Abacavir.

Abatacept.

Abiraterone acetate.

Abciximab.

Acamprosate calcium.

Acarbose.

Acebutolol.

Acepromazine.

Acetanilide and alkyl acetanilides (excluding when present as an excipient) for human therapeutic use.

Acetarsol.

Acetazolamide.

Acetohexamide.

Acetyl isovaleryltylosin.

Acetylcarbromal.

Acetylcholine.

Acetylcysteine except—

• (a)when included in Schedule 2; or
• (b)in preparations for oral use when labelled with a recommended daily dose of 1g or less of acetylcysteine.

Acetyldigitoxin.

Acetylmethyldimethyloximidophenylhydrazine.

Acetylstrophanthidin.

Aciclovir except in preparations containing 5 per cent or less of aciclovir for the treatment of herpes labialis in packs containing 10 g or less.

Acipimox.

Acitretin.

Aclidinium bromide.

Acokanthera ouabaio.

Acokanthera schimperi.

Aconitum spp. except—

• (a)when included in Schedule 2;
• (b)in preparations for oral use in adults in packs containing 0.02 mg or less of total alkaloids; or
• (c)in preparations for dermal use in adults containing 0.02 per cent or less of total alkaloids in packs containing 0.02 mg or less of total alkaloids.

Acrivastine.

Adalimumab.

Adapalene.

Adefovir.

Adenosine for human therapeutic use in preparations for injection.

Adiphenine.

Adonis vernalis.

Adrafinil.

Adrenaline except—

• (a)when included in Schedule 3; or
• (b)in preparations containing 0.02 per cent or less of adrenaline unless packed and labelled for injection.

Adrenocortical hormones except when separately specified in the schedules to these Regulations.

Afamelanotide.

Afatinib dimaleate.

Aflibercept.

Agalsidase.

Aglepristone.

Agomelatine.

Alatrofloxacin mesilate.

Albendazole except—

• (a)when included in schedules 5 or 6; or
• (b)in intraruminal implants each containing 3.85 g or less of albendazole for the treatment of animals.

Alclofenac.

Alclometasone except when included in Schedule 3.

Alcuronium.

Aldesleukin.

Aldosterone.

Alectinib.

Alefacept.

Alemtuzumab.

Alendronic acid.

Alfacalcidol.

Alfuzosin.

Alglucerase.

Alglucosidase.

Alimemazine except when included in schedules 2 or 3.

Alirocumab.

Aliskiren.

Allergens for therapeutic use.

Allopurinol.

Allylestrenol.

Alogliptin.

Alosetron.

Alpha1-proteinase inhibitor (human).

Alphadolone.

Alphaxalone.

Alprenolol.

Alprostadil.

Alseroxylon.

Alteplase.

Altrenogest.

Altretamine (hexamethylmelamine).

Amantadine.

Ambenonium chloride.

Ambrisentan.

Ambucetamide.

Ambutonium bromide.

Amcinonide.

Amifostine.

Amikacin.

Amiloride.

Aminocaproic acid.

Aminoglutethimide.

5-aminolevulinic acid.

Aminometradine.

Aminophenazone (amidopyrine) and derivatives for the treatment of animals.

Aminophylline except when included in Schedule 3.

Aminopterin.

4-aminopyridine for therapeutic use.

Aminorex.

Aminosalicylic acid.

Amiodarone.

Amiphenazole.

Amisometradine.

Amisulpride.

Amitriptyline.

Amlodipine.

Ammi visnaga.

Ammonium bromide for therapeutic use.

Amobarbital when packed and labelled for injection.

Amodiaquine.

Amorolfine except—

• (a)when included in Schedule 2; or
• (b)in preparations for the treatment of tinea pedis.

Amoxapine.

Amoxicillin.

Amphomycin.

Amphotericin b.

Ampicillin.

Amprenavir.

Amrinone.

Amsacrine.

Amyl nitrite.

Amylocaine.

Anabolic steroidal agents.

Anagrelide.

Anakinra.

Anastrozole.

Ancestim.

Ancrod and its immunoglobulin antidote.

Anecortave.

Androgenic steroidal agents.

Androisoxazole.

Androstanolone.

Androstenediol.

Androstenedione.

Angiotensin amide.

Anidulafungin.

Anistreplase.

Antazoline except when included in Schedule 2.

Antibiotic substances except—

• (a)when separately specified in the schedules to these Regulations; or
• (b)nisin.

Antigens for human therapeutic use except when separately specified in this schedule.

Antihistamines except—

• (a)when included in schedules 2 or 3; or
• (b)when separately specified in this schedule.

Antimony for therapeutic use except when separately specified in the schedules to these Regulations.

Antisera (immunosera) for human use by injection except when separately specified in the schedules to these Regulations.

Aod-9604 (CAS No. 221231-10-3).

Apalutamide.

Apixaban.

Apocynum spp.

Apraclonidine.

Apramycin.

Apremilast.

Aprepitant.

Apronal.

Aprotinin.

Arecoline.

Aripiprazole.

Armodafinil.

Arsenic for human therapeutic use except when separately specified in the schedules to these Regulations.

Artemether.

Articaine.

Asenapine.

Asfotase alfa.

Asparaginase.

Aspirin—

• (a)when combined with caffeine, paracetamol or salicylamide or any derivative of these substances; or
• (b)for injection.

Astemizole.

Asunaprevir.

Atamestane.

Atazanavir.

Atenolol.

Atezolizumab.

Atipamezole.

Atomoxetine.

Atorvastatin.

Atosiban.

Atovaquone.

Atracurium besilate.

Atropa belladonna (belladonna) except when included in Schedule 2.

Atropine except when included in Schedule 2.

Atropine methonitrate.

Auranofin.

Aurothiomalate sodium.

Avelumab.

Avilamycin except—

• (a)in animal feed premixes containing 15 per cent or less of avilamycin activity; or
• (b)in animal feeds containing 50 mg/kg or less of avilamycin activity.

Aviptadil.

Axitinib.

Avoparcin.

Azacitidine.

Azacyclonol.

Azaperone.

Azapropazone.

Azaribine.

Azatadine except when included in Schedule 3.

Azathioprine.

Azelaic acid except—

• (a)when included in Schedule 2; or
• (b)in preparations containing 1 per cent or less of azelaic acid for non-human use.

Azelastine except when included in Schedule 2.

Azithromycin.

Azlocillin.

Aztreonam.

Bacampicillin.

Bacitracin.

Baclofen.

Balsalazide.

Bambermycin (flavophospholipol) except—

• (a)when included in Schedule 6; or
• (b)in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.

Bambuterol.

Bamethan.

Bamipine.

Barbiturates except when separately specified in the schedules to these Regulations.

Baricitinib.

Basiliximab.

Bazedoxifene.

Becaplermin.

Beclamide.

Beclometasone except when included in Schedule 2.

Belatacept.

Belimumab.

Bemegride.

Benactyzine.

Benazepril.

Bendamustine.

Bendrofluazide.

Benethamine penicillin.

Benorylate.

Benoxaprofen.

Benperidol.

Benralizumab.

Benserazide.

Benzathine penicillin.

Benzilonium.

Benzocaine except—

• (a)when included in Schedule 2;
• (b)in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
• (c)in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

Benzodiazepine derivatives except when separately specified in the schedules to these Regulations.

Benzoyl peroxide in preparations for human therapeutic use except—

• (a)when included in Schedule 2; or
• (b)in preparations for external use containing 5 per cent or less of benzoyl peroxide.

Benzphetamine.

Benzthiazide.

Benzatropine.

Benzydamine except—

• (a)when included in Schedule 2;
• (b)in preparations for dermal use;
• (c)in divided topical oral preparations containing 3 mg or less of benzydamine; or
• (d)in undivided topical oral preparations containing 0.3 per cent or less of benzydamine in a primary pack containing not more than 50 ml.

Benzylpenicillin.

Bepridil.

Beractant.

Besifloxacin.

Betahistine.

Betamethasone.

Betaxolol.

Bethanechol chloride.

Bethanidine.

Bevacizumab.

Bevantolol.

Bexarotene.

Bezafibrate.

Bezlotoxumab.

Bicalutamide.

Bictegravir.

Bifonazole except—

• (a)when included in Schedule 2;
• (b)in preparations for dermal use containing 1 per cent or less of bifonazole for the treatment of the scalp; or
• (c)in preparations for dermal use for the treatment of tinea pedis.

Bimatoprost.

Binimetinib.

Biperiden.

Bismuth compounds for cosmetic use, except—

• (a)bismuth citrate when incorporated in hair colourant preparations in concentrations of 0.5 per or less; or
• (b)bismuth oxychloride.

Bismuth compounds for human therapeutic use, except bismuth formic iodide or bismuth subiodide in dusting powders containing 3 per cent or less of bismuth.

Bisoprolol.

Bivalirudin.

Bleomycin.

Blinatumomab.

Boceprevir.

Bolandiol.

Bolasterone.

Bolazine.

Boldenone (dehydrotestosterone).

Bolenol.

Bolmantalate.

