medicines amendment regulations (no 2) 2015 · medicines amendment regulations (no 2) 2015 (li...

Medicines Amendment Regulations (No 2) 2015(LI 2015/180)

Medicines Amendment Regulations (No 2) 2015: revoked, on 25 October 2018, by regulation 5 ofthe Medicines Amendment Regulations 2018 (LI 2018/179).

Jerry Mateparae, Governor-General

Order in Council

At Wellington this 27th day of July 2015

Present:His Excellency the Governor-General in Council

Pursuant to section 105(1)(j) of the Medicines Act 1981, His Excellency theGovernor-General makes the following regulations, acting—(a) on the advice and with the consent of the Executive Council; and(b) on the advice of the Minister of Health tendered after consultation with the

organisations or bodies appearing to the Minister to be representative of per-sons likely to be substantially affected.

ContentsPage

1 Title 22 Commencement 23 Principal regulations 24 Schedule 1 replaced 2

NoteChanges authorised by subpart 2 of Part 2 of the Legislation Act 2012 have been made in this official reprint.

Note 4 at the end of this reprint provides a list of the amendments incorporated.

These regulations are administered by the Ministry of Health.

Reprintas at 25 October 2018

1

http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=LMS69432

http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM56564



ScheduleSchedule 1 replaced

2

Regulations

1 TitleThese regulations are the Medicines Amendment Regulations (No 2) 2015.

2 CommencementThese regulations come into force on 6 August 2015.

3 Principal regulationsThese regulations amend the Medicines Regulations 1984 (the principal regu-lations).

4 Schedule 1 replacedReplace Schedule 1 with the Schedule 1 set out in the Schedule of these regula-tions.

ScheduleSchedule 1 replaced

r 4

Schedule 1Prescription, restricted, and pharmacy-only medicines

r 3

Every reference to a medicine in this schedule applies whether the medicine is syn-thetic in origin or is from biological or mineral sources.Unless specific reference is made otherwise, every reference applies also to medicinesthat are—• preparations and admixtures containing any proportion of any substance listed

in this schedule:• salts and esters of any substance listed in this schedule:• preparations or extracts of biological materials listed in this schedule:• salts or oxides of elements listed in this schedule.Unless specific reference is made otherwise, every reference to a medicine in thisschedule applies,—• if the medicine is an injection or eye preparation, to any concentration of that

medicine; and

r 1 Medicines Amendment Regulations (No 2) 2015Reprinted as at

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• if the medicine is not an injection or eye preparation, only if the concentrationof the medicine is greater than 10 milligrams per litre or per kilogram.

Where any reference is modified by a statement of the strength of the medicine, thestrength is calculated using the free acid, base, alcohol, or element unless specificallystated otherwise.

Part 1Prescription medicines

Amending or replacing this Part may affect designated prescriber regulations undersection 105(1)(q) of the Act.1 19-norandrostenedione2 2,4-dinitrochlorobenzene3 4-aminopyridine4 4-chloromethandienone5 4-chlorotestosterone6 5-aminolevulinic acid7 Abacavir8 Abatacept9 Abciximab10 Abiraterone11 Abrus precatorius; at all strengths12 Acamprosate13 Acarbose14 Acebutolol15 Acepromazine16 Acetanilides17 Acetarsol18 Acetazolamide19 Acetohexamide20 Acetylcarbromal21 Acetylcholine; except in medicines containing 1 milligram or less per litre or

per kilogram22 Acetylcysteine; for injection or inhalation23 Acetyldigitoxin24 Acetylmethyldimethyloximidophenylhydrazine25 Acetylstrophanthidin

Reprinted as at25 October 2018 Medicines Amendment Regulations (No 2) 2015 Schedule

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26 Aciclovir; except for external use for the treatment of herpes labialis27 Acipimox28 Acitretin29 Aclidinium bromide30 Acokanthera ouabaio31 Acokanthera schimperi32 Aconitum spp; except when specified elsewhere in this schedule33 Acrivastine34 Adalimumab35 Adapalene36 Adefovir37 Adenosine; for injection38 Adinazolam39 Adiphenine40 Adonis vernalis41 Adrafinil42 Adrenal extract; except for dermal use in medicines containing 0.02% or less

of ketosteroids43 Adrenaline; in medicines containing more than 1%44 Adrenocortical hormones; except adrenal extract for dermal use containing

0.02% or less of ketosteroids45 Afamelanotide46 Afatinib47 Aflibercept48 Agalsidase49 Agomelatine50 Alatrofloxacin51 Albendazole52 Albumin; except human albumin53 Alclofenac54 Alclometasone; except when specified elsewhere in this schedule55 Alcohol; for injection in medicines containing more than 20%56 Alcuronium57 Aldesleukin

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58 Aldosterone; except in medicines containing 10 micrograms or less per litre orper kilogram

59 Alefacept60 Alemtuzumab61 Alendronic acid62 Alfacalcidol63 Alfentanil64 Alfuzosin65 Alglucerase66 Alglucosidase67 Aliskiren68 Alkyl sulfonals69 Allergens70 Allopurinol71 Allylisopropylacetylurea; at all strengths72 Allyloestrenol73 Alogliptin74 Alosetron75 Alpha1-proteinase inhibitor76 Alphadolone77 Alphaxalone78 Alprazolam79 Alprenolol80 Alprostadil81 Alseroxylon82 Alteplase83 Altretamine84 Amantadine85 Ambenonium86 Ambrisentan87 Ambucetamide88 Ambutonium89 Amcinonide


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90 Amethocaine; for internal use; for external use in medicines containing morethan 10%; for ophthalmic use except when used in practice by an optometristregistered with the Optometrists and Dispensing Opticians Board

91 Amfebutamone92 Amfepramone93 Amidopyrine94 Amifostine95 Amikacin96 Amiloride97 Aminocaproic acid98 Aminoglutethimide99 Aminometradine100 Aminophenazone; at all strengths101 Aminophylline; except for oral use in liquid form in medicines containing 2%

or less102 Aminopterin103 Aminorex104 Aminosalicylic acid105 Amiodarone106 Amiphenazole107 Amisometradine108 Amisulpride109 Amitriptyline110 Amlodipine111 Ammi visnaga112 Ammonium bromide113 Amobarbital114 Amodiaquine115 Amorolfine; except when specified elsewhere in this schedule; except in prep-

arations for the treatment of tinea pedis only or when sold in practice by apodiatrist registered with the Podiatrists Board

116 Amoxapine117 Amoxycillin118 Amphomycin119 Amphotericin120 Ampicillin


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121 Amprenavir122 Amrinone123 Amsacrine124 Amygdalin; at all strengths125 Amyl nitrite; except when sold to a person who holds a controlled substances

licence (issued under section 95B of the Hazardous Substances and NewOrganisms Act 1996) authorising the person to possess cyanide; except whensold to an exempt laboratory covered by a Hazardous Substances and NewOrganisms Act 1996 approved code of practice

126 Amylocaine127 Anabolic steroids128 Anagrelide129 Anakinra130 Anastrozole131 Ancestim132 Anchusa officinalis; at all strengths133 Ancrod and its immunoglobulin antidote134 Androgenic and anabolic steroidal agents135 Androgens136 Androisoxazole137 Androstanolone138 Androstenediol139 Androstenedione140 Anecortave141 Angiotensinamide142 Anidulafungin143 Anistreplase144 Antazoline; except for ophthalmic use145 Antibiotic substances; except when specified elsewhere in this schedule146 Antigens147 Antihistamines; except when specified elsewhere in this schedule148 Antimony; except in medicines containing 1 milligram or less per litre or per

kilogram149 Antisera; for injection150 Apixaban151 Apocynum spp


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152 Apomorphine; except in medicines containing 1 milligram or less per litre orper kilogram

