeiaunits of lipaseper capsule
(1) capsulesPancreatin
(2) 25,000EuropeanPharmacopoeiaunits of lipaseper gram
(2) powder
PancuroniumBromide
(1) By inhaler
(2) 50mg(MD)
Papaverine
(2) Otherwisethan by inhaler
150mg(MDD)
(1) By inhaler
(2) Equivalentof 50mg ofPapaverine(MD)
PapaverineHydrochloride
(2) Otherwisethan by inhaler
Equivalentof 150mg ofPapaverine(MDD)
Paraldehyde
Paramethadione
ParamethasoneAcetate
ParathyroidGland
76
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
PargylineHydrochloride
ParoxetineHydrochloride
Pecilocin
Penamecillin
PenbutololSulphate
Penicillamine
PenicillamineHydrochloride
PentamidineIsethionate
5mg (MD)PenthienateBromide
15mg (MDD)
PentoliniumTartrate
Perfluamine
PergolideMesylate
PerhexilineMaleate
Pericyazine
Perindopril
PerindoprilErbumine
Perphenazine
Phenacetin 0.1 per cent
Phenazone External
PhenazoneSalicylate
PhenbutrazateHydrochloride
77
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Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
PhenelzineSulphate
PhenethicillinPotassium
PhenforminHydrochloride
PhenglutarimideHydrochloride
Phenindione
PhenoxybenzamineHydrochloride
Phenoxymethylpenicillin
PhenoxymethylpenicillinCalcium
PhenoxymethylpenicillinPotassium
Phenprocoumon
Phensuximide
PhentolamineHydrochloride
PhentolamineMesylate
Phenylbutazone
PhenylbutazoneSodium
Internal
(1) 25mg(MD)
PhenylpropanolamineHydrochloride
(1) allpreparationsexceptprolongedreleasecapsules, nasalsprays andnasal drops
100mg(MDD)
78
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
(2) 50mg(MD)
(2) prolongedreleasecapsules 100mg
(MDD)
(3) 2.0 percent
(3) nasalsprays andnasal drops
Phenytoin
PhenytoinSodium
Phthalylsulphathiazole
Physostigmine
PhysostigmineAminoxideSalicylate
PhysostigmineSalicylate
PhysostigmineSulphate
Picrotoxin
Pilocarpine
PilocarpineHydrochloride
PilocarpineNitrate
Pimozide
Pindolol
5mg (MD)PipenzolateBromide
15mg (MDD)
PiperacillinSodium
PiperazineOestroneSulphate
79
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
50mg (MD)PiperidolateHydrochloride
150mg(MDD)
PipothiazinePalmitate
Piracetam
PirbuterolAcetate
PirbuterolHydrochloride
PirenzepineHydrochloride
Piretanide
External
For the reliefof rheumaticpain, pain ofnon-seriousarthriticconditionsand muscularaches, painsand swellingssuch asstrains, sprainsand sportsinjuries
Piroxicam 0.5 per cent
For use inadults andchildren notless than 12years
For maximumperiod of 7days
Containeror packagecontaining notmore than 30gof medicinalproduct
PituitaryGland (WholeDried)
By inhaler
PituitaryPowdered
By inhaler
80
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
(PosteriorLobe)
Pivampicillin
PivampicillinHydrochloride
Pivmecillinam
PivmecillinamHydrochloride
Pizotifen
PizotifenMalate
Plicamycin
Podophyllotoxin
Podophyllum
PodophyllumIndian
ExternalPodophyllumResin
20.0 per cent
Ointment orimpregnatedplaster
2mg (MD)PoldineMethylsulphate
6mg (MDD)
Polidexide
PolyestradiolPhosphate
Polymyxin BSulphate
Polythiazide
PoppyCapsule
PotassiumArsenite
0.0127 percent
PotassiumBromide
81
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
PotassiumCanrenoate
PotassiumClavulanate
PotassiumPerchlorate
Practolol
PralidoximeChloride
PralidoximeIodide
PralidoximeMesylate
PravastatinSodium
PrazosinHydrochloride
Prednisolone
PrednisoloneAcetate
PrednisoloneButylacetate
PrednisoloneHexanoate
PrednisoloneMetasulphobenzoate
PrednisoloneMetasulphobenzoateSodium
PrednisolonePivalate
PrednisoloneSodiumPhosphate
PrednisoloneSteaglate
82
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Prednisone
PrednisoneAcetate
PrenalterolHydrochloride
PrenylamineLactate
