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The Prescription Only Medicines (Human Use) Order 1997

Status:

This is the original version (as it was originally made).

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

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

Exemptions from the restrictions on the sale and supply of prescription only medicines
Column 1Column 2Column 3Column 4Column 5
SubstanceMaximum strengthRoute of administration, use or pharmaceutical formTreatment limitationsMaximum quantity
Acarbose
Acebutolol Hydrochloride
Acemetacin
Acetarsol
Acetazolamide
Acetazolamide Sodium
Acetohexamide
Acetylcholine Chloride0.2 per centExternal
Acetylcysteine
Acipimox
Aciclovir5.0 per centExternalContainer or package containing not more than 2g of medicinal product
For treatment of herpes simplex virus infections of the lips and face (Herpes labialis)
Acitretin
Aclarubicin Hydrochloride
Aconite1.3 per centExternal
Acrivastine24 mg (MDD)Container or package containing not more than 240mg of Acrivastine
Acrosoxacin
Actinomycin C
Actinomycin D
Adenosine
Adrenaline(1) By inhaler
(2) External
Adrenaline Acid Tartrate(1) By inhaler
(2) External
Adrenaline Hydrochloride(1 )By inhaler
(2) External
Adrenocortical Extract
Albendazole
Alclofenac
Alclometasone Dipropionate
Alcuronium Chloride
Aldesleukin
Aldosterone
Alfacalcidol
Alfuzosin Hydrochloride
Allergen Extracts
Allopurinol
Allyloestrenol
Alphadolone Acetate
Alphaxalone
Alprenolol
Alprenolol Hydrochloride
Alprostadil
Alseroxylon
Amantadine Hydrochloride
Ambenonium Chloride
Ambutonium Bromide
Amcinonide
Ametazole Hydrochloride
AmethocaineNon-ophthalmic use
Amethocaine GentisateNon-ophthalmic use
Amethocaine HydrochlorideNon-ophthalmic use
Amikacin Sulphate
Amiloride Hydrochloride
Aminocaproic Acid
Aminoglutethimide
Aminopterin Sodium
Amiodarone Hydrochloride
Amiphenazole Hydrochloride
Amitriptyline
Amitriptyline Embonate
Amitriptyline Hydrochloride
Amlodipine Besylate
Ammonium Bromide
Amodiaquine Hydrochloride
Amorolfine Hydrochloride
Amoxapine
Amoxycillin
Amoxycillin Sodium
Amoxycillin Trihydrate
Amphomycin Calcium
Amphotericin
Ampicillin
Ampicillin Sodium
Ampicillin Trihydrate
Amsacrine
Amygdalin
Amyl Nitrite
Amylocaine HydrochlorideNon-ophthalmic use
Ancrod
Androsterone
Angiotensin Amide
Anistreplase
Anterior Pituitary Extract
Antimony Barium Tartrate
Antimony Dimercaptosuccinate
Antimony Lithium Thiomalate
Antimony Pentasulphide
Antimony Potassium Tartrate
Antimony Sodium Tartrate
Antimony Sodium Thioglycollate
Antimony Sulphate
Antimony Trichloride
Antimony Trioxide
Antimony Trisulphide
Apiol
Apomorphine
Apomorphine Hydrochloride
Aprotinin
Arecoline Hydrobromide
Argipressin
Aristolochia
Aristolochia Clematitis
Aristolochia Contorta
Aristolochia Debelis
Aristolochia Fang-chi
Aristolochia Manshuriensis
Aristolochia Serpentaria
Arsenic
Arsenic Triiodide
Arsenic Trioxide
Arsphenamine
AstemizoleOral10mg (MDD)Container or package containing not more than 100mg of Astemizole
For treatment of hayfever in adults and children not less than 12 years
Not a prolonged release preparation
Atenolol
Atracurium Besylate
Atropine(1) Internal
(a) by inhaler
(b) otherwise than by inhaler(b) 300mcg (MD)
1mg (MDD)
(2) External (except ophthalmic)
Atropine Methobromide(1) Internal
(a) by inhaler
(b) otherwise than by inhaler(b) 400mcg (MD)
1.3mg (MDD)
(2) External (except ophthalmic)
Atropine MethonitrateInternal
(a) by inhaler
(b) otherwise than by inhaler(b) 400mcg (MD)
1.3mg (MDD)
Atropine Oxide Hydrochloride(1) Internal
(a) by inhaler
(b) otherwise than by inhaler(b) 360mcg (MD)
1.2mg (MDD) 3
(2) External (except ophthalmic)
Atropine Sulphate(1) Internal
(a) by inhaler
(b) otherwise than by inhaler(b) 360mcg (MD)
1.2mg (MDD)
(2) External (except ophthalmic)
Auranofin
Azapropazone
Azathioprine
Azathioprine Sodium
Azelaic Acid
Azelastine HydrochlorideFor nasal administration140mcg per nostril (MD)Container or package containing not more than 5,040mcg of Azelastine Hydrochloride
For the treatment of seasonal allergic rhinitis280mcg per nostril (MDD)
For use in adults and children not less than 12 years
As a non-aerosol, aqueous form
Azidocillin Potassium
Azithromycin
Azlocillin Sodium
Aztreonam
Bacampicillin Hydrochloride
Bacitracin
Bacitracin Methylene Disalicylate
Bacitracin Zinc
Baclofen
Bambuterol Hydrochloride
Barium Carbonate
Barium Chloride
Barium Sulphide
Beclamide
Beclomethasone
Beclomethasone DipropionateFor nasal administration (non-aerosol)100mcg per nostril (MD)Container or package containing not more than 5,600mcg of Beclomethasone Dipropionate
200mcg per nostril (MDD)
For the prevention and treatment of allergic rhinitis
For use in adults and children not less than 12 years
Belladonna Herb(1) Internal(1) 1mg of the alkaloids (MDD)
(2) External
Belladonna Root(1) Internal(1) 1mg of the alkaloids (MDD)
(2) External
Bemegride
Bemegride Sodium
Benapryzine Hydrochloride
Bendrofluazide
Benethamine Penicillin
Benoxaprofen
Benperidol
Benserazide Hydrochloride
Bentiromide
Benzathine Penicillin
Benzbromarone
Benzhexol Hydrochloride
Benzilonium Bromide
BenzocaineAny use except ophthalmic use
Benzoctamine Hydrochloride
Benzoyl Peroxide10.0 per centExternal
N-Benzoyl Sulphanilamide
Benzquinamide
Benzquinamide Hydrochloride
Benzthiazide
Benztropine Mesylate
Benzylpenicillin Calcium
Benzylpenicillin Potassium
Benzylpenicillin Sodium
Beractant
Betahistine Hydrochloride
Betamethasone
Betamethasone Adamantoate
Betamethasone Benzoate
Betamethasone Dipropionate
Betamethasone Sodium Phosphate
Betamethasone Valerate
Betaxolol Hydrochloride
Bethanechol Chloride
Bethanidine Sulphate
Bezafibrate
Biperiden Hydrochloride
Biperiden Lactate
Bismuth Glycollylarsanilate
Bisoprolol Fumarate
Bleomycin
Bleomycin Sulphate
Bretylium Tosylate
Bromhexine Hydrochloride
Bromocriptine Mesylate
Bromperidol
Bromvaletone
Brotizolam
BudesonideFor nasal administration200mcg per nostril (MD)Container or package containing not more than 10mg of Budesonide
For the prevention or treatment of seasonal allergic rhinitis200mcg per nostril (MDD)
For use in adults and in children not less than 12 years
As a non-aerosol, aqueous form
Bufexamac
Bumetanide
Buphenine Hydrochloride6mg (MD)
18mg (MDD)
BupivacaineAny use except ophthalmic use
Bupivacaine HydrochlorideAny use except ophthalmic use
Buserelin Acetate
Buspirone Hydrochloride
Busulphan
Butacaine SulphateAny use except ophthalmic use
Butorphanol Tartrate
Butriptyline Hydrochloride
Calcipotriol
Calcitonin
Calcitriol
Calcium Amphomycin
Calcium Benzamidosalicylate
Calcium Bromide
Calcium Bromidolactobionate
Calcium Carbimide
Calcium Folinate
Calcium Metrizoate
Calcium Sulphaloxate
Candicidin
Canrenoic Acid
Cantharidin0.01 per centExternal
Capreomycin Sulphate
Captopril
Carbachol
Carbamazepine
Carbaryl
Carbenicillin Sodium
Carbenoxolone Sodium(1) Pellet(1) 5mg (MD)
25mg (MDD)
(2) 2.0 per cent(2) Gel
