Jersey R & O 9140

 

Medicines (Jersey) Law 1995

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MEDICINES (PRESCRIPTION ONLY) (JERSEY) ORDER 1997

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1.      Interpretation

2.      Prescription only medicines

3.      Medicinal products that are not prescription only medicines

4.      New medicinal products

5.      Appropriate practitioners

6.      Conditions for prescriptions

7.      Exemption for highly diluted medicinal products

8.      Exemptions for specified categories of persons

9.      Exemption for emergency sale or supply

10.  Exemption for sale or supply in hospitals

11.  Exemption for sale or supply in cases involving another’s default

12.  Exemption in the case of forged prescription

13.  Exemption for parenteral administration to human beings

14.  Exemption for non-parenteral administration to human beings

15.  Citation and commencement

 

THE HEALTH AND SOCIAL SERVICES COMMITTEE, in pursuance of Articles 57 and 111 of the Medicines (Jersey) Law 19951 (hereinafter referred to as “the Law”), and after consultation with the Medicines Advisory Council and having otherwise complied with Article 111 of the Law, hereby orders as follows –

 

Interpretation

1.-(1)  In this Order, unless the context otherwise requires –

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

“controlled drug” has the same meaning as it has in Article 3 of the Misuse of Drugs (Jersey) Law 19782;

“cyanogenetic substances” means preparations –

(a)     that are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17; or

(b)     that contain more than 0.1 per cent by weight of any substance having the formula α-cyanobenzyl-6-O-ß-d-glucopyranosyl-α-d-glucopyranoside or ß -cyanobenzyl- α -d-glucopyranoside 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; and

(b)     where a medicinal product is not in any such form, the quantity of the product that is used as the unit by reference to which the dose is measured;

“external use” means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal, when a local action only is intended and extensive systemic absorption is unlikely to occur; but does not mean application by means of a throat spray, throat pastille, throat lozenge, throat tablet, nasal drop, nasal spray, nasal inhalation or teething preparation;

“health prescription” means a prescription described in paragraph (1A) of Article 24 of the Health Insurance (Jersey) Law 19673;

“inhaler” does not include an aerosol;

“master” has the same meaning as it has in the Merchant Shipping Act 1894 of the United Kingdom;

“maximum daily dose” or “MDD” means, in relation to a substance contained in the amount of a medicinal product for internal use, the recommended maximum quantity to be taken or administered in a period of 24 hours;

“maximum dose” or “MD” means, in relation to a substance contained in the amount of a medicinal product for internal use, the recommended maximum quantity to be taken or administered at any one time;

“maximum strength” means such of the following as may be specified –

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

(b)     the maximum number of units of activity contained in a dosage unit or a weight of a medicinal product; and

(c)     the maximum percentage of a substance contained in a medicinal product calculated in terms of weight in weight, weight in volume, volume in weight or volume in volume, as appropriate;

“medicinal product” does not include a veterinary drug;

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

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

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

“prescription only medicine” means a medicinal product that is specified by this Order as a prescription only medicine;

“registered ophthalmic optician” has the same meaning as it has in paragraph (1) of Article 1 of the Opticians (Registration) (Jersey) Law 1962;

“repeatable prescription” means a prescription containing a direction that it shall or may be dispensed more than once;

“soaps” means any compounds of a fatty acid with an alkali or amine;

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

(2)     In this Order –

(a)     in the First and Second Schedules, the following abbreviations are used –

“g” for gram;

“iu” for international unit of activity;

“mcg” for microgram;

“mg” for milligram; and

“ml” for millilitre; and

(b)     in the First Schedule –

(i)      entries in any of columns 2, 3 and 4 of Parts I and II relate only to the substances specified in column 1 against which they appear;

(ii)     where, in relation to a particular substance specified in column 1, an entry in any of columns 2, 3 and 4 bears a number or letter, that entry relates only to entries in the other of columns 2, 3 and 4 that bear the same number or letter; and

(iii)    the entries in column 4 of Part I shall be read subject to the note at the end of that Part.

(3)     Without prejudice to Article 14 of the Interpretation (Jersey) Law 19544 (which Article relates to the interpretation of expressions in subordinate legislation), every provision in the Medicines (Jersey) Law 1995 that relates in any other way to its interpretation shall also apply in the same way to this Order, unless the context otherwise requires.

 

Prescription only medicines

2.             The following descriptions and classes of medicinal products are specified for the purposes of Article 57 of the Law, and are accordingly prescription only medicines, namely –

(a)     medicinal products that consist of or contain a substance specified in column 1 of Part I of the First Schedule to this Order;

(b)     medicinal products that are controlled drugs;

(c)     medicinal products that are for parenteral administration, whether or not they fall within sub-paragraph (a) or sub-paragraph (b) of this paragraph;

(d)     medicinal products that –

(i)      are not of a description and do not fall within a class specified in any of sub-paragraphs (a), (b) and (c) of this paragraph;

(ii)     are of a description in respect of which the conditions in paragraph (1) of Article 58 of the Law are fulfilled; and

(iii)    are products in respect of which a product licence is granted, after the commencement of this Order, containing a provision to the effect that the method of sale or supply of the medicinal product is to be only in accordance with a prescription given by a person who is an appropriate practitioner for the purposes of Article 57 of the Law; and

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

 

Medicinal products that are not prescription only medicines

3.-(1)  Notwithstanding Article 2 of this Order, a medicinal product shall not be a prescription only medicine by reason that it consists of or contains a substance specified in column 1 of Part I of the First Schedule to this Order, where –

(a)     in relation to that substance there is an entry in any of columns 2, 3 and 4;

(b)     the maximum strength in the product of that substance does not exceed the maximum strength (if any) specified in column 2; and

(c)     the medicinal product is sold or supplied –

(i)      if a pharmaceutical form or a route of administration is specified in column 3, in such pharmaceutical form, and for administration only by such route, as may be so specified;

(ii)     if a use is specified in column 3, in a container or package labelled (in either case) to show a use so specified to which the medicinal product is to be put but no use not so specified;

(iii)    if a maximum dose is specified in column 4, in a container or package labelled (in either case) to show a maximum dose not exceeding that specified; and

(iv)    if a maximum daily dose is specified in column 4, in a container or package labelled (in either case) to show a maximum daily dose not exceeding that specified.

(2)     Notwithstanding Article 2 of this Order, a medicinal product shall not be a prescription only medicine by reason that it is a controlled drug, where –

(a)     it contains not more than one of the substances specified in column 1 of Part II of the First Schedule to this Order (which are controlled drugs listed in the Second Schedule to the Misuse of Drugs (Jersey) Law 1978) and no other controlled drug;

(b)     it contains that substance at a strength that does not exceed the maximum strength specified in column 2; and

(c)     it is sold or supplied –

(i)      in such pharmaceutical form as may be specified in column 3; and

(ii)     in or from a container or package labelled (in either case) to show a maximum dose not exceeding that specified in column 4.

(3)     Notwithstanding Article 2 of this Order, a preparation of insulin for parenteral administration to human beings shall not be a prescription only medicine.

(4)     Notwithstanding Article 2 of this Order, a medicinal product specified in Part III or Part IV of the First Schedule to this Order shall not be a prescription only medicine.

 

New medicinal products

4.             For the purposes of sub-paragraph (a) of paragraph (2) of Article 58 of the Law (which relates to the duration of restrictions for certain new products) their duration shall be a period of five years.

 

Appropriate practitioners

5.             For the purposes of Article 57 of the Law doctors, dentists and veterinary surgeons shall be appropriate practitioners.

 

Conditions for prescriptions

6.-(1)  For the purposes of sub-paragraph (a) of paragraph (2) of Article 57 of the Law (read with paragraph (4) of that Article), a prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless the conditions in paragraph (2) of this Article are fulfilled.

(2)     The conditions to which paragraph (1) of this Article refers are –

(a)     the prescription shall be written in ink or otherwise so as to be indelible, unless it is a health prescription that is not for a controlled drug specified in any of the First, Second and Third Schedules to the Misuse of Drugs (General Provisions) (Jersey) Order 1989, in which case it may be written using carbon paper or similar material;

(b)     the prescription shall be signed in ink, with his own name, by the practitioner giving it;

(c)     the prescription shall contain the following information –

(i)      the address of the practitioner giving it;

(ii)     the appropriate date;

(iii)    whether the practitioner giving it is a doctor, dentist or veterinary surgeon;

(iv)    where the practitioner giving it is a doctor or dentist, the name and address of the person for whose treatment it is given and (if that person is under 12) his age; and

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

(d)     the prescription shall not be dispensed after the end of the period of six months from the appropriate date unless it is a repeatable prescription, in which case it shall not be dispensed for the first time after the end of that period or otherwise than in accordance with the direction contained in the repeatable prescription; and

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

(3)     The restrictions in sub-paragraph (a) of paragraph (2) of Article 57 of the Law shall not apply to a sale or supply of a prescription only medicine that, by reason only that a condition in paragraph (2) of this Article is not fulfilled, is not in accordance with a prescription given by an appropriate practitioner, where the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that that condition is fulfilled in relation to that sale or supply.

(4)     In paragraph (2) of this Article, “the appropriate date” means –

(a)     in the case of a health prescription –

(i)      the date on which it was signed by the practitioner by whom it was given; or

(ii)     if it also contains a date indicated by him as being the date before which it shall not be dispensed, the later of the two dates; and

(b)     in every other case, the date on which the prescription was signed by the practitioner by whom it was given.

 

Exemption for highly diluted medicinal products

7.             The restrictions in paragraph (2) of Article 57 of the Law shall not apply to the sale, supply or administration of a medicinal product that is not for parenteral administration and only consists of or only contains one or more of the substances specified in column 1 of Part I or Part II of the First Schedule to this Order, where –

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

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

 

Exemptions for specified categories of persons

8.-(1)  The restrictions in sub-paragraph (a) of paragraph (2) of Article 57 of the Law shall not apply –

(a)     to the sale or supply by a person specified in column 1 of Part I of the Second Schedule to this Order; or

(b)     to the supply by a person specified in column 1 of Part II of the Second Schedule to this Order,

of a prescription only medicine specified in column 2 of Part I or Part II of that Schedule in relation to that person, where the conditions in the corresponding paragraph in column 3 of that Part are fulfilled.