Boron, including boric acid and borax, for human therapeutic use except—

• (a)in preparations for internal use containing 6 mg or less of boron per recommended daily dose;
• (b)in preparations for dermal use containing 0.35 per cent or less of boron, which are not for paediatric or antifungal use; or
• (c)when present as an excipient.

Bortezomib.

Bosentan.

Bosutinib.

Botulinum toxins for human use except when separately specified in the schedules to these Regulations.

Brentuximab vedotin.

Bretylium tosilate.

Brexpiprazole.

Brigatinib.

Brimonidine.

Brinzolamide.

Brivaracetam.

Bromazepam.

Bromides, inorganic, for therapeutic use except when separately specified in the schedules to these Regulations.

Bromocriptine.

Bromoform for therapeutic use.

Brompheniramine except when included in schedules 2 or 3.

Bromvaletone.

Brugmansia spp.

Buclizine except when included in Schedule 3.

Budesonide except when included in Schedule 2.

Bufexamac except—

• (a)in preparations for dermal use containing 5 per cent or less of bufexamac; or
• (b)in suppositories.

Bumetanide.

Buphenine.

Bupivacaine except when included in Schedule 5.

Bupropion.

Buserelin.

Buspirone.

Busulphan.

Butacaine.

Butamben except in dermal preparations containing 2 per cent or less of total local anaesthetic substances.

Butoconazole except when included in Schedule 3.

Butraconazole.

Butylchloral hydrate.

Butyl nitrite.

Cabazitaxel.

Cabergoline.

Cabozantinib.

Cadmium compounds for human therapeutic use.

Calcipotriol.

Calcitonin.

Calcitonin salmon.

Calcitriol.

Calcium carbimide for therapeutic use.

Calcium hydroxyapatite in preparations for injection or implantation—

• (a)for tissue augmentation; or
• (b)for cosmetic use.

Calcium polystyrene sulphonate.

Calotropis gigantea.

Calotropis procera.

Calusterone.

Camphorated oil for therapeutic use.

Camphotamide.

Canagliflozin.

Canakinumab.

Candesartan cilexetil.

Candicidin.

Canine tick anti-serum.

Cantharidin.

Capecitabine.

Capreomycin.

Captodiame.

Captopril.

Capuride.

Caramiphen.

Carbachol.

Carbamazepine.

Carbaryl for human therapeutic use.

Carbazochrome.

Carbenicillin.

Carbenoxolone for internal use.

Carbetocin.

Carbidopa.

Carbimazole.

Carbocromen.

Carboplatin.

Carboprost.

Carbromal.

Carbutamide.

Carbuterol.

Carfilzomib.

Carglumic acid (n-carbamoyl-l-glutamic acid).

Carindacillin.

Carisoprodol.

Carmustine.

Carnidazole.

Carprofen.

Carvedilol.

Caspofungin.

Cathine.

Catumaxomab.

Cefacetrile.

Cefaclor.

Cefadroxil.

Cefalexin.

Cefaloridine.

Cefalotin (also known as cephalothin).

Cefamandole.

Cefapirin.

Cefazolin (also known as cephazolin).

Cefepime.

Cefetamet.

Cefixime.

Cefodizime.

Cefonicid.

Cefoperazone.

Cefotaxime (also known as cephotaxime).

Cefotetan.

Cefotiam.

Cefovecin for veterinary use.

Cefoxitin.

Cefpirome.

Cefpodoxime.

Cefquinome.

Ceftaroline fosamil.

Cefsulodin.

Ceftazidime.

Ceftibuten.

Ceftiofur.

Ceftriaxone.

Cefuroxime.

Celecoxib.

Celiprolol.

Cephaelis acuminata (ipecacuanha) except in preparations containing 0.2 per cent or less of emetine.

Cephaelis ipecacuanha except in preparations containing 0.2 per cent or less of emetine.

Cephalonium.

Cephradine.

Ceritinib.

Cerivastatin.

Cerliponase alfa.

Certolizumab pegol.

Ceruletide.

Cetirizine except—

• (a)when included in Schedule 2; or
• (b)in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when—
  • (i)in a primary pack containing not more than 10 days’ supply; and
  • (ii)labelled with a recommended daily dose not exceeding 10 mg of cetirizine.

Cetrorelix.

Cetuximab.

Chenodeoxycholic acid.

Chloral formamide.

Chloral hydrate except in preparations for topical use containing 2 per cent or less of chloral hydrate.

Chloralose except when included in Schedule 6.

Chlorambucil.

Chloramphenicol except when included in Schedule 3.

Chlorandrostenolone.

Chlorazanil.

Chlorcyclizine.

Chlordiazepoxide.

Chlormerodrin.

Chlormethiazole.

Chlormezanone.

Chloroform for use in anaesthesia.

4-chloromethandienone.

2-(4-chlorophenyl)-(1,2,4)triazolo[5,1-a]isoquinoline.

Chloroquine.

Chlorothiazide.

Chlorotrianisene.

Chloroxydienone.

Chlorphenamine except when included in schedules 2 or 3.

Chlorphentermine.

Chlorpromazine.

Chlorpropamide.

Chlorprothixene.

Chlorquinaldol for human topical use.

Chlortalidone.

Chlortetracycline except when included in Schedule 5.

Chlorzoxazone.

Cholera vaccine.

Cholic acid.

Chymopapain for human therapeutic use.

Ciclacillin.

Ciclesonide.

Ciclopirox except—

• (a)when included in schedules 2 or 3; or
• (b)in preparations for the treatment of tinea pedis.

Ciclosporin.

Cidofovir.

Cilastatin.

Cilazapril.

Cilostazol.

Cimetidine except when included in Schedule 3.

Cimicoxib.

Cinacalcet.

Cinchocaine except when included in Schedule 2.

Cinnarizine.

Cinoxacin.

Ciprofloxacin.

Cisapride.

Cisatracurium besilate.

Cisplatin.

Citalopram.

Cjc-1295 (CAS No. 863288-34-0).

Cladribine.

Clanobutin.

Clarithromycin.

Clavulanic acid.

Clemastine except when included in Schedule 3.

Clemizole.

Clenbuterol.

Clevidipine.

Clidinium bromide.

Clindamycin.

Clioquinol and other halogenated derivatives of oxyquinoline for human topical use exceptwhen separately specified in this schedule.

Clobazam.

Clobetasol.

Clobetasone (clobetasone-17-butyrate) except when included in Schedule 3.

Clocortolone.

Clodronic acid (includes sodium clodronate).

Clofarabine.

Clofazimine.

Clofenamide.

Clofibrate.

Clomifene.

Clomipramine.

Clomocycline.

Clonazepam.

Clonidine.

Clopamide.

Clopidogrel.

Cloprostenol.

Clorazepate.

Clorexolone.

Clorprenaline.

Clostebol (4-chlorotestosterone).

Clotrimazole except—

• (a)when included in schedules 2, 3 or 6; or
• (b)in preparations for dermal use for the treatment of tinea pedis.

Cloxacillin.

Clozapine.

Cobalt for human therapeutic use except as dicobalt edetate in preparations for the treatment of cyanide poisoning.

Cobicistat.

Cobimetinib.

Codeine when compounded with one or more other therapeutically active substances—

• (a)in divided preparations containing 30 mg or less of codeine per dosage unit; or
• (b)in undivided preparations containing 1 per cent or less of codeine.

Co-dergocrine.

Colchicine.

Colchicum autumnale.

Colestipol.

Colestyramine for human therapeutic use.

Colfosceril palmitate for human therapeutic use.

Colistin.

Collagen in preparations for injection or implantation—

• (a)for tissue augmentation; or
• (b)for cosmetic use.

Collagenase clostridium histolyticum.

Convallaria keiski.

Convallaria majalis.

Copper compounds for human use except—

• (a)when separately specified in the schedules to these Regulations;
• (b)in preparations for human internal use containing 5 mg or less of copper per recommended daily dose; or
• (c)in other preparations containing 5 per cent or less of copper compounds.

Corifollitropin alfa.

Coronilla spp.

Corticosterone.

Corticotrophin.

Cortisone.

Co-trimoxazole.

Coumarin for therapeutic use (excluding when present as an excipient).

Crisaborole.

Crizotinib.

Crofelemer.

Cuprimyxin.

Curare.

Cyclandelate.

Cyclizine except when included in Schedule 3.

Cyclobenzaprine.

Cyclofenil.

Cycloheximide.

Cyclopenthiazide.

Cyclopentolate.

Cyclophosphamide.

Cyclopropane for therapeutic use.

Cycloserine.

Cyclothiazide.

Cycrimine.

Cymarin.

Cyproheptadine except when included in Schedule 3.

Cyproterone.

Cytarabine.

Dabrafenib mesilate.

Dabigatran.

Dacarbazine.

Daclatasvir.

Daclizumab.

Dactinomycin.

Dalfopristin.

Dalteparin (includes dalteparin sodium).

Danaparoid (includes danaparoid sodium).

Danazol.

Danthron for human use.

Dantrolene.

Dapagliflozin.

