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

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

Annotations:
Amendments (Textual)

Exemptions from the restrictions on the sale and supply of prescription only medicines

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Maximum strength

Route of administration, use or pharmaceutical form

Treatment limitations

Maximum quantity

F49Acamprosate

Acarbose

Acebutolol Hydrochloride

F49Aceclofenac

Acemetacin

Acetarsol

Acetazolamide

Acetazolamide Sodium

Acetohexamide

Acetylcholine Chloride

0.2 per cent

External

Acetylcysteine

Acipimox

Aciclovir

5.0 per cent

External

Container or package containing not more than 2g of medicinal product

For treatment of herpes simplex virus infections of the lips and face (Herpes labialis)

Acitretin

Aclarubicin Hydrochloride

Aconite

1.3 per cent

External

Acrivastine

24 mg (MDD)

Container or package containing not more than 240mg of Acrivastine

Acrosoxacin

Actinomycin C

Actinomycin D

F46Adapalene

Adenosine

Adrenaline

(1) By inhaler

(2) External F69(except ophthalmic)

Adrenaline Acid Tartrate

(1) By inhaler

(2) External

Adrenaline Hydrochloride

(1) By inhaler

(2) External

Adrenocortical Extract

Albendazole

Alclofenac

Alclometasone Dipropionate

Alcuronium Chloride

Aldesleukin

Aldosterone

F49Alendronate Sodium

Alfacalcidol

Alfuzosin Hydrochloride

Allergen Extracts

Allopurinol

Allyloestrenol

F34Aloxiprin

(1) 620 mg

(1) Non-effervescent tablets and capsules

(1) The quantity sold or supplied in one container or package shall not exceed 32

The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

(2) All preparations other than non-effervescent tablets or capsules

Alphadolone Acetate

Alphaxalone

Alprenolol

Alprenolol Hydrochloride

Alprostadil

Alseroxylon

F46Altretamine

Amantadine Hydrochloride

Ambenonium Chloride

Ambutonium Bromide

Amcinonide

Ametazole Hydrochloride

Amethocaine

Non-ophthalmic use

Amethocaine Gentisate

Non-ophthalmic use

Amethocaine Hydrochloride

Non-ophthalmic use

Amikacin Sulphate

Amiloride Hydrochloride

Aminocaproic Acid

Aminoglutethimide

Aminopterin Sodium

Amiodarone Hydrochloride

Amiphenazole Hydrochloride

F77Amisulpride

Amitriptyline

Amitriptyline Embonate

Amitriptyline Hydrochloride

Amlodipine Besylate

Ammonium Bromide

Amodiaquine Hydrochloride

Amorolfine Hydrochloride

Amoxapine

Amoxycillin

Amoxycillin Sodium

Amoxycillin Trihydrate

Amphomycin Calcium

Amphotericin

Ampicillin

Ampicillin Sodium

Ampicillin Trihydrate

Amsacrine

Amygdalin

Amyl Nitrite

Amylocaine Hydrochloride

Non-ophthalmic use

F49Anastrozole

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

F46Apraclonidine 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

F19Aspirin

F381

75mg

F381

Non-effervescent tablets and capsules

F381

The quantity sold or supplied in one container or package shall not exceed 100

  • The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

F21F372

500 mg

F372

Non-effervescent tablets and capsules

F372

The quantity sold or supplied in one container or package shall not exceed 32

F373

All preparations other than non-effervescent tablets or capsules

  • The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

Astemizole

F22. . .

F22. . .

F22. . .

F22. . .

F22. . .

Atenolol

Atracurium Besylate

Atropine

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 300mcg (MD)

1mg (MDD)

(2) External (except ophthalmic)

Atropine Methobromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 400mcg (MD)

1.3mg (MDD)

(2) External (except ophthalmic)

Atropine Methonitrate

Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 400mcg (MD)

1.3mg (MDD)

Atropine Oxide Hydrochloride

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 360mcg (MD)

1.2mg (MDD) 3

(2) External (except ophthalmic)

Atropine Sulphate

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 360mcg (MD)

1.2mg (MDD)

(2) External (except ophthalmic)

Auranofin

Azapropazone

Azathioprine

Azathioprine Sodium

Azelaic Acid

Azelastine Hydrochloride

For nasal administration

140mcg per nostril (MD)

Container or package containing not more than 5,040mcg of Azelastine Hydrochloride

For the treatment of seasonal allergic rhinitis F52or perennial allergic rhinitis

280mcg per nostril (MDD)

For use in adults and children not less than F535 years

As a non-aerosol, aqueous form

Azidocillin Potassium

Azithromycin

Azlocillin Sodium

Aztreonam

Bacampicillin Hydrochloride

Bacitracin

Bacitracin Methylene Disalicylate

Bacitracin Zinc

Baclofen

F77Balsalazide Sodium

Bambuterol Hydrochloride

Barium Carbonate

Barium Chloride

Barium Sulphide

Beclamide

Beclomethasone

Beclomethasone Dipropionate

For nasal administration (non-aerosol)

100mcg per nostril (MD)

Container or package containing not more than F3920,000 mcg of Beclomethasone Dipropionate

For the prevention and treatment of allergic rhinitis

200 mcg per nostril (MDD)

F24For a maximum period of 3 months

F23For use in persons aged 18 years and over

Belladonna Herb

(1) Internal

(1) 1mg of the alkaloids (MDD)

(2) External

Belladonna Root

(1) Internal

(1) 1mg of the alkaloids (MDD)

(2) External

Bemegride

Bemegride Sodium

Benapryzine Hydrochloride

Bendrofluazide

Benethamine Penicillin

Benoxaprofen

Benperidol

F77Benserazide

Benserazide Hydrochloride

Bentiromide

Benzathine Penicillin

Benzbromarone

Benzhexol Hydrochloride

Benzilonium Bromide

Benzocaine

Any use except ophthalmic use

Benzoctamine Hydrochloride

Benzoyl Peroxide

10.0 per cent

External

N-Benzoyl Sulphanilamide

Benzquinamide

Benzquinamide Hydrochloride

Benzthiazide

Benztropine Mesylate

Benzylpenicillin Calcium

Benzylpenicillin Potassium

Benzylpenicillin Sodium

Beractant

Betahistine Hydrochloride

Betamethasone

Betamethasone Adamantoate

Betamethasone Benzoate

Betamethasone Dipropionate

Betamethasone Sodium Phosphate

Betamethasone Valerate

Betaxolol Hydrochloride

Bethanechol Chloride

Bethanidine Sulphate

Bezafibrate

F46Bicalutamide

Biperiden Hydrochloride

Biperiden Lactate

Bismuth Glycollylarsanilate

Bisoprolol Fumarate

Bleomycin

Bleomycin Sulphate

Bretylium Tosylate

F77Brimonidine Tartrate

Bromhexine Hydrochloride

Bromocriptine Mesylate

Bromperidol

Bromvaletone

Brotizolam

Budesonide

For nasal administration

200mcg per nostril (MD)

Container or package containing not more than 10mg of Budesonide

For the prevention or treatment of seasonal allergic rhinitis

F24For a maximum period of 3 months

200 mcg per nostril (MDD)

F23For use in persons aged 18 years and over

As a non-aerosol, aqueous form

Bufexamac

Bumetanide

Buphenine Hydrochloride

6mg (MD)

18mg (MDD)

Bupivacaine

Any use except ophthalmic use

Bupivacaine Hydrochloride

Any use except ophthalmic use

Buserelin Acetate

Buspirone Hydrochloride

Busulphan

Butacaine Sulphate

Any use except ophthalmic use

Butorphanol Tartrate

Butriptyline Hydrochloride

F64Cabergoline

Calcipotriol

F46Calcipotriol Hydrate

Calcitonin

Calcitriol

Calcium Amphomycin

Calcium Benzamidosalicylate

Calcium Bromide

Calcium Bromidolactobionate

Calcium Carbimide

Calcium Folinate

Calcium Metrizoate

Calcium Sulphaloxate

F43Candesartan Cilexetil

Candicidin

Canrenoic Acid

Cantharidin

0.01 per cent

External

Capreomycin Sulphate

Captopril

Carbachol

Carbamazepine

Carbaryl

F77Carbasalate Calcium

Carbenicillin Sodium

Carbenoxolone Sodium

(1) Pellet

(1) 5mg (MD)

25mg (MDD)

(2) 2.0 per cent

(2) Gel

(3) 1.0 per cent

(3) Granules for mouthwash in adults and children not less than 12 years

(3) 20mg (MD)

(3) Container or package containing not more than F1560mg 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

F77Cefdinir

Cefixime

Cefodizime Sodium

Cefotaxime Sodium

Cefoxitin Sodium

Cefpodoxime Proxetil

F64Cefprozil

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

F77Cerivastatin Sodium

Ceruletide Diethylamine

Cetirizine Hydrochloride

10mg (MDD)

F78. . .