(2)     The restriction in sub-paragraph (b) of paragraph (2) of Article 57 of the Law shall not apply to the administration by a person specified in column 1 of Part III of the Second Schedule to this Order of a prescription only medicine for parenteral administration specified in column 2 of that Part in relation to that person, where the conditions in the corresponding paragraph in column 3 of that Part are fulfilled.

 

Exemption for emergency sale or supply

9.-(1)..The restrictions in sub-paragraph (a) of paragraph (2) of Article 57 of the Law shall not apply to the sale or supply of a prescription only medicine by a person who is lawfully conducting a retail pharmacy business, where the conditions in paragraph (2) of this Article or the alternative conditions in paragraph (3) of this Article are fulfilled.

(2)     The conditions to which paragraph (1) of this Article refers are –

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

(b)     the doctor has undertaken to furnish the person lawfully conducting the retail pharmacy business with a prescription within 72 hours;

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

(d)     the prescription only medicine is not a controlled drug specified in any of the First, Second and Third Schedules to the Misuse of Drugs (General Provisions) (Jersey) Order 19895; and

(e)     an entry is made in the register to be kept under paragraph (1) of Article 3 of the Medicines (Sale and Supply) (Miscellaneous Provisions) (Jersey) Order 19976, within the appropriate time specified in that Article, of the information in paragraph 1 of the Second Schedule to that Order.

(3)     The alternative conditions to which paragraph (1) of this Article refers are –

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

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

(ii)     that treatment with that prescription only medicine has been prescribed on a previous occasion by a doctor for the person requesting it; and

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

(b)     the prescription only medicine –

(i)      will be sold or supplied in no greater quantity than will provide five days’ treatment;

(ii)     is an aerosol for the relief of asthma, an ointment or a cream, and has been made up for sale in a container elsewhere than at the place of sale or supply, and is the smallest pack that the pharmacist has available for sale or supply;

(iii)    is an oral contraceptive and is sufficient, but no more than sufficient, for a full cycle; or

(iv)    is an antibiotic for oral administration in liquid form, and is the smallest quantity that will provide a full course of treatment;

(c)     the prescription only medicine does not consist of or contain a substance specified in the Third Schedule to this Order and is not a controlled drug specified in any of the Schedules to the Misuse of Drugs (General Provisions) (Jersey) Order 1989;

(d)     an entry is made in the register to be kept under paragraph (1) of Article 3 of the Medicines (Sale and Supply) (Miscellaneous Provisions) (Jersey) Order 19977 within the appropriate time specified in that Article, of the information in paragraph 3 of the Second Schedule to that Order; and

(e)     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 (unless it is apparent from the name) the pharmaceutical form and strength of the prescription only medicine;

(iii)    the name of the person requesting the prescription only medicine;

(iv)    the name and address of the registered pharmacy from which the prescription only medicine is sold or supplied; and

(v)     the words “Emergency Supply”.

(4)     The conditions in sub-paragraph (d) of paragraph (2) of this Article and in sub-paragraph (c) of paragraph (3) of this Article shall not apply where the prescription only medicine –

(a)     consists of or contains phenobarbitone or phenobarbitone sodium (but no other substance specified in the Third Schedule to this Order or in any of the Schedules to the Misuse of Drugs (General Provisions) (Jersey) Order 1989); and

(b)     is sold or supplied for use in the treatment of epilepsy.

 

Exemption for sale or supply in hospitals

10.          The restrictions in sub-paragraph (a) of paragraph (2) of Article 57 of the Law shall not apply to the sale or supply of any prescription only medicine in the course of the business of a hospital and in accordance with the written directions of a doctor or dentist, notwithstanding that those directions do not fulfil the conditions in paragraph (2) of Article 6 of this Order.

 

Exemption for sale or supply in cases involving another’s default

11.          The restrictions in sub-paragraph (a) of paragraph (2) of Article 57 of the Law shall not apply to the sale or supply of a prescription only medicine by a person who, having exercised all due diligence, believes on reasonable grounds that the product sold or supplied is not a prescription only medicine, and it is because of an act or default of another person that the product is a product to which that sub-paragraph applies.

 

Exemption in the case of forged prescription

12.          The restrictions in sub-paragraph (a) of paragraph (2) of Article 57 of the Law shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a forged prescription where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine.

 

Exemption for parenteral administration to human beings

13.          The restriction in sub-paragraph (b) of paragraph (2) of Article 57 of the Law shall not apply to the administration to human beings of any of the following medicinal products for parenteral administration, namely –

 

adrenaline injection BP;

atropine sulphate injection;

chlorpheniramine injection;

cobalt edetate injection;

dextrose injection strong B.P.C.;

diphenhydramine injection;

glucagon injection;

hydrocortisone injection;

mepyramine injection;

naloxone injection;

promethazine hydrochloride injection;

snake venom antiserum;

sodium nitrite injection;

sodium thiosulphate injection; and

sterile pralidoxime injection,

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

 

Exemption for non-parenteral administration to human beings

14.          The restriction in sub-paragraph (b) of paragraph (2) of Article 57 of the Law shall not apply to the administration to human beings of a prescription only medicine that is not for parenteral administration.

 

Citation and commencement

15.          This Order may be cited as the Medicines (Prescription Only) (Jersey) Order 1997 and shall come into force on the first day of January 1998.

By Order of the Health and Social Services Committee,

 

C.M. NEWCOMBE

 

Deputy Greffier of the States.

1st October 1997.

FIRST SCHEDULE

PART I

(Articles 1(2), 2(a), 3(1) and 7)

PRESCRIPTION ONLY MEDICINES

[Note:

(x) indicates that the entry is to be read subject to paragraph 1 of the note at the end of Part I of the First Schedule

(y) indicates that the entry is to be read subject to paragraph 2 of the note at the end of Part I of the First Schedule]

 

Prescription Only Medicine

Circumstances In Which Substances Are Not Prescription Only Medicines

Column 1

Column 2

Column 3

Column 4

Substance

Maximum strength

Use, pharmaceutical form or route of administration

Maximum dose and maximum daily dose

Acebutolol Hydrochloride

Acemetacin

Acetarsol

Acetazolamide

Acetazolamide Sodium

Acetohexamide

Acetylcholine Chloride

0.2 per cent

External

Acetylcysteine

Acipimox

Acitretin

Aclarubicin Hydrochloride

Aconite

1.3 per cent

External

Acrivastine

Acrosoxacin

Actinomycin C

Actinomycin D

Acyclovir

Adenosine

Adrenaline

(1) By inhaler

(2) External

Adrenaline

(1) By inhaler

Acid Tartrate

(2) External

Adrenaline

(1) By inhaler

Hydrochloride

(2) External

Adrenocortical Extract

Aclofenac

Albendazole

Alclometasone

Dipropionate

Alcuronium Chloride

Aldesleukin

Aldosterone

Alfacalcidol

Alfuzosin Hydrochloride

Allergen Extracts

Allopurinol

Allyloestrenol

Alphadolone Acetate

Alphaxalone

Alprenolol

Alprenolol

Hydrochloride

Alprostadil

Alseroxylon

Amantadine Hydrochloride

Ambenonium Chloride

Ambutonium Bromide

Amcinonide

Ametazole Hydrochloride

Amethocaine

Any use (except local ophthalmic use)

Amethocaine Gentisate

Any use (except local ophthalmic use)

Amethocaine Hydrochloride

Any use (except local ophthalmic use)

Amikacin Sulphate

Amiloride Hydrochloride

Aminocaproic Acid

Aminoglutethimide

Aminopterin Sodium

Amiodarone Hydrochloride

Amiphenazole Hydrochloride

Amitriptyline

Amitriptyline Embonate

Amitriptyline Hydrochloride

Amlodipine Besylate

Ammonium Bromide

Amodiaquine Hydrochloride

Amorolfine Hydrochloride

Amoxapine

Amoxycillin

Amoxycillin Trihydrate

Amphomycin

Calcium

Amphotericin

Ampicillin

Ampicillin Sodium

Ampicillin Trihydrate

Amsacrine

Amygdalin

Amyl Nitrite

Amylocaine Hydrochloride

Any use (except local ophthalmic use)

Ancrod

Androsterone

Angiotensin

Amide

Anterior

Pituitary

Extract

Antimony Barium Tartrate

Antimony

Dimercapto-succinate

Antimony

Lithium

Thiomalate

Antimony

Pentasulphide

Antimony

Potassium Tartrate

Antimony Sodium Tartrate

Antimony Sodium Thioglycollate

Antimony Sulphate

Antimony Trichloride

Antimony Trioxide

Antimony Trisulphide

Apiol

Apomorphine

Apomorphine

Hydrochloride

Aprotinin

Arecoline Hydrobromide

Argipressin

Aristolochia

Aristolochia Clematitis

Aristolochia Contorta

Aristolochia Debelis

Aristolochia Fang-chi

Aristolochia Manshuriensis

Aristolochia Serpentaria

Arsenic

Arsenic Triiodide

Arsenic Trioxide

Arsphenamine

Astemizole

Atenolol

Atracurium Besylate

Atropine

(1) Internal: (a) by inhaler (b) otherwise than by inhaler (2) External (except local ophthalmic use)

(b) 300 mcg (MD) 1 mg (MDD)(x)

Atropine Methobromide

(1) Internal: (a) by inhaler (b) otherwise than by inhaler

(b)400 mcg (MD) 1.3mg (MDD)(x)

(2) External (except local ophthalmic use)

Atropine Methonitrate

Internal: (a) by inhaler (b) otherwise than by inhaler

(b)400 mcg (MD) 1.3 mg (MDD)(x)

Atropine Oxide Hydrochloride

(1) Internal: (a) by inhaler (b) otherwise than by inhaler

(b)360 mcg (MD) 1.2 mg (MDD)(x)

(2) External (except local opthalmic use)