153 Apraclonidine154 Aprepitant155 Apronal156 Aprotinin157 Arecoline158 Aripiprazole159 Aristolochia spp; at all strengths160 Aristolochic acid; at all strengths161 Arsenic; except in medicines containing 1 milligram or less per litre or per

kilogram162 Artemether163 Articaine; except when used as a local anaesthetic in practice by a dental thera-

pist registered with the Dental Council164 Asenapine165 Asparaginase166 Aspirin; for injection; when combined with caffeine, paracetamol, or salicyla-

mide167 Astemizole168 Atamestane169 Atazanavir170 Atenolol171 Atomoxetine172 Atorvastatin173 Atosiban174 Atovaquone175 Atracurium176 Atropa belladonna; except when specified elsewhere in this schedule; except in

medicines containing 300 micrograms or less of total solanaceous alkaloids perlitre or per kilogram

177 Atropine; except when specified elsewhere in this schedule; except when usedas an antidote in a device designed for self-injection; except in medicines con-taining 300 micrograms or less per litre or per kilogram

178 Atropine methonitrate179 Auranofin


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180 Aurothiomalate sodium181 Avanafil182 Aviptadil183 Axitinib184 Azacitidine185 Azacyclonol186 Azapropazone187 Azaribine188 Azatadine; except when specified elsewhere in this schedule189 Azathioprine190 Azelaic acid; except for dermal use191 Azelastine; except when specified elsewhere in this schedule192 Azithromycin193 Azlocillin194 Aztreonam195 Bacampicillin196 Bacitracin197 Baclofen198 Balsalazide199 Bambuterol200 Bamethan201 Bamipine202 Barbital203 Barbiturates204 Basiliximab205 Bazedoxifene206 Becaplermin207 Beclamide208 Beclomethasone; except when specified elsewhere in this schedule209 Belatacept210 Belimumab211 Bemegride212 Benactyzine213 Benazepril214 Bendamustine


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215 Bendrofluazide216 Benethamine penicillin217 Benorylate218 Benoxaprofen219 Benperidol220 Benserazide221 Benzathine penicillin222 Benzatropine223 Benzhexol224 Benzilonium225 Benzocaine; except when specified elsewhere in this schedule; except in der-

mal preparations containing 2% or less of total anaesthetic substances; exceptin lozenges containing 30 milligrams or less of total anaesthetic substances perdosage unit

226 Benzodiazepines227 Benzoyl metronidazole228 Benzoyl peroxide; except for external use in medicines containing 10% or less229 Benzthiazide230 Benzydamine; for internal use231 Benzylpenicillin232 Bepridil233 Beractant234 Besifloxacin235 Beta carotene; in medicines containing more than 18 milligrams per recom-

mended daily dose236 Betahistine237 Betamethasone238 Betaxolol239 Bethanechol240 Bethanidine241 Bevacizumab242 Bevantolol243 Bexarotene244 Bezafibrate245 Bicalutamide


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246 Bifonazole; except for dermal use247 Bimatoprost248 Biperiden249 Bismuth; except for external use in medicines containing 3% or less250 Bisoprolol251 Bithionol; at all strengths252 Bivalirudin253 Bleomycin254 Boceprevir255 Bolandiol256 Bolasterone257 Bolazine258 Boldenone259 Bolenol260 Bolmantalate261 Boron, including borax and boric acid; except for internal use in medicines

containing 6 milligrams or less per recommended daily dose; except in dermalmedicines for use other than paediatric use containing 0.35% or less; exceptwhen present as an excipient

262 Bortezomib263 Bosentan264 Botulinum toxins265 Bretylium266 Brimonidine267 Brinzolamide268 Bromazepam269 Bromocriptine270 Bromoform271 Brompheniramine; except when specified elsewhere in this schedule272 Bromvaletone273 Brotizolam274 Brugmansia spp275 Buclizine; except for oral use276 Budesonide; except when specified elsewhere in this schedule


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277 Bufexamac; except in suppositories or for dermal use in medicines containing5% or less

278 Bumetanide279 Buniodyl sodium; at all strengths280 Buphenine281 Bupivacaine282 Buprenorphine283 Bupropion284 Buserelin285 Buspirone286 Busulphan287 Butacaine288 Butobarbital289 Butoconazole; except for vaginal use290 Butorphanol291 Butyl aminobenzoate; except for dermal use in medicines containing 2% or

less292 Butyl nitrite293 Butylchloral hydrate294 Cabazitaxel295 Cabergoline296 Cacalia spp; at all strengths297 Cadmium298 Calcipotriol; except in medicines containing not more than 50 micrograms per

gram or per millilitre and when sold in a pack of not more than 30 grams or 30millilitres by a pharmacist to an adult with mild to moderate psoriasis previ-ously diagnosed by a doctor

299 Calcitonin300 Calcitriol301 Calcium carbimide302 Calcium polystyrene sulphonate303 Calotropis gigantea304 Calotropis procera305 Calusterone306 Camazepam307 Camphorated oil


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308 Camphotamide309 Canagliflozin310 Canakinumab311 Candesartan312 Candicidin313 Cannabidiol314 Capecitabine315 Capreomycin316 Captodiame317 Captopril318 Capuride319 Caramiphen320 Carbachol321 Carbamazepine322 Carbaryl; except for external use in medicines containing 2% or less323 Carbazochrome324 Carbenicillin325 Carbenoxolone; for internal use326 Carbetocin327 Carbidopa328 Carbimazole329 Carbocromen330 Carboplatin331 Carboprost332 Carbromal333 Carbutamide334 Carbuterol335 Carindacillin336 Carisoprodol337 Carmustine338 Carprofen339 Carvedilol340 Caspofungin341 Catumaxomab342 Cefacetrile


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343 Cefaclor344 Cefaloridine345 Cefamandole346 Cefapirin347 Cefazolin348 Cefepime349 Cefetamet350 Cefixime351 Cefodizime352 Cefonicid353 Cefoperazone354 Cefotaxime355 Cefotetan356 Cefotiam357 Cefoxitin358 Cefpirome359 Cefpodoxime360 Cefsulodin361 Ceftaroline fosamil362 Ceftazidime363 Ceftibuten364 Ceftolozane365 Ceftriaxone366 Cefuroxime367 Celecoxib368 Celiprolol369 Cephaelis acuminata; except in medicines containing less than 0.2% of emetine370 Cephaelis ipecacuanha; except in medicines containing less than 0.2% of emet-

ine371 Cephalexin372 Cephalothin373 Cephradine374 Cerivastatin375 Certolizumab pegol376 Ceruletide


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377 Cetirizine; except for oral use378 Cetrorelix379 Cetuximab380 Chenodeoxycholic acid381 Chloral hydrate; except for dermal use in medicines containing 2% or less382 Chloralformamide383 Chloralose384 Chlorambucil385 Chloramphenicol; except when sold in practice by an optometrist registered

with the Optometrists and Dispensing Opticians Board; except when specifiedelsewhere in this schedule

386 Chlorandrostenolone387 Chlorazanil388 Chlorcyclizine389 Chlordiazepoxide390 Chlormerodrin391 Chlormethiazole392 Chlormezanone393 Chloroform; for anaesthesia; except when specified elsewhere in this schedule394 Chloroquine395 Chlorothiazide396 Chlorotrianisene397 Chloroxydienone398 Chloroxymesterone399 Chlorpheniramine; except when specified elsewhere in this schedule400 Chlorphentermine401 Chlorpromazine402 Chlorpropamide403 Chlorprothixene404 Chlorquinaldol405 Chlortetracycline406 Chlorthalidone407 Chlorzoxazone408 Cholera vaccine; except in the form of an oral liquid containing vibrio cholerae

when sold in a pharmacy by a registered pharmacist


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409 Choline salicylate; except in medicines containing 10% or less and in packsizes of 15 grams or less