Chenodeoxycholic Acid

Chloral Hydrate

External

Chlorambucil

Chloramphenicol

Chloramphenicol Cinnamate

Chloramphenicol Palmitate

Chloramphenicol Sodium Succinate

Chlorhexadol

Chlormadinone Acetate

Chlormerodrin

Chlormethiazole

Chlormethiazole Edisylate

Chlormezanone

Chloroform20

(1) 5.0 per cent

(1) Internal

(2) External

Chloroquine Phosphate

Prophylaxis of malaria

Chloroquine Sulphate

Prophylaxis of malaria

Chlorothiazide

Chlorotrianisene

Chlorphenoxamine Hydrochloride

Chlorpromazine

Chlorpromazine Embonate

Chlorpromazine Hydrochloride

Chlorpropamide

Chlorprothixene

Chlorprothixene Hydrochloride

Chlortetracycline

Chlortetracycline Calcium

Chlortetracycline Hydrochloride

Chlorthalidone

Chlorzoxazone

Cholestyramine

Ciclacillin

Ciclobendazole

Cilastatin Sodium

Cilazapril

Cimetidine

(a) For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity and for the prophylaxis of meal-induced heartburn

(a) 200mg (MD)

800mg (MDD)

For a maximum period of 14 days

(b) For the prophylactic management of nocturnal heartburn by a single dose taken at night

(b) 100mg (MD) to be taken as a single dose at night

For a maximum period of 14 days

Cimetidine Hydrochloride

Cinchocaine

3.0 per cent

Non-ophthalmic use

Cinchocaine Hydrochloride

Equivalent of 3.0 per cent of Cinchocaine

Non-ophthalmic use

Cinchophen

Cinoxacin

Ciprofibrate

Ciprofloxacin

Ciprofloxacin Hydrochloride

Cisapride

Cisplatin

F46Citalopram Hydrobromide

Clarithromycin

Clavulanic Acid

Clidinium Bromide

Clindamycin

Clindamycin Hydrochloride

Clindamycin Palmitate Hydrochloride

Clindamycin Phosphate

Clioquinol

(1) External (other than treatment of mouth ulcers)

(2) 35mg

(2) Treatment of mouth ulcers

(2) 350mg (MDD)

Clobetasol Propionate

Clobetasone Butyrate

F760.05 per cent

F76Cream for use in adults and in children aged 12 years and over, for external use for the short term symptomatic treatment and control of patches of eczema and dermatitis (excluding seborrhoeic dermatitis)

F76Container or package containing not more than 15g of medicinal product

Clofazimine

Clofibrate

Clomiphene Citrate

Clomipramine

Clomipramine Hydrochloride

Clomocycline

Clomocycline Sodium

Clonidine

Clonidine Hydrochloride

Clopamide

Clopenthixol Decanoate

Clopenthixol Hydrochloride

Clorexolone

Clotrimazole

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

Cloxacillin Benzathine

Cloxacillin Sodium

Clozapine

Cocculus Indicus

Co-dergocrine Mesylate

Colaspase

Colchicine

Colestipol Hydrochloride

Colfosceril Palmitate

Colistin Sulphate

Colistin Sulphomethate

Colistin Sulphomethate Sodium

Coniine

Conium Leaf

7.0 per cent

External

Corticotrophin

Cortisone

Cortisone Acetate

Co-tetroxazine

Co-trimoxazole

Cropropamide

Crotethamide

Croton Oil

Croton Seed

Curare

Cyclofenil

Cyclopenthiazide

Cyclopentolate Hydrochloride

Cyclophosphamide

Cycloserine

Cyclosporin

Cyclothiazide

Cyproterone Acetate

Cytarabine

Cytarabine Hydrochloride

Dacarbazine

Dalteparin Sodium

Danazol

Danthron

Dantrolene Sodium

Dapsone

Dapsone Ethane Ortho Sulphonate

Daunorubicin Hydrochloride

Deanol Bitartrate

26mg (MDD)

Debrisoquine Sulphate

Demecarium Bromide

Demeclocycline

Demeclocycline Calcium

Demeclocycline Hydrochloride

Deoxycortone Acetate

Deoxycortone Pivalate

Deptropine Citrate

Dequalinium Chloride

(1) 0.25mg

(1) Internal: throat lozenges or throat pastilles

(2) 1.0 per cent

(2) External: paint

Deserpidine

Desferrioxamine Mesylate

Desflurane

Desipramine Hydrochloride

Deslanoside

Desmopressin

Desmopressin Acetate

Desogestrel

Desonide

Desoxymethasone

Dexamethasone

Dexamethasone Acetate

Dexamethasone Isonicotinate

Dexamethasone Phenylpropionate

Dexamethasone Pivalate

Dexamethasone Sodium Metasulphobenzoate

Dexamethasone Sodium Phosphate

Dexamethasone Troxundate

Dexfenfluramine Hydrochloride

Dextromethorphan Hydrobromide

Internal

(a) In the case of a prolonged release preparation: equivalent of 30mg of Dextromethorphan (MD)

equivalent of 75mg of Dextromethorphan (MDD)

(b) in any other case: equivalent of 15mg of Dextromethorphan (MD)

equivalent of 75mg of Dextromethorphan (MDD)

Dextrothyroxine Sodium

Diazoxide

Dibenzepin Hydrochloride

Dichloralphenazone

Dichlorphenamide

Diclofenac Diethylammonium

1.16 per cent

External

For maximum period of 7 days

Container or package containing not more than 30g of medicinal product

For local symptomatic relief of pain and inflammation in trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism

For use in adults and children not less than 12 years

Diclofenac Potassium

Diclofenac Sodium

Dicyclomine Hydrochloride

10mg (MD)

60mg (MDD)

F49Didanosine

Dienoestrol

Diethanolamine Fusidate

Diflucortolone Valerate

Diflunisal

Digitalin

Digitalis Leaf

Digitalis Prepared

Digitoxin

Digoxin

Dihydralazine Sulphate

Dihydroergotamine Mesylate

Dihydrostreptomycin

Dihydrostreptomycin Sulphate

Diloxanide Furoate

Diltiazem Hydrochloride

Dimercaprol

Dimethisoquin Hydrochloride

Non-ophthalmic use

Dimethisterone

Dimethothiazine Mesylate

Dimethyl Sulphoxide

Dimethyltubocurarine Bromide

Dimethyltubocurarine Chloride

Dimethyltubocurarine Iodide

Dinoprost

Dinoprost Trometamol

Dinoprostone

F34Diphenhydramine Hydrochloride

All preparations except liquid-filled capsules

F87Diphenoxylate Hydrochloride

F872.5 mg

F87In combination with Atropine Sulphate for short term use as an adjunctive therapy to appropriate rehydration in acute diarrhoea

F8725 mg (MDD)

F87Container or package containing not more than 20 tablets

For use in persons aged 16 years and over

Tablets

Dipivefrin Hydrochloride

Dipyridamole

Disodium Etidronate

Disodium Pamidronate

Disopyramide

Disopyramide Phosphate

Distigmine Bromide

Disulfiram

Dithranol

1.0 per cent

Dobutamine Hydrochloride

F87Dolasetron Mesilate

Domperidone

F54For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn

F5410mg of Domperidone (MD)

F54Container or package containing not more than 200mg of Domperidone

F5440mg of Domperidone (MDD)

Domperidone Maleate

F11For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn,

F2510 mg of Domperidone as Domperidone Maleate (MD)

F11Container or package containing not more than F55200mg of Domperidone as Domperidone Maleate;

F2540 mg of Domperidone as Domperidone Maleate (MDD)

F77Donepezil Hydrochloride

Dopamine Hydrochloride

Dopexamine Hydrochloride

F46Dorzolamide Hydrochloride

Dothiepin

Dothiepin Hydrochloride

Doxapram Hydrochloride

Doxazosin Mesylate

Doxepin Hydrochloride

Doxorubicin

Doxorubicin Hydrochloride

Doxycycline

Doxycycline Calcium Chelate

Doxycycline Hydrochloride

Droperidol

Dydrogesterone

Dyflos

Econazole

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

Econazole Nitrate

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

Ecothiopate Iodide

Edrophonium Chloride

Eflornithine Hydrochloride

F49Eformoterol Fumarate

Embutramide

Emepronium Bromide

Emetine

1.0 per cent

Emetine Bismuth Iodide

Emetine Hydrochloride

Equivalent of 1.0 per cent of Emetine

Enalapril Maleate

Encephalitis Virus, Tick-borne, Cent Eur

Enoxacin

Enoxaparin Sodium

Enoximone

Ephedrine

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

(1) 30mg (MD)

60mg (MDD)

(2) 2.0 per cent

(2) Nasal sprays or nasal drops

(3) External

Ephedrine Hydrochloride

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

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

Equivalent of 60mg of Ephedrine (MDD)