PrilocaineHydrochloride
Non-ophthalmicuse
Primidone
Probenecid
Probucol
ProcainamideHydrochloride
ProcaineHydrochloride
Non-ophthalmicuse
ProcainePenicillin
ProcarbazineHydrochloride
Prochlorperazine
ProchlorperazineEdisylate
ProchlorperazineMaleate
ProchlorperazineMesylate
ProcyclidineHydrochloride
Progesterone
Prolactin
Proligestone
83
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
ProlintaneHydrochloride
PromazineEmbonate
PromazineHydrochloride
Propafenone
PropafenoneHydrochloride
Propanidid
15mg (MD)PropanthelineBromide
45mg (MDD)
Propofol
PropranololHydrochloride
Propylthiouracil
Proquazone
ProtamineSulphate
Prothionamide
Protirelin
ProtriptylineHydrochloride
ProxymetacaineHydrochloride
Non-ophthalmicuse
(a) In the caseof a prolongedreleasepreparation
120mg (MD)
PseudoephedrineHydrochloride
Internal
240mg(MDD)
84
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
(b) in anyother case60mg (MD)
240mg(MDD)
60mg (MD)PseudoephedrineSulphate
180mg(MDD)
(a) For thetreatment ofenterobiosis,in adults andchildren notless than 12years
(a) 750mgMDD (as asingle dose)
(a) Containeror packagecontainingnot morethan 750mgof PyrantelEmbonate
(b) For thetreatment ofenterobiosis,in childrenless than 12years but notless than 6years
(b) 500mgMDD (as asingle dose)
(b) Containeror packagecontainingnot morethan 750mgof PyrantelEmbonate
PyrantelEmbonate
(c) For thetreatment ofenterobiosis inchildren lessthan 6 yearsbut not lessthan 2 years
(c) 250mgMDD (as asingle dose)
(c) Containeror packagecontainingnot morethan 750mgof PyrantelEmbonate
PyrantelTartrate
Pyrazinamide
PyridostigmineBromide
Pyrimethamine
Quinapril
Quinestradol
85
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Quinestrol
Quinethazone
Quinidine
QuinidineBisulphate
QuinidinePolygalacturonate
QuinidineSulphate
100mg (MD)Quinine
300mg(MDD)
Equivalentof 100mg ofQuinine (MD)
QuinineBisulphate
Equivalentof 300mgof Quinine(MDD)
Equivalentof 100mg ofQuinine (MD)
QuinineCinchophen
Equivalentof 300mgof Quinine(MDD)
Equivalentof 100mg ofQuinine (MD)
QuinineDihydrochloride
Equivalentof 300mgof Quinine(MDD)
Quinine EthylCarbonate
Equivalentof 100mg ofQuinine (MD)
86
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Equivalentof 300mgof Quinine(MDD)
Equivalentof 100mg ofQuinine (MD)
QuinineGlycerophosphate
Equivalentof 300mgof Quinine(MDD)
Equivalentof 100mg ofQuinine (MD)
QuinineHydrobromide
Equivalentof 300mgof Quinine(MDD)
Equivalentof 100mg ofQuinine (MD)
QuinineHydrochloride
Equivalentof 300mgof Quinine(MDD)
Equivalentof 100mg ofQuinine (MD)
QuinineIodobismuthate
Equivalentof 300mgof Quinine(MDD)
Equivalentof 100mg ofQuinine (MD)
QuininePhosphate
Equivalentof 300mgof Quinine(MDD)
87
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Equivalentof 100mg ofQuinine (MD)
QuinineSalicylate
Equivalentof 300mgof Quinine(MDD)
Equivalentof 100mg ofQuinine (MD)
QuinineSulphate
Equivalentof 300mgof Quinine(MDD)
Equivalentof 100mg ofQuinine (MD)
QuinineTannate
Equivalentof 300mgof Quinine(MDD)
Quinine incombinationwith UreaHydrochloride
Ramipril
Equivalentto 75mg ofRanitidine(MD)
Equivalentto 300mg ofRanitidine(MDD)
RanitidineHydrochloride
For theshort termsymptomaticrelief ofheartburn,dyspepsia,indigestion,acidindigestionandhyperacidity
For amaximumperiod of 14days
88
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
RauwolfiaSerpentina
RauwolfiaVomitoria
Razoxane
RemoxiprideHydrochloride
ReproterolHydrochloride
Rescinnamine
Reserpine
Rifabutin
Rifampicin
RifampicinSodium
Rifamycin
RimiterolHydrobromide
Risperidone
RitodrineHydrochloride
RolitetracyclineNitrate
Sabadilla
Salbutamol