(3) 1.0 per cent(3) Granules for mouthwash in adults and children not less than 12 years(3) 20mg (MD)(3) Container or package containing not more than 506mg of Carbenoxolone Sodium
80mg (MDD)
Carbidopa
Carbimazole
Carbocisteine
Carbon Tetrachloride
Carboplatin
Carboprost Trometamol
Carbuterol Hydrochloride
Carfecillin Sodium
Carindacillin Sodium
Carisoprodol
Carmustine
Carperidine
Carteolol Hydrochloride
Cefaclor
Cefadroxil
Cefazedone Sodium
Cefixime
Cefodizime Sodium
Cefotaxime Sodium
Cefoxitin Sodium
Cefpodoxime Proxetil
Cefsulodin Sodium
Ceftazidime
Ceftizoxime Sodium
Ceftriaxone Sodium
Cefuroxime Axetil
Cefuroxime Sodium
Celiprolol Hydrochloride
Cephalexin
Cephalexin Sodium
Cephaloridine
Cephalothin Sodium
Cephamandole Nafate
Cephazolin Sodium
Cephradine
Cerium Oxalate
Cerivastatin
Ceruletide Diethylamine
Cetirizine Hydrochloride10mg (MDD)Container or package containing not more than 100mg of Cetirizine Hydrochloride
Chenodeoxycholic Acid
Chloral HydrateExternal
Chlorambucil
Chloramphenicol
Chloramphenicol Cinnamate
Chloramphenicol Palmitate
Chloramphenicol Sodium Succinate
Chlorhexadol
Chlormadinone Acetate
Chlormerodrin
Chlormethiazole
Chlormethiazole Edisylate
Chlormezanone
Chloroform(1)(1) 5.0 per cent(1) Internal
(2) External
Chloroquine PhosphateProphylaxis of malaria
Chloroquine SulphateProphylaxis of malaria
Chlorothiazide
Chlorotrianisene
Chlorphenoxamine Hydrochloride
Chlorpromazine
Chlorpromazine Embonate
Chlorpromazine Hydrochloride
Chlorpropamide
Chlorprothixene
Chlorprothixene Hydrochloride
Chlortetracycline
Chlortetracycline Calcium
Chlortetracycline Hydrochloride
Chlorthalidone
Chlorzoxazone
Cholestyramine
Ciclacillin
Ciclobendazole
Cilastatin Sodium
Cilazapril
Cimetidine(a) For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity and for the prophylaxis of meal-induced heartburn(a) 200mg (MD)
800mg (MDD)
For a maximum period of 14 days
(b) For the prophylactic management of nocturnal heartburn by a single dose taken at night(b) 100mg (MD) to be taken as a single dose at night
For a maximum period of 14 days
Cimetidine Hydrochloride
Cinchocaine3.0 per centNon-ophthalmic use
Cinchocaine HydrochlorideEquivalent of 3.0 per cent of CinchocaineNon-ophthalmic use
Cinchophen
Cinoxacin
Ciprofibrate
Ciprofloxacin
Ciprofloxacin Hydrochloride
Cisapride
Cisplatin
Clarithromycin
Clavulanic Acid
Clidinium Bromide
Clindamycin
Clindamycin Hydrochloride
Clindamycin Palmitate Hydrochloride
Clindamycin Phosphate
Clioquinol(1) External (other than treatment of mouth ulcers)
(2) 35mg(2) Treatment of mouth ulcers(2) 350mg (MDD)
Clobetasol Propionate
Clobetasone Butyrate
Clofazimine
Clofibrate
Clomiphene Citrate
Clomipramine
Clomipramine Hydrochloride
Clomocycline
Clomocycline Sodium
Clonidine
Clonidine Hydrochloride
Clopamide
Clopenthixol Decanoate
Clopenthixol Hydrochloride
Clorexolone
ClotrimazoleExternal but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Cloxacillin Benzathine
Cloxacillin Sodium
Clozapine
Cocculus Indicus
Co-dergocrine Mesylate
Colaspase
Colchicine
Colestipol Hydrochloride
Colfosceril Palmitate
Colistin Sulphate
Colistin Sulphomethate
Colistin Sulphomethate Sodium
Coniine
Conium Leaf7.0 per centExternal
Corticotrophin
Cortisone
Cortisone Acetate
Co-tetroxazine
Co-trimoxazole
Cropropamide
Crotethamide
Croton Oil
Croton Seed
Curare
Cyclofenil
Cyclopenthiazide
Cyclopentolate Hydrochloride
Cyclophosphamide
Cycloserine
Cyclosporin
Cyclothiazide
Cyproterone Acetate
Cytarabine
Cytarabine Hydrochloride
Dacarbazine
Dalteparin Sodium
Danazol
Danthron
Dantrolene Sodium
Dapsone
Dapsone Ethane Ortho Sulphonate
Daunorubicin Hydrochloride
Deanol Bitartrate26mg (MDD)
Debrisoquine Sulphate
Demecarium Bromide
Demeclocycline
Demeclocycline Calcium
Demeclocycline Hydrochloride
Deoxycortone Acetate
Deoxycortone Pivalate
Deptropine Citrate
Dequalinium Chloride(1) 0.25mg(1) Internal: throat lozenges or throat pastilles
(2) 1.0 per cent(2) External: paint
Deserpidine
Desferrioxamine Mesylate
Desflurane
Desipramine Hydrochloride
Deslanoside
Desmopressin
Desmopressin Acetate
Desogestrel
Desonide
Desoxymethasone
Dexamethasone
Dexamethasone Acetate
Dexamethasone Isonicotinate
Dexamethasone Phenylpropionate
Dexamethasone Pivalate
Dexamethasone Sodium Metasulphobenzoate
Dexamethasone Sodium Phosphate
Dexamethasone Troxundate
Dexfenfluramine Hydrochloride
Dextromethorphan HydrobromideInternal(a) In the case of a prolonged release preparation: equivalent of 30mg of Dextromethorphan (MD)
equivalent of 75mg of Dextromethorphan (MDD)
(b) in any other case: equivalent of 15mg of Dextromethorphan (MD)
equivalent of 75mg of Dextromethorphan (MDD)
Dextrothyroxine Sodium
Diazoxide
Dibenzepin Hydrochloride
Dichloralphenazone
Dichlorphenamide
Diclofenac Diethylammonium1.16 per centExternalFor maximum period of 7 daysContainer or package containing not more than 30g of medicinal product
For local symptomatic relief of pain and inflammation in trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism
For use in adults and children not less than 12 years
Diclofenac Potassium
Diclofenac Sodium
Dicyclomine Hydrochloride10mg (MD)
60mg (MDD)
Dienoestrol
Diethanolamine Fusidate
Diflucortolone Valerate
Diflunisal
Digitalin
Digitalis Leaf
Digitalis Prepared
Digitoxin
Digoxin
Dihydralazine Sulphate
Dihydroergotamine Mesylate
Dihydrostreptomycin
Dihydrostreptomycin Sulphate
Diloxanide Furoate
Diltiazem Hydrochloride
Dimercaprol
Dimethisoquin HydrochlorideNon-ophthalmic use
Dimethisterone
Dimethothiazine Mesylate
Dimethyl Sulphoxide
Dimethyltubocurarine Bromide
Dimethyltubocurarine Chloride
Dimethyltubocurarine Iodide
Dinoprost
Dinoprost Trometamol
Dinoprostone
Dipivefrin Hydrochloride
Dipyridamole
Disodium Etidronate
Disodium Pamidronate
Disopyramide
Disopyramide Phosphate
Distigmine Bromide
Disulfiram
Dithranol1.0 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
Dydrogesterone
Dyflos
EconazoleExternal but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Econazole NitrateExternal but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Ecothiopate Iodide
Edrophonium Chloride
Eflornithine Hydrochloride
Embutramide
Emepronium Bromide
Emetine1.0 per cent
Emetine Bismuth Iodide
Emetine HydrochlorideEquivalent of 1.0 per cent of Emetine
Enalapril Maleate
Encephalitis Virus, Tick-borne, Cent Eur
Enoxacin
Enoxaparin Sodium
Enoximone
Ephedrine(1) Internal (other than nasal sprays or nasal drops)(1) 30mg (MD)
60mg (MDD)
(2) 2.0 per cent(2) Nasal sprays or nasal drops
(3) External
Ephedrine Hydrochloride(1) Internal (other than nasal sprays or nasal drops)(1) Equivalent of 30mg of Ephedrine (MD)
Equivalent of 60mg of Ephedrine (MDD)
(2) Equivalent of 2.0 per cent of Ephedrine(2) Nasal sprays or nasal drops
(3) External
Ephedrine Sulphate(1) Internal (other than nasal sprays or nasal drops)(1) Equivalent of 30mg of Ephedrine (MD)
Equivalent of 60mg of Ephedrine (MDD)
(2) Equivalent of 2.0 per cent of Ephedrine(2) Nasal sprays or nasal drops