(2) Equivalent of 2.0 per cent of Ephedrine

(2) Nasal sprays or nasal drops

(3) External

Ephedrine Sulphate

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

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

Equivalent of 60mg of Ephedrine (MDD)

(2) Equivalent of 2.0 per cent of Ephedrine

(2) Nasal sprays or nasal drops

(3) External

Epicillin

Epirubicin

Epirubicin Hydrochloride

Epithiazide

Epoetin Alfa

Epoetin Beta

Epoprostenol Sodium

Ergometrine Maleate

Ergometrine Tartrate

Ergot, Prepared

Ergotamine Tartrate

Erythromycin

Erythromycin Estolate

Erythromycin Ethylcarbonate

Erythromycin Ethyl Succinate

Erythromycin Lactobionate

Erythromycin Phosphate

Erythromycin Stearate

Erythromycin Thiocyanate

Esmolol Hydrochloride

Estramustine Phosphate

F7Estramustine Sodium Phosphate

Etafedrine Hydrochloride

Ethacrynic Acid

Ethambutol Hydrochloride

Ethamivan

Ethamsylate

Ethiazide

Ethinyl Androstenediol

Ethinyloestradiol

Ethionamide

Ethisterone

Ethoglucid

Ethoheptazine Citrate

Ethopropazine Hydrochloride

Ethosuximide

Ethotoin

Ethyl Biscoumacetate

Ethynodiol Diacetate

Etodolac

Etomidate

Etomidate Hydrochloride

Etoposide

Etretinate

F46Exemestane

Famciclovir

Famotidine

For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity, and prevention of these symptoms when associated with food and drink, including nocturnal symptoms

10mg (MD)

20mg (MDD)

For maximum period of 14 days

Fazadinium Bromide

Felbinac

3.17 per cent

External

For maximum period of 7 days

Container or package containing not more than F4450g of medicinal product

F26For the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries such as sprains, strains and contusions

For use in adults and children not less than 12 years

Felodipine

Felypressin

Fenbufen

Fenclofenac

Fenfluramine Hydrochloride

Fenofibrate

Fenoprofen

Fenoprofen Calcium

Fenoterol Hydrobromide

Fenticonazole Nitrate

F76External use (but in the case of vaginal use, only for the treatment of vaginal candidiasis)

Feprazone

Ferrous Arsenate

F46Ferumoxsil

F77Fexofenadine Hydrochloride

Filgrastim

Finasteride

Flavoxate Hydrochloride

Flecainide Acetate

Flosequinan

Fluanisone

Flubendazole

Fluclorolone Acetonide

Flucloxacillin Magnesium

Flucloxacillin Sodium

Fluconazole

For oral administration for the treatment of vaginal candidiasis F70or associated candidal balanitis in persons aged not less than 16 but less than 60 years

150mg (MD)

Container or package containing not more than 150mg of Fluconazole

Flucytosine

Fludrocortisone Acetate

Flufenamic Acid

Flumazenil

Flumethasone

Flumethasone Pivalate

Flunisolide

0.025 per cent

(a) For the prevention and treatment of seasonal allergic rhinitis, including hay fever

(a) 50mcg per nostril (MD)

(a) Container or package containing not more than 6,000mcg of Flunisolide

100mcg per nostril (MDD)

F27For use in persons aged 18 years and over

F28For a maximum period of 3 months

In the form of a non-pressurised nasal spray

F29...

F29...

F29...

F29. . .

F29. . .

F29. . .

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

F798.75 mg

F80Throat lozenges

F8143.75 mg (MDD)

F82Container or package containing not more than 140 mg of Flurbiprofen

Flurbiprofen Sodium

Fluspirilene

Flutamide

Fluticasone Propionate

F77Flutrimazole

Fluvastatin Sodium

Fluvoxamine Maleate

Folic Acic

500mcg (MDD)

Formestane

Formocortal

Foscarnet Sodium

Fosfestrol Sodium

Fosfomycin Trometamol

Fosinopril Sodium

Framycetin Sulphate

Frusemide

Furazolidone

Fusafungine

Fusidic Acid

Gabapentin

Gadoteridol

Gallamine Triethiodide

Ganciclovir

Ganciclovir Sodium

Gelsemine

0.1 per cent

Gelsemium

25mg (MD)

75mg (MDD)

Gemeprost

Gemfibrozil

Gentamicin

Gentamicin Sulphate

Gestodene

Gestrinone

Gestronol

Gestronol Hexanoate

Glibenclamide

Glibornuride

Gliclazide

Glipizide

Gliquidone

Glisoxepide

Glucagon

Glycopyrronium Bromide

1mg (MD)

2mg (MDD)

Glymidine

Gonadorelin

Goserelin Acetate

Gramicidin

0.2 per cent

External

Granisetron Hydrochloride

Griseofulvin

Growth Hormone

Guanethidine Monosulphate

Guanfacine Hydrochloride

Guanoclor Sulphate

Guanoxan Sulphate

Halcinonide

Halofantrine Hydrochloride

Haloperidol

Haloperidol Decanoate

Heparin

External

Heparin Calcium

External

Heparin Sodium

Hexachlorophane

External

(a) 2.0 per cent

(a) Soaps

(b) 0.1 per cent

(b) Aerosols

(c) 0.75 per cent

(c) preparations other than soaps and aerosols

Hexamine Phenylcinchoninate

Hexobarbitone

Hexobarbitone Sodium

Hexoestrol

Hexoestrol Dipropionate

L-Histidine Hydrochloride

Dietary supplementation

Homatropine

(1) Internal

(1) 0.15mg (MD)

0.45mg (MDD)

(2) External (except ophthalmic)

Homatropine Hydrobromide

0.2mg (MD)

0.6mg (MDD)

Homatropine Methylbromide

2mg (MD)

6mg (MDD)

Hydralazine Hydrochloride

Hydrargaphen

Local application to skin

Hydrobromic Acid

Hydrochlorothiazide

Hydrocortisone

F411

0.5 per cent

F411

External

  1. a

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

  2. b

    For use in adults and children not less than 10 years

F411

Container or package containing not more than 15g of medicinal product

F402

1.0 per cent

F402

External

  1. a

    For use either alone or in conjunction with Crotamiton in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and either in combination with Clotrimazole F3or Miconazole Nitrate for athlete’s foot and candidal intertrigo or in combination with lignocaine for anal and perianal itch associated with haemorrhoids

  2. b

    For use in adults and children not less than 10 years

  3. c

    Cream ointment or spray

F402

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

Hydrocortisone Acetate

Equivalent to 1.0 per cent Hydrocortisone

External

For use in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and in combination with one or more of the following: Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Peru Balsam, Pramoxine Hydrochloride, Zinc Oxide, for haemorrhoids F71or in combination with Miconazole Nitrate, for athlete’s foot and candidal intertrigo

Container or package containing not more than 15g of medicinal product

In the case of suppositories, container or package containing no more than 12

For use in adults and children not less than 10 years

Cream, ointment or suppositories

Hydrocortisone Butyrate

Hydrocortisone Caprylate

Hydrocortisone Hydrogen Succinate

Hydrocortisone Sodium Phosphate

Hydrocortisone Sodium Succinate

Equivalent to 2.5mg Hydrocortisone

External

Container or package containing not more than equivalent to 50mg of Hydrocortisone

For aphthous ulceration of the mouth for adults and children not less than 12 years

In the form of pellets

F34Hydrocyanic Acid

Hydroflumethiazide

Hydroxychloroquine Sulphate

Prophylaxis of malaria

Hydroxyprogesterone

Hydroxyprogesterone Enanthate

Hydroxyprogesterone Hexanoate

Hydroxyurea

Hydroxyzine Embonate

Hydroxyzine Hydrochloride

(a) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in adults and in children not less than 12 years

(a) 25mg (MD)

(a) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride

75mg (MDD)

(b) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in children not less than 6 years but less than 12 years

(b) 25 mg (MD)

(b) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride

50mg (MDD)

Hyoscine

(1) 0.15 per cent

(1) Internal

(2) External (except ophthalmic)

Hyoscine Butylbromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 20mg (MD)

(b) Container or package containing not more than 240mg of Hyoscine Butylbromide

80mg (MDD)

(2) External

Hyoscine Hydrobromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 300mcg (MD)

900mcg (MDD)

(2) External (except ophthalmic)

Hyoscine Methobromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 2.5mg (MD)

7.5mg (MDD)

(2) External

Hyoscine Methonitrate

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 2.5mg (MD)

7.5mg (MDD)

(2) External

Hyoscyamine

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 300mcg (MD)

1mg (MDD)

(2) External

Hyoscyamine Hydrobromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) Equivalent of 300mcg of Hyoscyamine (MD)

Equivalent of 1mg of Hyoscyamine (MDD)

(2) External

Hyoscyamine Sulphate

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) Equivalent of 300mcg of Hyoscyamine (MD)