Atropine Sulphate

(1) Internal: (a) by inhaler (b) otherwise than by inhaler

(b)360 mcg (MD) 1.2 mg (MD)(x)

(2) External (except local ophthalmic use)

Auranofin

Azapropazone

Azathioprine

Azathioprine Sodium

Azelaic Acid

Azelastine Hydrochloride

Azidocillin Potassium

Azithromycin

Azlocillin Sodium

Aztreonam

Bacampicillin Hydrochloride

Bacitracin

Bacitracin Methylene Disalicylate

Bacitracin Zinc

Baclofen

Bambuterol Hydrochloride

Barium Carbonate

Barium Chloride

Barium Sulphide

Beclamide

Beclomethasone

Beclomethasone Diproprionate

Belladonna Herb

(1) Internal (2) External

(1) 1 mg of the alkaloids (MDD)

Belladonna Root

(1) Internal (2) External

(1) 1 mg of the alkaloids (MDD)

Bemegride

Bemegride Sodium

Benapryzine Hydrochloride

Bendrofluazide

Benethamine Penicillin

Benoxaprofen

Benperidol

Benserazide Hydrochloride

Bentiromide

Benzathine Penicillin

Benzbromarone

Benzhexol Hydrochloride

Benzilonium Bromide

Benzocaine

Any use (except local ophthalmic use)

Benzoctamine Hydrochloride

Benzoyl Peroxide

10.0 per cent

External

N-Benzoyl Sulphanilamide

Benzquinamide

Benzquinamide Hydrochloride

Benzthiazide

Benztropine Mesylate

Benzylpenicil-lin Calcium

Benzylpenicil-lin Potassium

Benzylpenicil-lin Sodium

Betahistine Hydrochloride

Betamethasone

Betamethasone

Adamantoate

Betamethasone Benzoate

Betamethasone Dipropionate

Betamethasone Sodium Phosphate

Betamethasone Valerate

Betaxolol Hydrochloride

Bethanechol Chloride

Bethanidine

Sulphate

Bezafibrate

Biperiden Hydrochloride

Biperiden Lactate

Bismuth Glycollylarsa-nilate

Bisoprolol Fumarate

Bleomycin

Bleomycin Sulphate

Bretylium Tosylate

Bromhexine Hydrochloride

Bromocriptine Mesylate

Bromperidol

Bromvaletone

Brotizolam

Budesonide

Bufexamac

Bumetanide

Buphenine Hydrochloride

6 mg (MD) 18 mg (MDD)

Bupivacaine

Any use (except local ophthalmic use)

Bupivacaine Hydrochloride

Any use (except local ophthalmic use)

Buprenorphine

BuprenorphineHydrochloride

Buserelin Acetate

Buspirone Hydrochloride

Busulphan

Butacaine Sulphate

Any use (except local ophthalmic use)

Butorphenol Tartrate

Butriptyline Hydrochloride

Calcipotriol

Calcitonin

Calcitriol

Calcium Amphomycin

Calcium Benzamidosa-licylate

Calcium Bromide

Calcium Bromidolacto-bionate

Calcium Carbimide

Calcium Folinate

Calcium Metrizoate

Calcium Sulphaloxate

Candicidin

Canrenoic Acid

Cantharidin

0.01 per cent

External

Capreomycin Sulphate

Captopril

Carbachol

Carbamazepine

Carbaryl

Carbenicillin Sodium

Carbenoxolone

(1) Pellet

(1) 5 mg (MD)

Sodium

(2) 2.0 per cent

(2) Gel

25 mg (MDD)

Carbidopa

Carbimazole

Carbocisteine

Carbon Tetrachloride

Carboplatin

Carboprost Trometamol

Carbuterol Hydrochloride

Carfecillin Sodium

Carindacillin Sodium

Carisoprodol

Carmustine

Carperidine

Carteolol Hydrochloride

Cefaclor

Cefadroxil

Cefazedone Sodium

Cefixime

Cefodizime Sodium

Cefotaxime Sodium

Cefoxitin Sodium

Cefpodoxime Proxetil

Cefsulodin Sodium

Ceftazidime

Ceftizoxime Sodium

Ceftriaxone Sodium

Cefuroxime Axetil

Cefuroxime Sodium

Celiprolol Hydrochloride

Cephalexin

Cephalexin Sodium

Cephaloridine

Cephalothin Sodium

Cephamandole Nafate

Cephazolin Sodium

Cephradine

Cerium Oxalate

Ceruletide Diethylamine

Cetirizine

Chenodeoxy-cholic Acid

Chloral Hydrate

External

Chlorambucil

Chloramphe-nicol

Chlorampheni-col Cinnamate

Chlorampheni-col Palmitate

Chlorampheni-col Sodium Succinate

Chlorhexadol

Chlormadin-one Acetate

Chlormerodrin

Chlormethia-zole

Chlormethia-zole Edisylate

Chlormezanone

Chloroform

(1) 5.0 per cent

(1) Internal (2) External

Chloroquine Phosphate

Prophylaxis of malaria

Chloroquine Sulphate

Prophylaxis of malaria

Chlorothiazide

Chlorotrianis-ene

Chlorphenox-amine

Hydrochloride

Chlorpromaz-ine

Chlorpromaz-ine Embonate

Chlorpromaz-ine Hydrochloride

Chlorpropam-ide

Chlorprothix-ene

Chlorprothix-ene Hydrochloride

Chlortetracy-cline

Chlortetracy-cline Calcium

Chlortetracy-cline

Hydrochloride

Chlorthalidone

Chlorzoxazone

Cholestyramine

Chorionic Gonadotrophin

Ciclacillin

Ciclobendazole

Cilastatin Sodium

Cilazapril

Cimetidine

Cimetidine

Hydrochloride

Cinchocaine

3.0 per cent

Any use (except local ophthalmic use)

Cinchocaine Hydrochloride

Equivalent of 3.0 per cent of Cinchocaine

Any use (except local ophthalmic use)

Cinchophen

Cinoxacin

Ciprofibrate

Ciprofloxacin

Ciprofloxacin Hydrochloride

Cisapride

Cisplatin

Clarithromy-cin

Clavulanic Acid

Clenbuterol Hydrochloride

Clidinium Bromide

Clindamycin

Clindamycin Hydrochloride

Clindamycin Palmitate Hydrochloride

Clindamycin Phosphate

Clioquinol

(1) 35 mg

(1) Treatment of mouth ulcers (2) External (except treatment of mouth ulcer

(1) 350 mg (MDD)

Clobetasol Propionate

Clobetasone Butyrate

Clofazimine

Clofibrate

Clomiphene Citrate

Clomipramine

Clomipramine Hydrochloride

Clomocycline

Clomocycline Sodium

Clonidine

Clonidine Hydrochloride

Clopamide

Clopenthixol Decanoate

Clopenthixol Hydrochloride

Clorexolone

Clostebol Acetate

Clotrimazole

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

Cloxacillin Benzathine

Cloxacillin Sodium

Clozapine

Cocculus Indicus

Co-dergocrine Mesylate

Colaspase

Colchicine

Colestipol Hydrochloride

Colfosceril Palmitate

Colistin Sulphate

Colistin Sulphomethate

Colistin Sulphomethate Sodium

Coniine

Conium Leaf

7.0 per cent

External

Corticotrophin

Cortisone

Cortisone Acetate

Co-tetroxazine

Co-Trimoxazole

Copropamide

Crotethamide

Croton Oil

Croton Seed

Curare

Cyclofenil

Cyclopenth-iazide

Cyclopentolate Hydrochloride

Cyclophos-phamide

Cycloserine

Cyclosporin

Cyclothiazide

Cyproterone Acetate

Cytarabine

Cytarabine

Hydrochloride

Dacarbazine

Dalteparin Sodium

Danazol

Danthron

Dantrolene Sodium

Dapsone

Dapsone Ethane Ortho Sulphonate

Daunorubicin Hydrochloride

Deanol Bitartrate

26 mg (MDD)

Debrisoquine

Sulphate

Demecarium Bromide

Demeclocy-cline

Demeclocy-cline Calcium

Demeclocy-cline Hydrochloride

Deoxycortone Acetate

Deoxycortone Pivalate

Deptotropine Citrate

Dequalinium Chloride

(1) 0.25 mg

(1) Internal: throat lozenges or throat

pastilles

(2) 1.0 per cent

(2) External: paint

Deserpidine

Desferriox-amine Mesylate

Desfluoro-triamcinolone

Desipramine Hydrochloride

Deslanoside

Desmopressin

Desogestrel

Desonide

Desoxymetha-sone

Dexamethasone

Dexametha-sone Acetate

Dexametha-sone Isonicotinate

Dexametha-sone Phenylprop-ionate

Dexametha-one Pivalate

Dexametha-sone Sodium m-Sulphoben-zoate

Dexametha-sone Sodium Phosphate

Dexametha-sone Troxundate

Dexfenflur-amine Hydrochloride

Dextrometh-orphan Hydrobromide

Internal

In the case of a controlled release preparation: equivalent of 30 mg of Dextromethorphan (MD) equivalent of 75 mg of Dextromethorphan (MDD)

In any other case: equivalent of 15 mg of Dextromethorphan (MD) equivalent of 75 mg of Dextromethorphan (MDD)

Dextrothy-roxine Sodium

Diltiazem Hydrochloride

Diazoxide

Dibenzepin Hydrochloride

Dichloral-phenazone

Dichlorphen-amide

Diclofenac Diethyl-ammonium

Diclofenac Potassium

Diclofenac Sodium

Dicyclomine Hydrochloride

10 mg (MD) 60 mg (MDD)

Dienoestrol

Diethanolam-ine Fusidate

Diflucortolone Valerate

Diflunisal

Digitalin

Digitalis Leaf

Digitalis, Prepared

Digitoxin

Digoxin

Dihydralazine Sulphate

Dihydroergot-amine Mesylate

Dihydrostrep-tomycin

Dihydrostrep-tomycin Sulphate

Diloxanide Furoate

Dimercaprol

Dimethisoquin Hydrochloride

Any use (except local ophthalmic use)