(3) External
Epicillin
Epirubicin
Epirubicin Hydrochloride
Epithiazide
Epoetin Alfa
Epoetin Beta
Epoprostenol Sodium
Ergometrine Maleate
Ergometrine Tartrate
Ergot, Prepared
Ergotamine Tartrate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylcarbonate
Erythromycin Ethyl Succinate
Erythromycin Lactobionate
Erythromycin Phosphate
Erythromycin Stearate
Erythromycin Thiocyanate
Esmolol Hydrochloride
Estramustine Phosphate
Etafedrine Hydrochloride
Ethacrynic Acid
Ethambutol Hydrochloride
Ethamivan
Ethamsylate
Ethiazide
Ethinyl Androstenediol
Ethinyloestradiol
Ethionamide
Ethisterone
Ethoglucid
Ethoheptazine Citrate
Ethopropazine Hydrochloride
Ethosuximide
Ethotoin
Ethyl Biscoumacetate
Ethynodiol Diacetate
Etodolac
Etomidate
Etomidate Hydrochloride
Etoposide
Etretinate
Famciclovir
FamotidineFor the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity, and prevention of these symptoms when associated with food and drink, including nocturnal symptoms10mg (MD)
20mg (MDD)
For maximum period of 14 days
Fazadinium Bromide
Felbinac3.17 per centExternalFor maximum period of 7 daysContainer or package containing not more than 30g of medicinal product
For the relief of symptoms associated with soft tissue injury such as strains, sprains and contusions
For use in adults and children not less than 12 years
Felodipine
Felypressin
Fenbufen
Fenclofenac
Fenfluramine Hydrochloride
Fenofibrate
Fenoprofen
Fenoprofen Calcium
Fenoterol Hydrobromide
Fenticonazole Nitrate
Feprazone
Ferrous Arsenate
Filgrastim
Finasteride
Flavoxate Hydrochloride
Flecainide Acetate
Flosequinan
Fluanisone
Flubendazole
Fluclorolone Acetonide
Flucloxacillin Magnesium
Flucloxacillin Sodium
FluconazoleFor oral administration for the treatment of vaginal candidiasis in persons aged not less than 16 but less than 60 years150mg (MD)Container or package containing not more than 150mg of Fluconazole
Flucytosine
Fludrocortisone Acetate
Flufenamic Acid
Flumazenil
Flumethasone
Flumethasone Pivalate
Flunisolide0.025 per cent(a) For the prevention and treatment of seasonal allergic rhinitis, including hay fever(a) 50mcg per nostril (MD)(a) Container or package containing not more than 6,000mcg of Flunisolide
100mcg per nostril (MDD)
For use in adults and children not less than 16 years
In the form of a non-pressurised nasal spray
(b) For the prevention and treatment of seasonal allergic rhinitis including hay fever(b) 25mcg per nostril (MD)(b) Container or package containing not more than 6,000mcg of Flunisolide
75mcg per nostril (MDD)
For use in children not less than 12 years but less than 16 years
In the form of a non-pressurised nasal spray
Fluocinolone Acetonide
Fluocinonide
Fluocortin Butyl
Fluocortolone
Fluocortolone Hexanoate
Fluocortolone Pivalate
Fluorescein Dilaurate
Fluorometholone
Fluorouracil
Fluorouracil Trometamol
Fluoxetine Hydrochloride
Flupenthixol Decanoate
Flupenthixol Hydrochloride
Fluperolone Acetate
Fluphenazine Decanoate
Fluphenazine Enanthate
Fluphenazine Hydrochloride
Fluprednidene Acetate
Fluprednisolone
Fluprostenol Sodium
Flurandrenolone
Flurbiprofen
Flurbiprofen Sodium
Fluspirilene
Flutamide
Fluticasone Propionate
Fluvastatin Sodium
Fluvoxamine Maleate
Folic Acic500mcg (MDD)
Formestane
Formocortal
Foscarnet Sodium
Fosfestrol Sodium
Fosfomycin Trometamol
Fosinopril Sodium
Framycetin Sulphate
Frusemide
Furazolidone
Fusafungine
Fusidic Acid
Gabapentin
Gadoteridol
Gallamine Triethiodide
Ganciclovir
Ganciclovir Sodium
Gelsemine0.1 per cent
Gelsemium25mg (MD)
75mg (MDD)
Gemeprost
Gemfibrozil
Gentamicin
Gentamicin Sulphate
Gestodene
Gestrinone
Gestronol
Gestronol Hexanoate
Glibenclamide
Glibornuride
Gliclazide
Glipizide
Gliquidone
Glisoxepide
Glucagon
Glycopyrronium Bromide1mg (MD)
2mg (MDD)
Glymidine
Gonadorelin
Goserelin Acetate
Gramicidin0.2 per centExternal
Granisetron Hydrochloride
Griseofulvin
Growth Hormone
Guanethidine Monosulphate
Guanfacine Hydrochloride
Guanoclor Sulphate
Guanoxan Sulphate
Halcinonide
Halofantrine Hydrochloride
Haloperidol
Haloperidol Decanoate
HeparinExternal
Heparin CalciumExternal
Heparin Sodium
HexachlorophaneExternal
(a) 2.0 per cent(a) Soaps
(b) 0.1 per cent(b) Aerosols
(c) 0.75 per cent(c) preparations other than soaps and aerosols
Hexamine Phenylcinchoninate
Hexobarbitone
Hexobarbitone Sodium
Hexoestrol
Hexoestrol Dipropionate
L-Histidine HydrochlorideDietary supplementation
Homatropine(1) Internal(1) 0.15mg (MD)
0.45mg (MDD)
(2) External (except ophthalmic)
Homatropine Hydrobromide0.2mg (MD)
0.6mg (MDD)
Homatropine Methylbromide2mg (MD)
6mg (MDD)
Hydralazine Hydrochloride
HydrargaphenLocal application to skin
Hydrobromic Acid
Hydrochlorothiazide
Hydrocortisone1.0 per centExternalContainer or package containing not more than 15g of medicinal product (cream or ointment) or 30ml (spray)
For use either alone or in conjunction with Crotamiton in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and either in combination with Clotrimazole for athlete’s foot and candidal intertrigo or in combination with lignocaine for anal and perianal itch associated with haemorrhoids
For use in adults and children not less than 10 years
Cream ointment or spray
Hydrocortisone AcetateEquivalent to 1.0 per cent HydrocortisoneExternal
For use in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and in combination with one or more of the following: Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Peru Balsam, Pramoxine Hydrochloride, Zinc Oxide, for haemorrhoidsContainer or package containing not more than 15g of medicinal product
In the case of suppositories, container or package containing no more than 12
For use in adults and children not less than 10 years
Cream, ointment or suppositories
Hydrocortisone Butyrate
Hydrocortisone Caprylate
Hydrocortisone Hydrogen Succinate
Hydrocortisone Sodium Phosphate
Hydrocortisone Sodium SuccinateEquivalent to 2.5mg HydrocortisoneExternalContainer or package containing not more than equivalent to 50mg of Hydrocortisone
For aphthous ulceration of the mouth for adults and children not less than 12 years
In the form of pellets
Hydroflumethiazide
Hydroxychloroquine SulphateProphylaxis of malaria
Hydroxyprogesterone
Hydroxyprogesterone Enanthate
Hydroxyprogesterone Hexanoate
Hydroxyurea
Hydroxyzine Embonate
Hydroxyzine Hydrochloride(a) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in adults and in children not less than 12 years(a) 25mg (MD)(a) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride
75mg (MDD)
(b) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in children not less than 6 years but less than 12 years(b) 25 mg (MD)(b) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride
50mg (MDD)
Hyoscine(1) 0.15 per cent(1) Internal
(2) External (except ophthalmic)
Hyoscine Butylbromide(1) Internal
(a) by inhaler
(b) otherwise than by inhaler(b) 20mg (MD)(b) Container or package containing not more than 240mg of Hyoscine Butylbromide
80mg (MDD)
(2) External