Dapoxetine.

Dapsone.

Daptomycin.

Daratumumab.

Darbepoetin.

Darifenacin.

Darunavir.

Datura spp. except—

• (a)when included in Schedule 2; or
• (b)when separately specified in this schedule.

Dasabuvir.

Dasatinib.

Datura stramonium (stramonium) except—

• (a)when included in Schedule 2; or
• (b)for smoking or burning.

Datura tatula (stramonium) except—

• (a)when included in Schedule 2; or
• (b)for smoking or burning.

Daunorubicin.

Deanol for therapeutic use.

Debrisoquine.

Decamethonium.

Deferasirox.

Deferiprone.

Deflazacort.

Degarelix.

Dehydrochloromethyltestosterone.

Dehydrocorticosterone.

Delavirdine mesilate.

Dembrexine except when included in Schedule 5.

Demecarium.

Demeclocycline.

Dengue vaccine.

Denosumab.

Deoxycholic acid.

Deoxycortone.

Deoxyribonuclease except—

• (a)when separately specified in this schedule; or
• (b)for external use.

Deracoxib.

Dermatophagoides pteronyssinus and dermatophagoides farinae extract.

Desferrioxamine.

Desflurane.

Desipramine.

Desirudin.

Deslanoside.

Desloratadine except when included in Schedule 2.

Deslorelin.

Desmopressin (d.d.a.v.p.).

Desogestrel.

Desonide.

Desoxymethasone.

Desvenlafaxine.

Detomidine.

Dexamethasone.

Dexchlorphenamine except when included in schedules 2 or 3.

Dexfenfluramine.

Dexmedetomidine.

Dextromethorphan (excluding its stereoisomers) except when included in Schedule 2.

Dextropropoxyphene–

• (a)in divided preparations containing 135 mg of dextropropoxyphene or less per dosage unit; or
• (b)liquid preparations containing 2.5 per cent or less of dextropropoxyphene.

Dextrorphan (excluding its stereoisomers).

Diamthazole.

Diaveridine.

Diazepam.

Diazoxide.

Dibenzepin.

Dibotermin.

Dibromopropamidine for therapeutic use except when included in Schedule 2.

Dichloralphenazone.

Dichlorophen for human therapeutic use.

Dichlorphenamide.

Diclofenac except—

• (a)when included in schedules 2 or 3; or
• (b)in preparations for dermal use unless—
  • (i)for the treatment of solar keratosis; or
  • (ii)containing more than 4 per cent of diclofenac.

Dicloxacillin.

Dicyclomine.

Didanosine.

Dienestrol.

Dienogest.

Diethazine.

Diethylcarbamazine for human therapeutic use.

Diethylpropion.

Difenoxin in preparations containing, per dosage unit, 0.5 mg or less of difenoxin and a quantity of atropine sulfate equivalent to at least 5 per cent of the dose of difenoxin.

Diflorasone.

Difloxacin.

Diflucortolone.

Diflunisal.

Digitalis lanata.

Digitalis purpurea.

Digitoxin.

Digoxin.

Digoxin-specific antibody fragment f (ab).

Dihydralazine.

Dihydrocodeine when compounded with one or more other therapeutically active substances—

• (a)in divided preparations containing not more than 100 mg of dihydrocodeine per dosage unit; or
• (b)in undivided preparations with a concentration of not more than 2.5 per cent of dihydrocodeine,

except when included in Schedule 3.

Dihydroergotoxine.

Dihydrolone.

Dihydrostreptomycin.

Dihydrotachysterol.

Diiodohydroxyquinoline (iodoquinol) except—

• (a)when included in Schedule 3; or
• (b)for human internal use.

Diisopropylamine dichloroacetate.

Diltiazem.

Dimenhydrinate except when included in schedules 2 or 3.

Dimercaprol.

Dimethandrostanolone.

Dimethazine.

Dimethindene except when included in Schedule 3.

Dimethothiazine.

Dimethoxanate.

Dimethyl fumarate.

Dimethyl sulfoxide (excluding dimethyl sulfone) for therapeutic use except—

• (a)when included in Schedule 6;
• (b)in in-vitro test kits; or
• (c)when used as a flavour component in compliance with the current therapeutic goods (permissible ingredients) determination for listed medicines.

Dimetridazole.

2,4-dinitrochlorobenzene for therapeutic use.

Dinitrocresols for therapeutic use except when separately specified in the schedules to these Regulations.

Dinitronaphthols for therapeutic use except when separately specified in the schedules to these Regulations.

Dinitrophenols for therapeutic use.

Dinitrothymols for therapeutic use except when separately specified in the schedules to these Regulations.

Dinoprost.

Dinoprostone.

Diperodon.

Diphemanil except in preparations for dermal use.

Diphenhydramine except when included in schedules 2 or 3.

Diphenidol.

Diphenoxylate in preparations containing, per dosage unit, 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1 per cent of the dose of diphenoxylate except when included in Schedule 3.

Diphenylpyraline.

Diphtheria toxoid.

Dipivefrin.

Dipyridamole.

Dirithromycin.

Dirlotapide.

Disophenol.

Disopyramide.

Distigmine.

Disulfiram for therapeutic use.

Disulphamide.

Dithiazanine except when included in Schedule 6.

Ditiocarb.

Dobutamine.

Docetaxel.

Dofetilide.

Dolasetron.

Dolutegravir.

Domperidone.

Donepezil.

Dopamine.

Dopexamine.

Doripenem.

Dornase.

Dorzolamide.

Dosulepin.

Doxantrazole.

Doxapram.

Doxazosin.

Doxepin.

Doxorubicin.

Doxycycline.

Doxylamine except when included in schedules 2 or 3.

Dronedarone.

Droperidol.

Drospirenone.

Drostanolone.

Drotrecogin.

Duboisia leichhardtii except when included in Schedule 2.

Duboisia myoporoides except when included in Schedule 2.

Duloxetine.

Dupilumab.

Durvalumab.

Dutasteride.

Dydrogesterone.

Econazole except—

• (a)when included in schedules 2, 3 or 6; or
• (b)in preparations for dermal use for the treatment of tinea pedis.

Ecothiopate (includes ecothiopate iodide).

Ectylurea.

Eculizumab.

Edetic acid for human therapeutic use except—

• (a)in preparations containing 0.25 per cent or less of edetic acid;
• (b)as dicobalt edetate in preparations for the treatment of cyanide poisoning; or
• (c)in contact lens preparations.

Edoxudine.

Edrophonium.

Efalizumab.

Efavirenz.

Eflornithine.

Elbasvir.

Eletriptan.

Elosulfase alfa.

Elotuzumab.

Eltenac.

Eltrombopag.

Eluxadoline.

Elvitegravir.

Emepronium.

Emetine except in preparations containing 0.2 per cent or less of emetine.

Empagliflozin.

Emtricitabine.

Enalapril.

Encorafenib.

Enestebol.

Enflurane for therapeutic use.

Enfuvirtide.

Enobosarm.

Enoxacin.

Enoxaparin.

Enoximone.

Enprostil.

Enrofloxacin.

Entacapone.

Entecavir.

Enzalutamide.

Ephedra spp. except in preparations containing 0.001 per cent or less of ephedrine.

Ephedrine.

Epicillin.

Epinastine.

Epirubicin.

Epitiostanol.

Eplerenone.

Epoetins.

Epoprostenol.

Eprosartan.

Eptifibatide.

Erenumab.

Ergometrine.

Ergot.

Ergotamine.

Ergotoxine.

Eribulin mesilate.

Erlotinib.

Ertapenem.

Ertugliflozin.

Erysimum spp.

Erythromycin.

Erythropoietin.

Erythropoietins except when separately specified in the schedules to these Regulations.

Escitalopram.

Esmolol.

Esomeprazole except when included in Schedule 2.

Estradiol except when included in Schedule 5.

Estriol.

Estramustine.

Estrogens except when separately specified in the schedules to these Regulations.

Estrone.

Estropipate (piperazine estrone sulfate).

Etacrynic acid.

Etanercept.

Ethambutol.

Ethamivan.

Ethchlorvynol.

Ether for use in anaesthesia.

Ethinamate.

Ethinylestradiol.

Ethionamide.

Ethisterone.

Ethoglucid.

Ethoheptazine.

Ethopropazine.

Ethosuximide.

Ethotoin.

Ethoxzolamide.

Ethyl chloride for human therapeutic use.

Ethyldienolone.

Ethylestrenol.

Etidocaine.

Etidronic acid (includes etidronate disodium)—

• (a)for internal use; or
• (b)in topical preparations except in preparations containing 1 per cent or less of etidronic acid.

Etilefrin.

Etiproston.

Etodolac.

Etofenamate except when included in Schedule 2.

Etonogestrel.

Etoposide.

Etoricoxib.

Etravirine.

Etretinate.

Etynodiol.

Everolimus.

Exemestane.

Exenatide.

Ezetimibe.

Famciclovir except when included in Schedule 3.

Famotidine except when included in Schedule 2.

Febuxostat.

Felbinac except when included in Schedule 2.