Dimethister-one

Dimethoth-iazine Mesylate

Dimethyl Sulphoxide

Dimethyltub-ocurarine Bromide

Dimethyltub-ocurarine Chloride

Dimethyltubo-curarine lodide

Dinoprost

Dinoprost Trometamol

Dinoprostone

Dipivefrin Hydrochloride

Dipyridamole

Disodium Etidronate

Disopyramide

Disopyramide Phosphate

Distigmine Bromide

Disulfiram

Dithranol

1.00 per cent

Dobutamine Hydrochloride

Domperidone

Domperidone Maleate

Dopamine Hydrochloride

Dopexamine Hydrochloride

Dothiepin

Dothiepin Hydrochloride

Doxapram Hydrochloride

Doxazosin Mesylate

Doxepin Hydrochloride

Doxorubicin

Doxorubicin Hydrochloride

Doxycycline

Doxycycline Calcium Chelate

Doxycycline Hydrochloride

Droperidol

Drostanolone

Drostanolone Propionate

Dydrogesterone

Dyflos

Econazole

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

Econazole Nitrate

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

Ecothiopate Iodide

Edrophonium Chloride

Eflornithine Hydrochloride

Embutramide

Emepronium Bromide

Emetine

1.0 per cent

Emetine Bismuth Iodide

Emetine Hydrochloride

Equivalent of 1.0 per cent of Emetine

Enalapril Maleate

Encephalitis Virus, Tick-borne, Central European

Enoxacin

Enoxaparin Sodium

Enoximone

Ephedrine

(1) Internal (other than nasal sprays or nasal drops) (2) Nasal sprays or nasal drops (3) External

(1) 30 mg (MD) 60 mg (MDD)

(2) 2.0 per cent

Ephedrine Hydrochloride

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

(1) Equivalent of 30 mg of Ephedrine (MD) Equivalent of 60 mg of Ephedrine (MDD)

(2) Equivalent of 2.0 per cent of Ephedrine

(2) Nasal sprays or nasal drops (3) External

Ephedrine Sulphate

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

(1) Equivalent of 30 mg of Ephedrine (MD) Equivalent of 60 mg of Ephedrine (MDD)

(2) Equivalent of 2.0 per cent of Ephedrine

(2) Nasal sprays or nasal drops (3) External

Epicillin

Epirubicin

Epirubicin Hydrochloride

Epithiazide

Epoetin Alfa

Epoetin Beta

Epoprostenol Sodium

Ergometrine Maleate

Ergometrine Tartrate

Ergot, Prepared

Ergotamine Tartrate

Erythromycin

Erythromycin Estolate

Erythromycin Ethyl Carbonate

Erythromycin Ethyl Succinate

Erythromycin Lactobionate

Erythromycin Phosphate

Erythromycin Stearate

Erythromycin Thiocyanate

Esmolol Hydrochloride

Estramustine Phosphate

Etafedrine Hydrochloride

Ethacrynic Acid

Ethambutol Hydrochloride

Ethamivan

Ethamsylate

Ethiazide

Ethinyl Androstenediol

Ethinyloest-radiol

Ethionamide

Ethisterone

Ethoglucid

Ethoheptazine Citrate

Ethopropazine

Hydrochloride

Ethosuximide

Ethotoin

Ethyl Biscoum-acetate

Ethyloestrenol

Ethynodiol Diacetate

Etodolac

Etomidate

Etoposide

Etretinate

Famotidine

Fazadinium Bromide

Felbinac

Felodipine

Felypressin

Fenbufen

Fencamfamin Hydrochloride

Fenclofenac

Fenfluramine Hydrochloride

Fenofibrate

Fenoprofen

Fenoprofen Calcium

Fenoterol Hydrobromide

Fenticonazole Nitrate

Feprazone

Ferrous Arsenate

Filgrastim

Finasteride

Flavoxate Hydrochloride

Flecainide Acetate

Flosequinan

Fluanisone

Flubendazole

Fluclorolone Acetonide

Flucloxacillin Sodium

Fluconazole

Flucylosine

Fludrocortisone Acetate

Flufenamic Acid

Flumazenil

Flumethasone

Flumethasone Pivalate

Flunisolide

Fluocinolone Acetonide

Fluocinonide

Fluocortin Butyl

Fluocortolone

Fluocortolone Hexanoate

Fluocortolone Pivalate

Fluorescein Dilaurate

Fluorometho-lone

Fluorouracil

Fluorouracil Trometamol

Fluoxetine Hydrochloride

Fluoxymest-erone

Flupenthixol Decanoate

Flupenthixol Hydrochloride

Fluperolone Acetate

Fluphenazine Decanoate

Fluphenazine Enantate

Fluphenazine Hydrochloride

Fluprednidene Acetate

Flupredniso-lone

Fluprostenol Sodium

Flurandrenol-one

Flurbiprofen

Fluspirilene

Flutamide

Fluticasone Propionate

Fluvoxamine Maleate

Folic Acid

500 mcg (MDD)

Formestane

Formocortal

Foscarnet Sodium

Fosfestrol

Sodium

Fosfomycin Trometamol

Fosinopril Sodium

Framycetin Sulphate

Frusemide

Furazolidone

Fusafungine

Fusidic Acid

Gadoteridol

Gallamine Triethiodide

Ganciclovir

Gelsemine

0.1 per cent

Gelsemium

25 mg (MD) 75 mg (MDD)

Gemeprost

Gemfibrozil

Gentamicin

Gentamicin Sulphate

Gestodene

Gestrinone

Gestronol

Gestronol Hexanoate

Glibenclamide

Glibornuride

Gliclazide

Glipizide

Gliquidone

Glisoxepide

Glucagon

Glycopyrron-ium Bromide

1 mg (MD) 2mg (MDD)

Glymidine

Gonadorelin

Goserelin Acetate

Gramicidin

0.2 per cent

External

Granisetron Hydrochloride

Griseofulvin

Growth Hormone

Guanethidine Monosulphate

Guanfacine Hydrochloride

Guanoclor Sulphate

Guanoxan Sulphate

Halcinonide

Halofantrine Hydrochloride

Haloperidol

Heparin

External

Heparin Calcium

External

Hexachloro-phane

External:

(a) 2.0 per cent (b) 0.1 per cent (c) 0.75 per cent

(a) soaps (b) aerosols (c) preparations other than soaps and aerosols

Hexobarbitone

Hexobarbitone Sodium

Hexoestrol

Hexoestrol Dipropionate

L-Histidine Hydrochloride

Dietary or nutritive use

Homatropine

(1) Internal

(1) 0.15 mg (MD) 0.45 mg (MDD)

(2) External (except local ophthalmic use)

Homatropine Hydrobromide

0.2 mg (MD) 0.6 mg (MDD)

Homatropine Methylbromide

2 mg (MD) 6 mg (MDD)

Hydralazine Hydrochloride

Hydrargaphen

Local application to skin

Hydrobromic Acid

Hydrochloro-thiazide

Hydrocortis-one

Hydrocortis-one Acetate

Hydrocortis-one Butyrate

Hydrocortis-one Caprylate

Hydrocortis-one Hydrogen Succinate

Hydrocortis-one Sodium Phosphate

Hydrocortis-one Sodium Suconate

Hydroflumeth-iazide

Hydroxy-chloroquine Sulphate

Prophylaxis of malaria

Hydroxy-progesterone

Hydroxypro-gesterone Enanthate

Hydroxy-progesterone Hexanoate

Hydroxyurea

Hydroxyzine Embonate

Hydroxyzine Hydrochloride

Hyoscine

(1) 0.15 per cent

(1) Internal (2) External (except local ophthalmic use)

Hyoscine Butylbromide

(1) Internal: (a) by inhaler (2) External

(MDD) (x)

Hyoscine Hydrobromide

(1) Internal: (a) by inhaler (b) otherwise than by inhaler

(b) 300 mcg (MD) 900 mcg (MDD)(x)

(2) External (except local ophthalmic use)

Hyoscine Methobromide

(1) Internal: (a) by inhaler

(b) otherwise than by inhaler (2) External

(b) 2.5 mg (MD) 7.5 mg (MDD)(x)

Hyoscine Methonitrate

(1) Internal: (a) by inhaler (b) otherwise than by inhaler (2) External

(b) 2.5 mg (MD) 7.5 mg (MDD)(x)

Hyoscyamine

(1) Internal: (a) by inhaler (b) otherwise than by inhaler (2) External (3) Preparations for the relief of asthma in the form of cigarettes, smoking mixtures or fumigants which contain Hyoscyamine as an alkaloid of Stramonium

(b) 300 mcg (MD) 1 mg (MDD)(x)

Hyoscyamine Hydrobromide

(1) Internal: (a) by inhaler (b) otherwise than by inhaler

(b) Equiva-lent of 300 mcg of Hyoscyamine (MD) Equi-valent of 1 mg of Hyos-cyamine (MDD)(x)

(2) External

Hyoscyamine Sulphate

(1) Internal: (a) by inhaler (b) otherwise than by inhaler

(b) Equiva-lent of 300 mcg of Hyoscyamine (MD) Equivalent of 1 mg of Hyoscyamine (MDD)(x)

(2) External

Ibuprofen

Rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza: (1) Internal

(1) In the case of a controlled release preparation: 600 mg (MD) 1200 mg (MDD) In any other case: 400 mg

(2) 5.0 per cent

(MD) 1200 mg (MDD) (2) External

Idarubicin Hydrochloride

Idoxuridine

Ifosfamide

Ignatius Bean

Imipenem Hydrochloride

Imipramine

Imipramine Hydrochloride

Imipramine Ion Exchange Resin Bound Salt or Complex

Indapamide Hemihydrate

Indomethacin

Indoramin Hydrochloride

Indoprofen

Inosine Pranobex

Iodamide

Iodamide Meglumine

Iodamide Sodium

Iohexol

Iomeprol

Iopamidol

Iopentol

Iothalamic Acid

Ioversol

Ioxaglic Acid

Ipratropium Bromide

Iprindole Hydrochloride

Iproniazid Phosphate

Isoaminile

Isoaminile Citrate

Isocarboxazid

Isoconazole Nitrate

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

Isoetharine

Isoetharine Hydrochloride

Isoetharine Mesylate

Isoniazid

Isoprenaline Hydrochloride

Isoprenaline Sulphate

Isopropamide Iodide

Equivalent of 2.5 mg

of Isoprop-amide ion (MD) Equivalent of 5.0 mg of Isoprop-amide ion (MDD)