Hyoscine Hydrobromide(1) Internal
(a) by inhaler
(b) otherwise than by inhaler(b) 300mcg (MD)
900mcg (MDD)
(2) External (except ophthalmic)
Hyoscine Methobromide(1) Internal
(a) by inhaler
(b) otherwise than by inhaler(b) 2.5mg (MD)
7.5mg (MDD)
(2) External
Hyoscine Methonitrate(1) Internal
(a) by inhaler
(b) otherwise than by inhaler(b) 2.5mg (MD)
7.5mg (MDD)
(2) External
Hyoscyamine(1) Internal
(a) by inhaler
(b) otherwise than by inhaler(b) 300mcg (MD)
1mg (MDD)
(2) External
Hyoscyamine Hydrobromide(1) Internal
(a) by inhaler
(b) otherwise than by inhaler(b) Equivalent of 300mcg of Hyoscyamine (MD)
Equivalent of 1mg of Hyoscyamine (MDD)
(2) External
Hyoscyamine Sulphate(1) Internal
(a) by inhaler
(b) otherwise than by inhaler(b) Equivalent of 300mcg of Hyoscyamine (MD)
Equivalent of 1mg of Hyoscyamine (MDD)
(2) External
IbuprofenRheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza
(1) Internal(1)(a) In the case of a prolonged release preparation 600mg (MD)
1,200mg (MDD)
(b) in any other case 400mg (MD)
1,200mg (MDD)
(2) 5.0 per cent(2) External
Idarubicin Hydrochloride
Idoxuridine
Ifosfamide
Ignatius Bean
Imipenem Hydrochloride
Imipramine
Imipramine Hydrochloride
Imipramine Ion Exchange Resin Bound Salt or Complex
Indapamide Hemihydrate
Indomethacin
Indomethacin Sodium
Indoprofen
Indoramin Hydrochloride
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 NitrateExternal but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Isoetharine
Isoetharine Hydrochloride
Isoetharine Mesylate
Isoniazid
Isoprenaline Hydrochloride
Isoprenaline Sulphate
Isopropamide IodideEquivalent of 2.5mg of Isopropamide ion (MD)
Equivalent of 5.0mg of Isopropamide ion (MDD)
Isotretinoin
Isradipine
Itraconazole
JaborandiExternal
Kanamycin Acid Sulphate
Kanamycin Sulphate
Ketamine Hydrochloride
Ketoconazole2.0 per centFor the prevention and treatment of dandruff and seborrhoeic dermatitis of the scalpMaximum frequency of application of once every 3 daysContainer or package containing not more than 120ml of medicinal product and containing not more than 2,400mg of Ketoconazole
In the form of a shampoo
Ketoprofen2.5 per centExternalFor maximum period of 7 daysContainer or package containing not more than 30g of medicinal product
For rheumatic and muscular pain in adults and children not less than 12
Ketorolac Trometamol
Ketotifen Fumarate
Labetalol Hydrocholoride
Lachesine Chloride
Lacidipine
Lamotrigine
Lanatoside C
Lanatoside Complex A, B and C
Latamoxef Disodium
Levallorphan Tartrate
Levobunolol Hydrochloride
Levodopa
Levonorgestrel
Lidoflazine
LignocaineNon-ophthalmic use
Lignocaine HydrochlorideNon-ophthalmic use
Lincomycin
Lincomycin Hydrochloride
Liothyronine Sodium
Lisinopril
Lithium CarbonateEquivalent of 5mg of Lithium (MD)
Equivalent of 15mg of Lithium (MDD)
Lithium Citrate
Lithium Succinate
Lithium SulphateEquivalent of 5mg of Lithium (MD)
Equivalent of 15mg of Lithium (MDD)
Lobeline(1) Internal(1) 3mg (MD)
9mg (MDD)
(2) External
Lobeline Hydrochloride(1) Internal(1) Equivalent of 3mg of Lobeline (MD)
Equivalent of 9mg of Lobeline (MDD)
(2) External
Lobeline Sulphate(1) Internal(1) Equivalent of 3mg of Lobeline (MD)
Equivalent of 9mg of Lobeline (MDD)
(2) External
Lodoxamide Trometamol
Lofepramine
Lofepramine Hydrochloride
Lofexidine Hydrochloride
Lomefloxacin Hydrochloride
Lomustine
Loperamide HydrochlorideTreatment of acute diarrhoea
Loratidine10mg (MDD)Container or package containing not more than 100mg of Loratidine
Loxapine Succinate
Lung Surfactant Porcine
Luteinising Hormone
Lymecycline
Lynoestrenol
Lypressin
Lysuride Maleate
Mafenide
Mafenide Acetate
Mafenide Hydrochloride
Mafenide Propionate5.0 per centEye drops
Magnesium Fluoride
Magnesium Metrizoate
Mandragora Autumnalis
Mannomustine Hydrochloride
Maprotiline Hydrochloride
Mebanazine
MebendazoleFor oral use in the treatment of enterobiasis in adults and in children not less than 2 years100mg (MD)Container or package containing not more than 800mg of Mebendazole
Mebeverine HydrochlorideFor the symptomatic relief of irritable bowel syndrome135mg (MD)
405mg (MDD)
Mebeverine Pamoate
Mebhydrolin
Mebhydrolin Napadisylate
Mecamylamine Hydrochloride
Mecillinam
Meclofenoxate Hydrochloride
Medigoxin
Medrogestone
Medroxyprogesterone Acetate
Mefenamic Acid
Mefloquine Hydrochloride
Mefruside
Megestrol
Megestrol Acetate
Meglumine Gadopentetate
Meglumine Iodoxamate
Meglumine Ioglycamate
Meglumine Iothalamate
Meglumine Iotroxate
Meglumine Ioxaglate
Melphalan
Melphalan Hydrochloride
Menotrophin
Mepenzolate Bromide25mg (MD)
75mg (MDD)
Mephenesin
Mephenesin Carbamate
Mepivacaine HydrochlorideAny use except ophthalmic use
Meptazinol Hydrochloride
Mequitazine
Mercaptopurine
Mersalyl
Mersalyl Acid
Mesalazine
Mesna
Mestranol
Metaraminol Tartrate
Metergoline
Metformin Hydrochloride
Methacycline
Methacycline Calcium
Methacycline Hydrochloride
Methallenoestril
Methicillin Sodium
Methixene
Methixene Hydrochloride
Methocarbamol
MethocidinThroat lozenges and throat pastilles
Methohexitone Sodium
Methoin
Methoserpidine
Methotrexate
Methotrexate Sodium
Methotrimeprazine
Methotrimeprazine Hydrochloride
Methotrimeprazine Maleate
Methoxamine Hydrochloride0.25 per centNasal sprays or nasal drops not containing liquid paraffin as a vehicle
Methsuximide
Methyclothiazide
Methyldopa
Methyldopate Hydrochloride
Methylephedrine Hydrochloride30mg (MD)
60mg (MDD)
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Sodium Succinate
Methylthiouracil
Methysergide Maleate
Metipranolol
Metirosine
Metoclopramide Hydrochloride
Metolazone
Metoprolol Fumarate
Metoprolol Succinate
Metoprolol Tartrate
Metronidazole
Metronidazole Benzoate
Metyrapone
Mexiletine Hydrochloride
Mezlocillin Sodium
Mianserin Hydrochloride
MiconazoleExternal but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Miconazole NitrateExternal but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Mifepristone
Miglitol
Milrinone
Milrinone Lactate
Minocycline
Minocycline Hydrochloride
Minoxidil2.0 per centExternal
Misoprostol
Mitobronitol
Mitomycin
Mitozantrone Hydrochloride
Mivacurium Chloride
Moclobemide
Molgramostim
Molindone Hydrochloride
Mometasone Furoate
Moracizine Hydrochloride
Morazone Hydrochloride
Mupirocin
Mupirocin Calcium
Mustine Hydrochloride
Nabilone
Nabumetone
Nadolol
Nafarelin Acetate
Naftidrofuryl Oxalate
Naftifine Hydrochloride
Nalbuphine Hydrochloride
Nalidixic Acid
Nalorphine Hydrobromide
Naloxone Hydrochloride
Naltrexone Hydrochloride
Naphazoline Hydrochloride(1) 0.05 per cent(1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle
(2) 0.015 per cent(2) Eye drops
Naphazoline Nitrate0.05 per centNasal sprays or nasal drops not containing liquid paraffin as a vehicle
Naproxen
Naproxen Sodium
Natamycin
Nedocromil Sodium
Nefazodone Hydrochloride
Nefopam Hydrochloride
Neomycin
Neomycin Oleate
Neomycin Palmitate
Neomycin Sulphate
Neomycin Undecanoate
Neostigmine Bromide
Neostigmine Methylsulphate