SalbutamolSulphate
Salcatonin
SalcatoninAcetate
Salmefamol
SalmeterolXinafoate
89
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Salsalate
SaralasinAcetate
SelegilineHydrochloride
SemisodiumValproate
SerumGonadotrophin
SilverSulphadiazine
Simvastatin
Sissomicin
SissomicinSulphate
Snake Venoms
SodiumAcetrizoate
SodiumAminosalicylate
SodiumAntimonylgluconate
SodiumArsanilate
SodiumArsenate
SodiumArsenite
0.013 per cent
SodiumBromide
SodiumClodronate
SodiumCromoglycate
(a) For nasaladmistration
90
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
(b) For thetreatment ofacute seasonalallergicconjunctivitis
(b) 2.0 percent
In the form ofaqueous eyedrops
(b) Containeror packagecontainingnot morethan 10mlof medicinalproduct
(c) For thetreatment ofacute seasonalallergicconjunctivitis
(c) 4.0 percent
In the formof an eyeointment
(c) Containeror packagecontaining notmore than 5gof medicinalproduct
SodiumEthacrynate
(1) Dentifrices
(2) Otherpreparationsfor use in theprevention ofdental caries
In the form of
(1) 0.33 percent
(a) tablets ordrops
(a) 2.2 mg(MDD)
(b) 0.2 percent
(b) mouthrinses otherthan those fordaily use
SodiumFluoride
(c) 0.05 percent
(c) mouthrinses for dailyuse
SodiumFusidate
SodiumMetrizoate
91
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
SodiumMonofluorophosphate
1.14 per cent Dentrifrice
SodiumOxidronate
SodiumStibogluconate
SodiumValproate
SomatorelinAcetate
SotalolHydrochloride
Spectinomycin
SpectinomycinHydrochloride
Spiramycin
SpiramycinAdipate
Spironolactone
StannousFluoride
0.62 per cent Dentifrice
Stilboestrol
StilboestrolDipropionate
Streptodornase External
Streptokinase External
Streptomycin
StreptomycinSulphate
Strychnine
StrychnineArsenate
StrychnineHydrochloride
92
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Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Styramate
Succinylsulphathiazole
Sucralfate
SulbactamSodium
Sulbenicillin
SulbenicillinSodium
SulconazoleNitrate
External(exceptvaginal)
Sulfacytine
Sulfadoxine
Sulfamerazine
SulfamerazineSodium
Sulfametopyrazine
Sulfamonomethoxine
Sulindac
Sulphacetamide
SulphacetamideSodium
Sulphadiazine
SulphadiazineSodium
Sulphadimethoxine
Sulphadimidine
SulphadimidineSodium
Sulphafurazole
SulphafurazoleDiethanolamine
Sulphaguanidine 93
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
SulphaloxicAcid
Sulphamethizole
Sulphamethoxazole
Sulphamethoxydiazine
Sulphamethoxypyridazine
SulphamethoxypyridazineSodium
Sulphamoxole
Sulphanilamide
Sulphaphenazole
Sulphapyridine
SulphapyridineSodium
Sulphasalazine
Sulphathiazole
SulphathiazoleSodium
Sulphaurea
Sulphinpyrazone
Sulpiride
Sultamicillin
SultamicillinTosylate
Sulthiame
SumatriptanSuccinate
Suprofen
SuxamethoniumBromide
SuxamethoniumChloride
94
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Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
SuxethoniumBromide
TacrineHydrochloride
Talampicillin
TalampicillinHydrochloride
TalampicillinNapsylate
Tamoxifen
TamoxifenCitrate
TazobactamSodium
Teicoplanin
TemocillinSodium
Tenoxicam
TerazosinHydrochloride
Terbinafine
Terbutaline
TerbutalineSulphate
Terfenadine 120mg(MDD)
Containeror packagecontainingno more than1,200mg ofTerfenadine
Terlipressin
TerodilineHydrochloride
Tetrabenazine
Tetracosactrin 95
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
TetracosactrinAcetate
Tetracycline
TetracyclineHydrochloride
TetracyclinePhosphateComplex
Tetroxoprim
ThalliumAcetate
ThallousChloride
Thiabendazole
Thiambutosine
ThiethylperazineMalate
ThiethylperazineMaleate
Thiocarlide
Thioguanine
ThiopentoneSodium
ThiopropazateHydrochloride