Equivalent of 1mg of Hyoscyamine (MDD)

(2) External

Ibuprofen

Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza

(1) Internal

(1)(a) In the case of a prolonged release preparation 600mg (MD)

1,200mg (MDD)

(b) in any other case 400mg (MD)

1,200mg (MDD)

(2) 5.0 per cent

(2) External

F47(3) 10.0 per cent

F47(3) External

F47(3) 125 mg (MD) 500 mg (MDD)

F47(3) Container or package containing not more than F5650g of medicinal product

F34Ibuprofen Lysine

Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza

(a) in the case of a prolonged release preparation 600 mg (MD) 1,200 mg (MDD)

Internal

(b) in any other case 400 mg (MD) 1,200 mg (MDD)

Idarubicin Hydrochloride

Idoxuridine

Ifosfamide

Ignatius Bean

F49Imidapril Hydrochloride

Imipenem Hydrochloride

Imipramine

Imipramine Hydrochloride

Imipramine Ion Exchange Resin Bound Salt or Complex

F64Indapamide

Indapamide Hemihydrate

Indomethacin

Indomethacin Sodium

Indoprofen

Indoramin Hydrochloride

Inosine Pranobex

F18Insulin

Iodamide

Iodamide Meglumine

Iodamide Sodium

Iohexol

Iomeprol

Iopamidol

Iopentol

Iothalamic Acid

Ioversol

Ioxaglic Acid

Ipratropium Bromide

Iprindole Hydrochloride

Iproniazid Phosphate

F77Irbesartan

Isoaminile

Isoaminile Citrate

Isocarboxazid

Isoconazole Nitrate

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

Isoetharine

Isoetharine Hydrochloride

Isoetharine Mesylate

Isoniazid

Isoprenaline Hydrochloride

Isoprenaline Sulphate

Isopropamide Iodide

Equivalent of 2.5mg of Isopropamide ion (MD)

Equivalent of 5.0mg of Isopropamide ion (MDD)

Isotretinoin

Isradipine

Itraconazole

Jaborandi

External

Kanamycin Acid Sulphate

Kanamycin Sulphate

Ketamine Hydrochloride

Ketoconazole

2.0 per cent

F31(a)F30External

F31(a) Maximum frequency of application of once every 3 days

F31(a) Container or package containing not more than 120ml of medicinal product and containing not more than 2,400mg of Ketoconazole

For the prevention and treatment of dandruff and seborrhoeic dermatitis of the scalp

In the form of a shampoo

F32(b) For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo

Ketoprofen

2.5 per cent

External

For maximum period of 7 days

Container or package containing not more than 30g of medicinal product

For rheumatic and muscular pain in adults and children not less than 12

Ketorolac Trometamol

Ketotifen Fumarate

Labetalol Hydrocholoride

Lachesine Chloride

Lacidipine

Lamotrigine

Lanatoside C

Lanatoside Complex A, B and C

F64Lansoprazole

Latamoxef Disodium

F64Lercanidipine Hydrochloride

Levallorphan Tartrate

Levobunolol Hydrochloride

F34Levocabastine Hydrochloride

Equivalent of 0.05 per cent Levocabastine

(1) Nasal sprays

(1) Container or package containing not more than 10 ml of medicinal product

For the symptomatic treatment of seasonal allergic rhinitis

(2) Aqueous eye drops

(2) Container or package containing not more than 4 ml of medicinal product

For the symptomatic treatment of seasonal allergic conjunctivitis

F45Levocarnitine

F45For dietary supplementation

Levodopa

F77Levofloxacin

Levonorgestrel

F680.75mg

F68for use as an emergency contraceptive in women aged 16 years and over

Lidoflazine

Lignocaine

Non-ophthalmic use

Lignocaine Hydrochloride

Non-ophthalmic use

Lincomycin

Lincomycin Hydrochloride

Liothyronine Sodium

Lisinopril

Lithium Carbonate

Equivalent of 5mg of Lithium (MD)

Equivalent of 15mg of Lithium (MDD)

Lithium Citrate

Lithium Succinate

Lithium Sulphate

Equivalent of 5mg of Lithium (MD)

Equivalent of 15mg of Lithium (MDD)

Lobeline

(1) Internal

(1) 3mg (MD)

9mg (MDD)

(2) External

Lobeline Hydrochloride

(1) Internal

(1) Equivalent of 3mg of Lobeline (MD)

Equivalent of 9mg of Lobeline (MDD)

(2) External

Lobeline Sulphate

(1) Internal

(1) Equivalent of 3mg of Lobeline (MD)

Equivalent of 9mg of Lobeline (MDD)

(2) External

Lodoxamide Trometamol

F57equivalent of 0.1 per cent Lodoxamide

F58For the treatment of ocular signs and symptoms of allergic conjunctivitis, in adults and in children aged 4 years and over

Lofepramine

Lofepramine Hydrochloride

Lofexidine Hydrochloride

Lomefloxacin Hydrochloride

Lomustine

Loperamide Hydrochloride

Treatment of acute diarrhoea

Loratidine

10mg (MDD)

F83. . .

F43Lornoxicam

F43Losartan Potassium

Loxapine Succinate

Lung Surfactant Porcine

Luteinising Hormone

Lymecycline

Lynoestrenol

Lypressin

Lysuride Maleate

Mafenide

Mafenide Acetate

Mafenide Hydrochloride

Mafenide Propionate

5.0 per cent

Eye drops

Magnesium Fluoride

Magnesium Metrizoate

Mandragora Autumnalis

Mannomustine Hydrochloride

Maprotiline Hydrochloride

Mebanazine

Mebendazole

For oral use in the treatment of enterobiasis in adults and in children not less than 2 years

100mg (MD)

Container or package containing not more than 800mg of Mebendazole

Mebeverine Hydrochloride

F4a

For the symptomatic relief of irritable bowel syndrome

F4a

135 mg (MD)

405 mg (MDD)

b

For uses other than the symptomatic relief of irritable bowel syndrome

F4b

100 mg (MD)

300 mg (MDD)

Mebeverine Pamoate

Mebhydrolin

Mebhydrolin Napadisylate

Mecamylamine Hydrochloride

Mecillinam

Meclofenoxate Hydrochloride

Medigoxin

Medrogestone

Medroxyprogesterone Acetate

Mefenamic Acid

Mefloquine Hydrochloride

Mefruside

Megestrol

Megestrol Acetate

Meglumine Gadopentetate

Meglumine Iodoxamate

Meglumine Ioglycamate

Meglumine Iothalamate

Meglumine Iotroxate

Meglumine Ioxaglate

F64Meloxicam

Melphalan

Melphalan Hydrochloride

Menotrophin

Mepenzolate Bromide

25mg (MD)

75mg (MDD)

Mephenesin

Mephenesin Carbamate

Mepivacaine Hydrochloride

Any use except ophthalmic use

Meptazinol Hydrochloride

Mequitazine

F77Mercaptamine Bitartrate

Mercaptopurine

Mersalyl

Mersalyl Acid

Mesalazine

Mesna

Mestranol

Metaraminol Tartrate

Metergoline

Metformin Hydrochloride

Methacycline

Methacycline Calcium

Methacycline Hydrochloride

Methallenoestril

Methicillin Sodium

Methixene

Methixene Hydrochloride

Methocarbamol

Methocidin

Throat lozenges and throat pastilles

Methohexitone Sodium

Methoin

Methoserpidine

Methotrexate

Methotrexate Sodium

Methotrimeprazine

Methotrimeprazine Hydrochloride

Methotrimeprazine Maleate

Methoxamine Hydrochloride

0.25 per cent

Nasal sprays or nasal drops not containing liquid paraffin as a vehicle

Methsuximide

Methyclothiazide

Methyldopa

Methyldopate Hydrochloride

Methylephedrine Hydrochloride

30mg (MD)

60mg (MDD)

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Sodium Succinate

Methylthiouracil

Methysergide Maleate

Metipranolol

Metirosine

Metoclopramide Hydrochloride

Metolazone

Metoprolol Fumarate

Metoprolol Succinate

Metoprolol Tartrate

Metronidazole

Metronidazole Benzoate

Metyrapone

Mexiletine Hydrochloride

Mezlocillin Sodium

Mianserin Hydrochloride

Miconazole

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

Miconazole Nitrate

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

Mifepristone

Miglitol

Milrinone

Milrinone Lactate

Minocycline

Minocycline Hydrochloride

Minoxidil

F12(1) 2.0 per cent

F12(1) External

F12(2) 5.0 per cent

(2) External use for the treatment of alopecia androgenetica, in men aged 18 to 65 (but not in women);