Netilmicin Sulphate
Nicardipine Hydrochloride
Nicergoline
Nicotinic AcidAny use, except for the treatment of hyperlipidaemia600mg (MDD)
Nicoumalone
Nifedipine
Nifenazone
Nikethamide
Nimodipine
Niridazole
Nitrendipine
Nitrofurantoin
Nitrofurazone
NizatidineFor the prevention of the symptoms of food-related heartburn75mg (MD)
Maximum of 4 such doses in any period of 14 days
For use in adults and children not less than 16 years
Nomifensine Maleate
Noradrenaline
Noradrenaline Acid Tartrate
Norethisterone
Norethisterone Acetate
Norethisterone Enanthate
Norethynodrel
Norfloxacin
Norgestimate
Norgestrel
Nortriptyline Hydrochloride
Noscapine
Noscapine Hydrochloride
Novobiocin Calcium
Novobiocin Sodium
Nux Vomica Seed
Nystatin
Octacosactrin
Octreotide
Oestradiol
Oestradiol Benzoate
Oestradiol Cypionate
Oestradiol Dipropionate
Oestradiol Diundecanoate
Oestradiol Enanthate
Oestradiol Phenylpropionate
Oestradiol Undecanoate
Oestradiol Valerate
Oestriol
Oestriol Succinate
Oestrogenic Substances Conjugated
Oestrone
Ofloxacin
Olsalazine Sodium
Omeprazole
Ondansetron Hydrochloride
Orciprenaline Sulphate
Orphenadrine Citrate
Orphenadrine Hydrochloride
Ouabain
Ovarian Gland Dried
Oxamniquine
Oxantel Embonate
Oxaprozin
Oxatomide
Oxedrine Tartrate
Oxethazaine10mg (MD)Container or package containing not more than 400mg of Oxethazaine
30mg (MDD)
Oxitropium Bromide
Oxolinic Acid
Oxpentifylline
Oxprenolol Hydrochloride
Oxybuprocaine HydrochlorideNon-ophthalmic use
Oxybutynin Hydrochloride
Oxypertine
Oxypertine Hydrochloride
Oxyphenbutazone
Oxyphencyclimine Hydrochloride
Oxyphenonium Bromide5mg (MD)
15mg (MDD)
Oxytetracycline
Oxytetracycline Calcium
Oxytetracycline Dihydrate
Oxytetracycline Hydrochloride
Oxytocin, natural
Oxytocin, synthetic
Pancreatin(1) 21,000 European Pharmacopoeia units of lipase per capsule(1) capsules
(2) 25,000 European Pharmacopoeia units of lipase per gram(2) powder
Pancuronium Bromide
Papaverine(1) By inhaler
(2) Otherwise than by inhaler(2) 50mg (MD)
150mg (MDD)
Papaverine Hydrochloride(1) By inhaler
(2) Otherwise than by inhaler(2) Equivalent of 50mg of Papaverine (MD)
Equivalent of 150mg of Papaverine (MDD)
Paraldehyde
Paramethadione
Paramethasone Acetate
Parathyroid Gland
Pargyline Hydrochloride
Paroxetine Hydrochloride
Pecilocin
Penamecillin
Penbutolol Sulphate
Penicillamine
Penicillamine Hydrochloride
Pentamidine Isethionate
Penthienate Bromide5mg (MD)
15mg (MDD)
Pentolinium Tartrate
Perfluamine
Pergolide Mesylate
Perhexiline Maleate
Pericyazine
Perindopril
Perindopril Erbumine
Perphenazine
Phenacetin0.1 per cent
PhenazoneExternal
Phenazone Salicylate
Phenbutrazate Hydrochloride
Phenelzine Sulphate
Phenethicillin Potassium
Phenformin Hydrochloride
Phenglutarimide Hydrochloride
Phenindione
Phenoxybenzamine Hydrochloride
Phenoxymethylpenicillin
Phenoxymethylpenicillin Calcium
Phenoxymethylpenicillin Potassium
Phenprocoumon
Phensuximide
Phentolamine Hydrochloride
Phentolamine Mesylate
Phenylbutazone
Phenylbutazone Sodium
Phenylpropanolamine HydrochlorideInternal
(1) all preparations except prolonged release capsules, nasal sprays and nasal drops(1) 25mg (MD)
100mg (MDD)
(2) prolonged release capsules(2) 50mg (MD)
100mg (MDD)
(3) 2.0 per cent(3) nasal sprays and nasal drops
Phenytoin
Phenytoin Sodium
Phthalylsulphathiazole
Physostigmine
Physostigmine Aminoxide Salicylate
Physostigmine Salicylate
Physostigmine Sulphate
Picrotoxin
Pilocarpine
Pilocarpine Hydrochloride
Pilocarpine Nitrate
Pimozide
Pindolol
Pipenzolate Bromide5mg (MD)
15mg (MDD)
Piperacillin Sodium
Piperazine Oestrone Sulphate
Piperidolate Hydrochloride50mg (MD)
150mg (MDD)
Pipothiazine Palmitate
Piracetam
Pirbuterol Acetate
Pirbuterol Hydrochloride
Pirenzepine Hydrochloride
Piretanide
Piroxicam0.5 per centExternalFor maximum period of 7 daysContainer or package containing not more than 30g of medicinal product
For the relief of rheumatic pain, pain of non-serious arthritic conditions and muscular aches, pains and swellings such as strains, sprains and sports injuries
For use in adults and children not less than 12 years
Pituitary Gland (Whole Dried)By inhaler
Pituitary Powdered (Posterior Lobe)By inhaler
Pivampicillin
Pivampicillin Hydrochloride
Pivmecillinam
Pivmecillinam Hydrochloride
Pizotifen
Pizotifen Malate
Plicamycin
Podophyllotoxin
Podophyllum
Podophyllum Indian
Podophyllum Resin20.0 per centExternal
Ointment or impregnated plaster
Poldine Methylsulphate2mg (MD)
6mg (MDD)
Polidexide
Polyestradiol Phosphate
Polymyxin B Sulphate
Polythiazide
Poppy Capsule
Potassium Arsenite0.0127 per cent
Potassium Bromide
Potassium Canrenoate
Potassium Clavulanate
Potassium Perchlorate
Practolol
Pralidoxime Chloride
Pralidoxime Iodide
Pralidoxime Mesylate
Pravastatin Sodium
Prazosin Hydrochloride
Prednisolone
Prednisolone Acetate
Prednisolone Butylacetate
Prednisolone Hexanoate
Prednisolone Metasulphobenzoate
Prednisolone Metasulphobenzoate Sodium
Prednisolone Pivalate
Prednisolone Sodium Phosphate
Prednisolone Steaglate
Prednisone
Prednisone Acetate
Prenalterol Hydrochloride
Prenylamine Lactate
Prilocaine HydrochlorideNon-ophthalmic use
Primidone
Probenecid
Probucol
Procainamide Hydrochloride
Procaine HydrochlorideNon-ophthalmic use
Procaine Penicillin
Procarbazine Hydrochloride
Prochlorperazine
Prochlorperazine Edisylate
Prochlorperazine Maleate
Prochlorperazine Mesylate
Procyclidine Hydrochloride
Progesterone
Prolactin
Proligestone
Prolintane Hydrochloride
Promazine Embonate
Promazine Hydrochloride
Propafenone
Propafenone Hydrochloride
Propanidid
Propantheline Bromide15mg (MD)
45mg (MDD)
Propofol
Propranolol Hydrochloride
Propylthiouracil
Proquazone
Protamine Sulphate
Prothionamide
Protirelin
Protriptyline Hydrochloride
Proxymetacaine HydrochlorideNon-ophthalmic use
Pseudoephedrine HydrochlorideInternal(a) In the case of a prolonged release preparation
120mg (MD)
240mg (MDD)
(b) in any other case 60mg (MD)
240mg (MDD)
Pseudoephedrine Sulphate60mg (MD)
180mg (MDD)
Pyrantel Embonate(a) For the treatment of enterobiosis, in adults and children not less than 12 years(a) 750mg MDD (as a single dose)(a) Container or package containing not more than 750mg of Pyrantel Embonate
(b) For the treatment of enterobiosis, in children less than 12 years but not less than 6 years(b) 500mg MDD (as a single dose)(b) Container or package containing not more than 750mg of Pyrantel Embonate
(c) For the treatment of enterobiosis in children less than 6 years but not less than 2 years(c) 250mg MDD (as a single dose)(c) Container or package containing not more than 750mg of Pyrantel Embonate
Pyrantel Tartrate
Pyrazinamide
Pyridostigmine Bromide
Pyrimethamine
Quinapril
Quinestradol
Quinestrol
Quinethazone
Quinidine
Quinidine Bisulphate
Quinidine Polygalacturonate
Quinidine Sulphate
Quinine100mg (MD)
300mg (MDD)