Isotretinoin

Isradipine

Itraconazole

Jaborandi

External

Kanamycin Sulphate

Ketamine Hydrochloride

Ketoconazole

Ketoprofen

Ketorolac Trometamol

Ketotifen Pumarate

Labetalol Hydrochloride

Lachesine Chloride

Lacidipine

Lamotrigine

Lanatoside C

Lanatoside Complex A, B and C

Latamoxef Disodium

Levallorphan Tartrate

Levobunolol Hydrochloride

Levodopa

Levonorgestrel

Lidoflazine

Lignocaine

Any use (except local ophthalmic use)

Lignocaine Hydrochloride

Any use (except local ophthalmic use)

Lincomycin

Lincomycin Hydrochloride

Liothyronine Sodium

Lisinopril

Lithium Carbonate

Equivalent of 5 mg of Lithium (MD) Equivalent of 15 mg of Lithium (MDD)

Lithium Citrate

Lithium Sulphate

Equivalent of 5 mg of Lithium (MD) Equivalent of 5 mg of Lithium (MDD)

Lithium Succinate

Lobeline

(1) Internal (2) External

(1) 3 mg (MD) 9 mg (MDD)

Lobeline Hydrochloride

(1) Internal

(1) Equiva-lent of 3 mg of Lobeline (MD)

Equivalent of 9 mg of Lobeline (MDD)

(2) External

Lobeline Sulphate

(1) Internal (2) External

(1) Equiva-lent of 3 mg of Lobeline (MD) Equivalent of 9 mg of Lobeline (MDD)

Lodaximide Trometamol

Lofepramine

Lofepramine Hydrochloride

Lofexidine Hydrochloride

Lomefloxacin Hydrochloride

Lomustine

Loperamide Hydrochloride

Treatment of acute diarrhoea

Loratidine

Loxapine Succinate

Luteinising Hormone

Lymecycline

Lynoestrenol

Lypressin

Lysuride Maleate

Mafenide

Mafenide Acetate

Mafenide Hydrochloride

Mafenide Propionate

5.0 per cent

Eye drops

Magnesium Fluoride

Magnesium Metrizoate

Mandragora

Autumnalis

Mannomustine Hydrochloride

Maprotiline Hydrochloride

Mebanazine

Mebendazole

Mebeverine Hydrochlorise

For the symptomatic relief of irritable bowel syndrome

135 mg (MD) 405 mg (MDD)

Mebhydrolin

Mebhydrolin Napadisylate

Mecamylamine

Hydrochloride

Mecillinam

Meclofenoxate Hydrochloride

Medigoxin

Medrogestone

Medroxypro-gesterone Acetate

Mefenamic Acid

Mefloquine Hydrochloride

Mefruside

Megestrol

Megestrol Acetate

Meglumine Gadopentetate

Meglumine lodoxamate

Meglumine loglycamate

Meglumine lothalamate

Meglumine lotroxate

Meglumine loxaglate

Melphalan

Melphalan Hydrochloride

Menotrophin

Mepenzolate Bromide

25 mg (MD)

75mg (MDD)

Mephenesin

Mephenesin Carbamate

Mepivacaine Hydrochloride

Any use (except local ophthalmic use)

Meptazinol Hydrochloride

Mequitazine

Mercaptopurine

Mersalyl

Mersalyl Acid

Mesalazine

Mesna

Mesterolone

Mestranol

Metaraminol Tartrate

Metergoline

Metformin Hydrochloride

Methacycline

Methacycline Calcium

Methacycline Hydrochloride

Methallenoest-ril

Methandien-one

Methicillin Sodium

Methixene

Methixene Hydrochloride

Methocarbamol

Methocidin

Throat lozenges and throat pastilles

Methohexitone Sodium

Methoin

Methoserpidine

Methotrexate

Methotrexate Sodium

Methotrime-prazine

Methotrime-prazine Hydrochloride

Methotrime-prazine Maleate

Methoxamine Hydrochloride

0.25 per cent

Nasal sprays, or nasal drops, not containing in either case liquid paraffin as a vehicle

Methsuximide

Methycloth-iazide

Methyldopa

Methyldopa

Hydrochloride

Methylephed-rine Hydrochloride

30 mg (MD) 60 mg (MDD)

Methylpred-nisolone Acetate

Methylpred-nisolone Sodium Succinate

Methyltestost-erone

Methylthiour-acil

Methysergide Maleate

Metipranolol

Metirosine

Metoclopram-ide Hydrochloride

Metolazone

Metoloprolol Tartrate

Metoprolol Fumarate

Metoprolol Succinate

Metronidazole

Metronidazole Benzoate

Metyrapone

Mexiletine Hydrochloride

Mezlocillin Sodium

Mianserin Hydrochloride

Miconazole

External

Miconazole Nitrate

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

Midazolam

Mifepristone

Milrinone

Milrinone Lactate

Minocycline

Minocycline Hydrochloride

Minoxidil

2.0 per cent

External

Misoprostol

Mitobronitol

Mitomycin C

Mitozantrone Hydrochloride

Mivacurium Chloride

Moclobemide

Molgramostim

Molindone Hydrochloride

Mometasone Furoate

Moracizine Hydrochloride

Morazone Hydrochloride

Mupirocin

Mustine Hydrochloride

Nabilone

Nabumetone

Nadolol

Nafarelin Acetate

Naftidrofuryl Oxalate

Naftifine

Hydrochloride

Nalbuphine Hydrochloride

Nalidixic Acid

Nalorphine Hydrobromide

Naloxone Hydrochloride

Naltrexone Hydrochloride

Nandrolone Decanoate

Nandrolone Laurate

Nandrolone Phenylprop-ionate

Naphazoline

(1) 0.05 per cent

(1) Nasal

Hydrochloride

(2) 0.015 per cent

sprays, or nasal drops, not containing in either case liquid paraffin as a vehicle (2) Eye drops

Naphazoline Nitrate

0.05 per cent

Nasal sprays, or nasal drops, not containing in either case liquid paraffin as a vehicle

Naproxen

Naproxen Sodium

Natamycin

Nedocromil Sodium

Nefopam Hydrochloride

Neomycin

Neomycin Oleate

Neomycin Palmitate

Neomycin Sulphate

Neomycin Undecanoate

Neostigmine Bromide

Neostigmine Methylsulphate

Netilmicin Sulphate

Nicardipine Hydrochloride

Nicergoline

Nicotinic Acid

Any use (except for the treatment of hyperlipid-aemia)

600 mg (MDD)

Nicoumalone

Nifedipine

Nifenazone

Nikethamide

Nimodipine

Niridazole

Nitrendipine

Nitrofurantoin

Nitrofurazone

Nizatidine

Nomifensine Maleate

Noradrenaline

Noradrenaline Acid Tartrate

Norethandrol-one

Norethisterone Acetate

Norethisterone Heptanoate

Norethynodrel

Norfloxacin

Norgestimate

Norgestrel

Nortriptyline Hydrochloride

Noscapine

Noscapine Hydrochloride

Novobiocin Calcium

Novobiocin Sodium

Nux Vomica Seed

Nystatin

Octacosactrin

Octreotide

Oestradiol

Oestradiol

Benzoate

Oestradiol Cypionate

Oestradiol Dipropionate

Oestradiol Diundecanoate

Oestradiol Enanthate

Oestradiol Phenylprop-ionate

Oestradiol Undecanoate

Oestradiol Valerate

Oestriol

Oestriol Di-Hemi Succinate

Oestrogenic Substances, Conjugated

Oestrone

Ofloxacin

Olsalazine Sodium

Omeprazole

Ondansetron Hydrochloride

Orciprenaline Sulphate

Orphenadrine Citrate

Orphenadrine

Hydrochloride

Ouabain

Ovarian Gland, Dried

Oxamniquine

Oxandronol-one

Oxantel Pamoate

Oxaprozin

Oxatomide

Oxedrine Tartrate

Oxethazaine

Oxidronate Sodium

Oxitropium Bromide

Oxolinic Acid

Oxpentifylline

Oxprenolol Hydrochloride

Any use (except local ophthalmic use)

Oxybuprocaine Hydrochloride

Oxybutynin Hydrochloride

Oxymetholone

Oxypertine

Oxypertine Hydrochloride

Oxyphenbut-azone

Oxyphencyc-limine Hydrochloride

Oxyphenonium Bromide

5 mg (MD) 15 mg (MDD)

Oxytetracycline

Oxytetracycline Calcium

Oxytetracycline Dihydrate

Oxytetracycline Hydrochloride

Oxytocin, Natural

Oxytocin, Synthetic

Pamidronate Disodium

Pancreatin

(1) 21,000 European Pharmacopoeia units of lipase per capsule (2) 25,000 European Pharmacopoeia units of lipase per g

(1) Capsules (2) Powder

Pancuronium Bromide

Papaverine

(1) By inhaler (2) Otherwise than by inhaler

(2) 50 mg (MD) 150 mg (MDD)

Papaverine Hydrochloride

(1) By inhaler (2) Otherwise

(2) Equi-valent of 50 mg of Papaverine (MD) Equivalent of 150 mg of Papaverine (MDD)

than by inhaler

Paraldehyde

Paramethad-ione

Paramethasone Acetate

Parathyroid Gland

Pargyline Hydrochloride

Paroxetine Hydrochloride

Pecilocin

Pemoline

Penamecillin

Penbutolol Sulphate

Penicillinamine

Penicillinamine Hydrochloride

Pentamidine Isethionate

Pentamidronate Disodium

Penthienate Methobromide

5 mg (MD) 15 mg (MDD)