F49Mirtazapine

Misoprostol

Mitobronitol

Mitomycin

Mitozantrone Hydrochloride

Mivacurium Chloride

F7Mizolastine

Moclobemide

F77Modafinil

F46Moexipril Hydrochloride

Molgramostim

Molindone Hydrochloride

Mometasone Furoate

Moracizine Hydrochloride

Morazone Hydrochloride

F49Moxonidine

Mupirocin

Mupirocin Calcium

Mustine Hydrochloride

Nabilone

Nabumetone

Nadolol

Nafarelin Acetate

Naftidrofuryl Oxalate

Naftifine Hydrochloride

Nalbuphine Hydrochloride

Nalidixic Acid

Nalorphine Hydrobromide

Naloxone Hydrochloride

Naltrexone Hydrochloride

Naphazoline Hydrochloride

(1) 0.05 per cent

(1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle

(2) 0.015 per cent

(2) Eye drops

Naphazoline Nitrate

0.05 per cent

Nasal sprays or nasal drops not containing liquid paraffin as a vehicle

Naproxen

Naproxen Sodium

F77Naratriptan Hydrochloride

Natamycin

F43Nebivolol Hydrochloride

Nedocromil Sodium

F332.0 per cent

F33For the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis

F33Container or package containing not more than 3 ml of medicinal product

Nefazodone Hydrochloride

Nefopam Hydrochloride

Neomycin

Neomycin Oleate

Neomycin Palmitate

Neomycin Sulphate

Neomycin Undecanoate

Neostigmine Bromide

Neostigmine Methylsulphate

Netilmicin Sulphate

Nicardipine Hydrochloride

Nicergoline

F7Niceritrol

Nicotinic Acid

Any use, except for the treatment of hyperlipidaemia

600mg (MDD)

Nicoumalone

Nifedipine

Nifenazone

Nikethamide

F34Nilutamide

Nimodipine

Niridazole

F43Nisoldipine

Nitrendipine

Nitrofurantoin

Nitrofurazone

Nizatidine

For the prevention F13and treatment of the symptoms of food-related heartburn F13and meal-induced indigestion

75mg (MD)

F14150mg (MDD)

F15For a maximum period of 14 days

For use in adults and children not less than 16 years

Nomifensine Maleate

Noradrenaline

Noradrenaline Acid Tartrate

Norethisterone

Norethisterone Acetate

Norethisterone Enanthate

Norethynodrel

Norfloxacin

Norgestimate

Norgestrel

Nortriptyline Hydrochloride

Noscapine

Noscapine Hydrochloride

Novobiocin Calcium

Novobiocin Sodium

Nux Vomica Seed

Nystatin

F423.0 per cent

F42External

F42Container or package containing not more than 15g of medicinal product

For use in combination with Hydrocortisone of maximum strength 0.5 per cent for intertrigo

For use in adults and children not less than 10 years

Octacosactrin

Octreotide

Oestradiol

Oestradiol Benzoate

Oestradiol Cypionate

Oestradiol Dipropionate

Oestradiol Diundecanoate

Oestradiol Enanthate

Oestradiol Phenylpropionate

Oestradiol Undecanoate

Oestradiol Valerate

Oestriol

Oestriol Succinate

Oestrogenic Substances Conjugated

Oestrone

Ofloxacin

Olsalazine Sodium

Omeprazole

F49Omeprazole Magnesium

Ondansetron Hydrochloride

Orciprenaline Sulphate

Orphenadrine Citrate

Orphenadrine Hydrochloride

Ouabain

Ovarian Gland Dried

Oxamniquine

Oxantel Embonate

Oxaprozin

Oxatomide

Oxedrine Tartrate

Oxethazaine

10mg (MD)

Container or package containing not more than 400mg of Oxethazaine

30mg (MDD)

Oxitropium Bromide

Oxolinic Acid

Oxpentifylline

Oxprenolol Hydrochloride

Oxybuprocaine Hydrochloride

Non-ophthalmic use

Oxybutynin Hydrochloride

Oxypertine

Oxypertine Hydrochloride

Oxyphenbutazone

Oxyphencyclimine Hydrochloride

Oxyphenonium Bromide

5mg (MD)

15mg (MDD)

Oxytetracycline

Oxytetracycline Calcium

Oxytetracycline Dihydrate

Oxytetracycline Hydrochloride

Oxytocin, natural

Oxytocin, synthetic

Pancreatin

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

(1) capsules

(2) 25,000 European Pharmacopoeia units of lipase per gram

(2) powder

Pancuronium Bromide

F64Pantoprazole Sodium

Papaverine

(1) By inhaler

(2) Otherwise than by inhaler

(2) 50mg (MD)

150mg (MDD)

Papaverine Hydrochloride

(1) By inhaler

(2) Otherwise than by inhaler

(2) Equivalent of 50mg of Papaverine (MD)

Equivalent of 150mg of Papaverine (MDD)

F19Paracetamol

1

F59250mg

1

Non-effervescent tablets and capsules F60wholly or mainly for use in children aged less than 12 years

1

The quantity sold or supplied in one container or package shall not exceed 32

  • The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

2

500 mg

2

Non-effervescent tablets and capsules F61wholly or mainly for use in adults and children not less than 12 years

3

All preparations other than non-effervescent tablets and capsules

2

The quantity sold or supplied in one container or package shall not exceed 32

  • The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

Paraldehyde

Paramethadione

Paramethasone Acetate

Parathyroid Gland

Pargyline Hydrochloride

Paroxetine Hydrochloride

Pecilocin

Penamecillin

Penbutolol Sulphate

F64Penciclovir

Penicillamine

Penicillamine Hydrochloride

Pentamidine Isethionate

Penthienate Bromide

5mg (MD)

15mg (MDD)

Pentolinium Tartrate

Perfluamine

Pergolide Mesylate

Perhexiline Maleate

Pericyazine

Perindopril

Perindopril Erbumine

Perphenazine

Phenacetin

0.1 per cent

Phenazone

External

Phenazone Salicylate

Phenbutrazate Hydrochloride

Phenelzine Sulphate

Phenethicillin Potassium

Phenformin Hydrochloride

Phenglutarimide Hydrochloride

Phenindione

F20Phenolphthalein.

Phenoxybenzamine Hydrochloride

Phenoxymethylpenicillin

Phenoxymethylpenicillin Calcium

Phenoxymethylpenicillin Potassium

Phenprocoumon

Phensuximide

Phentolamine Hydrochloride

Phentolamine Mesylate

Phenylbutazone

Phenylbutazone Sodium

Phenylpropanolamine Hydrochloride

Internal

(1) all preparations except prolonged release capsules, nasal sprays and nasal drops

(1) 25mg (MD)

100mg (MDD)

(2) prolonged release capsules

(2) 50mg (MD)

100mg (MDD)

(3) 2.0 per cent

(3) nasal sprays and nasal drops

Phenytoin

Phenytoin Sodium

Phthalylsulphathiazole

Physostigmine

Physostigmine Aminoxide Salicylate

Physostigmine Salicylate

Physostigmine Sulphate

F34Phytomenadione

Any use except the prevention or treatment of haemorrhagic disorders

Picrotoxin

Pilocarpine

Pilocarpine Hydrochloride

Pilocarpine Nitrate

Pimozide

Pindolol

Pipenzolate Bromide

5mg (MD)

15mg (MDD)

Piperacillin Sodium

Piperazine Oestrone Sulphate

Piperidolate Hydrochloride

50mg (MD)

150mg (MDD)

Pipothiazine Palmitate

Piracetam

Pirbuterol Acetate

Pirbuterol Hydrochloride

F16Pirenzepine Dihydrochloride Monohydrate

Pirenzepine Hydrochloride

Piretanide

Piroxicam

0.5 per cent

External

For maximum period of 7 days

Container or package containing not more than 30g of medicinal product

For the relief of rheumatic pain, pain of non-serious arthritic conditions and muscular aches, pains and swellings such as strains, sprains and sports injuries

For use in adults and children not less than 12 years

F7Piroxicam Beta-cyclodextrin

Pituitary Gland (Whole Dried)

By inhaler

Pituitary Powdered (Posterior Lobe)

By inhaler

Pivampicillin

Pivampicillin Hydrochloride

Pivmecillinam

Pivmecillinam Hydrochloride

Pizotifen

Pizotifen Malate

Plicamycin

Podophyllotoxin

Podophyllum

Podophyllum Indian

Podophyllum Resin

20.0 per cent

External

Ointment or impregnated plaster

Poldine Methylsulphate

2mg (MD)

6mg (MDD)

Polidexide

Polyestradiol Phosphate

Polymyxin B Sulphate

Polythiazide

Poppy Capsule

Potassium Arsenite

0.0127 per cent

Potassium Bromide

Potassium Canrenoate

Potassium Clavulanate

Potassium Perchlorate

Practolol

Pralidoxime Chloride

Pralidoxime Iodide

Pralidoxime Mesylate

F77Pramipexole Hydrochloride

Pravastatin Sodium

Prazosin Hydrochloride

Prednisolone

Prednisolone Acetate

Prednisolone Butylacetate

Prednisolone Hexanoate

Prednisolone Metasulphobenzoate

Prednisolone Metasulphobenzoate Sodium

Prednisolone Pivalate

Prednisolone Sodium Phosphate

Prednisolone Steaglate

Prednisone

Prednisone Acetate

Prenalterol Hydrochloride

Prenylamine Lactate

Prilocaine Hydrochloride

Non-ophthalmic use

Primidone

Probenecid

Probucol

Procainamide Hydrochloride

Procaine Hydrochloride

Non-ophthalmic use

Procaine Penicillin

Procarbazine Hydrochloride

Prochlorperazine

Prochlorperazine Edisylate

Prochlorperazine Maleate

F763mg

F76Buccal tablets for the treatment of nausea and vomiting in cases of previously diagnosed migraine only. For use in persons aged 18 years and over.