Quinine BisulphateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine CinchophenEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine DihydrochlorideEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine Ethyl CarbonateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine GlycerophosphateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine HydrobromideEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine HydrochlorideEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine IodobismuthateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine PhosphateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine SalicylateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine SulphateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine TannateEquivalent of 100mg of Quinine (MD)
Equivalent of 300mg of Quinine (MDD)
Quinine in combination with Urea Hydrochloride
Ramipril
Ranitidine HydrochlorideFor the short term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidityEquivalent to 75mg of Ranitidine (MD)
Equivalent to 300mg of Ranitidine (MDD)
For a maximum period of 14 days
Rauwolfia Serpentina
Rauwolfia Vomitoria
Razoxane
Remoxipride Hydrochloride
Reproterol Hydrochloride
Rescinnamine
Reserpine
Rifabutin
Rifampicin
Rifampicin Sodium
Rifamycin
Rimiterol Hydrobromide
Risperidone
Ritodrine Hydrochloride
Rolitetracycline Nitrate
Sabadilla
Salbutamol
Salbutamol Sulphate
Salcatonin
Salcatonin Acetate
Salmefamol
Salmeterol Xinafoate
Salsalate
Saralasin Acetate
Selegiline Hydrochloride
Semisodium Valproate
Serum Gonadotrophin
Silver Sulphadiazine
Simvastatin
Sissomicin
Sissomicin Sulphate
Snake Venoms
Sodium Acetrizoate
Sodium Aminosalicylate
Sodium Antimonylgluconate
Sodium Arsanilate
Sodium Arsenate
Sodium Arsenite0.013 per cent
Sodium Bromide
Sodium Clodronate
Sodium Cromoglycate(a) For nasal admistration
(b) 2.0 per cent(b) For the treatment of acute seasonal allergic conjunctivitis(b) Container or package containing not more than 10ml of medicinal product
In the form of aqueous eye drops
(c) 4.0 per cent(c) For the treatment of acute seasonal allergic conjunctivitis(c) Container or package containing not more than 5g of medicinal product
In the form of an eye ointment
Sodium Ethacrynate
Sodium Fluoride(1) 0.33 per cent(1) Dentifrices
(2) Other preparations for use in the prevention of dental caries
In the form of
(a) tablets or drops(a) 2.2 mg (MDD)
(b) 0.2 per cent(b) mouth rinses other than those for daily use
(c) 0.05 per cent(c) mouth rinses for daily use
Sodium Fusidate
Sodium Metrizoate
Sodium Monofluorophosphate1.14 per centDentrifrice
Sodium Oxidronate
Sodium Stibogluconate
Sodium Valproate
Somatorelin Acetate
Sotalol Hydrochloride
Spectinomycin
Spectinomycin Hydrochloride
Spiramycin
Spiramycin Adipate
Spironolactone
Stannous Fluoride0.62 per centDentifrice
Stilboestrol
Stilboestrol Dipropionate
StreptodornaseExternal
StreptokinaseExternal
Streptomycin
Streptomycin Sulphate
Strychnine
Strychnine Arsenate
Strychnine Hydrochloride
Styramate
Succinylsulphathiazole
Sucralfate
Sulbactam Sodium
Sulbenicillin
Sulbenicillin Sodium
Sulconazole NitrateExternal (except vaginal)
Sulfacytine
Sulfadoxine
Sulfamerazine
Sulfamerazine Sodium
Sulfametopyrazine
Sulfamonomethoxine
Sulindac
Sulphacetamide
Sulphacetamide Sodium
Sulphadiazine
Sulphadiazine Sodium
Sulphadimethoxine
Sulphadimidine
Sulphadimidine Sodium
Sulphafurazole
Sulphafurazole Diethanolamine
Sulphaguanidine
Sulphaloxic Acid
Sulphamethizole
Sulphamethoxazole
Sulphamethoxydiazine
Sulphamethoxypyridazine
Sulphamethoxypyridazine Sodium
Sulphamoxole
Sulphanilamide
Sulphaphenazole
Sulphapyridine
Sulphapyridine Sodium
Sulphasalazine
Sulphathiazole
Sulphathiazole Sodium
Sulphaurea
Sulphinpyrazone
Sulpiride
Sultamicillin
Sultamicillin Tosylate
Sulthiame
Sumatriptan Succinate
Suprofen
Suxamethonium Bromide
Suxamethonium Chloride
Suxethonium Bromide
Tacrine Hydrochloride
Talampicillin
Talampicillin Hydrochloride
Talampicillin Napsylate
Tamoxifen
Tamoxifen Citrate
Tazobactam Sodium
Teicoplanin
Temocillin Sodium
Tenoxicam
Terazosin Hydrochloride
Terbinafine
Terbutaline
Terbutaline Sulphate
Terfenadine120mg (MDD)Container or package containing no more than 1,200mg of Terfenadine
Terlipressin
Terodiline Hydrochloride
Tetrabenazine
Tetracosactrin
Tetracosactrin Acetate
Tetracycline
Tetracycline Hydrochloride
Tetracycline Phosphate Complex
Tetroxoprim
Thallium Acetate
Thallous Chloride
Thiabendazole
Thiambutosine
Thiethylperazine Malate
Thiethylperazine Maleate
Thiocarlide
Thioguanine
Thiopentone Sodium
Thiopropazate Hydrochloride
Thioproperazine Mesylate
Thioridazine
Thioridazine Hydrochloride
Thiosinamine
Thiotepa
Thiothixene
Thiouracil
Thymoxamine Hydrochloride
Thyroid
Thyrotrophin
Thyroxine Sodium
Tiamulin Fumarate
Tiaprofenic Acid
Tibolone
Ticarcillin Sodium
Tigloidine Hydrobromide
Timolol Maleate
Tinidazole
Tinzaparin
Tioconazole(1) 2.0 per cent(1) External (except vaginal)
(2) Vaginal for treatment of vaginal candidiasis
Tobramycin
Tobramycin Sulphate
Tocainide Hydrochloride
Tofenacin Hydrochloride
Tolazamide
Tolazoline HydrochlorideExternal
Tolbutamide
Tolbutamide Sodium
Tolfenamic Acid
Tolmetin Sodium
Tramadol Hydrochloride
Trandolapril
Tranexamic Acid
Tranylcypromine Sulphate
Trazodone Hydrochloride
Treosulfan
Tretinoin
Triamcinolone
Triamcinolone Acetonide0.1 per centFor the treatment of common mouth ulcersContainer or package containing not more than 5g of medicinal product
Triamcinolone Diacetate
Triamcinolone Hexacetonide
Triamterene
Tribavirin
Triclofos Sodium
Trientine Dihydrochloride
Trifluoperazine
Trifluoperazine Hydrochloride
Trifluperidol
Trifluperidol Hydrochloride
Trilostane
Trimeprazine
Trimeprazine Tartrate
Trimetaphan Camsylate
Trimetazidine
Trimetazidine Hydrochloride
Trimethoprim
Trimipramine Maleate
Trimipramine Mesylate
Tropicamide
Tropisetron Hydrochloride
Troxidone
L-Tryptophan(1) Oral
Dietary supplementation
(2) External
Tubocurarine Chloride
Tulobuterol
Tulobuterol Hydrochloride
TyrothricinThroat lozenges or throat pastilles
Uramustine
Urea Stibamine
Urethane
Uridine 5'-triphosphate
Urofollitrophin
Urokinase
Ursodeoxychoic Acid
Vaccine: Bacillus Salmonella Typhi
Vaccine: Poliomyelitis (Oral)
Valproic Acid
Vancomycin Hydrochloride
Vasopressin
Vasopressin Tannate
Vecuronium Bromide
Verapamil Hydrochloride
Veratrine
Veratrum, Green
Veratrum, White
Vidarabine
Vigabatrin
Viloxazine Hydrochloride
Vinblastine Sulphate
Vincristine Sulphate
Vindesine Sulphate
Viomycin Pantothenate
Viomycin Sulphate
Vitamin A(1) Internal(1) 7,500iu (2,250mcg Retinol equivalent) (MDD)
(2) External
Vitamin A Acetate(1) Internal(1) Equivalent to 7,500iu Vitamin A (2,250mcg Retinol equivalent) (MDD)
(2) External
Vitamin A Palmitate(1) Internal(1) Equivalent to 7,500iu Vitamin A (2,250mcg Retinol equivalent) (MDD)
(2) External
Warfarin
Warfarin Sodium
Xamoterol Fumarate
Xipamide
Yohimbine Hydrochloride
Zidovudine
Zimeldine Hydrochloride
Zolpidem Tartrate
Zomepirac Sodium
Zopiclone
Zuclopenthixol Acetate
Zuclopenthixol Decanoate
Zuclopenthixol Hydrochloride