Felodipine.

Felypressin.

Fenbufen.

Fencamfamin.

Fenclofenac.

Fenfluramine.

Fenofibrate.

Fenoldopam.

Fenoprofen.

Fenoterol.

Fenpipramide.

Fenpiprane.

Fenproporex.

Fenprostalene.

Ferric derisomaltose.

Fexofenadine except—

• (a)when included in Schedule 2; or
• (b)in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when—
  • (i)in a primary pack containing 20 dosage units or less and not more than 10 days’ supply; and
  • (ii)labelled with a recommended daily dose not exceeding 120 mg of fexofenadine.

Fibrinolysin except for external use.

Fibroblast growth factors.

Fidaxomicin.

Filgrastim.

Finasteride.

Fingolimod.

Firocoxib.

Flecainide.

Fleroxacin.

Floctafenine.

Florfenicol.

Fluanisone.

Fluclorolone.

Flucloxacillin.

Fluconazole except when included in Schedule 3.

Flucytosine.

Fludarabine.

Fludrocortisone.

Flufenamic acid.

Flumazenil.

Flumetasone.

Flumethiazide.

Flunisolide.

Flunixin meglumine.

Fluocinolone.

Fluocinonide.

Fluocortin.

Fluocortolone.

Fluorescein in preparations for injection.

Fluorides in preparations for human use except when included in or expressly excluded from schedules 2 or 3.

Fluorometholone.

Fluorouracil.

Fluoxetine.

Fluoxymesterone.

Flupentixol.

Fluphenazine.

Fluprostenol.

Flurandrenolone.

Flurazepam.

Flurbiprofen except when included in Schedule 2.

Fluroxene for human therapeutic use.

Fluspirilene.

Flutamide.

Fluticasone except when included in Schedule 2.

Fluvastatin.

Fluvoxamine.

Folic acid in preparations for human use for injection.

Folinic acid in preparations for human use for injection.

Follicle-stimulating hormone except when separately specified in this schedule.

Follistatin.

Follitropin alfa.

Follitropin beta.

Follitropin delta.

Fomepizole.

Fomivirsen.

Fondaparinux.

Formebolone.

Formestane.

Formoterol.

Fosamprenavir.

Fosaprepitant.

Foscarnet.

Fosfestrol (diethylstilbestrol diphosphate).

Fosfomycin.

Fosinopril.

Fosphenytoin.

Fotemustine.

Framycetin.

Fulvestrant.

Furaltadone.

Furazabol.

Furazolidone.

Furosemide (frusemide).

Fusidic acid.

Gabapentin.

Galantamine.

Galanthus spp.

Gallamine.

Galsulfase.

Ganciclovir.

Ganirelix.

Gatifloxacin.

Grazoprevir.

Gefitinib.

Gemcitabine.

Gemeprost.

Gemfibrozil.

Gemifloxacin.

Gemtuzumab ozogamicin.

Gentamicin.

Gestodene.

Gestonorone.

Gestrinone.

Ghrh injectable plasmid.

Gitalin.

Glatiramer acetate.

Glecaprevir.

Glibenclamide.

Glibornuride.

Gliclazide.

Glimepiride.

Glipizide.

Glisoxepide.

Glutathione for parenteral use.

Glutethimide.

Glyceryl trinitrate except when included in Schedule 3.

Glycopyrronium in preparations for injection.

Glymidine.

Gnrh vaccine.

Golimumab.

Gonadorelin.

Gonadotrophic hormones except when separately specified in this schedule.

Goserelin.

Gramicidin.

Granisetron.

Grepafloxacin.

Griseofulvin.

Growth hormone releasing hormones* (ghrhs).

Growth hormone releasing peptides (ghrps).

Growth hormone releasing peptide-6 (ghrp-6).

Growth hormone secretagogues* (ghss).

Guaifenesin for human therapeutic use except—

• (a)when included in Schedule 2;
• (b)in oral liquid preparations containing 2 per cent or less of guaifenesin; or
• (c)in divided preparations containing 200 mg or less of guaifenesin per dosage unit.

Guanabenz.

Guanacline.

Guanethidine.

Guanfacine.

Guanidine for therapeutic use.

Guselkumab.

Hachimycin.

Haematin.

Haemophilus influenzae vaccine.

Halcinonide.

Halofantrine.

Halofenate.

Halofuginone in preparations containing 0.1 per cent or less of halofuginone for the treatment of animals.

Haloperidol.

Halothane for therapeutic use.

Hemerocallis (hemerocallis flava).

Heparins for internal use except when separately specified in this schedule.

Hepatitis a vaccine.

Hepatitis b vaccine.

Hetacillin.

Hexachlorophene—

• (a)in preparations for use on infants; or
• (b)in other preparations except—
  • (i)when included in schedules 2 or 6; or
  • (ii)in preparations containing 0.75 per cent or less of hexachlorophene.

Hexamethonium.

Hexarelin.

Hexetidine for human internal use.

Hexobendine.

Hexocyclium.

Hexoprenaline.

Hexyl aminolevulinate (as hydrochloride).

Histamine for therapeutic use except in preparations containing 0.5 per cent or less of histamine.

Hmg-coa reductase inhibitors (including “statins”) except when separately specified in the schedules to these Regulations.

Homatropine.

Human chorionic gonadatrophin except in pregnancy test kits.

Human papillomavirus vaccine.

Hyaluronic acid and its polymers in preparations for injection or implantation—

• (a)for tissue augmentation;
• (b)for cosmetic use; or
• (c)for the treatment of animals.

Hydralazine.

Hydrargaphen.

Hydrochlorothiazide.

Hydrocortisone—

• (a)for human use except when included in schedules 2 or 3; or
• (b)for the treatment of animals.

Hydrocyanic acid for therapeutic use.

Hydroflumethiazide.

Hydroquinone (other than its alkyl ethers separately specified in this schedule) in preparations for human therapeutic or cosmetic use except—

• (a)when included in Schedule 2;
• (b)in hair preparations containing 0.3 per cent or less of hydroquinone; or
• (c)in cosmetic nail preparations containing 0.02 per cent or less of hydroquinone.

Hydroxycarbamide.

Hydroxychloroquine.

Hydroxyephedrine.

Hydroxyphenamate.

Hydroxyprogesterone.

Hydroxystenozol.

Hydroxyzine.

Hygromycin.

Hyoscine except when included in Schedule 2.

Hyoscyamine except when included in Schedule 2.

Hyoscyamus niger except—

• (a)when included in Schedule 2; or
• (b)in a pack containing 0.03 mg or less of total solanaceous alkaloids.

Hypothalamic releasing factors except when separately specified in this schedule.

Hypromellose in preparations for injection.

Ibafloxacin for veterinary use.

Ibandronic acid.

Ibogaine.

Ibritumomab.

Ibrutinib.

Ibufenac.

Ibuprofen except—

• (a)when included in or expressly excluded from schedules 2 or 3; or
• (b)in preparations for dermal use.

Ibutamoren.

Ibuterol.

Ibutilide.

Icatibant.

Idarubicin.

Idarucizumab.

Idebenone.

Idoxuridine except in preparations containing 0.5 per cent or less of idoxuridine for dermal use.

Idursulfase.

Ifosfamide.

Iloprost.

Imatinib.

Imepitoin.

Imidapril.

Imiglucerase.

Imipenim.

Imipramine.

Imiquimod.

Immunoglobulins for human parenteral use except when separately specified in the schedules to these Regulations.

Indacaterol.

Indapamide.

Indinavir.

Indometacin except when included in Schedule 2.

Indoprofen.

Indoramin.

Infliximab.

Influenza and coryza vaccines—

• (a)for parenteral use; or
• (b)for nasal administration.

Ingenol mebutate.

Inotuzumab ozogamicin.

Insulin degludec.

Insulin glargine.

Insulin-like growth factor 1.

Insulin-like growth factors except when separately specified in this schedule.

Insulins.

Interferons.

Interleukins except when separately specified in the schedules to these Regulations.

Iodothiouracil.

Ipamorelin.

Ipilimumab.

Ipratropium except when included in Schedule 2.

Ipriflavone.

Iprindole.

Iproniazid.

Irbesartan.

Irinotecan.

Iron compounds in injectable preparations for human use.

Isoaminile.

Isoamyl nitrite.

Isobutyl nitrite.

Isocarboxazid.

Isoconazole except when included in schedules 2, 3 or 6.

Isoetarine.

Isoflurane for therapeutic use.

Isometheptene.

Isoniazid.

Isoprenaline.

Isoprinosine.

Isopropamide except when included in Schedule 2.

Isosorbide dinitrate except when included in Schedule 3.

Isosorbide mononitrate.

Isotretinoin.

Isoxicam.

Isoxsuprine.

Isradipine.

Itraconazole.

Ivabradine.

Ivacaftor.

Ivermectin—

• (a)for human use; or
• (b)for the treatment of mange in dogs.

Ixabepilone.

Ixazomib.

Ixekizumab.

Japanese encephalitis vaccine.

Kanamycin.