ThioproperazineMesylate
Thioridazine
ThioridazineHydrochloride
Thiosinamine
Thiotepa
Thiothixene
Thiouracil 96
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
ThymoxamineHydrochloride
Thyroid
Thyrotrophin
ThyroxineSodium
TiamulinFumarate
TiaprofenicAcid
Tibolone
TicarcillinSodium
TigloidineHydrobromide
TimololMaleate
Tinidazole
Tinzaparin
(1) External(exceptvaginal)
Tioconazole (1) 2.0 percent
(2) Vaginalfor treatmentof vaginalcandidiasis
Tobramycin
TobramycinSulphate
TocainideHydrochloride
TofenacinHydrochloride
Tolazamide
97
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Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
TolazolineHydrochloride
External
Tolbutamide
TolbutamideSodium
TolfenamicAcid
TolmetinSodium
TramadolHydrochloride
Trandolapril
TranexamicAcid
TranylcypromineSulphate
TrazodoneHydrochloride
Treosulfan
Tretinoin
Triamcinolone
TriamcinoloneAcetonide
0.1 per cent For thetreatmentof commonmouth ulcers
Containeror packagecontaining notmore than 5gof medicinalproduct
TriamcinoloneDiacetate
TriamcinoloneHexacetonide
Triamterene
Tribavirin
TriclofosSodium
98
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Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
TrientineDihydrochloride
Trifluoperazine
TrifluoperazineHydrochloride
Trifluperidol
TrifluperidolHydrochloride
Trilostane
Trimeprazine
TrimeprazineTartrate
TrimetaphanCamsylate
Trimetazidine
TrimetazidineHydrochloride
Trimethoprim
TrimipramineMaleate
TrimipramineMesylate
Tropicamide
TropisetronHydrochloride
Troxidone
(1) Oral
Dietarysupplementation
L-Tryptophan
(2) External
TubocurarineChloride
Tulobuterol
99
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Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
TulobuterolHydrochloride
Tyrothricin Throatlozenges orthroat pastilles
Uramustine
UreaStibamine
Urethane
Uridine 5'-triphosphate
Urofollitrophin
Urokinase
UrsodeoxychoicAcid
Vaccine:BacillusSalmonellaTyphi
Vaccine:Poliomyelitis(Oral)
Valproic Acid
VancomycinHydrochloride
Vasopressin
VasopressinTannate
VecuroniumBromide
VerapamilHydrochloride
Veratrine
Veratrum,Green
100
Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
Veratrum,White
Vidarabine
Vigabatrin
ViloxazineHydrochloride
VinblastineSulphate
VincristineSulphate
VindesineSulphate
ViomycinPantothenate
ViomycinSulphate
(1) Internal (1) 7,500iu(2,250mcgRetinolequivalent)(MDD)
Vitamin A
(2) External
(1) Internal (1) Equivalentto 7,500iuVitamin A(2,250mcgRetinolequivalent)(MDD)
Vitamin AAcetate
(2) External
Vitamin APalmitate
(1) Internal (1) Equivalentto 7,500iuVitamin A(2,250mcgRetinolequivalent)(MDD)
101
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Exemptions from the restrictions on the sale and supply ofprescription only medicines
Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum
strengthRoute ofadministration,use orpharmaceuticalform
Treatmentlimitations
Maximumquantity
(2) External
Warfarin
WarfarinSodium
XamoterolFumarate
Xipamide
YohimbineHydrochloride
Zidovudine
ZimeldineHydrochloride
ZolpidemTartrate
ZomepiracSodium
Zopiclone
ZuclopenthixolAcetate
ZuclopenthixolDecanoate
ZuclopenthixolHydrochloride
SCHEDULE 2 Articles 6(1) and 10
Circumstances excluding medicinal products from the class ofprescription only medicines
Column 1 Column 2 Column 3 Column 4Substance Maximum strength Pharmaceutical
FormMaximum Dose
Codeine and its salts Equivalent of 1.5per cent of codeinemonohydrate
Equivalent of 20 mg ofcodeine monohydrate
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Document Generated: 2021-04-22Status: This is the original version (as it was originally made).