F7612mg (MDD)

F76Container or package containing not more than 8 tablets

Prochlorperazine Mesylate

Procyclidine Hydrochloride

Progesterone

Prolactin

Proligestone

Prolintane Hydrochloride

Promazine Embonate

Promazine Hydrochloride

Propafenone

Propafenone Hydrochloride

Propanidid

Propantheline Bromide

15mg (MD)

45mg (MDD)

F43Propiverine Hydrochloride

Propofol

Propranolol Hydrochloride

Propylthiouracil

Proquazone

Protamine Sulphate

Prothionamide

Protirelin

Protriptyline Hydrochloride

Proxymetacaine Hydrochloride

Non-ophthalmic use

Pseudoephedrine Hydrochloride

Internal

(a) In the case of a prolonged release preparation

120mg (MD)

240mg (MDD)

(b) in any other case 60mg (MD)

240mg (MDD)

Pseudoephedrine Sulphate

60mg (MD)

180mg (MDD)

Pyrantel Embonate

(a) For the treatment of enterobiosis, in adults and children not less than 12 years

(a) 750mg MDD (as a single dose)

(a) Container or package containing not more than 750mg of Pyrantel Embonate

(b) For the treatment of enterobiosis, in children less than 12 years but not less than 6 years

(b) 500mg MDD (as a single dose)

(b) Container or package containing not more than 750mg of Pyrantel Embonate

(c) For the treatment of enterobiosis in children less than 6 years but not less than 2 years

(c) 250mg MDD (as a single dose)

(c) Container or package containing not more than 750mg of Pyrantel Embonate

Pyrantel Tartrate

Pyrazinamide

Pyridostigmine Bromide

Pyrimethamine

F43Quetiapine Fumarate

F46Quinagolide Hydrochloride

Quinapril

F16Quinapril Hydrochloride

Quinestradol

Quinestrol

Quinethazone

Quinidine

Quinidine Bisulphate

Quinidine Polygalacturonate

Quinidine Sulphate

Quinine

100mg (MD)

300mg (MDD)

Quinine Bisulphate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Cinchophen

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Dihydrochloride

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Ethyl Carbonate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Glycerophosphate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Hydrobromide

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Hydrochloride

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Iodobismuthate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Phosphate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Salicylate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Sulphate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Tannate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine in combination with Urea Hydrochloride

Ramipril

F49Ranitidine Bismuth Citrate

Ranitidine Hydrochloride

For the short term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity F5or the prevention of these symptoms when associated with consuming food and drink

Equivalent to 75mg of Ranitidine (MD)

Equivalent to 300mg of Ranitidine (MDD)

For a maximum period of 14 days

Rauwolfia Serpentina

Rauwolfia Vomitoria

Razoxane

F77Reboxetine Mesilate

Remoxipride Hydrochloride

Reproterol Hydrochloride

Rescinnamine

Reserpine

Rifabutin

Rifampicin

Rifampicin Sodium

Rifamycin

F49Rimexolone

Rimiterol Hydrobromide

Risperidone

Ritodrine Hydrochloride

Rolitetracycline Nitrate

F87Ropinirole Hydrochloride

Sabadilla

Salbutamol

Salbutamol Sulphate

Salcatonin

Salcatonin Acetate

Salmefamol

Salmeterol Xinafoate

Salsalate

Saralasin Acetate

Selegiline Hydrochloride

Semisodium Valproate

F77Sertindole

F49Sertraline Hydrochloride

Serum Gonadotrophin

F49Sevoflurane

Silver Sulphadiazine

Simvastatin

Sissomicin

Sissomicin Sulphate

Snake Venoms

Sodium Acetrizoate

Sodium Aminosalicylate

Sodium Antimonylgluconate

Sodium Arsanilate

Sodium Arsenate

Sodium Arsenite

0.013 per cent

Sodium Bromide

Sodium Clodronate

Sodium Cromoglycate

(a) For nasal admistration

(b) 2.0 per cent

(b) For the treatment of acute seasonal allergic conjunctivitis F6or perennial allergic conjunctivitis

(b) Container or package containing not more than 10ml of medicinal product

In the form of aqueous eye drops

(c) 4.0 per cent

(c) For the treatment of acute seasonal allergic conjunctivitis

(c) Container or package containing not more than 5g of medicinal product

In the form of an eye ointment

Sodium Ethacrynate

Sodium Fluoride

(1) 0.33 per cent

(1) Dentifrices

(2) Other preparations for use in the prevention of dental caries

In the form of

(a) tablets or drops

(a) 2.2 mg (MDD)

(b) 0.2 per cent

(b) mouth rinses other than those for daily use

(c) 0.05 per cent

(c) mouth rinses for daily use

Sodium Fusidate

Sodium Metrizoate

Sodium Monofluorophosphate

1.14 per cent

Dentrifrice

Sodium Oxidronate

Sodium Stibogluconate

Sodium Valproate

Somatorelin Acetate

Sotalol Hydrochloride

F46Sparfloxacin

Spectinomycin

Spectinomycin Hydrochloride

Spiramycin

Spiramycin Adipate

Spironolactone

Stannous Fluoride

(F721) 0.62 per cent

(F721) Dentifrice

F72(2) 0.4 per

F72(2) Dental gels for use in the prevention and treatment of dental caries and decalcification of the teeth

Stilboestrol

Stilboestrol Dipropionate

Streptodornase

External

Streptokinase

External

Streptomycin

Streptomycin Sulphate

Strychnine

Strychnine Arsenate

Strychnine Hydrochloride

F34Strychnine Nitrate

Styramate

Succinylsulphathiazole

Sucralfate

Sulbactam Sodium

Sulbenicillin

Sulbenicillin Sodium

Sulconazole Nitrate

External (except vaginal)

F34Sulfabenzamide

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

F43Tacalcitol Monohydrate

Tacrine Hydrochloride

Talampicillin

Talampicillin Hydrochloride

Talampicillin Napsylate

Tamoxifen

Tamoxifen Citrate

F64Tamsulosin Hydrochloride

F49Tazarotene

Tazobactam Sodium

Teicoplanin

F77Temocapril Hydrochloride

Temocillin Sodium

Tenoxicam

Terazosin Hydrochloride

Terbinafine

F841.0 per cent

F85External use for the treatment of tinea pedis, tinea cruris and tinea corporis. In the form of a gel

F86Container or package containing not more than 30 grams of medicinal product

F48Terbinafine Hydrochloride

F481.0 per cent

(F741) F73Preparations, other than spray solutions, forF48external use for the treatment of tinea pedis and tinea cruris

(F741) F48Container or package containing not more than 15 g of medicinal product.

F75(2) Spray solutions for external use for the treatment of tinea corporis, tinea cruris and tinea pedis

F75(2) Container containing not more than 30ml of medicinal product

Terbutaline

Terbutaline Sulphate

Terfenadine

F2. . .

F2...