Ketamine.

Ketanserin except in topical veterinary preparations containing 0.5 per cent or less of ketanserin.

Ketazolam.

Ketoconazole except—

• (a)when included in Schedule 2;
• (b)in preparations for dermal use containing 1 per cent or less of ketoconazole for the treatment of the scalp; or
• (c)in preparations for dermal use for the treatment of tinea pedis.

Ketoprofen except—

• (a)in preparations for dermal use; or
• (b)when included in Schedule 3.

Ketorolac (includes ketoralac trometamol).

Ketotifen except when included in Schedule 2.

Khellin.

Kitasamycin except—

• (a)when included in Schedule 5; or
• (b)in animal feeds for growth promotion containing 100 mg/kg or less of antibiotic substances.

Labetalol.

Lacidipine.

Lacosamide.

Lamivudine.

Lamotrigine.

Lanadelumab.

Lanatosides.

Lanreotide.

Lansoprazole except when included in schedules 2 or 3.

Lanthanum for therapeutic use.

Lapatinib.

Laronidase.

Laropiprant.

Latamoxef.

Latanoprost.

Laudexium.

Lauromacrogols in preparations for injection except—

• (a)when present as an excipient; or
• (b)when separately specified in the schedules to these Regulations.

Lead for human therapeutic use.

Ledipasvir.

Lefetamine.

Leflunomide.

Lenalidomide.

Lenograstim.

Lenvatinib.

Lepirudin.

Leptazol.

Lercanidipine.

Lesinurad.

Letermovir.

Letrozole.

Leuprorelin.

Levallorphan.

Levamisole—

• (a)for human therapeutic use; or
• (b)in preparations for the prevention or treatment of heartworm in dogs.

Levetiracetam.

Levobunolol.

Levobupivacaine.

Levocabastine except when included in Schedule 2.

Levocetirizine except—

• (a)when included in Schedule 2; or
• (b)in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when—
  • (i)in a primary pack containing not more than 5 days’ supply; and
  • (ii)labelled with a recommended daily dose not exceeding 5 mg of levocetirizine.

Levodopa.

Levomepromazine.

Levomilnacipran.

Levonorgestrel except when included in Schedule 3.

Levosimendan.

Lidocaine except—

• (a)when included in schedules 2 or 5;
• (b)in dermal preparations containing 2 per cent or less of total local anaesthetic substances per dosage unit; or
• (c)in lozenges containing 30 mg or less of total anaesthetic substances per dosage unit.

Lidoflazine.

Lifitegrast.

Linagliptin.

Lincomycin.

Lindane for human therapeutic use except when included in Schedule 2.

Linezolid.

Liothyronine.

Lipegfilgrastim.

Liraglutide.

Lisinopril.

Lisuride.

Lithium for therapeutic use except—

• (a)when included in Schedule 2;
• (b)when present as an excipient in preparations for dermal use containing 0.25 per cent or less of lithium; or
• (c)in preparations containing 0.01 per cent or less of lithium.

Lixisenatide.

Lodoxamide except when included in Schedule 2.

Lofexidine.

Logiparin for internal use.

Lomefloxacin.

Lomustine.

Loperamid except—

• (a)when included in Schedule 2; or
• (b)in divided oral preparations containing 2 mg or less of loperamide per dosage unit, in a primary pack containing 8 dosage units or less.

Lopinavir.

Loprazolam.

Loracarbef.

Loratadine except—

• (a)when included in Schedule 2; or
• (b)in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 6 years of age and over, when—
  • (i)in a primary pack containing 10 dosage units or less; and
  • (ii)labelled with a recommended daily dose not exceeding 10 mg of loratadine.

Lorazepam.

Lormetazepam.

Losartan.

Loteprednol.

Loxapine.

Lumacaftor.

Lumefantrine.

Lumiracoxib.

Lurasidone.

Luteinising hormone except in ovulation test kits.

Lymecycline.

Macitentan for human use.

Mafenide except when included in Schedule 6.

Mandragora officinarum.

Mannomustine.

Maprotiline.

Maraviroc.

Marbofloxacin.

Maropitant.

Mavacoxib.

Mazindol.

Measles vaccine.

Mebanazine.

Mebeverine.

Mebhydrolin.

Mebolazine.

Mebutamate.

Mecamylamine.

Mecasermin.

Mecillinam.

Meclocycline.

Meclofenamate.

Meclofenoxate.

Meclozine except when included in Schedule 2.

Medazepam.

Medetomidine.

Medigoxin (methyldigoxin).

Medroxyprogesterone.

Medrysone.

Mefenamic acid except when included in Schedule 2.

Mefenorex.

Mefloquine.

Mefruside.

Megestrol.

Melagatran.

Melanotan ii.

Melatonin for human use.

Melengestrol except when included in Schedule 6.

Meloxicam.

Melphalan.

Memantine.

Meningococcal vaccine.

Meningococcal group b vaccine.

Menotrophin.

Mepacrine.

Mepenzolate.

Mephenesin.

Mephentermine.

Mepindolol.

Mepitiostane.

Mepivacaine.

Meprobamate.

Meptazinol.

Mepyramine except when included in schedules 2 or 3.

Mequitazine.

Mercaptamine for human therapeutic use.

Mercaptomerin.

Mercaptopurine.

Mercurochrome except when included in schedules 2 or 6.

Mercury for cosmetic or therapeutic use except—

• (a)when separately specified in the schedules to these Regulations; or
• (b)in a sealed device which prevents access to the mercury.

Meropenem.

Mersalyl.

Mesabolone.

Mesalazine.

Mesna.

Mestanolone (androstalone).

Mesterolone.

Mestranol.

Metandienone.

Metaraminol.

Metenolone.

Metergoline.

Metformin.

Methacholine.

Methacycline.

Methallenestril.

Methandriol.

Methanthelinium.

Methazolamide.

Methdilazine except when included in Schedule 3.

Methenolone.

Methicillin.

Methimazole.

Methisazone.

Methixene.

Methocarbamol.

Methohexitone.

Methoin.

Methotrexate.

Methoxamine except—

• (a)when included in Schedule 2; or
• (b)in preparations for external use containing 1 per cent or less of methoxamine.

Methoxsalen.

Methoxyflurane.

Methsuximide.

Methyclothiazide.

Methyl aminolevulinate.

Methylandrostanolone.

Methylclostebol.

Methyldopa.

Methylene blue in preparations for injection.

Methylergometrine.

Methylmercury for therapeutic use.

Methylnaltrexone.

Methylpentynol.

Methylphenobarbital.

Methylprednisolone.

Methylrosanilinium chloride for human use except when used as a dermal marker.

Methyl salicylate in preparations for internal therapeutic use.

Methyltestosterone.

Methylthiouracil.

Methyltrienolone.

Methyprylone.

Methysergide.

Metoclopramide except when included in Schedule 3.

Metolazone.

Metoprolol.

Metribolone.

Metrifonate (trichlorfon) for human therapeutic use.

Metronidazole.

Metyrapone.

Mexiletine.

Mezlocillin.

Mianserin.

Mibefradil.

Mibolerone.

Micafungin.

Miconazole except—

• (a)when included in schedules 2, 3 or 6; or
• (b)in preparations for dermal use for the treatment of tinea pedis.

Midazolam.

Midostaurin.

Midodrine.

Mifepristone.

Migalastat.

Miglitol.

Miglustat.

Milbemycin oxime except when included in Schedule 5.

Milnacipran.

Milrinone.

Minocycline.

Minoxidil except when included in Schedule 2.

Mirabegron.

Mirtazapine.

Misoprostol

Mitobronitol.

Mitomycin.

Mitotane.

Mitoxantrone.

Mitratapide.

Mivacurium chloride.

Moclobemide.

Modafinil.

Molgramostim.

Molindone.

Mometasone except when included in Schedule 2.

Monensin except—

• (a)when included in schedules 5 or 6; or
• (b)in animal feeds containing 360 mg/kg or less of antibiotic substances.

Monobenzone and alkyl ethers of hydroquinone for human therapeutic use or cosmetic use except in cosmetic nail preparations containing 0.02 per cent or less of monobenzone or alkyl ethers of hydroquinone.

Monoclonal antibodies for therapeutic use except—

• (a)in diagnostic test kits; or
• (b)when separately specified in the schedules to these Regulations.

Monoethanolamine in preparations for injection.

Montelukast.

Moperone.

Morazone.

Moricizine.

Motrazepam.

Motretinide.

Moxidectin in preparations for injection containing 10 per cent or less of moxidectin except when included in schedules 5 or 6.

Moxifloxacin.

Moxonidine.

Mumps vaccine.

Mupirocin.

Muraglitazar.

Muromonab.

Mustine (nitrogen mustard).

Mycophenolic acid (includes mycophenolate mofetil).

Nabumetone.

Nadolol.

Nadroparin.

Nafarelin.

Naftidrofuryl.

Nalbuphine.

Nalidixic acid.

Nalmefene.

Nalorphine.

Naloxegol.

Naloxone except when in Schedule 3.

Naltrexone.