410 Chorionic gonadotrophin; except in pregnancy test kits411 Chymopapain412 Ciclacillin413 Ciclesonide414 Ciclopirox; except for external use415 Cidofovir416 Cilastatin417 Cilazapril418 Cilostazol419 Cimetidine; except when specified elsewhere in this schedule420 Cinacalcet421 Cinchocaine; for injection; for ophthalmic use; for external use in medicines

containing more than 0.5%422 Cinchophen423 Cinoxacin424 Ciprofloxacin425 Cisapride426 Cisatracurium427 Cisplatin428 Citalopram429 Cladribine430 Clarithromycin431 Clavulanic acid432 Clemastine; except for oral use433 Clemizole434 Clenbuterol435 Clevidipine436 Clidinium437 Clindamycin438 Clioquinol; at all strengths439 Clobazam440 Clobetasol441 Clobetasone; except when specified elsewhere in this schedule


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442 Clocortolone443 Clodronic acid444 Clofarabine445 Clofazimine446 Clofenamide447 Clofibrate448 Clomiphene449 Clomipramine450 Clomocycline451 Clonazepam452 Clonidine453 Clopamide454 Clopidogrel455 Clorexolone456 Clorprenaline457 Clostebol458 Clotiazepam459 Clotrimazole; except in medicines for vaginal or external use460 Cloxacillin461 Cloxazolam462 Clozapine463 Cobalt464 Cobicistat465 Cocaine; except when specified elsewhere in this schedule466 Codeine; except when specified elsewhere in this schedule467 Co-dergocrine468 Colaspase469 Colchicine470 Colchicum471 Colecalciferol; in medicines containing more than 25 micrograms per recom-

mended daily dose except in parenteral nutrition replacement preparations472 Colestipol473 Colestyramine474 Colfosceril475 Colistin


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476 Collagen; in injections or implants for tissue augmentation or cosmetic use477 Collagenase clostridium histolyticum478 Conium maculatum; at all strengths479 Convallaria keiski480 Convallaria majalis481 Corifollitropin alfa482 Coronilla spp483 Corticosterone484 Corticotrophin485 Cortisone and other steroidal hormones of the adrenal cortex; except when spe-

cified elsewhere in this schedule; except adrenal extract for dermal use in med-icines containing 0.02% or less of ketosteroids

486 Cotarnine; at all strengths487 Co-trimoxazole488 Coumarin489 Crizotinib490 Crofelemer491 Crotalaria spp; at all strengths492 Croton tiglium; except in medicines containing 1 milligram or less per litre or

per kilogram493 Crystal violet494 Curare495 Cyclandelate496 Cyclizine; except when specified elsewhere in this schedule497 Cyclobenzaprine498 Cyclofenil499 Cycloheximide500 Cyclopenthiazide501 Cyclopentolate; except when used in practice by an optometrist registered with

the Optometrists and Dispensing Opticians Board502 Cyclophosphamide503 Cyclopropane504 Cycloserine505 Cyclosporin506 Cyclothiazide


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507 Cycrimine508 Cymarin509 Cynoglossum spp; at all strengths510 Cyproheptadine; except for oral use511 Cyproterone512 Cysteamine513 Cytarabine514 Dabigatran515 Dabrafenib mesilate516 Dacarbazine517 Daclizumab518 Dactinomycin519 Dalfopristin520 Dalteparin521 Danaparoid522 Danazol523 Danthron524 Dantrolene525 Dapagliflozin526 Dapoxetine527 Dapsone528 Daptomycin529 Darbepoetin530 Darifenacin531 Darunavir532 Dasabuvir533 Dasatinib534 Datura spp; except for oral use when specified elsewhere in this schedule;

except datura stramonium or datura tatula for smoking or burning535 Daunorubicin536 Deanol537 Debrisoquine538 Decamethonium539 Deferasirox540 Deferiprone


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541 Deflazacort542 Degarelix543 Dehydrochloromethyltestosterone544 Dehydrocorticosterone545 Delavirdine546 Delorazepam547 Demecarium548 Demeclocycline549 Denosumab550 Deoxycortone551 Deoxyribonuclease; except for external use552 Desferrioxamine553 Desflurane554 Desipramine555 Desirudin556 Deslanoside557 Desloratadine; except for oral use558 Deslorelin559 Desmopressin560 Desogestrel561 Desonide562 Desoximetasone563 Desvenlafaxine564 Dexamethasone565 Dexamfetamine566 Dexchlorpheniramine; except when specified elsewhere in this schedule567 Dexfenfluramine568 Dexmedetomidine569 Dextromethorphan; except when specified elsewhere in this schedule570 Dextromoramide571 Dextropropoxyphene572 Dextrorphan573 Di-iodohydroxy quinoline; except for vaginal use574 Di-isopropylamine dichloroacetate575 Diazepam


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576 Diazoxide577 Dibenzepin578 Dibotermin579 Dibrompropamidine; except for ophthalmic use580 Dichloralphenazone581 Dichlorophen582 Dichlorphenamide583 Diclofenac; in preparations for the treatment of solar keratosis; except when

specified elsewhere in this schedule; except in preparations for external useother than for the treatment of solar keratosis

584 Dicloxacillin585 Dicyclomine586 Didanosine587 Dienoestrol588 Dienogest589 Diethazine590 Diethylcarbamazine591 Diethylstilbestrol592 Diflorasone593 Diflucortolone594 Diflunisal595 Digitalis lanata596 Digitalis purpurea597 Digitoxin598 Digoxin599 Digoxin-specific antibody fragment600 Dihydralazine601 Dihydrocodeine602 Dihydroergotoxine603 Dihydrolone604 Dihydrotachysterol605 Diltiazem606 Dimenhydrinate; except when specified elsewhere in this schedule607 Dimercaprol608 Dimethandrostanolone


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609 Dimethazine610 Dimethindene; except for oral use611 Dimethothiazine612 Dimethoxanate613 Dimethyl fumarate614 Dimethyl sulphoxide615 Dinitrocresols616 Dinitronaphthols617 Dinitrophenols618 Dinitrothymols619 Dinoprost620 Dinoprostone621 Diperodon622 Diphemanil; except for dermal use623 Diphenhydramine; except when specified elsewhere in this schedule624 Diphenidol625 Diphenoxylate; except when specified elsewhere in this schedule626 Diphenylpyraline627 Diphtheria, tetanus and pertussis (acellular, component) vaccine; except when

administered in a single dose to a person 18 years of age or over by a registeredpharmacist who has successfully completed a vaccinator training courseapproved by the Ministry of Health and who is complying with the immunisa-tion standards of the Ministry of Health

628 Diphtheria toxoid629 Diphtheria vaccine630 Dipivefrin631 Dipyridamole632 Dirithromycin633 Disopyramide634 Distigmine635 Disulfiram636 Disulphamide637 Ditiocarb638 Dobutamine639 Docetaxel