Pentolinium Tartrate

Perfluamine

Pergolide Mesylate

Perhexiline Maleate

Perindopril

Pericyazine

Perphenazine

Phenacetin

0.1 per cent

Phenazone

External

Phenazone and Caffeine Citrate

Phenazone

Salicylate

Phenbutrazate Hydrochloride

Phenelzine Sulphate

Phenethicillin Potassium

Phenformin Hydrochloride

Phenglutarim-ide Hydrochloride

Phenindione

Phenoxybenz-amine Hydrochloride

Phenoxymeth-ylpenicillin

Phenoxymeth-ylpenicillin Calcium

Phenoxymeth-ylpenicillin Potassium

Phenproc-oumon

Phensuximide

Phentolamine Hydrochloride

Phentolamine Mesylate

Phenylbutazone

Phenylbutazone Sodium

Phenylmeth-ylbarbituric

Acid

Phenylprop-anolamine Hydrochloride

Internal: (a) all preparations (except controlled release capsules, nasal sprays or nasal drops) (b) controlled release capsules

(a) 25 mg (MD) 100 mg (MDD) (b) 50 mg (MD) 100 mg (MDD)

(c) 2.0 per cent

(c) nasal sprays or nasal drops

Phenytoin

Phenytoin Sodium

Phthalylsulph-athiazole

Physostigmine

Physostigmine Aminoxide Salicylate

Physostigmine Salicylate

Physostigmine Sulphate

Picrotoxin

Pilocarpine

Pilocarpine Hydrochloride

Pilocarpine Nitrate

Pimozide

Pindolol

Pipenzolate Bromide

5 mg (MD) 15 mg

Piperacillin Sodium

Piperazine Oestrone Sulphate

Piperidolate Hydrochloride

50 mg (MD) 150 mg (MDD)

Pipothiazine Palmitate

Piracetam

Pirbuterol Acetate

Pirbuterol Hydrochloride

Pirenzepine Hydrochloride

Piroxicam

Pituitary Gland (Whole Dried)

By inhaler

Pituitary, Powdered (Posterior Lobe)

By inhaler

Pivampicillin Hydrochloride

Pivmecillinam

Pivmecillinam Hydrochloride

Pizotifen

Pizotifen Malate

Plicamycin

Podophyllo-toxin

Podophyllum

Podophyllum Indian

Podophyllum Resin

20.0 per cent

External: ointment or impregnated plaster

Poldine Methylsulph-ate

2 mg (MDD) 6 mg (MDD)

Polidexide

Polymyxin B Sulphate

Polyestradiol Phosphate

Polythiazide

Poppy Capsule

Potassium Arsenite

0.0127 per cent

Potassium Bromide

Potassium Canrenoate

Potassium Clavulanate

Potassium Perchlorate

Practolol

Pralidoxime Chloride

Pralidoxime lodide

Pralidoxime Mesylate

Pravastatin Sodium

Prazosin Hydrochloride

Prednisolone

Prednisolone Acetate

Prednisolone Butylacetate

Prednisolone Hexanoate

Prednisolone Pivalate

Prednisolone Sodium Phosphate

Prednisolone Sodium m-Sulphobenz-oate

Prednisolone 21-Steaglate

Prednisolone m-Sulpho-benzoate

Prednisone

Prednisone Acetate

Prenalterol Hydrochloride

Prenylamine Lactate

Prilocaine Hydrochloride

Any use (except local ophthalmic use)

Primidone

Probenecid

Probucol

Procainamide Hydrochloride

Procaine Hydrochloride

Any use (except local ophthalmic use)

Procaine Penicillin

Procarbazine Hydrochloride

Prochlorpera-zine Edisylate

Prochlorpera-zine Maleate

Prochlorpera-zine Mesylate

Procyclidine Hydrochloride

Progesterone

Prolactin

Proligestone

Prolintane Hydrochloride

Promazine Embonate

Promazine Hydrochloride

Propafenone

Propanidid

Propantheline Bromide

15 mg (MD) 45 mg (MDD)

Propofol

Propranolol Hydrochloride

Propylthiour-acil

Proquazone

Protamine Sulphate

Prothionamide

Protirelin

Protriptyline Hydrochloride

Proxymeta-caine Hydrochloride

Any use (except local ophthalmic use)

Pseudoephed-rine Hydrochloride

Internal

In the case of a controlled release preparation: 120 mg (MD) 180 mg (MDD) In any other case: 60 mg (MD) 180 mg (MDD)

Pseudoephed-rine Sulphate

60 mg (MD) 180 mg (MDD)

Pyrantel Embonate

Pyrantel Tartrate

Pyrazinamide

Pyridostigmine Bromide

Pyrimethamine

Quinapril

Quinestradol

Quinestrol

Quinethazone

Quinidine

Quinidine Bisulphate

Quinidine Phenylethyl-barbiturate

Quinidine Polygalact-uronate

Quinidine Sulphate

Quinine

100 mg (MD) 300 mg (MDD)

Quinine Bisulphate

Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)

Quinine Dihydro-chloride

Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)

Quinine Ethyl Carbonate

Equivalent  of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)

Quinine Glycero-phosphate

Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)

Quinine Hydrobromide

Equivalent of 100 mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD)

Quinine Hydrocholride

Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)

Quinine Iodobismuthate

Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)

Quinine Phenylcinch-oninate

Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)

Quinine Phosphate

Equivalent of 100 mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD)

Quinine Salicylate

Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)

Quinine Sulphate

Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)

Quinine Tannate

Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)

Quinine and Urea Hydrochloride

Ramipril

Ramitidine Hydrochloride

Rauwolfia Serpentina

Rauwolfia Vomitoria

Razoxane

Remoxipride

Hydrochloride

Reproterol Hydrochloride

Rescinnamine

Reserpine

Rifampicin

Rifamycin

Rimiterol Hydrobromide

Risperidone

Ritodrine Hydrochloride

Rolitetracycline Nitrate

Sabadilla

Salbutamol

Salbutamol Sulphate

Salcatonin

Salcatonin Hydrated Polyacetate

Salmefamol

Salmeterol Hydroxy-naphthoate

Salsalate

Saralasin Acetate

Selegiline Hydrochloride

Sera and Antisera –

Botulin Antitoxin

Diphtheria Antitoxin

Gas-gangrene Antitoxin (Oedematiens)

Gas-gangrene Antitoxin (Perfringens)

Gas-gangrene Antitoxin (Septicum)

Mixed Gas-gangrene Antitoxin

Leptospira Antiserum

Rabies

Antiserum

Scorpion Venom Antiserum

Snake Venom Antiserum

Tetanus Antitoxin

Serum Gonadotrophin

Sermorelin

Sertraline Hydrochloride

Silver Sulphadiazine

Simvastatin

Sissomicin

Sissomicin Sulphate

Snake Venoms

Sodium Acetrizoate

Sodium Aminosali-cylate

Sodium Antimonyl-gluconate

Sodium Arsanilate

Sodium Arsenate

Sodium Arsenite

0.013 per cent

Sodium Bromide

Sodium Clodronate

Sodium Cromoglycate

Administration through the nose

Sodium Ethacrynate

Sodium Fluoride

(1) 0.33 per cent (y)

(1) Dentifrices

(2) Other preparations for use in the prevention of dental of dental caries in the form of – (a)tablets or drops;

(a) 2.2 mg (MDD)

(b) 0.2 per cent

(b) mouth-washes (other than those for daily use);

(c) 0.05 per cent

(c) mouth-washes for daily use

Sodium Fusidate

Sodium Metrizoate

Sodium Monofluo-rophosphate

1.14 per cent (y)

Dentifrice

Sodium Stibogluconate

Sodium Valproate

Somatorelin Acetate

Somatrem

Somatropin

Sotalol Hydrochloride

Spectinomycin

Spectinomycin Hydrocloride

Spiramycin

Spiramycin Adipate

Spironolactone

Stannous Fluoride

0.62 per cent (y)

Dentifrice

Stanolone

Stanozolol

Stilboestrol

Stilboestrol

Dipropionate

Streptodornase

External

Streptokinase

External

Streptomycin

Streptomycin Sulphate

Strychnine

Strychnine Arsenate

Strychnine Hydrochloride

Styramate

Succinylsul-phathiazole

Sucralfate

Sulbactam

Sodium

Sulbenicillin

Sulbenicillin Sodium

Sulbenicillin Tosylate

Sulconazole Nitrate

External (except vaginal use)

Sulfacytine

Sulfadoxine

Sulfamonomethoxine

Sulindac

Sulphacetamide

Sulphacetamide Sodium

Sulphadiazine

Sulphadiazine Sodium

Sulphadi-methoxine

Sulphadimidine

Sulphadimidine Sodium

Sulphafurazole

Sulphafurazole Diethanolamine

Sulphaguani-dine

Sulphaloxic Acid

Sulphamera-zine

Sulphamera-zine Sodium

Sulphamethiz-ole

Sulphameth-oxazole

Sulphameth-oxydazine

Sulphameth-oxypyridazine

Sulphameth-oxypyridazine Sodium

Sulphameto-pyrazine

Sulphamoxole

Sulphanilamide

Sulphaphen-azole

Sulphapyridine

Sulphapyridine Sodium

Sulphasalazine

Sulphathiazole

Sulphathiazole Sodium

Sulphaurea

Sulphinpyraz-one

Sulpiride

Sultamicillin Tosylate

Sulthiame

Sumatriptan Succinate

Suprofen

Suxamethon-ium Bromide

Suxamethon-ium Chloride

Suxethonium Bromide

Tacrine Hydrochloride

Talampicillin

Talampicillin

Hydrochloride

Talampicillin Napsylate

Tamoxifen

Tamoxifen Citrate

Tazobactam Sodium

Teicoplanin

Temocillin Sodium

Tenoxicam

Terazosan Hydrochloride

Terbinafine

Terbutaline

Terbutaline Sulphate

Terfenadine

Terodiline Hydrochloride

Tertipressin

Testosterone Acetate

Testosterone 17B Chloral Hemiacetal

Testosterone Cyclohexyl-propionate

Testosterone Cypionate

Testosterone

Decanoate

Testosterone Enanthate

Testosterone Isocaproate

Testosterone Phenylprop-ionate

Testosterone Propionate

Testosterone Undecanoate

Tetrabenazine

Tetracosactrin

Tetracosactrin Acetate

Tetracycline

Tetracycline Hydrochloride

Tetracycline Phosphate Complex

Tetroxoprim

Thallium Acetate

Thallous Chloride

Thiabendazole

Thiambutosine

Thiethylperaz-ine

Thiethylperaz-ine Maleate

Thiocarlide

Thioguanine

Thiopentone Sodium

Thiopropazate Hydrochloride

Thioproperaz-ine Mesylate

Thioridazine

Thioridazine Hydrochloride

Thiosinamine

Thiotepa

Thiothixene

Thiouracil

Thymoxamine Hydrochloride

Thyroid

Thyrotrophin

Thyroxine Sodium

Tiamulin Fumarate

Tiaprofenic Acid

Tibolone

Ticarcillin Sodium

Tigloidine Hydrobromide

Timolol Maleate

Tinidazole

Tinzaparin

Tioconazole

2.0 per cent

(1) External, but in the case of vaginal use only, external use for treatment of vaginal candidiasis