Nandrolone.

Naproxen except when included in schedules 2 or 3.

Narasin except—

• (a)when included in Schedule 6; or
• (b)in animal feeds containing 100 mg/kg or less of antibiotic substances.

Naratriptan.

Natalizumab.

Natamycin except for use as a food additive.

Nateglinide.

Nebacumab.

Nebivolol.

Nedocromil.

Nefazodone.

Nefopam.

Nelfinavir (includes nelfinavir mesilate).

Neomycin.

Neostigmine.

Nepafenac.

Neratinib.

Nerium oleander.

Nesiritide.

Netilmicin.

Netupitant.

Nevirapine.

Nialamide.

Nicardipine.

Nicergoline.

Nicofuranose.

Nicorandil.

Nicotine in preparations for human therapeutic use except when included in Schedule 2.

Nicotinic acid for human therapeutic use except—

• (a)when separately specified in the schedules to these Regulations;
• (b)in preparations containing 100 mg or less of nicotinic acid per dosage unit; or
• (c)nicotinamide.

Nicoumalone.

Nifedipine.

Nifenazone.

Nikethamide.

Nilotinib.

Nilutamide.

Nimesulide.

Nimodipine.

Nimorazole.

Nintedanib.

Niridazole.

Nisoldipine.

Nitisinone.

Nitrazepam.

Nitrendipine.

Nitric oxide for human therapeutic use.

Nitrofurantoin.

Nitrofurazone.

Nitrous oxide for therapeutic use.

Nitroxoline.

Nivolumab.

Nizatidine except when included in Schedule 2.

Nomegestrol.

Nomifensine.

Noradrenaline.

19-norandrostenediol.

19-norandrostenedione.

Norandrostenolone.

Norbolethone.

Norclostebol.

Norelgestromin.

Norethandrolone.

Norethisterone.

Norfloxacin.

Norgestrel.

Noribogaine.

Normal human immunoglobulin.

Normethandrone.

Nortriptyline.

Novobiocin.

Noxiptyline.

Nusinersen.

Nystatin except when included in schedules 2 or 3.

Obeticholic acid.

Oclacitinib.

Ocrelizumab.

Ocriplasmin.

Octamylamine.

Octatropine.

Octreotide.

Octyl nitrite.

Ofatumumab.

Ofloxacin.

Olanzapine.

Olaparib.

Olaratumab.

Oleandomycin except—

• (a)when included in Schedule 5; or
• (b)in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.

Oleandrin.

Olmesartan.

Olodaterol.

Olopatadine.

Olsalazine.

Omalizumab.

Ombitasvir.

Omega-3-acid ethyl esters (excluding salts and derivatives) for human therapeutic use, for the treatment of post-myocardial infarction and/or hypertriglyceridaemia.

Omeprazole except when included in schedules 2 or 3.

Ondansetron.

Opipramol.

Orbifloxacin.

Orciprenaline.

Organophosphorus compounds with anticholinesterase activity for human therapeutic use except—

• (a)when separately specified in the schedules to these Regulations; or
• (b)in preparations containing 2 per cent or less of malathion for external use.

Orlistat except when included in Schedule 3.

Ornidazole.

Ornipressin.

Orphenadrine.

Orthopterin.

Oseltamivir.

Osimertinib.

Ouabain.

Ovandrotone.

Oxabolone.

Oxacillin.

Oxaliplatin.

Oxandrolone.

Oxaprozin.

Oxazepam.

Oxcarbazepine.

Oxedrine for human internal use except in preparations labelled with a recommended daily dose of 30 mg or less of oxedrine.

Oxetacaine (oxethazaine) except when included in Schedule 2.

Oxiconazole except—

• (a)when included in schedules 2 or 3; or
• (b)in preparations for the treatment of tinea pedis.

Oxitropium.

Oxolamine.

Oxolinic acid.

Oxprenolol.

Oxybuprocaine.

Oxybutynin.

Oxymesterone.

Oxymetholone.

Oxyphenbutazone.

Oxyphencyclimine.

Oxyphenonium.

Oxytetracycline except when included in Schedule 5.

Oxytocin.

Paclitaxel.

Palbociclib.

Palifermin.

Paliperidone.

Palivizumab.

Palonosetron.

Pamaquin.

Pamidronic acid (includes pamidronate disodium).

Pancreatic enzymes except—

• (a)in preparations containing 20,000 bp units or less of lipase activity per dosage unit; or
• (b)when separately specified in the schedules to these Regulations.

Pancuronium.

Panitumumab.

Panobinostat.

Pantoprazole except when included in schedules 2 or 3.

Papaverine in preparations for injection.

Paracetamol—

• (a)when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in the schedules to these Regulations;
• (b)when combined with ibuprofen in a primary pack containing more than 30 dosage units;
• (c)in slow release tablets or capsules containing more than 665 mg paracetamol;
• (d)in non-slow release tablets or capsules containing more than 500 mg paracetamol;
• (e)in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
• (f)in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules;
• (g)in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2; or
• (h)for injection.

Paraldehyde.

Paramethadione.

Paramethasone.

Parecoxib.

Paricalcitol.

Paritaprevir.

Paromomycin.

Paroxetine.

Pasireotide.

Patiromer sorbitex calcium.

Pazopanib.

Pecazine.

Pefloxacin.

Pegaptanib.

Pegaspargase.

Pegfilgrastim.

Peginterferon.

Pegvisomant.

Pembrolizumab.

Pemetrexed.

Pemoline.

Pempidine.

Penbutolol.

Penciclovir except in preparations containing 1 per cent or less of penciclovir for the treatment of herpes labialis in packs containing 10 g or less.

Penethamate.

Penicillamine.

Pentaerythrityl tetranitrate.

Pentagastrin.

Pentamethonium.

Pentamidine (includes pentamidine isetionate).

Penthienate.

Pentobarbital when packed and labelled for injection.

Pentolinium.

Pentosan polysulfate sodium.

Pentoxifylline.

Peramivir.

Perampanel

Pergolide.

Perhexiline.

Periciazine.

Perindopril.

Permethrin for human therapeutic use except in preparations containing 5 per cent or less of permethrin.

Perphenazine.

Pertussis antigen.

Pertuzumab.

Phenacemide.

Phenacetin for therapeutic use (excluding when present as an excipient).

Phenaglycodol.

Phenazone except when included in schedules 2 or 5.

Phenazopyridine.

Phenelzine.

Pheneticillin.

Phenformin.

Phenglutarimide.

Phenindione.

Pheniramine except when included in schedules 2 or 3.

Phenisatin.

Phenobarbital.

Phenol in preparations for injection.

Phenolphthalein for human therapeutic use.

Phenoxybenzamine.

Phenoxymethylpenicillin.

Phensuximide.

Phentermine.

Phenthimentonium.

Phentolamine.

Phenylbutazone.

Phenylephrine—

• (a)in preparations for injection; or
• (b)in preparations for human ophthalmic use containing 5 per cent or more of phenylephrine.

Phenylpropanolamine.

Phenyltoloxamine.

Phenytoin.

Phleum pratense pollen extract (timothy-grass pollen extract).

Pholcodine—

• (a)in divided preparations containing 100 mg or less of pholcodine per dosage unit; or
• (b)in undivided preparations containing 2.5 per cent or less of pholcodine,

except when included in Schedule 2.

Phosphodiesterase type 5 inhibitors except—

• (a)when separately specified in the schedules to these Regulations; or
• (b)when present as an unmodified, naturally occurring substance.

Phthalylsulfathiazole.

Physostigmine.

Pibrentasvir.

Picrotoxin.

Pilocarpine except in preparations containing 0.025 per cent or less of pilocarpine.

Pimecrolimus.

Pimobendan.

Pimozide.

Pinacidil.

Pindolol.

Pioglitazone.

Pipecuronium.

Pipemidic acid.

Pipenzolate.

Piperacillin.

Piperidine.

Piperidolate.

Pipobroman.

Pipothiazine.

Pipradrol.

Piracetam.

Pirbuterol.

Pirenoxine (catalin).

Pirenzepine.

Piretanide.

Pirfenidone.

Piroxicam except in preparations for dermal use.

Pirprofen.

Pitavastatin.

Pituitary hormones except when separately specified in the schedules to these Regulations.

Pivampicillin.

Pizotifen.

Plicamycin.

Plerixafor.

Pneumococcal vaccine.

Podophyllotoxin for human use—

• (a)internally;
• (b)in preparations for the treatment of anogenital warts; or
• (c)in other preparations except when included in schedules 2 or 3.

Podophyllum emodi (podophyllin) for human use—

• (a)internally;
• (b)in preparations for the treatment of anogenital warts; or
• (c)in other preparations except when included in schedules 2 or 3.

Podophyllum peltatum (podophyllin) for human use—

• (a)internally;
• (b)in preparations for the treatment of anogenital warts; or
• (c)in other preparations except when included in schedules 2 or 3.

Polidexide.

Poliomyelitis vaccine.

Polyacrylamide in preparations for injection or implantation—

• (a)for tissue augmentation; or
• (b)for cosmetic use.