Terlipressin

Terodiline Hydrochloride

F77Testosterone

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

F64Ticlopidine Hydrochloride

Tigloidine Hydrobromide

F64Tiludronate Disodium

Timolol Maleate

Tinidazole

Tinzaparin

Tioconazole

(1) 2.0 per cent

(1) External (except vaginal)

(2) Vaginal for treatment of vaginal candidiasis

F46Tizanidine Hydrochloride

Tobramycin

Tobramycin Sulphate

Tocainide Hydrochloride

Tofenacin Hydrochloride

Tolazamide

Tolazoline Hydrochloride

External

Tolbutamide

Tolbutamide Sodium

Tolfenamic Acid

Tolmetin Sodium

F49Topiramate

F7Torasemide

F64Toremifene

Tramadol Hydrochloride

Trandolapril

Tranexamic Acid

Tranylcypromine Sulphate

Trazodone Hydrochloride

Treosulfan

Tretinoin

Triamcinolone

Triamcinolone Acetonide

F62(1) 0.1 per cent

F62(1) For the treatment of common mouth ulcers

F62(1) Container or package containing not more than 5g of medicinal product

F63(2) In the form of a non-pressurised nasal spray, for the treatment of symptoms of seasonal allergic rhinitis in persons aged 18 years and over

F63(2) 110mcg per nostril (MD)

F63Container or package containing not more than 3.575mg of Triamcinolone Acetonide

110mcg per nostril (MDD)

For a maximum period of 3 months

Triamcinolone Diacetate

Triamcinolone Hexacetonide

Triamterene

Tribavirin

Triclofos Sodium

Trientine Dihydrochloride

Trifluoperazine

Trifluoperazine Hydrochloride

Trifluperidol

Trifluperidol Hydrochloride

Trilostane

Trimeprazine

Trimeprazine Tartrate

Trimetaphan Camsylate

Trimetazidine

Trimetazidine Hydrochloride

Trimethoprim

Trimipramine Maleate

Trimipramine Mesylate

Tropicamide

Tropisetron Hydrochloride

Troxidone

L-Tryptophan

(1) Oral

Dietary supplementation

(2) External

Tubocurarine Chloride

Tulobuterol

Tulobuterol Hydrochloride

Tyrothricin

Throat lozenges or throat pastilles

Uramustine

Urea Stibamine

Urethane

Uridine 5'-triphosphate

Urofollitrophin

Urokinase

Ursodeoxychoic Acid

Vaccine: Bacillus Salmonella Typhi

Vaccine: Poliomyelitis (Oral)

F46Valaciclovir Hydrochloride

Valproic Acid

F77Valsartan

Vancomycin Hydrochloride

Vasopressin

Vasopressin Tannate

Vecuronium Bromide

F46Venlafaxine Hydrochloride

Verapamil Hydrochloride

Veratrine

Veratrum, Green

Veratrum, White

Vidarabine

Vigabatrin

Viloxazine Hydrochloride

Vinblastine Sulphate

Vincristine Sulphate

Vindesine Sulphate

Viomycin Pantothenate

Viomycin Sulphate

Vitamin A

(1) Internal

(1) 7,500iu (2,250mcg Retinol equivalent) (MDD)

(2) External

Vitamin A Acetate

(1) Internal

(1) Equivalent to 7,500iu Vitamin A (2,250mcg Retinol equivalent) (MDD)

(2) External

Vitamin A Palmitate

(1) Internal

(1) Equivalent to 7,500iu Vitamin A (2,250mcg Retinol equivalent) (MDD)

(2) External

Warfarin

Warfarin Sodium

Xamoterol Fumarate

Xipamide

Yohimbine Hydrochloride

F46Zalcitabine

Zidovudine

Zimeldine Hydrochloride

Zolpidem Tartrate

Zomepirac Sodium

Zopiclone

Zuclopenthixol Acetate

Zuclopenthixol Decanoate

Zuclopenthixol Hydrochloride

F114SCHEDULE 2SUBSTANCES WHICH MAY BE EXCLUDED FROM THE CLASS OF PRESCRIPTION ONLY MEDICINES AT HIGH DILUTION

Article 10(1)

Annotations:
  • Codeine and its salts

  • Dihydrocodeine and its salts

  • Ethylmorphine and its salts

  • Morphine and its salts

  • Medicinal Opium

  • Pholcodine and its salts

SCHEDULE 3DESCRIPTIONS AND CLASSES OF PRESCRIPTION ONLY MEDICINES IN RELATION TO WHICH F115community practitioner nurse prescribers ARE APPROPRIATE PRACTITIONERS

Article 2(b)

Annotations:
  • F8Co-danthramer Capsules NPF

  • F8Co-danthramer Capsules, Strong NPF

  • Co-danthramer-Oral Suspension NPF

  • Co-danthramer-Oral Suspension Strong NPF

  • Co-danthrusate Capsules

  • F8Co-danthrusate Oral Suspension NPF

  • Mebendazole Tablets NPF

  • Mebendazole Oral Suspension NPF

  • Miconazole Oral Gel NPF

  • Nystatin Oral Suspension

  • Nystatin Pastilles NPF

  • Streptokinase and Streptodornase Topical Powder NPF

  • F89Water for Injections

F116SCHEDULE 3ACONTROLLED DRUGS WHICH MAY BE PRESCRIBED, ADMINISTERED OR DIRECTED FOR ADMINISTRATION BY NURSE INDEPENDENT PRESCRIBERS AND CONDITIONS FOR SUCH PRESCRIPTION OR ADMINISTRATION

Article 3A

Annotations:

Column 1

Column 2

Substance

Requirements as to use or route of administration

Buprenorphine

Transdermal administration in palliative care

Chlordiazepoxide hydrochloride

Oral administration

Codeine Phosphate

Oral administration

Co-Phenotrope

Oral administration

Diamorphine hydrochloride

Oral or parenteral administration

Diazepam

Oral, parenteral or rectal administration

Dihydrocodeine Tartrate

Oral administration

Fentanyl

Transdermal administration in palliative care

Lorazepam

Oral or parenteral administration

Midazolam

Parenteral or buccal administration

Morphine sulphate

Oral, parenteral or rectal administration

Morphine hydrochloride

Rectal administration

Oxycodone hydrochloride

Oral or parenteral administration in palliative care

F90SCHEDULE 3BPARTICULARS FOR CLINICAL MANAGEMENT PLANS

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

Annotations:

A clinical management plan shall contain the following particulars—

a

the name of the patient to whom the plan relates;

b

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

c

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

d

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

e

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

f

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

g

the arrangements for notification of—

i

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

ii

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

h

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

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

Article 8(4)(c)

  • Ammonium Bromide

  • Calcium Bromide

  • Calcium Bromidolactobionate

  • Embutramide

  • Fencamfamin Hydrochloride

  • Fluanisone

  • Hexobarbitone

  • Hexobarbitone Sodium

  • Hydrobromic Acid

  • Meclofenoxate Hydrochloride

  • Methohexitone Sodium

  • Pemoline

  • Piracetam

  • Potassium Bromide

  • Prolintane Hydrochloride

  • Sodium Bromide

  • Strychnine Hydrochloride

  • Tacrine Hydrochloride

  • Thiopentone Sodium

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

Article 11(1)(a)

PART IEXEMPTION FROM RESTRICTIONS ON SALE OR SUPPLY

Annotations:
Amendments (Textual)
F110

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

F111

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

Column 1

Column 2

Column 3

Persons exempted

Prescription only medicines to which the exemption applies

Conditions

1. Persons selling or supplying prescription only medicines to universities, other institutions concerned with higher education or institutions concerned with research.

1. All prescription only medicines

  1. 1

    The sale or supply shall be–

    1. 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–

      1. i

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

      2. ii

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

      3. iii

        the total quantity required, and

    2. b

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

  1. 1

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

    1. 1

      a public analyst appointed under section 27 of the Food Safety Act 199021 or article 36 of the Food (Northern Ireland) Order 198922,

    2. 2

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

    3. 3

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

    4. 4

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

    5. 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 197723, the National Health Service (Scotland) Act 197824 and the Health and Personal Social Services (Northern Ireland) Order 197225, or under any subordinate legislation made under those Acts or that Order.

3. All prescription only medicines.

  1. 1

    The sale or supply shall be–

    1. 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

    2. b

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

4. Registered midwives.

  1. 1

    Prescription only medicines containing any of the following substances–

    • Chloral hydrate

    • Ergometrine maleate

    • Pentazocine hydrochloride

    • F36Phytomenadione

    • 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.

  1. 1

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

    1. a

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

    2. b

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

    3. c

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

5. The sale or supply shall be subject to the presentation of an order signed by a F110registered optometrist.

6. F111Registered optometrists

6. Prescription only medicines listed in column 2 of paragraph 5.

  1. 1

    The sale or supply shall be only–

    1. a

      in the course of their professional practice and

    2. b

      in an emergency.

F1076A Persons lawfully conducting a retail pharmacy business within the meaning of section 69.

Homotropine hydrobromide

Ketotifen

Levocabastine

Lodoxamide

Nedocromil sodium

Olopatadine

Pilocarpine hydrochloride

F113Pilocarpine nitrate

Polymyxin B/bacitracin

Polymyxin B/trimethoprim

Sodium cromoglycate.

The sale or supply shall be subject to the presentation of an order signed by an additional supply optometrist.

6B Additional supply optometrists.

Prescription only medicines specified in column 2 of paragraph 6A.

The sale or supply shall be only—

  1. a

    in the course of their professional practice, and

  2. b

    in an emergency.

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

7. All prescription only medicines.

  1. 1

    The sale or supply shall be–

    1. 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

    2. 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.

  1. 1

    The sale or supply shall be only–

    1. a

      to a pharmacist,

    2. 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

    3. 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 197226 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 197627.

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.

F117F910

Registered chiropodists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2.

10

The following prescription only medicines—

a

Co-dydramol 10/500 tablets;

b

Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight;

c

Amorolfine hydrochloride lacquer where the maximum strength of the Amorolfine in the lacquer does not exceed 5 per cent by weight in volume; F118...

d

Topical hydrocortisone where the maximum strength of the hydrocortisone in the medicinal product does not exceed 1 per cent by weight F119in weight; and

F120e

Amoxicillin;

f

Erythromycin;

g

Flucoxacillin;

h

Tioconazole 28%; and

i

Silver Sulfadiazine.