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640 Dofetilide641 Dolasetron642 Dolutegravir643 Domperidone644 Donepezil645 Dopamine646 Dopexamine647 Doripenem648 Dornase649 Dorzolamide650 Dothiepin651 Doxantrazole652 Doxapram653 Doxazosin654 Doxepin655 Doxorubicin656 Doxycycline657 Doxylamine; except when specified elsewhere in this schedule658 Dronedarone659 Droperidol660 Drospirenone661 Drostanolone662 Drotrecogin663 Duboisia leichhardtii; except when specified elsewhere in this schedule664 Duboisia myoporides; except when specified elsewhere in this schedule665 Dulcin; at all strengths666 Duloxetine667 Dutasteride668 Dydrogesterone669 Econazole; except in medicines for vaginal or dermal use670 Ecothiopate671 Ectylurea672 Eculizumab673 Edetic acid; in medicines containing more than 0.25%; except in contact lens

preparations; except dicobalt edetate for the treatment of cyanide poisoning


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674 Edoxudine675 Edrophonium676 Efalizumab677 Efavirenz678 Eflornithine679 Eletriptan680 Eltrombopag olamine681 Elvitegravir682 Emepronium683 Emetine; in medicines containing more than 0.2%684 Empagliflozin685 Emtricitabine686 Enalapril687 Enestebol688 Enflurane689 Enfuvirtide690 Enobosarm691 Enoxacin692 Enoxaparin693 Enoximone694 Enprostil695 Entacapone696 Entecavir697 Enzalutamide698 Ephedrine699 Epicillin700 Epinastine701 Epirubicin702 Epitiostanol703 Eplerenone704 Epoetins705 Epoprostenol706 Eprosartan707 Eptifibatide


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708 Ergocalciferol; in medicines containing more than 25 micrograms per recom-mended daily dose

709 Ergometrine710 Ergot711 Ergotamine712 Ergotoxine713 Eribulin714 Erlotinib715 Ertapenem716 Erysimum spp; except in medicines containing 1 milligram or less per litre or

per kilogram717 Erythromycin718 Erythropoietin719 Escitalopram720 Esmolol721 Esomeprazole722 Estazolam723 Estramustine724 Estropipate725 Etanercept726 Ethacrynic acid727 Ethambutol728 Ethamivan729 Ethanolamine; for injection730 Ethchlorvynol731 Ether; for anaesthesia732 Ethinamate733 Ethinyloestradiol734 Ethionamide735 Ethisterone736 Ethoglucid737 Ethoheptazine738 Ethopropazine739 Ethosuximide740 Ethotoin


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741 Ethoxzolamide742 Ethyl chloride; for inhalation743 Ethyl loflazepate744 Ethyldienolone745 Ethylhexanediol; at all strengths746 Ethyloestrenol747 Ethynodiol748 Etidocaine749 Etidronic acid; except in medicines for external use containing 1% or less750 Etilefrine751 Etodolac752 Etofenamate; except for external use753 Etonogestrel754 Etoposide755 Etoricoxib756 Etravirine757 Etretinate758 Everolimus759 Exemestane760 Exenatide761 Ezetimibe762 Factor VIII inhibitor bypassing fraction763 Famciclovir; except when specified elsewhere in this schedule764 Famotidine; except when specified elsewhere in this schedule765 Fampridine766 Farfugium japonicum; at all strengths767 Febuxostat768 Felbinac; except for external use769 Felodipine770 Felypressin; except when combined with a local anaesthetic and used in prac-

tice by a dental therapist registered with the Dental Council771 Fenbufen772 Fenclofenac773 Fenfluramine774 Fenofibrate


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775 Fenoldopam776 Fenoprofen777 Fenoterol778 Fenpipramide779 Fenpiprane780 Fentanyl781 Ferric carboxymaltose782 Fexofenadine; except for oral use783 Fibrin784 Fibrinolysin; except for external use785 Fidaxomicin786 Filgrastim787 Finasteride788 Fingolimod789 Flecainide790 Fleroxacin791 Floctafenine792 Fluanisone793 Fluclorolone794 Flucloxacillin795 Fluconazole; except when specified elsewhere in this schedule796 Flucytosine797 Fludarabine798 Fludiazepam799 Fludrocortisone800 Flufenamic acid801 Flumazenil802 Flumethasone803 Flumethiazide804 Flunisolide805 Flunitrazepam806 Fluocinolone807 Fluocinonide808 Fluocortin809 Fluocortolone


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810 Fluorescein; for injection811 Fluorides; for internal use in medicines containing more than 0.5 milligrams

per dose unit except in medicines containing 15 milligrams or less per litre orper kilogram; except in parenteral nutrition replacement preparations; for exter-nal use in medicines containing more than 5.5 grams per litre or per kilogramexcept when supplied to a dental professional registered with the Dental Coun-cil

812 Fluorometholone813 Fluorouracil814 Fluoxetine815 Fluoxymesterone816 Flupenthixol817 Fluphenazine818 Flurandrenolone819 Flurazepam820 Flurbiprofen; except in locally acting oromucosal preparations containing 10

milligrams or less per dosage unit821 Fluroxene822 Fluspirilene823 Flutamide824 Fluticasone; except when specified elsewhere in this schedule825 Fluvastatin826 Fluvoxamine827 Folic acid; for injection except in parenteral nutrition replacement preparations828 Folinic acid; for injection829 Follicle-stimulating hormone; except in medicines containing 100 micrograms

or less per litre or per kilogram830 Follistatin831 Follitropin832 Fomivirsen833 Fondaparinux834 Formebolone835 Formestane836 Formoterol837 Fosamprenavir838 Fosaprepitant


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839 Foscarnet840 Fosfestrol841 Fosinopril842 Fosphenytoin843 Fotemustine844 Framycetin845 Fulvestrant846 Furaltadone847 Furazabol848 Furazolidone849 Furosemide850 Fusidic acid851 Gabapentin852 Galantamine853 Galanthus spp854 Gallamine855 Galsulfase856 Ganciclovir857 Ganirelix858 Gatifloxacin859 Gefitinib860 Gemcitabine861 Gemeprost862 Gemfibrozil863 Gemifloxacin864 Gemtuzumab ozogamicin865 Gentamicin866 Gestodene867 Gestonorone868 Gestrinone869 Ghrelin870 Gitalin871 Glatiramer acetate872 Glibenclamide873 Glibornuride


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874 Gliclazide875 Glimepiride876 Glipizide877 Glisoxepide878 Glutathione; for injection879 Glyceryl trinitrate; for injection; for transdermal use; except in medicines con-

taining 100 micrograms or less per litre or per kilogram880 Glycopyrronium881 Glymidine882 Golimumab883 Gonadorelin884 Gonadotrophic hormones; except when specified elsewhere in this schedule885 Goserelin886 Gramicidin887 Granisetron888 Grepafloxacin889 Griseofulvin890 Guaiphenesin; for oral use in medicines containing more than 2% or 200 milli-

grams per dose form except when specified elsewhere in this schedule; exceptfor oral use in modified release form with a maximum recommended dailydose of not more than 2.4 grams when sold in the manufacturer’s original packcontaining not more than 10 days’ supply

891 Guanabenz892 Guanethidine893 Guanidine894 Hachimycin895 Haematin896 Haemophilus influenzae vaccine; except in oral vaccines for the prophylaxis of

bacterial complications of colds897 Halazepam898 Halcinonide899 Halofantrine900 Halofenate901 Haloperidol; except in medicines containing 1 milligram or less per litre or per

kilogram902 Halothane


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903 Haloxazolam904 Halquinol; for internal use905 Heliotropium spp; at all strengths906 Hemerocallis907 Heparins; for internal use; except when present as an excipient908 Hepatitis A vaccine909 Hepatitis B vaccine910 Hetacillin911 Hexachlorophane; in medicines containing more than 3%912 Hexamethonium913 Hexarelin914 Hexetidine; for internal use915 Hexobendine916 Hexocyclium917 Hexoprenaline918 Histamine; in medicines containing more than 0.5%919 Homatropine920 Human chorionic gonadotrophin; except in pregnancy test kits921 Human growth hormone secretagogues922 Human papillomavirus vaccine923 Human protein C924 Hyaluronic acid; in injections or implants for tissue augmentation or cosmetic

use925 Hydralazine926 Hydrargaphen927 Hydrochlorothiazide928 Hydrocortisone; except when specified elsewhere in this schedule929 Hydrocyanic acid; except when specified elsewhere in this schedule; except in

medicines containing 1 microgram or less per litre or per kilogram930 Hydroflumethiazide931 Hydromorphone932 Hydroquinone; except in medicines for external use containing 2% or less933 Hydroxychloroquine934 Hydroxyephedrine935 Hydroxyphenamate