Circumstances excluding medicinal products from the class ofprescription only medicines
Column 1 Column 2 Column 3 Column 4Substance Maximum strength Pharmaceutical
FormMaximum Dose
Dihydrocodeine andits salts
Equivalent of 1.5 percent of dihydrocodeine
Equivalent of 10 mg ofdihydrocodeine
Ethylmorphine anditssalts
Equivalent of 0.2 percent of ethylmorphine
Equivalent of 7.5 mgof ethylmorphine
(1) Equivalent of 0.02per cent anhydrousmorphine
(1) Liquid (1) Equivalent of3 mg of anhydrousmorphine
Morphine and its salts
(2) Equivalent of0.04 per cent ofanhydrous morphine;equivalent of 300mcg of anhydrousmorphine
(2) Solid (2) Equivalent of3 mg of anhydrousmorphine
(1) Equivalent of 0.02per cent of anhydrousmorphine
(1) Liquid (1) Equivalent of3 mg of anhydrousmorphine
Medicinal Opium
(2) Equivalent of 0.04per cent of anhydrousmorphine
(2) Solid (2) Equivalent of3 mg of anhydrousmorphine
Pholcodine and itssalts
Equivalent of 1.5 percent of pholcodinemonohydrate
Equivalent of 20mg of pholcodinemonohydrate
SCHEDULE 3 Article 2(b)
DESCRIPTIONS AND CLASSES OF PRESCRIPTION ONLY MEDICINES IN RELATION TOWHICH APPROPRIATE NURSE PRACTITIONERS ARE APPROPRIATE PRACTITIONERS
Co-danthramer-Oral Suspension NPFCo-danthramer-Oral Suspension Strong NPFCo-danthrusate CapsulesMebendazole Tablets NPFMebendazole Oral Suspension NPFMiconazole Oral Gel NPFNystatin Oral SuspensionNystatin Pastilles NPFStreptokinase and Streptodornase Topical Powder NPF
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SCHEDULE 4 Article 8(4)(c)
SUBSTANCES NOT TO BE CONTAINED IN A PRESCRIPTION ONLY MEDI CINESOLD OR SUPPLIED UNDER THE EXEMPTION CONFERRED BY ARTICLE 8(3)Ammonium BromideCalcium BromideCalcium BromidolactobionateEmbutramideFencamfamin HydrochlorideFluanisoneHexobarbitoneHexobarbitone SodiumHydrobromic AcidMeclofenoxate HydrochlorideMethohexitone SodiumPemolinePiracetamPotassium BromideProlintane HydrochlorideSodium BromideStrychnine HydrochlorideTacrine HydrochlorideThiopentone Sodium
SCHEDULE 5 Article 11(1)(a)
EXEMPTION FOR CERTAIN PERSONS FROM SECTION 58(2) OF THE ACT
PART IEXEMPTION FROM RESTRICTIONS ON SALE OR SUPPLY
Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
1. Persons selling or supplyingprescription only medicines touniversities, other institutionsconcerned with highereducation or institutionsconcerned with research.
1. All prescription onlymedicines
1. The sale or supply shallbe–(a) subject to the
presentation ofan order signedby the principalof the institution
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Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
concerned witheducation orresearch or theappropriate headof departmentin charge of aspecified course ofresearch stating–(i) the name of
the institutionfor which theprescriptiononly medicineis required,
(ii) the purposefor which theprescriptiononly medicineis required,and
(iii) the totalquantityrequired, and
(b) for the purposesof the educationor researchwith which theinstitution isconcerned.
2. Persons selling orsupplying prescriptiononly medicines to any ofthe following–(1) a public analyst
appointed undersection 27 of theFood Safety Act1990(21) or article36 of the Food(Northern Ireland)Order 1989(22),
(2) an authorizedofficer withinthe meaning ofsection 5(6) of the
2. All prescription onlymedicines.
2. The sale or supply shall besubject to the presentation ofan order signed by or on behalfof any person listed in column1 of this paragraph stating thestatus of the person signing itand the amount of prescriptiononly medicine required, andshall be only in connectionwith the exercise by thosepersons of their statutoryfunctions.
(21) 1990 c. 16.(22) S.I. 1989/846 (N.I. 6).
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Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
Food Safety Act1990,
(3) a sampling officerwithin the meaningof article 38(1) ofthe Food (NorthernIreland) Order1989,
(4) a person dulyauthorized byan enforcementauthority undersections 111 and112,
(5) a sampling officerwithin the meaningof Schedule 3 to theAct.
3. Persons selling or supplyingprescription only medicinesto any person employed orengaged in connection with ascheme for testing the qualityand checking the amountof the drugs and appliancessupplied under the NationalHealth Service Act 1977(23),the National Health Service(Scotland) Act 1978(24) andthe Health and Personal SocialServices (Northern Ireland)Order 1972(25), or under anysubordinate legislation madeunder those Acts or that Order.
3. All prescription onlymedicines.
3. The sale or supply shallbe–(a) subject to the
presentation of anorder signed by oron behalf of theperson so employedor engaged statingthe status of theperson signing itand the amount ofprescription onlymedicine required,and
(b) for the purposes ofa scheme referredto in column 1 inthis paragraph.