Tobramycin

Tobramycin Sulphate

Tocainide Hydrochloride

Tofenacin Hydrochloride

Tolazamide

Tolazoline Hydrochloride

External

Tolbutamide

Tolbutamide Sodium

Tolfenamic Acid

Tolmetin Sodium

Tramadol Hydrochloride

Trandolapril

Tranexamic Acid

Tranylepro-mine Sulphate

Trazodone Hydrochloride

Treosulfan

Tretinoin

Triamcinolone

Triamcinolone Acetonide

Triamcinolone Diacetate

Triamcinolone Hexacetonide

Triamterene

Tribavirin

Triclofos Sodium

Trientine Dihydro-chloride

Trifluoperazine

Trifluoperazine Hydrochloride

Trifluperidol

Trifluperidol Hydrochloride

Trilostane

Trimeprazine

Trimeprazine Tartrate

Trimetaphan Camsylate

Trimetazidine

Trimetazidine Hydrochloride

Trimethoprim

Trimipramine Maleate

Trimipramine Mesylate

Tropicamide

Tropisetron Hydrochloride

Troxidone

L-Tryptophan

(1) Dietary or nutritive use (2) Any external use

Tubocurarine Chloride

Tulobuterol

Tulobuterol Hydrochloride

Tyrothricin

Throat lozenges or throat pastilles

Uramustine

Urea Stibamine

Urethane

Uridine-5-Triphosphoric Acid

Urofollitrophin

Urokinase

Ursodeoxy-chloric Acid

Vaccines’ –

Athrax Vaccine (Bacillus) Anthracis)

Bacillus Calmette- Guerin Vaccine

Bacillus Salmonella Typhi Vaccine

Percutaneous Bacillus Calmette- Guerin Vaccine

Cholera Vaccine

Diphtheria Vaccine

Adsorbed Diphtheria Vaccine

Diphtheria and Tetanus Vaccine

Adsorbed Diphtheria and Tetanus Vaccine

Diphtheria, Tetanus and Pertussis Vaccine

Adsorbed Diphtheria, Tetanus and Pertussis Vaccine

Diphtheria, Tetanus and Poliomyelitis Vaccine

Diphtheria,

Tetanus, Pertussis and Poliomyelitis Vaccine

Eltor Vaccine

Influenza Vaccine

Hepatitis B Vaccine

Measles Vaccine (Live Attenuated)

Meningo-coccal Poly-saccharide Vaccine

Mumps Vaccine

Pertussis

Vaccine

Plague Vaccine

Pneumococcal Vaccine (Bacterial Antigen)

Poliomyelitis Vaccine (Inactivated)

Poliomyelitis Vaccine (Live Oral)

Rabies Vaccine

Rubella Vaccine (Live Attenuated)

Rubella,

Mumps, Measles Vaccine

Tetanus Vaccine

Adsorbed Tetanus Vaccine

Tetanus and Pertussis Vaccine

Tuberculin Purified Protein Derivative

Old Tuberculin

Typhoid Vaccine

Typhoid –

Paratyphoid A and B Vaccine

Typhoid – Paratyphoid A and B and Cholera Vaccine

Typhoid – Paratyphoid A and B and Tetanus Vaccine

Typhus Vaccine

Yellow Fever Vaccine

Valproic Acid

Vancomycin Hydrochloride

Vasopressin Injection

Vasopressin Tannate

Vecuronium Bromide

Verapamil Hydrochloride

Veratrine

Veratrum (Green and White)

Vidarabine

Vigabatrin

Viloxazine Hydrochloride

Vinblastine Sulphate

Vincristine Sulphate

Vindesine Sulphate

Viomycin Pantothenate

Viomycin Sulphate

Vitamin A

(1) Internal

(1) 7500 iu (2250 mcg Retinol equivalent) (MDD)

(2) External

Vitamin A Acetate

(1) Internal

(1) Equi-valent to 7500 iu Vitamin A (2250 mcg Retinol equivalent)

(MDD)

(2) External

Vitamin A Palmitate

(1) Internal

(1) Equi-valent to 7500 iu Vitamin A (2250 mcg Retinol equivalent) (MDD)

(2) External

Warfarin

Warfarin Sodium

Xamoterol Fumarate

Xipamide

Yohimbine Hydrochloride

Zidovudine

Zimeldine Hydrochloride

Zomepirac Sodium

Zopiclone

Zuclopen-thixol Acetate

Zuclopen-thixol Decanoate

Zuclopen-thixol Hydrochloride

Note:  -

1.     In relation to a medicinal product that contains more than one of the substances Atropine, Atropine Methobromide, Atropine Methonitrate, Atropine Oxide Hydrochloride, Atropine Sulphate, Hyoscine, Hyoscine Butylbromide, Hyoscine Hydrobromide, Hyoscine Methobromide, Hyoscine Methonitrate, Hyoscyamine, Hyoscyamine Hydrobromide and Hyoscyamine Sulphate, the maximum daily dose for the purposes of column 4 is 1 mg of the total alkaloids contained in the product that are derived from Belladonna, Hyoscyamus, Stramonium or other solanaceous plant, and there is no maximum dose.

2.     In relation to a medicinal product that contains more than one of the substances Sodium Fluoride, Sodium Monofluorophosphate and Stannous Fluoride combined in a dentifrice, the maximum strength of the combination for the purposes of column 2 shall not exceed 0.15 per cent calculated as Fluorine.

 

PART II

(Articles 1(2), 3(2) and 7)

 

 

PART III

(Article 3(4))

NAMED PRODUCTS THAT ARE NOT PRESCRIPTION ONLY MEDICINES

 

 

 

PART IV

(Article 3(4))

OTHER MEDICINAL PRODUCTS THAT ARE NOT PRESCRIPTION ONLY MEDICINES

1.         A medicinal product shall not be a prescription only medicine by reason that it contains the substance acrivastine, where –

(a)     the medicinal product is sold or supplied in a container, or package, containing not more than 240 mg of acrivastine; and

(b)     the container or package is labelled to show a maximum daily dose of 24 mg of acrivastine.

2.         A medicinal product shall not be a prescription only medicine, by reason that it consists of or contains the substance astemizole, where –

(a)     the medicinal product is for oral use;

(b)     the medicinal product is not a sustained release preparation;

(c)     the medicinal product is sold or supplied in a container, or package, containing not more than 100 mg of the medicinal product;

(d)     the container or package is labelled to show a maximum daily dose of 10 mg of the medicinal product; and

(e)     the medicinal product is indicated only for the treatment of hay fever in persons aged not less than 12 years.

3.         A medicinal product shall not be a prescription only medicine by reason that it contains the substance azelastine hydrochloride, where –

(a)     the medicinal product is in non-aerosol, aqueous form for nasal administration;

(b)     the medicinal product is sold or supplied in a container, or package, containing not more than 36 doses, each of which contains not more than 140 mcg of azelastine hydrochloride;

(c)     the container or package is labelled to show a maximum dose of 140 mcg per nostril and a maximum daily dose of 280 mcg per nostril of azelastine hydrochloride; and

(d)     the medicinal product is indicated only for the treatment of seasonal allergic rhinitis, in persons aged not less than 12 years.

4.         A medicinal product shall not be a prescription only medicine by reason that it contains the substance beclomethasone dipropionate, where –

(a)     the medicinal product is in non-aerosol, aqueous form for nasal administration;

(b)     the medicinal product is sold or supplied in a container, or package, containing not more than 200 doses of the medicinal product;

(c)     the container or package is labelled to show a maximum dose of 100 mcg per nostril and a maximum daily dose of 200 mcg per nostril of beclomethasone dipropionate; and

(d)     the medicinal product is indicated only for the prevention or treatment of seasonal allergic rhinitis, in persons aged not less than 12 years.

5.         A medicinal product shall not be a prescription only medicine by reason that it contains the substance budesonide, where –

(a)     the medicinal product is in non-aerosol, aqueous form for nasal administration;

(b)     the medicinal product is sold or supplied in a container, or package, containing not more than 10 mg of the medicinal product;

(c)     the container or package is labelled to show a maximum dose, and a maximum daily dose of 200 mcg per nostril of budesonide; and

(d)     the medicinal product is indicated only for the prevention or treatment of seasonal allergic rhinitis, in persons aged not less than 12 years.

6.         A medicinal product shall not be a prescription only medicine by reason that it contains the substance carbenoxolone sodium, where –

(a)     the medicinal product is in the form of granules;

(b)     the maximum strength of the carbenoxolone sodium in the medicinal product does not exceed one per cent, calculated in terms of weight in weight;

(c)     the medicinal product is sold or supplied in a container, or package, containing not more than 560 mg of carbenoxolone sodium;

(d)     the container or package is labelled to show a maximum dose of 20 mg and a maximum daily dose of 80 mg of carbenoxolone sodium; and

(e)     the medicinal product is indicated only for treatment by mouthwash, in persons aged not less than 12 years.