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936 Hydroxyprogesterone937 Hydroxystenozol938 Hydroxyurea939 Hydroxyzine940 Hylan polymer; in injections or implants for tissue augmentation or cosmetic

use941 Hyoscine; except when specified elsewhere in this schedule; except in medi-

cines containing 300 micrograms or less per litre or per kilogram942 Hyoscine butylbromide; except when specified elsewhere in this schedule943 Hyoscyamine; except when specified elsewhere in this schedule; except in

medicines containing 300 micrograms or less per litre or per kilogram944 Hyoscyamus niger; except when specified elsewhere in this schedule; except in

medicines containing 300 micrograms or less of total solanaceous alkaloids perlitre or per kilogram

945 Hypothalamic releasing factors946 Hypromellose; for injection; except in intraocular viscoelastic products947 Ibandronic acid948 Ibogaine949 Ibritumomab tiuxetan950 Ibrutinib951 Ibufenac952 Ibuprofen; except when specified elsewhere in this schedule953 Ibuterol954 Ibutilide955 Icatibant956 Idarubicin957 Idoxuridine; except for dermal use in medicines containing 0.5% or less958 Idursulfase959 Ifosfamide960 Iloprost961 Imatinib962 Imiglucerase963 Imipenem964 Imipramine965 Imiquimod966 Immunoglobulins


25 October 2018

32

967 Indacaterol968 Indapamide969 Indinavir970 Indomethacin; except for external use in medicines containing 1% or less;

except in medicines containing 1 milligram or less per litre or per kilogram971 Indoprofen972 Indoramin973 Infliximab974 Influenza and coryza vaccines; for injection; for nasal use975 Influenza vaccine; except when administered to a person 18 years of age or

over by a registered pharmacist who has successfully completed a vaccinatortraining course approved by the Ministry of Health and who is complying withthe immunisation standards of the Ministry of Health

976 Ingenol mebutate977 Insulin-like growth factors; except when specified elsewhere in this schedule978 Insulins979 Interferons980 Interleukins981 Iodothiouracil982 Ipamorelin983 Ipecacuanha; except in medicines containing less than 0.2% of emetine984 Ipilimumab985 Ipratropium; except for nasal use986 Ipriflavone987 Iprindole988 Iproniazid989 Irbesartan990 Irinotecan991 Iron; for injection except in parenteral nutrition replacement preparations992 Isoaminile993 Isoamyl nitrite994 Isobutyl nitrite995 Isocarboxazid996 Isoconazole; except in medicines for vaginal or dermal use997 Isoetarine


33

998 Isoflurane999 Isometheptene1000 Isoniazid1001 Isoprenaline1002 Isoprinosine1003 Isopropamide; except for dermal use in preparations containing 2% or less1004 Isosorbide dinitrate1005 Isosorbide mononitrate1006 Isotretinoin1007 Isoxicam1008 Isoxsuprine1009 Isradipine1010 Itraconazole1011 Ivabradine1012 Ivacaftor1013 Ivermectin1014 Ixabepilone1015 Japanese encephalitis vaccine1016 Juniperus sabina; at all strengths1017 Kanamycin1018 Ketamine1019 Ketanserin1020 Ketazolam1021 Ketoconazole; except for dermal use1022 Ketoprofen; except when specified elsewhere in this schedule; except for der-

mal use1023 Ketorolac1024 Ketotifen; except for ophthalmic use in medicines containing 0.025% or less1025 Khellin1026 Labetalol1027 Lacidipine1028 Lacosamide1029 Lamivudine1030 Lamotrigine1031 Lanatosides


25 October 2018

34

1032 Lanreotide1033 Lansoprazole; except when specified elsewhere in this schedule1034 Lanthanum1035 Lapatinib1036 Laronidase-rch1037 Laropiprant1038 Latamoxef1039 Latanoprost1040 Laudexium1041 Lauromacrogols; for injection1042 Lead1043 Ledipasvir1044 Lefetamine1045 Leflunomide1046 Lenalidomide1047 Lenograstim1048 Lepirudin1049 Leptazol1050 Lercanidipine1051 Letrozole1052 Leucovorin; for injection1053 Leuprorelin1054 Levallorphan1055 Levamisole1056 Levetiracetam1057 Levobunolol1058 Levobupivacaine1059 Levocabastine; except for nasal or ophthalmic use1060 Levocetirizine; except for oral use1061 Levodopa1062 Levomepromazine1063 Levonorgestrel; except when specified elsewhere in this schedule; except in

medicines for use as emergency post-coital contraception when sold by nursesrecognised by their professional body as having competency in the field of sex-ual and reproductive health


35

1064 Levosimendan1065 Lidoflazine1066 Lignocaine; for injection except when used as a local anaesthetic in practice by

a nurse whose scope of practice permits the performance of general nursingfunctions or by a podiatrist registered with the Podiatrists Board or dentaltherapist registered with the Dental Council; for oral use except in throat loz-enges containing 30 milligrams or less per dose form; for ophthalmic useexcept when used in practice by an optometrist registered with the Optomet-rists and Dispensing Opticians Board; for external use in medicines containingmore than 10%

1067 Ligularia dentata; at all strengths1068 Linagliptin1069 Lincomycin1070 Lindane; except for external use in medicines containing 2% or less1071 Linezolid1072 Liothyronine1073 Liraglutide1074 Lisinopril1075 Lisuride1076 Lithium; except when specified elsewhere in this schedule; except when

present as an excipient in dermal medicines containing 0.25% or less1077 Lixisenatide1078 Lodoxamide; except in medicines for ophthalmic use1079 Lofexidine1080 Lomefloxacin1081 Lomustine1082 Loperamide; except when specified elsewhere in this schedule1083 Lopinavir1084 Loprazolam1085 Loracarbef1086 Loratadine; except for oral use1087 Lorazepam1088 Lormetazepam1089 Losartan1090 Loteprednol1091 Lovastatin; except when present as an unmodified, naturally occurring sub-

stance in a food that has not been subject to a manufacturing process other than


25 October 2018

36

heating, freezing, drying, preserving, bottling, canning, or packaging in retortpouches

1092 Loxapine1093 Lumefantrine1094 Lumiracoxib1095 Lurasidone1096 Luteinising hormone1097 Lymecycline1098 Macitentan1099 Mafenide1100 Mannomustine1101 Maprotiline1102 Maraviroc1103 Mazindol1104 Measles vaccine1105 Mebanazine1106 Mebeverine1107 Mebhydrolin1108 Mebolazine1109 Mebutamate1110 Mecamylamine1111 Mecasermin1112 Mecillinam1113 Meclocycline1114 Meclofenamate1115 Meclofenoxate1116 Meclozine; except when specified elsewhere in this schedule1117 Medazepam1118 Medigoxin1119 Medroxyprogesterone1120 Medrysone1121 Mefenamic acid; except when specified elsewhere in this schedule1122 Mefloquine1123 Mefruside1124 Megestrol