4. Registered midwives. 4. Prescription onlymedicines containingany of the followingsubstances–
Chloral hydrateErgometrinemaleate
4. The sale or supply shallbe only in the course of theirprofessional practice and in thecase of Ergometrine maleateonly when contained in amedicinal product which is notfor parenteral administration.
(23) 1977 c. 49.(24) 1978 c. 29.(25) S.I. 1972/1265 (N.I. 14).
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Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
PentazocinehydrochlorideTriclofos sodium.
5. Persons lawfully conductinga retail pharmacy businesswithin the meaning ofsection 69.
5. Prescription onlymedicines which arenot for parenteraladministration andwhich–(a) are eyes drops and
are prescriptiononly medicinesby reason onlythat they containnot more than0.5 per centChloramphenicol,or
(b) are eye ointmentsand are prescriptiononly medicinesby reason onlythat they containnot more than1.0 per centChloramphenicol,or
(c) are prescriptiononly medicines byreason only thatthey contain anyof the followingsubstances:
AtropinesulphateBethanecolchlorideCarbacholCyclopentolatehydrochlorideHomatropinehydrobromideNaphazolinehydrochlorideNaphazolinenitratePhysostigminesalicylate
5. The sale or supply shall besubject to the presentation ofan order signed by a registeredophthalmic optician.
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Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
PhysostigminesulphatePilocarpinehydrochloridePilocarpinenitrateTropicamide.
6. Registered ophthalmicopticians.
6. Prescription only medicineslisted in column 2 of paragraph5.
6. The sale or supply shallbe only–(a) in the course of
their professionalpractice and
(b) in an emergency.
7. Persons selling or supplyingprescription only medicinesto the British StandardsInstitution.
7. All prescription onlymedicines.
7. The sale or supply shallbe–(a) subject to the
presentation ofan order signedon behalf of theBritish StandardsInstitution statingthe status of theperson signing itand the amount ofthe prescriptiononly medicinerequired, and
(b) only for thepurpose of testingcontainers ofmedicinal productsor determining thestandards for suchcontainers.
8. Holders of marketingauthorizations, productlicences or manufacturer’slicences.
8. Prescription only medicinesreferred to in the authorizationsor licences.
8. The sale or supply shallbe only–(a) to a pharmacist,(b) so as to enable
that pharmacistto prepare anentry relating tothe prescriptiononly medicinein question in atablet or capsuleidentification
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Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
guide or similarpublication, and
(c) of no greaterquantity thanis reasonablynecessary for thatpurpose.
9. Pharmacists selling orsupplying to persons towhom cyanide salts may besold by virtue of section 3(regulation of poisons) orsection 4 (exclusion of salesby wholesale and certainother sales) of the Poisons Act1972(26) or by virtue of article5 (prohibitions and regulationswith respect to sale of poisons)or article 6 (exemption withrespect to certain sales) of thePoisons (Northern Ireland)Order 1976(27).
9. Amyl nitrite. 9. The sale or supply shallonly be so far as is necessaryto enable an antidote to beavailable to persons at risk ofcyanide poisoning.
Article 11(1)(b)
PART IIEXEMPTIONS FROM THE RESTRICTION ON SUPPLY
Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
1. Royal National LifeboatInstitution and certified firstaiders of the Institution.
1. All prescription onlymedicines.
1. The supply shall be only sofar as is necessary for the thetreatment of sick or injuredpersons in the exercise of thefunctions of the Institution.
2. The owner or the master ofa ship which does not carry adoctor on board as part of hercomplement.
2. All prescription onlymedicines.
2. The supply shall be onlyso far as is necessary for thetreatment of persons on theship.
(26) 1972 c. 66.(27) S.I. 1976/1214 (N.I. 23).
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Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
3. Persons authorized bylicences granted underregulation 5 of the Misuse ofDrugs Regulations to supply acontrolled drug.
3. Such prescription onlymedicines, being controlleddrugs, as are specified in thelicence.
3. The supply shall be subjectto such conditions and in suchcircumstances and to such anextent as may be specified inthe licence.
4. Persons requiringprescription only medicinesfor the purpose of enablingthem, in the course of anybusiness carried on by them, tocomply with any requirementsmade by or in pursuance ofany enactment with respect tothe medical treatment of theiremployees.
4. Such prescription onlymedicines as may be specifiedin the relevant enactment.
4. The supply shall be–(a) for the purpose
of enabling themto comply withany requirementsmade by or inpursuance of anysuch enactment,and
(b) subject to suchconditions and insuch circumstancesas may be specifiedin the relevantenactment.