7.         A medicinal product shall not be a prescription only medicine by reason that it contains the substance cetirizine, where –

(a)     the medicinal product is sold or supplied in a container, or package, containing not more than 100 mg of cetirizine; and

(b)     the container or package is labelled to show a maximum daily dose of 10 mg of cetirizine.

8.         A medicinal product shall not be a prescription only medicine by reason that it contains the substance cimetidine, where –

(a)     the container or package in which the medicinal product is sold or supplied is labelled to show a maximum dose of 200 mg and a maximum daily dose of 800 mg of cimetidine for a maximum period of 14 days; and

(b)     the medicinal product is indicated for the short-term symptomatic relief of heartburn, dyspepsia and hyperacidity.

9.         A medicinal product shall not be a prescription only medicine by reason that it contains the substance cimetidine, where –

(a)     the medicinal product is for the prophylactic management of nocturnal heartburn; and

(b)     the container or package in which the medicinal product is sold or supplied is labelled to show a maximum dose of 100 mg of cimetidine to be taken once daily at night for a maximum period of 14 days.

10.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance diclofenac diethylammonium, where –

(a)     the maximum strength of the diclofenac diethylammonium in the medicinal product does not exceed 1.16 per cent, calculated in terms of weight in weight;

(b)     the medicinal product is sold or supplied in a container, or package, containing not more than 30 g of the medicinal product;

(c)     the container or package is labelled to show a maximum period of use of 7 days; and

(d)     the medicinal product is indicated for external application for the local symptomatic relief of pain and inflammation in trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism, in persons aged not less than 12 years.

11.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance famotidine, where –

(a)     the container or package in which the medicinal product is sold or supplied is labelled to show a maximum dose of 10 mg and a maximum daily dose of 20 mg of famotidine for a maximum period of 14 days; and

(b)     the medicinal product is indicated for –

(i)      the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion or hyperacidity; or

(ii)     the prevention of the symptoms of heartburn, dyspepsia, indigestion, acid indigestion or hyperacidity where they are associated with the consumption of food or drink, including the prevention of sleep disturbance because of those symptoms.

12.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance felbinac, where –

(a)     the maximum strength of the felbinac in the medicinal product does not exceed 3.17 per cent, calculated in terms of weight in weight;

(b)     the medicinal product is sold or supplied in a container, or package, containing not more than 30 g of the medicinal product; and

(c)     the container or package is labelled to show a maximum period of use of 7 days; and

(d)     the medicinal product is indicated for external application for the relief of symptoms associated with soft tissue injury such as strains, sprains and contusions, in persons aged not less than 12 years.

13.       A medicinal product shall not be a prescription only medicine by reason that it consists of or contains the substance fluconazole, where –

(a)     the medicinal product is sold or supplied in a container, or package, containing not more than 150 mg of the medicinal product;

(b)     the container or package is labelled to show a maximum dose of 150 mg of fluconazole; and

(c)     the medicinal product is indicated for oral administration for the treatment of vaginal candidiasis, in persons aged not less than 16 but less than 60 years.

14.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance flunisolide, where –

(a)     the medicinal product is in the form of a non-pressurised nasal spray;

(b)     the maximum strength of the flunisolide in the medicinal product does not exceed 0.025 per cent, calculated in terms of weight in volume;

(c)     the medicinal product is sold or supplied in a container, or package, containing not more than 240 metered doses of the medicinal product;

(d)     the container or package is labelled to show a maximum dose of 50 mcg per nostril and a maximum daily dose of 100 mcg per nostril of flunisolide in the case of persons aged not less than 16 years, and a maximum dose of 25 mcg per nostril and a maximum daily dose of 75 mcg per nostril in the case of children aged not less than 12 but less than 16 years; and

(e)     the medicinal product is indicated for the prevention and treatment of seasonal allergic rhinitis, including hayfever, in persons aged not less than 12 years.

15.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance hydroxyzine hydrochloride, where –

(a)     the medicinal product is sold or supplied in a container, or package, containing not more than 750 mg of the medicinal product;

(b)     the container or package is labelled to show a maximum dose of 25 mg, and to show a maximum daily dose of 75 mg in the case of persons aged not less than 12 years and a maximum daily dose of 50 mg in the case of children aged not less than 6 years but less than 12 years; and

(c)     the medicinal product is indicated for the management of pruritus associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in persons aged not less than 6 years.

16.       A medicinal product shall not be a prescription only medicine, by reason that it consists of or contains the substance hyoscine butylbromide, where –

(a)     the route of administration of the medicinal product is internal and is otherwise than by means of an inhaler;

(b)     the medicinal product is sold or supplied in a container, or package, containing not more than 240 mg of the medicinal product; and

(c)     the container or package is labelled to show a maximum dose of 20 mg and a maximum daily dose of 80 mg of the medicinal product.

17.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance ketoconazole, where –

(a)     the medicinal product is in the form of a shampoo;

(b)     the maximum strength of the ketoconazole in the medicinal product does not exceed 2 per cent, calculated in terms of weight in weight;

(c)     the medicinal product is sold or supplied in a container, or package, containing not more than 120 ml of the medicinal product and containing in the medicinal product not more than 2400 mg of ketoconazole;

(d)     the container or package is labelled to show a maximum frequency of application of once every 3 days; and

(e)     the medicinal product is indicated for the prevention and treatment of dandruff and seborrhoeic dermatitis of the scalp.

18.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance ketoprofen, where –

(a)     the maximum strength of the ketoprofen in the medicinal product does not exceed 2.5 per cent, calculated in terms of weight in weight;

(b)     the medicinal product is sold or supplied in a container, or package, containing not more than 30 grams of the medicinal product; and

(c)     the medicinal product is indicated only for treatment by external topical application, for rheumatic and muscular pain, in persons aged not less than 12 years, for a maximum period of 7 days.

19.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance loratadine, where –

(a)     the medicinal product is sold or supplied in a container, or package, containing not more than 100 mg of loratadine; and

(b)     the container or package is labelled to show a maximum daily dose of 10 mg of loratadine.

20.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance mebendazole, where –

(a)     the medicinal product is sold or supplied in a container, or package, containing not more than 800 mg of mebendazole;

(b)     the container or package is labelled to show a maximum dose of 100 mg of mebendazole; and

(c)     the medicinal product is indicated for oral use in the treatment of enterobiasis, in persons aged not less than 2 years.

21.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance nizatidine, where –

(a)     the container or package in which the medicinal product is sold or supplied is labelled to show a maximum dose of 75 mg of nizatidine and a maximum of 4 such doses in any period of 14 days; and

(b)     the medicinal product is indicated only for the prevention of the symptoms of food-related heartburn, in persons aged not less than 16 years.

22.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance oxethazaine, where –

(a)     the medicinal product is sold or supplied in a container, or package, containing not more than 400 ml of oxethazaine; and

(b)     the container or package is labelled to show a maximum dose of 10 ml and a maximum daily dose of 30 ml of oxethazaine.

23.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance piroxicam, where –

(a)     the maximum strength of the piroxicam in the medicinal product does not exceed 0.5 per cent, calculated in terms of weight in weight;

(b)     the medicinal product is sold or supplied in a container, or package, containing not more than 30 g of the medicinal product;

(c)     the container or package is labelled to show a maximum period of use of 7 days; and

(d)     the medicinal product is indicated for external application for the relief of rheumatic pain and muscular aches, pains and swellings such as strains, sprains and sports injuries, in persons aged not less than 12 years.

24.       A medicinal product shall not be a prescription only medicine by reason that it consists of or contains the substance pyrantel embonate, where –

(a)     the medicinal product is sold or supplied in a container or package containing not more than 750 mg of the medicinal product;

(b)     the container or package is labelled to show a maximum daily dose (to be taken as a single dose) of pyrantel embonate of 750 mg in the case of persons aged not less than 12 years, of 500 mg in the case of children aged not less than 6 years but less than 12 years, and of 250 mg in the case of children aged not less than 2 years but less than 6 years; and

(c)     the medicinal product is indicated for the treatment of enterobiasis, in persons aged not less than 2 years.

25.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance ranitidine hydrochloride, where –

(a)     the container or package in which the medicinal product is sold or supplied is labelled to show a maximum dose equivalent to 75 ml and a maximum daily dose equivalent to 300 ml of ranitidine for a maximum period of use of 14 days; and

(b)     the medicinal product is indicated for the short-term symptomatic relief of heartburn, dyspepsia and hyperacidity.

25.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance sodium cromoglycate, where –

(a)     the medicinal product is in the form of aqueous eye drops;

(b)     the maximum strength of the sodium cromoglycate in the medicinal product does not exceed 2 per cent, calculated in terms of weight in volume;

(c)     the medicinal product is sold or supplied in a container containing not more than 10 ml of the medicinal product; and

(d)     the medicinal product is indicated for the treatment of acute seasonal allergic conjunctivitis.

27.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance sodium cromoglycate, where –

(a)     the medicinal product is in the form of an eye ointment;

(b)     the maximum strength of the sodium cromoglycate in the medicinal product is 4 per cent, calculated in terms of weight in weight;

(c)     the medicinal product is sold or supplied in a container, or package, containing not more than 5 g of the medicinal product; and

(d)     the medicinal product is indicated for the treatment of acute seasonal allergic conjunctivitis.

28.       A medicinal product shall not be a prescription only medicine by reason that it contains the substance terfenadine, where –

(a)     the medicinal product is sold or supplied in a container, or package, containing not more than 1200 mg of terfenadine; and

(b)     the container or package is labelled to show a maximum daily dose of 120 mg of terfenadine.

SECOND SCHEDULE

EXEMPTION FOR CERTAIN PERSONS FROM ARTICLE 57(2) OF THE LAW

PART I

(Articles 1(2)(a) and 8(1))

 

 

PART II

(Articles 1(2) and 8(1))

 

 

PART III

(Articles 1(2) and 8(2))

 

THIRD SCHEDULE

(Articles 9(3)(c) and (4)(a))

SUBSTANCES THAT MUST NOT BE CONTAINED IN A PRESCRIPTION ONLY MEDICINE EXEMPTED BY ARTICLE 9