37

1125 Melagatran1126 Melanocyte stimulating compounds1127 Melatonin1128 Melengestrol1129 Melia azedarach; at all strengths1130 Meloxicam1131 Melphalan1132 Memantine1133 Meningococcal vaccine; except when administered to a person 16 years of age

or over by a registered pharmacist who has successfully completed a vaccinatortraining course approved by the Ministry of Health and who is complying withthe immunisation standards of the Ministry of Health

1134 Menotrophin1135 Mepacrine1136 Mepenzolate1137 Mephenesin1138 Mephentermine1139 Mepindolol1140 Mepitiostane1141 Mepivacaine1142 Meprobamate1143 Meptazinol1144 Mepyramine; except when specified elsewhere in this schedule1145 Mequitazine1146 Mercaptomerin1147 Mercaptopurine1148 Mercurochrome; except when specified elsewhere in this schedule1149 Mercury; except when specified elsewhere in this schedule; except in medi-

cines containing 1 milligram or less per litre or per kilogram1150 Meropenem1151 Mersalyl1152 Mesabolone1153 Mesalazine1154 Mesna1155 Mestanolone


25 October 2018

38

1156 Mesterolone1157 Mestranol1158 Metamfetamine1159 Metandienone1160 Metaraminol1161 Metenolone1162 Metergoline1163 Metformin1164 Methacholine1165 Methacycline1166 Methadone1167 Methallenoestril1168 Methandriol1169 Methanthelinium1170 Methazolamide1171 Methdilazine; except for oral use1172 Methicillin1173 Methimazole1174 Methisazone1175 Methixene1176 Methocarbamol1177 Methohexitone1178 Methoin1179 Methotrexate1180 Methoxamine; except for external use1181 Methoxsalen1182 Methoxyflurane1183 Methsuximide1184 Methyclothiazide1185 Methyl aminolevulinate1186 Methyl androstanolone1187 Methyl clostebol1188 Methyl mercury; except in medicines containing 300 micrograms or less per

litre or per kilogram


39

1189 Methyl salicylate; for internal use except when present as an excipient in medi-cines containing 1.04% or less per dose form

1190 Methyl trienolone1191 Methyldopa1192 Methylene blue; for injection1193 Methylergometrine1194 Methylnaltrexone1195 Methylpentynol1196 Methylphenidate1197 Methylphenobarbital1198 Methylprednisolone1199 Methyltestosterone1200 Methylthiouracil1201 Methyprylon1202 Methysergide1203 Metoclopramide; except when specified elsewhere in this schedule1204 Metolazone1205 Metoprolol1206 Metribolone1207 Metrifonate1208 Metronidazole1209 Metyrapone1210 Mexiletine1211 Mezlocillin1212 Mianserin1213 Mibefradil1214 Mibolerone1215 Micafungin1216 Miconazole; except when specified elsewhere in this schedule; except in medi-

cines for tinea pedis only or when sold in practice by a podiatrist registeredwith the Podiatrists Board

1217 Midazolam1218 Midodrine1219 Mifepristone1220 Miglitol


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1221 Miglustat1222 Milrinone1223 Minocycline1224 Minoxidil; except for dermal use in medicines containing 5% or less1225 Mirabegron1226 Mirtazapine1227 Misoprostol1228 Mitobronitol1229 Mitomycin1230 Mitoxantrone1231 Mitragyna speciosa1232 Mitragynine1233 Mivacurium1234 Moclobemide1235 Modafinil1236 Molgramostim1237 Molindone1238 Mometasone; except when specified elsewhere in this schedule1239 Monobenzone1240 Monoclonal antibodies; except in pregnancy test kits1241 Montelukast1242 Moperone1243 Morazone1244 Moricizine1245 Morphine; except when specified elsewhere in this schedule1246 Motrazepam1247 Motretinide1248 Moxifloxacin1249 Mumps vaccine1250 Mupirocin1251 Muraglitazar1252 Muromonab1253 Mustine1254 Mycophenolic acid1255 Nabilone


41

1256 Nabumetone1257 Nadolol1258 Nadroparin1259 Nafarelin1260 Naftidrofuryl1261 Nalbuphine1262 Nalidixic acid1263 Nalmefene1264 Nalorphine1265 Naloxone1266 Naltrexone1267 Nandrolone1268 Naproxen; except when specified elsewhere in this schedule1269 Naratriptan1270 Natalizumab1271 Natamycin1272 Nateglinide1273 Nebacumab1274 Nebivolol1275 Nedocromil1276 Nefazodone1277 Nefopam1278 Nelfinavir1279 Neomycin1280 Neostigmine1281 Nepafenac1282 Nerium oleander1283 Nesiritide1284 Netilmicin1285 Nevirapine1286 Nialamide1287 Nicardipine1288 Nicergoline1289 Nicofuranose1290 Nicorandil


25 October 2018

42

1291 Nicotine; for nasal use except when sold from a smoking cessation clinic rununder the auspices of a registered medical practitioner; in medicines other thanfor smoking cessation

1292 Nicotinic acid except nicotinamide; in medicines containing more than 250milligrams per dose form

1293 Nicoumalone1294 Nifedipine1295 Nifenazone1296 Nikethamide1297 Nilotinib1298 Nilutamide1299 Nimesulide1300 Nimetazepam1301 Nimodipine1302 Nimorazole1303 Nintedanib1304 Niridazole1305 Nisoldipine1306 Nitisinone1307 Nitrazepam1308 Nitrendipine1309 Nitric oxide1310 Nitrofurantoin1311 Nitrofurazone1312 Nitrous oxide; when supplied for inhalation1313 Nitroxoline1314 Nizatidine; except when specified elsewhere in this schedule1315 Nomegestrol1316 Nomifensine1317 Noradrenaline1318 Norandrostenolone1319 Norbolethone1320 Norclostebol1321 Nordazepam1322 Norelgestromin


43

1323 Norethandrolone1324 Norethisterone1325 Norfloxacin1326 Norgestrel1327 Noribogaine1328 Normethandrone1329 Nortriptyline1330 Noxiptyline1331 Nux vomica; except in medicines containing 1 milligram or less per litre or per

kilogram of strychnine1332 Nystatin; except when specified elsewhere in this schedule; except in medi-

cines for tinea pedis only or when sold in practice by a podiatrist registeredwith the Podiatrists Board

1333 Obinutuzumab1334 Ocriplasmin1335 Octamylamine1336 Octatropine1337 Octreotide1338 Octyl nitrite1339 Oestradiol; except in medicines containing 10 micrograms or less per litre or

per kilogram1340 Oestriol1341 Oestrogens1342 Oestrone; except in medicines containing 1 milligram or less per litre or per

kilogram1343 Ofatumumab1344 Ofloxacin1345 Olanzapine1346 Oleandomycin1347 Oleandrin1348 Olmesartan1349 Olodaterol1350 Olopatadine1351 Olsalazine1352 Omalizumab1353 Ombitasvir