Polycaprolactone in preparations for injection or implantation—

• (a)for tissue augmentation; or
• (b)for cosmetic use.

Polyestradiol.

Polylactic acid in preparations for injection or implantation—

• (a)for tissue augmentation; or
• (b)for cosmetic use.

Polymyxin.

Polysulfated glycosaminoglycans in preparations for injection, except when separately specified in the schedules to these Regulations.

Polythiazide.

Pomalidomide.

Poractant.

Posaconazole.

Potassium bromide for therapeutic use.

Potassium chloride in oral preparations for human therapeutic use except—

• (a)when containing less than 550 mg of potassium chloride per dosage unit;
• (b)in preparations for oral rehydration therapy;
• (c)in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures; or
• (d)in preparations for enteral feeding.

Potassium perchlorate for therapeutic use.

Practolol.

Pradofloxacin.

Pralatrexate.

Pralidoxime.

Pramipexole.

Pramocaine.

Pralmorelin (growth hormone releasing peptide-2 (ghrp-2)).

Prampine.

Prasterone (dehydroepiandrosterone, dehydroisoandrosterone).

Prasugrel.

Pravastatin.

Prazepam.

Praziquantel for human therapeutic use.

Prazosin.

Prednisolone.

Prednisone.

Pregabalin.

Pregnenolone.

Prenalterol.

Prenylamine.

Prilocaine except when included in Schedule 2.

Primaquine.

Primidone.

Probenecid.

Probucol.

Procainamide.

Procaine.

Procaine benzylpenicillin.

Procarbazine.

Prochlorperazine except when included in Schedule 3.

Procyclidine except when included in Schedule 2.

Progesterone except when included in Schedule 5.

Progestogens except when separately specified in the schedules to these Regulations.

Proglumide.

Proguanil.

Prolintane.

Promazine.

Promethazine except when included in schedules 2 or 3.

Promoxolane.

Propafenone.

Propamidine for therapeutic use except when included in Schedule 2.

Propanidid.

Propantheline.

Propentofylline.

Propetandrol.

Propionibacterium acnes for therapeutic use.

Propofol.

Propranolol.

Propylhexedrine.

Propylthiouracil.

Propyphenazone.

Proquazone.

Proscillaridin.

Prostaglandins except when separately specified in this schedule.

Prostianol.

Protamine.

Prothionamide.

Prothipendyl.

Protirelin.

Protoveratrines.

Protriptyline.

Proxymetacaine.

Prucalopride.

Pseudoephedrine

Pyrazinamide.

Pyridinolcarbamate.

Pyridostigmine.

Pyridoxine, pyridoxal or pyridoxamine for human therapeutic use except—

• (a)in oral preparations containing 200 mg or less but more than 50 mg of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose when compliant with the labelling requirements under the Act; or
• (b)in oral preparations containing 50 mg or less of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose.

Pyrimethamine.

Pyrovalerone.

Pyrvinium.

Quazepam.

Quetiapine.

Quinagolide.

Quinapril.

Quinbolone.

Quinethazone.

Quinidine.

Quinine for human therapeutic use except when the maximum recommended daily dose is 50 mg or less of quinine.

Quinisocaine (dimethisoquin).

Quinupristin.

Rabeprazole except when included in schedules 2 or 3.

Rabies vaccine.

Ractopamine except when included in Schedule 5.

Raloxifene.

Raltegravir.

Raltitrexed.

Ramipril.

Ramucirumab.

Ranibizumab.

Ranitidine except—

• (a)when included in Schedule 2;
• (b)in divided preparations for oral use containing 150 mg or less of ranitidine per dosage unit when supplied in the manufacturer’s original pack containing not more than 14 dosage units; or
• (c)in divided preparations for oral use containing 300 mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 7 dosage units.

Ranolazine

Rapacuronium.

Rasagiline.

Rasburicase.

Rauwolfia serpentina.

Rauwolfia vomitoria.

Razoxane.

Reboxetine.

Red yeast rice for human therapeutic use.

Regorafenib.

Remoxipride.

Repaglinide.

Reserpine.

Reslizumab.

Retapamulin.

Reteplase.

Retigabine.

Ribavirin.

Ribociclib.

Ridaforolimus.

Rifabutin.

Rifampicin.

Rifamycin.

Rifapentine.

Rifaximin.

Rilpivirine.

Riluzole.

Rimexolone.

Rimiterol.

Rimonabant.

Riociguat.

Risedronic acid.

Risperidone.

Ritodrine.

Ritonavir.

Rituximab.

Rivaroxaban.

Rivastigmine.

Rizatriptan.

Robenacoxib.

Rocuronium.

Rofecoxib.

Roflumilast.

Rolitetracycline.

Romidepsin.

Romifidine.

Romiplostim.

Romosozumab.

Ronidazole.

Ropinirole.

Ropivacaine.

Rosiglitazone.

Rosoxacin.

Rosuvastatin.

Rotigotine.

Roxibolone.

Roxithromycin.

Rubella vaccine.

Ruboxistaurin.

Rufinamide.

Rupatadine.

Ruxolitinib.

Sacubitril.

Safinamide.

Salbutamol except when included in Schedule 3.

Salicylamide when combined with aspirin, caffeine or paracetamol or any derivative of these substances.

Salinomycin except—

• (a)when included in Schedule 6; or
• (b)in animal feeds containing 60 mg/kg or less of antibiotic substances.

Salmeterol.

Sapropterin.

Saquinavir.

Sarilumab.

Saxagliptin.

Schoenocaulon officinale (sabadilla) except in preparations containing 10 mg/kg or 10 mg/l or less of total alkaloids of schoenocaulon officinale.

Scopolia carniolica for therapeutic use.

Sebelipase alfa.

Secukinumab.

Selective androgen receptor modulators (sarm).

Selegiline.

Selenium—

• (a)for human oral use with a recommended daily dose of more than 300 μg; or
• (b)for the treatment of animals except—
  • (i)when included in schedules 6 or 7;
  • (ii)in solid, slow release bolus preparations each weighing 100 g or more and containing 300 mg or less of selenium per dosage unit;
  • (iii)in other divided preparations containing 30 μg or less of selenium per dosage unit;
  • (iv)as elemental selenium, in pellets containing 100 g/kg or less of selenium; or
  • (v)in feeds containing 1 g/tonne or less of selenium.

Serelaxin.

Selexipag.

Sermorelin.

Sertindole.

Sertraline.

Sevelamer.

Sevoflurane.

Sex hormones and all substances having sex hormonal activity except when separately specified in the schedules to these Regulations.

Sibutramine.

Silandrone.

Sildenafil.

Silicones for intra-ocular use.

Silodosin.

Siltuximab.

Silver sulfadiazine.

Simeprevir.

Simvastatin.

Sirolimus.

Sisomicin (sisomycin).

Sitagliptin.

Sitaxentan.

Sodium bromide for therapeutic use.

Sodium cellulose phosphate for human internal use.

Sodium cromoglycate except when included in Schedule 2.

Sodium morrhuate in preparations for injection.

Sodium nitroprusside for human therapeutic use.

Sodium phenylbutyrate.

Sodium phosphate in preparations for oral laxative use.

Sodium polystyrene sulphonate for human therapeutic use.

Sodium salicylate in preparations for injection for the treatment of animals.

Sodium tetradecylsulfate in preparations for injection.

Sodium zirconium cyclosilicate.

Sofosbuvir.

Solasodine.

Solifenacin.

Somatostatin.

Somatotropin equine.

Somatropin (human growth hormone).

Sonidegib.

Sontoquine.

Sorafenib.

Sotalol.

Sparfloxacin.

Sparteine.

Spectinomycin.

Spiramycin.

Spirapril.

Spironolactone.

Stanolone.

Stanozolol.

Stavudine.

Stenabolic (sr9009) and other synthetic rev-erb agonists.

Stenbolone.

Steroid hormones except when separately specified in the schedules to these Regulations.

Stilbestrol (diethylstilbestrol).

Stiripentol.

Streptodornase.

Streptokinase.

Streptomycin.

Strontium ranelate.

Strophanthins.

Strophanthus spp.

Strychnine in preparations containing 1.5 per cent or less of strychnine for the treatment of animals.

Strychnos spp. except in preparations containing 1 mg or less per litre or per kilogram of strychnine.

Styramate.

Succimer.

Sugammadex.

Sulbactam.

Sulconazole except when included in Schedule 2.

Sulfacetamide except when included in schedules 3 or 5.

Sulfadiazine except when included in Schedule 5.

Sulfadimethoxine.

Sulfadimidine except when included in Schedule 5.

Sulfadoxine.

Sulfafurazole.

Sulfaguanidine.

Sulfamerazine except when included in Schedule 5.

Sulfamethizole.

Sulfamethoxazole.

Sulfamethoxydiazine.

Sulfamethoxypyridazine.

Sulfametrole.

Sulfamonomethoxine.

Sulfamoxole.

Sulfaphenazole.

Sulfapyridine.

Sulfaquinoxaline.