Articles 6(1) and 10

SCHEDULE 2

Column 1 Circumstances excluding medicinal products from the class of prescription only medicines
Column 2Column 3Column 4
SubstanceMaximum strengthPharmaceutical FormMaximum Dose
Codeine and its saltsEquivalent of 1.5 per cent of codeine monohydrateEquivalent of 20 mg of codeine monohydrate
Dihydrocodeine and its saltsEquivalent of 1.5 per cent of dihydrocodeineEquivalent of 10 mg of dihydrocodeine
Ethylmorphine andits saltsEquivalent of 0.2 per cent of ethylmorphineEquivalent of 7.5 mg of ethylmorphine
Morphine and its salts(1) Equivalent of 0.02 per cent anhydrous morphine(1) Liquid(1) Equivalent of 3 mg of anhydrous morphine
(2) Equivalent of 0.04 per cent of anhydrous morphine; equivalent of 300 mcg of anhydrous morphine(2) Solid(2) Equivalent of 3 mg of anhydrous morphine
Medicinal Opium(1) Equivalent of 0.02 per cent of anhydrous morphine(1) Liquid(1) Equivalent of 3 mg of anhydrous morphine
(2) Equivalent of 0.04 per cent of anhydrous morphine(2) Solid(2) Equivalent of 3 mg of anhydrous morphine
Pholcodine and its saltsEquivalent of 1.5 per cent of pholcodine monohydrateEquivalent of 20 mg of pholcodine monohydrate

Article 2(b)

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

  • Co-danthramer-Oral Suspension NPF

  • Co-danthramer-Oral Suspension Strong NPF

  • Co-danthrusate Capsules

  • Mebendazole Tablets NPF

  • Mebendazole Oral Suspension NPF

  • Miconazole Oral Gel NPF

  • Nystatin Oral Suspension

  • Nystatin Pastilles NPF

  • Streptokinase and Streptodornase Topical Powder NPF

Article 8(4)(c)

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

  • Ammonium Bromide

  • Calcium Bromide

  • Calcium Bromidolactobionate

  • Embutramide

  • Fencamfamin Hydrochloride

  • Fluanisone

  • Hexobarbitone

  • Hexobarbitone Sodium

  • Hydrobromic Acid

  • Meclofenoxate Hydrochloride

  • Methohexitone Sodium

  • Pemoline

  • Piracetam

  • Potassium Bromide

  • Prolintane Hydrochloride

  • Sodium Bromide

  • Strychnine Hydrochloride

  • Tacrine Hydrochloride

  • Thiopentone Sodium

Article 11(1)(a)

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

PART IEXEMPTION FROM RESTRICTIONS ON SALE OR SUPPLY

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
1. Persons selling or supplying prescription only medicines to universities, other institutions concerned with higher education or institutions concerned with research.1. All prescription only medicines
1.