25 October 2018

44

1354 Omeprazole; except when specified elsewhere in this schedule1355 Ondansetron1356 Opipramol1357 Opium; except when specified elsewhere in this schedule1358 Orciprenaline1359 Orlistat; except in medicines for weight control containing 120 milligrams or

less per dose form1360 Ornidazole1361 Ornipressin1362 Orphenadrine1363 Orthopterin1364 Oseltamivir; except when specified elsewhere in this schedule1365 Ouabain1366 Ovandrotone1367 Oxabolone1368 Oxacillin1369 Oxaliplatin1370 Oxandrolone1371 Oxaprozin1372 Oxazepam1373 Oxazolam1374 Oxcarbazepine1375 Oxedrine; in medicines containing more than 30 milligrams per recommended

daily dose1376 Oxetacaine; except for internal use1377 Oxiconazole; except when specified elsewhere in this schedule1378 Oxitropium1379 Oxolamine1380 Oxolinic acid1381 Oxpentifylline1382 Oxprenolol1383 Oxybuprocaine; except when used in practice by an optometrist registered with

the Optometrists and Dispensing Opticians Board1384 Oxybutynin1385 Oxycodone


45

1386 Oxymesterone1387 Oxymetholone1388 Oxyphenbutazone1389 Oxyphencyclimine1390 Oxyphenisatin; at all strengths1391 Oxyphenonium1392 Oxytetracycline1393 Oxytocin; except in medicines containing 1 microgram or less per litre or per

kilogram1394 Paclitaxel1395 Palifermin1396 Paliperidone1397 Palivizumab1398 Palonosetron1399 Pamaquin1400 Pamidronic acid1401 Pancreatic enzymes; in medicines containing more than 20 000 BP units of

lipase activity1402 Pancuronium1403 Panitumumab1404 Pantoprazole; except when specified elsewhere in this schedule1405 Papaveretum1406 Papaverine; for injection1407 Paracetamol; except when specified elsewhere in this schedule1408 Paraldehyde1409 Paramethadione1410 Paramethasone1411 Parecoxib1412 Paricalcitol1413 Paromomycin1414 Paroxetine1415 Pasireotide1416 Pazopanib1417 Pecazine1418 Pefloxacin


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46

1419 Pegaptanib1420 Pegfilgrastim1421 Peginterferon1422 Pegvisomant1423 Pemetrexed1424 Pemoline1425 Pempidine1426 Penbutolol1427 Penciclovir; except for external use for the treatment of herpes labialis1428 Penicillamine1429 Pentaerythrityl tetranitrate1430 Pentagastrin1431 Pentamethonium1432 Pentamidine1433 Pentazocine1434 Penthienate1435 Pentolinium1436 Pentosan polysulfate sodium1437 Pentoxifylline1438 Perampanel1439 Pergolide1440 Perhexiline1441 Pericyazine1442 Perindopril1443 Permethrin; in medicines containing more than 5%1444 Perphenazine1445 Pertussis antigen1446 Pertussis (whooping cough) vaccine1447 Pertuzumab1448 Pethidine1449 Phenacemide1450 Phenacetin; except when present as an excipient1451 Phenaglycodol1452 Phenazone; except for external use1453 Phenazopyridine


47

1454 Phenelzine1455 Pheneticillin1456 Phenformin1457 Phenglutarimide1458 Phenindione1459 Pheniramine; except when specified elsewhere in this schedule1460 Phenisatin1461 Phenobarbital1462 Phenol; for injection1463 Phenolphthalein1464 Phenoperidine1465 Phenoxybenzamine1466 Phenoxymethylpenicillin1467 Phensuximide1468 Phentermine1469 Phenthimentonium1470 Phentolamine1471 Phenylbutazone1472 Phenylephrine; except when specified elsewhere in this schedule1473 Phenylpropanolamine1474 Phenyltoloxamine1475 Phenytoin1476 Pholcodine; except when specified elsewhere in this schedule1477 Phosphodiesterase type 5 inhibitors; except when present as an unmodified,

naturally occurring substance; except when specified elsewhere in this sched-ule

1478 Phthalylsulfathiazole1479 Physostigmine1480 Picric acid1481 Picrotoxin1482 Pilocarpine; except in medicines containing 0.025% or less1483 Pimecrolimus1484 Pimozide1485 Pinacidil1486 Pinazepam


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1487 Pindolol1488 Pioglitazone1489 Pipecuronium1490 Pipemidic acid1491 Pipenzolate1492 Piperacillin1493 Piperidine1494 Piperidolate1495 Pipobroman1496 Pipothiazine1497 Pipradrol1498 Piracetam1499 Pirbuterol1500 Pirenoxine1501 Pirenzepine1502 Piretanide1503 Piroxicam; except for external use1504 Pirprofen1505 Pitavastatin1506 Pituitary hormones1507 Pivampicillin1508 Pizotifen1509 Plerixafor1510 Plicamycin1511 Pneumococcal vaccine; except in oral vaccines for the prophylaxis of bacterial

complications of colds1512 Podophyllotoxin; for internal use; for external use for the treatment of anogeni-

tal warts; for other external use in medicines containing more than 1%; exceptin medicines containing 1 milligram or less of podophyllin per litre or per kilo-gram

1513 Podophyllum emodi; for internal use; for external use for the treatment of ano-genital warts; for other external use in medicines containing more than 20% ofpodophyllin; except in medicines containing 1 milligram or less of podophyllinper litre or per kilogram

1514 Podophyllum peltatum; for internal use; for external use for the treatment ofanogenital warts; for other external use in medicines containing more than 20%


49

of podophyllin; except in medicines containing 1 milligram or less of podo-phyllin per litre or per kilogram

1515 Polidexide1516 Poliomyelitis vaccine1517 Polyacrylamide; in injections or implants for tissue augmentation or cosmetic

use1518 Polyestradiol1519 Polylactic acid; in injections or implants for tissue augmentation or cosmetic

use1520 Polymyxin1521 Polysulfated glycosaminoglycans; for injection except in intraocular viscoelas-

tic products1522 Polythiazide1523 Pomalidomide1524 Poractant alfa1525 Posaconazole1526 Potassium bromide1527 Potassium perchlorate1528 Practolol1529 Pradofloxacin1530 Pralatrexate1531 Pralidoxime1532 Pramipexole1533 Pramocaine1534 Prampine1535 Prasterone1536 Prasugrel1537 Pravastatin1538 Prazepam1539 Praziquantel1540 Prazosin1541 Prednisolone1542 Prednisone1543 Pregabalin1544 Pregnenolone


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50

1545 Prenalterol1546 Prenylamine1547 Prilocaine; for injection except when used as a local anaesthetic in practice by

a dental therapist registered with the Dental Council; except when specifiedelsewhere in this schedule

1548 Primaquine1549 Primidone1550 Probenecid1551 Probucol1552 Procainamide1553 Procaine1554 Procaine penicillin1555 Procarbazine1556 Prochlorperazine; except when specified elsewhere in this schedule; except

when sold for the treatment of nausea associated with emergency contraceptionby pharmacists or nurses accredited to sell levonorgestrel for emergency con-traception

1557 Procyclidine; except for dermal use in medicines containing 5% or less1558 Progesterone; except in medicines containing 1 milligram or less per litre or

per kilogram1559 Progestogens1560 Proglumide1561 Proguanil1562 Prolintane1563 Promazine1564 Promethazine; except when specified elsewhere in this schedule1565 Promoxolane1566 Propafenone1567 Propamidine; except for ophthalmic use1568 Propanidid1569 Propantheline1570 Propetandrol1571 Propionibacterium acnes1572 Propofol1573 Propranolol; except in medicines containing 1 milligram or less per litre or per

kilogram


51

1574 Propylthiouracil1575 Propyphenazone1576 Proquazone1577 Proscillaridin1578 Prostaglandins1579 Protamine1580 Prothionamide1581 Prothipendyl1582 Protirelin1583 Protoveratrines1584 Protriptyline1585 Proxymetacaine; except when used in practice by an optometrist registered

with the Optometrists and Dispensing Opticians Board1586 Prucalopride1587 Pseudoephedrine1588 Pulmonaria spp; at all strengths1589 Pyrazinamide1590 Pyridinolcarbamate1591 Pyridostigmine1592 Pyridoxal; in medicines containing more than 200 milligrams per recommen-

ded daily dose1593 Pyridoxamine; in medicines containing more than 200 milligrams per recom-

mended daily dose1594 Pyridoxine; in medicines containing more than 200 milligrams per recommen-

ded daily dose1595 Pyrimethamine1596 Pyrvinium1597 Quazepam1598 Quetiapine1599 Quinagolide1600 Quinapril1601 Quinbolone1602 Quinethazone1603 Quinidine1604 Quinine; except in medicines containing 50 milligrams or less per recommen-

ded daily dose


25 October 2018

52

1605 Quinisocaine1606 Quinupristin1607 Rabeprazole1608 Rabies vaccine1609 Raloxifene1610 Raltegravir1611 Raltitrexed1612 Ramipril1613 Ranibizumab1614 Ranitidine; except when specified elsewhere in this schedule; except in medi-

cines containing 150 milligrams or less per dose unit when sold in the manu-facturer’s original pack containing not more than 7 days’ supply