5. Persons operating anoccupational health scheme.
5. Prescription only medicinessold or supplied to a personoperating an occupationalhealth scheme in response toan order in writing signed by adoctor or a registered nurse.
5. —(1) The supply shall be
in the course of anoccupational healthscheme.
(2) The individualsupplying theprescription onlymedicine, if nota doctor, shallbe a registerednurse acting inaccordance with thewritten instructionsof a doctor as to thecircumstances inwhich prescriptiononly medicines ofthe description inquestion are to beused in the courseof the occupationalhealth scheme.
6. The operator or commanderof an aircraft.
6. Prescription only medicineswhich are not for parenteraladministration and which havebeen sold or supplied to the
6. The supply shall be onlyso far as is necessary for theimmediate treatment of sick orinjured persons on the aircraft
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Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
operator or commander of theaircraft in response to an orderin writing signed by a doctor.
and shall be in accordance withthe written instructions of adoctor as to the circumstancesin which prescription onlymedicines of the description inquestion are to be used on theaircraft.
7. Persons employed asqualified first-aid personnel onoffshore installations.
7. All prescription onlymedicines.
7. The supply shall be onlyso far as is necessary for thetreatment of persons on theinstallation.
Article 11(2)
PART IIIEXEMPTIONS FROM RESTRICTION ON ADMINISTRATION Column 1
Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
1. State registered chiropodistswho hold a certificate ofcompetence in the use ofanalgesics issued by orwith the approval of theChiropodists Board.
1. Prescription onlymedicines for parenteraladministration thatcontain,as the sole activeingredient, not more thanone of the followingsubstances–
BupivacainehydrochlorideLignocainehydrochloridePrilocainehydrochloride.
1. The administration shallbe only in the course of theirprofessional practice.
2. Registered midwives. 2. Prescription onlymedicines for parenteraladministration containingany of the followingsubstances but no othersubstance specified incolumn 1 of Schedule 1to this Order–
ErgometrinemaleateLignocaine
2. The administration shallbe only in the course of theirprofessional practice andin the case of Promazinehydrochloride, Lignocaine andLignocaine hydrochloride shallbe only while attending on awoman in childbirth.
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Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
LignocainehydrochlorideNaloxonehydrochlorideOxytocins, naturaland syntheticPentazocine lactatePethidinehydrochloridePhytomenadionePromazinehydrochloride.
3. Persons who are authorizedas members of a group by agroup authority granted underregulations 8(3) or 9(3) of theMisuse of Drugs Regulationsto supply a controlled drug byway of administration only.
3. Prescription only medicinesthat are specified in the groupauthority.
3. The administration shallbe subject to such conditionsand in such circumstancesand to such extent as maybe specified in the groupauthority.
4. The owner or master of aship which does not carry adoctor on board as part of hercomplement.
4. All prescription onlymedicines that are forparenteral administration.
4. The administration shall beonly so far as is necessary forthe treatment of persons on theship.
5. Persons operating anoccupational health scheme.
5. Prescription only medicinesfor parenteral administrationsold or supplied to the personoperating an occupationalhealth scheme in response toan order in writing signed by adoctor or a registered nurse.
5. —(1) The administration
shall be in thecourse of anoccupational healthscheme.
(2) The individualadministering theprescription onlymedicine, if neithera doctor nor actingin accordance withthe directions ofa doctor, shallbe a registerednurse acting inaccordance with thewritten instructionsof a doctor as to thecircumstances inwhich prescriptiononly medicines ofthe description inquestion are to be
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Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
used in the courseof the occupationalhealth scheme.
6. The operator or commanderof an aircraft.
6. Prescription only medicinesfor parenteral administrationwhich have been sold orsupplied to the operator orcommander of the aircraft inresponse to an order in writingsigned by a doctor.
6. The administration shallbe only so far as is necessaryfor the immediate treatmentof sick or injured persons onthe aircraft and shall be inaccordance with the writteninstructions of a doctor as tothe circumstances in whichprescription only medicines ofthe description in question areto be used on the aircraft.
7. Persons who are, and at 11thFebruary 1982 were, personscustomarily administeringmedicinal products tohuman beings by parenteraladministration in the courseof a business in the fieldof osteopathy, naturopathy,acupuncture or other similarfield except chiropody.
7. Medicinal products that areprescription only medicinesby reason only that they fallwithin the class specifiedin article 3(c) (products forparenteral administration).