10

The sale or supply shall be only in the course of their professional practice and (a) in the case of Co-dydramol 10/500 tablets the quantity sold or supplied to a person at any one time shall not exceed the amount sufficient for 3 days' treatment to a maximum of 24 tablets.

PART IIEXEMPTIONS FROM THE RESTRICTION ON SUPPLY

Article 11(1)(b)

Annotations:

Column 1

Column 2

Column 3

Persons exempted

Prescription only medicines to which the exemption applies

Conditions

1. Royal National Lifeboat Institution and certified first aiders of the Institution.

1. All prescription only medicines.

1. The supply shall be only so far as is necessary for the the treatment of sick or injured persons in the exercise of the functions of the Institution.

2. The owner or the master of a ship which does not carry a doctor on board as part of her complement.

2. All prescription only medicines.

2. The supply shall be only so far as is necessary for the treatment of persons on the ship.

3. Persons authorized by licences granted under regulation 5 of the Misuse of Drugs Regulations to supply a controlled drug.

3. Such prescription only medicines, being controlled drugs, as are specified in the licence.

3. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence.

F1093A. Persons employed or engaged in the provision of lawful drug treatment services.

3A. Ampoules of sterile water for injection containing not more than 2 ml of sterile water.

3A. The supply shall be only in the course of provision of lawful drug treatment services.

4. Persons requiring prescription only medicines for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees.

4. Such prescription only medicines as may be specified in the relevant enactment.

  1. 1

    The supply shall be–

    1. a

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

    2. 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.

  1. 1

    1. 1

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

    2. 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.

F1218. Persons who hold a certificate in first aid from the Mountain Rescue Council of England and Wales, or from the Northern Ireland Mountain Rescue Co-ordinating Committee.

8 Prescription only medicines supplied to a person specified in column 1 in response to an order in writing signed by a doctor.

8 The supply shall be only so far as is necessary for the treatment of sick or injured persons in the course of providing mountain rescue services.

PART IIIEXEMPTIONS FROM RESTRICTION ON ADMINISTRATION Column 1

Article 11(2)

Annotations:
Amendments (Textual)

Column 1

Column 2

Column 3

Persons exempted

Prescription only medicines to which the exemption applies

Conditions

F1221. Registered chiropodists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2..

  1. 1

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

    • F123Adrenaline

    • F10Bupivacaine hydrochloride

    • Bupivacaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of bupivacaine hydrochloride

    • F123Levobupivacaine hydrochloride

    • Lignocaine hydrochloride

    • Lignocaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of lignocaine hydrochloride

    • F35Mepivacaine hydrochloride

    • F123Methylprednisolone

    • Prilocaine hydrochloride.

    • F123Ropivacaine hydrochloride

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

2. Registered midwives.

  1. 1

    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–

    • F96Diamorphine

    • Ergometrine maleate

    • Lignocaine

    • Lignocaine hydrochloride

    • F96Morphine

    • 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.

  1. 1

    1. 1

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

    2. 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 F65or persons who are F95registered paramedics.

  1. 1

    The following prescription only medicines for parenteral administration–

    1. a

      Diazepam 5 mg per ml emulsion for injection;

    2. b

      Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion;

    3. bb

      F66medicines containing the substances Ergometrine Maleate 500mcg per ml with Oxytocin 5 iu per ml, but no other active ingredient

    4. d

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

      • Adrenaline Acid Tartrate

      • F103Amiodarone

      • Anhydrous Glucose

      • F67Benzylpenicillin

      • F17Bretylium Tosylate

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

      • Ergometrine Maleate

      • F67Frusemide

      • Glucose

      • Heparin Sodium

      • Lignocaine Hydrochloride

      • F67Metoclopramide

      • F67Morphine Sulphate

      • Nalbuphine Hydrochloride

      • Naloxone Hydrochloride

      • Polygeline

      • F100Reteplase

      • Sodium Bicarbonate

      • Sodium Chloride

      • F67Streptokinase

      • F100Tenecteplase.

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.

SCHEDULE 6ORDERS REVOKED

Article 16(1)

Column 1

Column 2

Orders

References

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Order 1983

S.I. 1983/1212

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1984

S.I. 1984/756

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1986

S.I. 1986/586

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1987

S.I. 1987/674

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1987

S.I. 1987/1250

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1988

S.I. 1988/2017

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1991

S.I. 1991/962

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1992

S.I. 1992/1534

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1992

S.I. 1992/2937

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1993

S.I. 1993/1890

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1993

S.I. 1993/3256

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1994

S.I. 1994/558

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1994

S.I. 1994/3016

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 3) Order 1994

S.I. 1994/3050

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1995

S.I. 1995/1384

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1995

S.I. 1995/3174

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1996

S.I. 1996/1514

The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1996

S.I. 1996/3193

F50SCHEDULE 7

Articles 12A to 12C

Annotations:

PART IPARTICULARS TO BE INCLUDED IN A PATIENT GROUP DIRECTION

a

the period during which the Direction shall have effect;

b

the description or class of prescription only medicine to which the Direction relates;

c

whether there are any restrictions on the quantity of medicine which may be supplied on any one occasion, and, if so, what restrictions;

d

the clinical situations which prescription only medicines of that description or class may be used to treat;

e

the clinical criteria under which a person shall be eligible for treatment;

f

whether any class of person is excluded from treatment under the Direction and, if so, what class of person;

g

whether there are circumstances in which further advice should be sought from a doctor or dentist and, if so, what circumstances;

h

the pharmaceutical form or forms in which prescription only medicines of that description or class are to be administered;

i

the strength, or maximum strength, at which prescription only medicines of that description or class are to be administered;

j

the applicable dosage or maximum dosage;

k

the route of administration;

l

the frequency of administration;

m

any minimum or maximum period of administration applicable to prescription only medicines of that description or class;

n

whether there are any relevant warnings to note, and, if so, what warnings;

o

whether there is any follow up action to be taken in any circumstances, and, if so, what action and in what circumstances;

p

arrangements for referral for medical advice;

q

details of the records to be kept of the supply, or the administration, of medicines under the Direction.

PART IIPERSONS ON WHOSE BEHALF A PATIENT GROUP DIRECTION MUST BE SIGNED

Annotations:

Column 1

Column 2

Class of person by whom a prescription only medicine is supplied or administered

Person on whose behalf the Direction must be signed

Common Services Agency

The Agency

F88Strategic Health Authority

F88The Strategic Health Authority

Health Authority

The Health Authority

Special Health Authority

The Special Health Authority

NHS trust F97or NHS foundation trust

The trust

Primary Care Trust

The Trust

A person who supplies or administers a prescription only medicine pursuant to an arrangement made with the Common Services Agency, a Health Authority, a Special Health Authority, an NHS trust, F99, an NHS foundation trust or a Primary Care Trust

The Common Services Agency, where the arrangement has been made with the Agency; or the Health Authority, Special Health Authority, NHS trust F98or NHS foundation trust or Primary Care Trust with which the arrangement has been made

F91PART IIAPERSONS BY WHOM OR ON WHOSE BEHALF A PATIENT GROUP DIRECTION USED IN THE PROVISION OF HEALTH CARE BY OR ON BEHALF OF THE POLICE, THE PRISON SERVICES OR THE ARMED FORCES MUST BE SIGNED

Annotations:

Column 1

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

Column 2

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

A police force in England or Wales

The chief officer of police for that police force (within the meaning of the Police Act 1996)

A police force in Scotland

The chief constable of that police force (within the meaning of the Police (Scotland) Act 1997)

The Police Service of Northern Ireland

The Chief Constable of the Police Service of Northern Ireland

The prison service in England and Wales

The governor of the prison in relation to which the health care in question is being provided

The prison service in Scotland

The Scottish Prison Service Management Board

The prison service in Northern Ireland

The Northern Ireland Prison Service Management Board

Her Majesty’s Forces

i

the Surgeon General,

ii

a Medical Director General, or

iii

a chief executive of an executive agency of the Ministry of Defence

PART IIICLASSES OF INDIVIDUAL F51BY WHOM PRESCRIPTION ONLY MEDICINES MAY BE SUPPLIED OR ADMINISTERED

Annotations:
  • F92Registered paramedics or individuals who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State.

  • Pharmacists.

  • F102...

  • Registered midwives.

  • Registered nurses.

  • F112Registered optometrists

  • F93Registered chiropodists.

  • F94Registered orthoptists.

  • Registered physiotherapists.

  • Registered radiographers.

  • F101“Registered dietitians.”;

  • F101“Registered occupational therapists.”;

  • F101“Registered orthotists and prosthetists.”; and

  • F101“Registered speech and language therapists.”