The sale or supply shall be–

(a)

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

(i)

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

(ii)

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

(iii)

the total quantity required, and

(b)

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

2.

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

(1)

a public analyst appointed under section 27 of the Food Safety Act 1990(2) or article 36 of the Food (Northern Ireland) Order 1989(3),

(2)

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

(3)

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

(4)

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

(5)

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

2. All prescription only medicines.2. The sale or supply shall be subject to the presentation of an order signed by or on behalf of any person listed in column 1 of this paragraph stating the status of the person signing it and the amount of prescription only medicine required, and shall be only in connection with the exercise by those persons of their statutory functions.
3. Persons selling or supplying prescription only medicines to any person employed or engaged in connection with a scheme for testing the quality and checking the amount of the drugs and appliances supplied under the National Health Service Act 1977(4), the National Health Service (Scotland) Act 1978(5) and the Health and Personal Social Services (Northern Ireland) Order 1972(6), or under any subordinate legislation made under those Acts or that Order.3. All prescription only medicines.
3.

The sale or supply shall be–

(a)

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

(b)

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

4. Registered midwives.
4.

Prescription only medicines containing any of the following substances–

  • Chloral hydrate

  • Ergometrine maleate

  • Pentazocine hydrochloride

  • Triclofos sodium.

4. The sale or supply shall be only in the course of their professional practice and in the case of Ergometrine maleate only when contained in a medicinal product which is not for parenteral administration.
5. Persons lawfully conducting a retail pharmacy business within the meaning of section 69.
5.

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

(a)

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

(b)

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

(c)

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

  • Atropine sulphate

  • Bethanecol chloride

  • Carbachol

  • Cyclopentolate hydrochloride

  • Homatropine hydrobromide

  • Naphazoline hydrochloride

  • Naphazoline nitrate

  • Physostigmine salicylate

  • Physostigmine sulphate

  • Pilocarpine hydrochloride

  • Pilocarpine nitrate

  • Tropicamide.

5. The sale or supply shall be subject to the presentation of an order signed by a registered ophthalmic optician.
6. Registered ophthalmic opticians.6. Prescription only medicines listed in column 2 of paragraph 5.
6.

The sale or supply shall be only–

(a)

in the course of their professional practice and

(b)

in an emergency.

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

The sale or supply shall be–

(a)

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

(b)

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

8. Holders of marketing authorizations, product licences or manufacturer’s licences.8. Prescription only medicines referred to in the authorizations or licences.
8.

The sale or supply shall be only–

(a)

to a pharmacist,

(b)

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

(c)

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

9. Pharmacists selling or supplying to persons to whom cyanide salts may be sold by virtue of section 3 (regulation of poisons) or section 4 (exclusion of sales by wholesale and certain other sales) of the Poisons Act 1972(7) or by virtue of article 5 (prohibitions and regulations with respect to sale of poisons) or article 6 (exemption with respect to certain sales) of the Poisons (Northern Ireland) Order 1976(8).9. Amyl nitrite.9. The sale or supply shall only be so far as is necessary to enable an antidote to be available to persons at risk of cyanide poisoning.

Article 11(1)(b)

PART IIEXEMPTIONS FROM THE RESTRICTION ON SUPPLY

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
1. Royal National Lifeboat Institution and certified first aiders of the Institution.1. All prescription only medicines.1. The supply shall be only so far as is necessary for the the treatment of sick or injured persons in the exercise of the functions of the Institution.
2. The owner or the master of a ship which does not carry a doctor on board as part of her complement.2. All prescription only medicines.2. The supply shall be only so far as is necessary for the treatment of persons on the ship.
3. Persons authorized by licences granted under regulation 5 of the Misuse of Drugs Regulations to supply a controlled drug.3. Such prescription only medicines, being controlled drugs, as are specified in the licence.3. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence.
4. Persons requiring prescription only medicines for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees.4. Such prescription only medicines as may be specified in the relevant enactment.
4.

The supply shall be–

(a)

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

(b)

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

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

(1)

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

(2)

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

6. The operator or commander of an aircraft.6. Prescription only medicines which are not for parenteral administration and which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.6. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
7. Persons employed as qualified first-aid personnel on offshore installations.7. All prescription only medicines.7. The supply shall be only so far as is necessary for the treatment of persons on the installation.

Article 11(2)

PART IIIEXEMPTIONS FROM RESTRICTION ON ADMINISTRATION Column 1

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

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

  • Bupivacaine hydrochloride

  • Lignocaine hydrochloride

  • Prilocaine hydrochloride.

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

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

  • Ergometrine maleate

  • Lignocaine

  • Lignocaine hydrochloride

  • Naloxone hydrochloride

  • Oxytocins, natural and synthetic

  • Pentazocine lactate

  • Pethidine hydrochloride

  • Phytomenadione

  • Promazine hydrochloride.

2. The administration shall be only in the course of their professional practice and in the case of Promazine hydrochloride, Lignocaine and Lignocaine hydrochloride shall be only while attending on a woman in childbirth.
3. Persons who are authorized as members of a group by a group authority granted under regulations 8(3) or 9(3) of the Misuse of Drugs Regulations to supply a controlled drug by way of administration only.3. Prescription only medicines that are specified in the group authority.3. The administration shall be subject to such conditions and in such circumstances and to such extent as may be specified in the group authority.
4. The owner or master of a ship which does not carry a doctor on board as part of her complement.4. All prescription only medicines that are for parenteral administration.4. The administration shall be only so far as is necessary for the treatment of persons on the ship.
5. Persons operating an occupational health scheme.5. Prescription only medicines for parenteral administration sold or supplied to the person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.
5.

(1)

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

(2)

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

6. The operator or commander of an aircraft.6. Prescription only medicines for parenteral administration which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.6. The administration shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
7. Persons who are, and at 11th February 1982 were, persons customarily administering medicinal products to human beings by parenteral administration in the course of a business in the field of osteopathy, naturopathy, acupuncture or other similar field except chiropody.7. Medicinal products that are prescription only medicines by reason only that they fall within the class specified in article 3(c) (products for parenteral administration).7. The person administering the prescription only medicine shall have been requested by or on behalf of the person to whom it is administered and in that person’s presence to use his own judgement as to the treatment required.
8. Persons employed as qualified first-aid personnel on offshore installations.8. All prescription only medicines that are for parenteral administration.8. The administration shall be only so far as is necessary for the treatment of persons on the installation.
9. Persons who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State.
9.

The following prescription only medicines for parenteral administration–

(a)

Diazepam 5 mg per ml emulsion for injection;

(b)

Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion;

(c)

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

  • Adrenaline Acid Tartrate

  • Anhydrous Glucose

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

  • Ergometrine Maleate

  • Glucose

  • Heparin Sodium

  • Lignocaine Hydrochloride

  • Nalbuphine Hydrochloride

  • Naloxone Hydrochloride

  • Polygeline

  • Sodium Bicarbonate

  • Sodium Chloride

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

Article 16(1)

SCHEDULE 6ORDERS REVOKED

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

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