Sulfasalazine.

Sulfathiazole except when included in Schedule 5.

Sulfatroxazole.

Sulfinpyrazone.

Sulfomyxin.

Sulfonamides except—

• (a)when separately specified in this schedule;
• (b)when included in schedules 3, 5 or 6; or
• (c)when packed and labelled solely for use as a herbicide.

Sulfonmethane (sulfonal) and alkyl sulfonals.

Sulindac.

Sultamicillin.

Sulthiame.

Sumatriptan.

Sunitinib.

Suprofen.

Sutilains.

Suxamethonium.

Suxethonium.

Suvorexant.

Tacrine.

Tacrolimus.

Tadalafil.

Tafenoquine succinate.

Tafluprost.

Taliglucerase alfa.

Talimogene laherparepvec.

Tamoxifen.

Tamsulosin.

Tanacetum vulgare except in preparations containing 0.8 per cent or less of oil of tansy.

Tasonermin.

Tazarotene.

Tazobactam.

Tb-500.

T-cell receptor antibody.

Teduglutide.

Tegafur.

Tegaserod.

Telaprevir.

Telithromycin.

Teicoplanin.

Telbivudine.

Telmisartan.

Telotristat ethyl.

Temazepam.

Temozolomide.

Temsirolimus.

Tenecteplase.

Teniposide.

Tenofovir.

Tenoxicam.

Tepoxalin.

Terazosin.

Terbinafine except—

• (a)when included in Schedule 2; or
• (b)in preparations for dermal use for the treatment of tinea pedis.

Terbutaline except when included in Schedule 3.

Terfenadine.

Teriflunomide.

Teriparatide.

Terlipressin.

Terodiline.

Teropterin.

Testolactone.

Testosterone except when included in Schedule 6.

Tetanus antitoxin except when used for short-term protection or treatment of tetanus in animals.

Tetanus toxoid for human use.

Tetrabenazine.

Tetracaine except—

• (a)when included in Schedule 2; or
• (b)in dermal preparations containing 2 per cent or less of total local anaesthetic substances.

Tetracosactide.

Tetracycline except when included in Schedule 5.

Tetraethylammonium.

Tetroxoprim.

Tezacaftor.

Thalidomide.

Thenyldiamine.

Theophylline except when included in Schedule 3.

Thevetia peruviana.

Thevetin.

Thiacetarsamide in preparations for the prevention or treatment of heartworm in dogs.

Thiambutosine.

Thiazosulfone.

Thiethylperazine.

Thioacetazone.

Thiocarlide.

Thiomesterone (tiomesterone).

Thiopental.

Thiopropazate.

Thioproperazine.

Thioridazine.

Thiostrepton.

Thiotepa.

Thiothixene.

Thiouracil.

Thiourea for therapeutic use except in preparations containing 0.1 per cent or less of thiourea.

Thymosin beta 4 (thymosin β4).

Thymoxamine (includes thymoxamine hydrochloride).

Thyroid except when separately specified in this schedule.

Thyrotrophin.

Thyroxine (includes thyroxine sodium).

Tiagabine.

Tiamulin.

Tianeptine.

Tiaprofenic acid.

Tiaramide.

Tibolone.

Ticagrelor.

Ticarcillin.

Ticlopidine.

Tiemonium.

Tienilic acid.

Tigecycline.

Tigloidine.

Tildipirosin.

Tiletamine.

Tilmanocept.

Tilmicosin.

Tiludronic acid (includes disodium tiludronate).

Timolol.

Tinidazole.

Tinzaparin (includes tinzaparin sodium).

Tioconazole except—

• (a)when included in schedules 2 or 3; or
• (b)in preparations for dermal use for the treatment of tinea pedis.

Tioguanine.

Tiotropium.

Tipepidine.

Tipiracil.

Tipranavir.

Tirilazad.

Tirofiban.

Tobramycin.

Tocainide.

Toceranib.

Tocilizumab.

Tofacitinib.

Tolazamide.

Tolazoline.

Tolbutamide.

Tolcapone.

Tolfenamic acid.

Tolmetin.

Tolonium.

Tolpropamine.

Tolrestat.

Tolterodine.

Tolvaptan.

Topiramate.

Topotecan.

Torasemide.

Toremifene.

Toxoids for human parenteral use except when separately specified in the schedules to these Regulations.

Tramadol.

Trandolapril.

Trametinib dimethyl sulfoxide.

Tranexamic acid except in preparations containing 3 per cent or less of cetyl tranexamate hydrochloride for dermal cosmetic use.

Tranylcypromine.

Trastuzumab.

Trastuzumab emtansine.

Travoprost.

Trazodone.

Trenbolone (trienbolone, trienolone) except when included in Schedule 5.

Treosulphan.

Treprostinil.

Trestolone.

Tretamine.

Tretinoin.

Triacetyloleandomycin.

Triamcinolone except when included in schedules 2 or 3.

Triamterene.

Triaziquone.

Triazolam.

Trichlormethiazide.

Trichloroacetic acid for human dermal use except when in preparations containing 12.5 per cent or less of trichloroacetic acid for the treatment of warts other than anogenital warts.

Trichloroethylene for therapeutic use.

Triclofos.

Tricyclamol.

Tridihexethyl.

Trifluoperazine.

Trifluperidol.

Triflupromazine.

Trifluridine.

Trihexyphenidyl.

Trilostane.

Trimetaphan.

Trimethoprim.

Trimipramine.

Trimustine.

Trinitrophenol (excluding its derivatives) in preparations for human therapeutic use.

Trioxysalen.

Tripelennamine.

Triple antigen vaccine.

Triprolidine except when included in schedules 2 or 3.

Triptorelin.

Troglitazone.

Trolamine when in preparations for tattoo removal.

Trometamol in preparations for injection except in preparations containing 3 per cent or less of trometamol.

Tropicamide.

Tropisetron.

Trovafloxacin.

Troxidone.

Tryptophan for human therapeutic use except in preparations labelled with a recommended daily dose of 100 mg or less of tryptophan.

Tuberculin.

Tubocurarine.

Tulathromycin.

Tulobuterol.

Tylosin.

Typhoid vaccine.

Ulipristal except when included in Schedule 3.

Umeclidinium.

Unoprostone.

Uracil.

Urapidil.

Urethane (excluding its derivatives) for therapeutic use.

Urofollitropin.

Urokinase.

Ursodeoxycholic acid.

Ustekinumab.

Vaccines for human therapeutic use except when separately specified in this schedule.

Vaccines — plasmid DNA for animal use except when separately specified in the schedules to these Regulations.

Vaccines, veterinary live virus except—

• (a)poultry vaccines;
• (b)pigeon pox vaccine; or
• (c)scabby mouth vaccine.

Vaccinia virus vaccine.

Valaciclovir.

Valdecoxib.

Valganciclovir.

Valnoctamide.

Valproic acid.

Valsartan.

Vancomycin.

Vandetanib.

Vardenafil.

Varenicline.

Varicella vaccine.

Recombinant varicella zoster virus glycoprotein E antigen.

Vasopressin.

Vecuronium.

Vedaprofen.

Vedolizumab.

Velaglucerase alfa.

Velpatasvir.

Vemurafenib.

Venetoclax.

Venlafaxine.

Verapamil.

Veratrum spp. except when separately specified in this schedule.

Vernakalant.

Verteporfin.

Vidarabine.

Vigabatrin.

Vilanterol.

Vildagliptin.

Viloxazine.

Vinblastine.

Vincamine.

Vincristine.

Vindesine.

Vinflunine.

Vinorelbine.

Vinyl ether for therapeutic use.

Virginiamycin except when included in Schedule 5.

Vismodegib.

Visnadine.

Vitamin A for human therapeutic or cosmetic use except—

• (a)in preparations for topical use containing 1 per cent or less of vitamin A;
• (b)in preparations for internal use containing 3000 μg retinol equivalents or less of vitamin A per daily dose; or
• (c)in preparations for parenteral nutrition replacement.

Vitamin D for human internal therapeutic use except—

• (a)in preparations containing 25 μg or less of vitamin D per recommended daily dose; or
• (b)when included in Schedule 3.

Vorapaxar.

Voriconazole.

Vorinostat.

Vortioxetine.

Voxilaprevir.

Warfarin for therapeutic use.

Xamoterol.

Xanthinol nicotinate.

Ximelagatran.

Xipamide.

Xylazine.

Yohimbine.

Zafirlukast.

Zalcitabine.

Zaleplon.

Zanamivir.

Zeranol except when included in Schedule 6.

Zidovudine.

Zilpaterol.

Zimeldine.

Zinc compounds for human internal use except—

• (a)in preparations with a recommended daily dose of 25 mg or less of zinc; or
• (b)in preparations with a recommended daily dose of more than 25 mg but not more than 50 mg of zinc when compliant with the labelling requirements under the Act.

Ziprasidone.

Zolazepam.

Zoledronic acid.

Zolmitriptan.

Zolpidem.

Zonisamide.

Zopiclone.

Zoxazolamine.

Zuclopenthixol.