7. The person administeringthe prescription only medicineshall have been requested byor on behalf of the person towhom it is administered and inthat person’s presence to usehis own judgement as to thetreatment required.
8. Persons employed asqualified first-aid personnel onoffshore installations.
8. All prescription onlymedicines that are forparenteral administration.
8. The administration shall beonly so far as is necessary forthe treatment of persons on theinstallation.
9. Persons who hold acertificate of proficiency inambulance paramedic skillsissued by, or with the approvalof, the Secretary of State.
9. The followingprescription onlymedicines for parenteraladministration–(a) Diazepam 5 mg per
ml emulsion forinjection;
(b) SuccinylatedModified FluidGelatin 4 percent intravenousinfusion;
(c) prescriptiononly medicinescontaining oneor more ofthe followingsubstances, but noactive ingredient–
9. The administration shallbe only for the immediate,necessary treatment of sick orinjured persons and in the caseof a prescription only medicinecontaining Heparin Sodiumshall be only for the purpose ofcannula flushing.
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Column 1 Column 2 Column 3Persons exempted Prescription only medicines
to which the exemptionapplies
Conditions
AdrenalineAcid TartrateAnhydrousGlucoseCompoundSodiumLactateIntravenousInfusion(Hartmann’sSolution)ErgometrineMaleateGlucoseHeparinSodiumLignocaineHydrochlorideNalbuphineHydrochlorideNaloxoneHydrochloridePolygelineSodiumBicarbonateSodiumChloride
SCHEDULE 6 Article 16(1)
ORDERS REVOKED
Column 1 Column 2Orders References
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Order 1983
S.I. 1983/1212
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment Order1984
S.I. 1984/756
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment Order1986
S.I. 1986/586
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Column 1 Column 2Orders References
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment Order1987
S.I. 1987/674
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment (No. 2)Order 1987
S.I. 1987/1250
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment Order1988
S.I. 1988/2017
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment Order1991
S.I. 1991/962
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment Order1992
S.I. 1992/1534
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment (No. 2)Order 1992
S.I. 1992/2937
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment Order1993
S.I. 1993/1890
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment (No. 2)Order 1993
S.I. 1993/3256
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment Order1994
S.I. 1994/558
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment (No. 2)Order 1994
S.I. 1994/3016
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment (No. 3)Order 1994
S.I. 1994/3050
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment Order1995
S.I. 1995/1384
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment (No. 2)Order 1995
S.I. 1995/3174
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment Order1996
S.I. 1996/1514
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Column 1 Column 2Orders References
The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment (No. 2)Order 1996
S.I. 1996/3193
EXPLANATORY NOTE
(This note is not part of the Order)
This Order consolidates with amendments the Medicines (Products Other Than Veterinary Drugs)(Prescription Only) Order 1983 as amended. That Order and the Orders amending it (“the 1983Order as amended”) are revoked by article 16 and Schedule 6.This Order specifies the descriptions and classes of prescription only medicines (i.e. medicinalproducts which, subject to exemptions, may be sold or supplied by retail only in accordance witha prescription given by an appropriate practitioner and which may be administered only by or inaccordance with the directions of such a practitioner). Many medicinal products are included in aclass of such medicines by reason of the substances contained in them (seeSchedule 1) but othersare included because of other criteria, such as their method of administration (seearticle 3). In manycases 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 authorizationshave been granted by the European Community. They include as prescription only medicines thosemedicines in respect of which such an authorization has been granted which classifies a medicine asbeing subject to medical prescription (article 3(f)). They exclude from the class of prescription onlymedicines those medicines in respect of which such an authorization provides for supply which isnot subject to medical prescription (article 6(3)).The differences between this Order and the 1983 Order as amended are in the main technical changesconcerning the location of provisions such as the division of material in Schedule 1 to the 1983Order as amended between the new Schedules 1 and 2. But within the new Schedule 1 there arechanges which relate to–
(a) the deletion from Column 1 of substances which are no longer used in those medicinalproducts which are on the market;
(b) the use of current names for the substances which are specified in that Column where theirnames have changed;
(c) the incorporation in that Schedule of provisions from article 4 of, and Part IV of Schedule 1to, 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 formthe criteria for exemptions from the sale or supply requirements of section 58(2) of theMedicines Act 1968 instead of the criteria for excluding medicinal products from the classof prescription only medicines (see alsoarticle 5);
(e) the introduction of a fifth Column which specifies the maximum pack sizes to whichexemptions apply.
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As this order will impose no additional costs to business a compliance cost assessment has not beenprepared.
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