1615 Rapacuronium1616 Rasagiline1617 Rasburicase1618 Rauwolfia serpentina1619 Rauwolfia vomitoria1620 Razoxane1621 Reboxetine1622 Regorafenib1623 Remestemcel-L1624 Remifentanil1625 Remoxipride1626 Repaglinide1627 Reserpine1628 Retapamulin1629 Reteplase1630 Retigabine1631 Ribavirin1632 Ridaforolimus1633 Rifabutin1634 Rifampicin1635 Rifamycin1636 Rifapentine1637 Rifaximin


53

1638 Rilpivirine1639 Riluzole1640 Rimexolone1641 Rimiterol1642 Rimonabant1643 Riociguat1644 Risedronic acid1645 Risperidone1646 Ritodrine1647 Ritonavir1648 Rituximab1649 Rivaroxaban1650 Rivastigmine1651 Rizatriptan; except when specified elsewhere in this schedule1652 Rocuronium1653 Rofecoxib1654 Roflumilast1655 Rolitetracycline1656 Romidepsin1657 Romiplostim1658 Ropinirole1659 Ropivacaine1660 Rosiglitazone1661 Rosoxacin1662 Rosuvastatin1663 Rotavirus vaccine1664 Rotigotine1665 Roxibolone1666 Roxithromycin1667 Rubella vaccine1668 Ruboxistaurin1669 Rupatadine1670 Ruxolitnib1671 Sabadilla; except in preparations containing 10 milligrams or less of total alka-

loids of schoenocaulon officinale per litre or per kilogram


25 October 2018

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1672 Safrole; for internal use except in medicines containing 0.1% or less1673 Salbutamol1674 Salcatonin1675 Salmeterol1676 Sapropterin1677 Saquinavir1678 Saxagliptin1679 Schoenocaulon officinale; except in preparations containing 10 milligrams or

less of total alkaloids of schoenocaulon officinale per litre or per kilogram1680 Scopolia carniolica1681 Secbutabarbital1682 Secobarbital1683 Selective androgen receptor modulators1684 Selegiline1685 Selenium; except when specified elsewhere in this schedule; except for oral use

in medicines containing 150 micrograms or less per recommended daily dose;except for external use in medicines containing 3.5% or less of selenium sul-phide

1686 Selexipag1687 Serelaxin1688 Sermorelin1689 Sertindole1690 Sertraline1691 Serum, dried human1692 Sevelamer1693 Sevoflurane1694 Sex hormones and all substances having sex hormone activity1695 Sialoepoetin1696 Sibutramine1697 Silandrone1698 Sildenafil and its structural analogues; except sildenafil in medicines for oral

use containing 100 milligrams or less per dose unit when sold in the manufac-turer’s original pack containing not more than 12 solid dosage units for thetreatment of erectile dysfunction in males aged 35–70 years by a registeredpharmacist who has successfully completed a training programme endorsed bythe Pharmaceutical Society of New Zealand

1699 Silicones; for injection


55

1700 Siltuximab1701 Silver sulfadiazine; except for external use in packs containing 50 grams or less1702 Simeprevir1703 Simvastatin1704 Sirolimus1705 Sisomicin1706 Sitagliptin1707 Sitaxentan1708 Sodium bromide1709 Sodium cellulose phosphate; for internal use1710 Sodium cromoglycate; except for nasal and ophthalmic use1711 Sodium morrhuate; for injection1712 Sodium nitroprusside1713 Sodium phosphate; in oral laxative preparations1714 Sodium polystyrene sulphonate1715 Sodium tetradecyl sulphate; for injection1716 Sofosbuvir1717 Solasadine1718 Solifenacin1719 Somatostatin1720 Somatropin1721 Sontoquine1722 Sorafenib1723 Sotalol1724 Sparfloxacin1725 Sparteine1726 Spectinomycin1727 Spiramycin1728 Spirapril1729 Spironolactone1730 Stanolone1731 Stanozolol1732 Staphylococcus aureus vaccine; except in oral vaccines for the prophylaxis of

bacterial complications of colds1733 Stavudine


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1734 Stenbolone1735 Steroid hormones1736 Stilboestrol1737 Stramonium; except for oral use when specified elsewhere in this schedule;

except datura stramonium or datura tatula for smoking or burning1738 Streptococcus beta-haemolyticus vaccine; except in oral vaccines for the pro-

phylaxis of bacterial complications of colds1739 Streptodornase1740 Streptokinase1741 Streptomycin1742 Strontium ranelate1743 Strophanthins1744 Strophanthus spp1745 Strychnos spp; except in medicines containing 1 milligram or less per litre or

per kilogram of strychnine1746 Styramate1747 Succimer1748 Sufentanil1749 Sugammadex1750 Sulbactam1751 Sulconazole; except for dermal use1752 Sulfacetamide; except for ophthalmic use in medicines containing 10% or less1753 Sulfadiazine; except silver sulfadiazine for external use in pack sizes of 50

grams or less1754 Sulfadimethoxine1755 Sulfadimidine1756 Sulfadoxine1757 Sulfafurazole1758 Sulfaguanidine1759 Sulfamerazine1760 Sulfamethizole1761 Sulfamethoxazole1762 Sulfamethoxydiazine1763 Sulfamethoxypyridazine1764 Sulfametrole


57

1765 Sulfamonomethoxine1766 Sulfamoxole1767 Sulfaphenazole1768 Sulfapyridine1769 Sulfasalazine1770 Sulfathiazole1771 Sulfatroxazole1772 Sulfinpyrazone1773 Sulfomyxin1774 Sulfonmethane1775 Sulindac1776 Sultamicillin1777 Sulthiame1778 Sumatriptan; except when specified elsewhere in this schedule1779 Sunitinib1780 Suprofen1781 Sutilains1782 Suxamethonium1783 Suxethonium1784 T cell receptor antibody1785 Tacrine1786 Tacrolimus1787 Tadalafil and its structural analogues1788 Tafluprost1789 Taliglucerase alfa1790 Tamoxifen1791 Tamsulosin1792 Tanacetum vulgare; in medicines containing more than 0.8% of oil of tansy1793 Tapentadol1794 Tasonermin1795 Tazarotene1796 Tazobactam1797 Tegafur1798 Tegaserod1799 Teicoplanin


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1800 Telaprevir1801 Telbivudine1802 Telithromycin1803 Telmisartan1804 Temazepam1805 Temozolomide1806 Temsirolimus1807 Tenecteplase1808 Teniposide1809 Tenofovir1810 Tenoxicam1811 Terazosin1812 Terbinafine; except in medicines for dermal use1813 Terbutaline1814 Terfenadine1815 Teriflunomide1816 Teriparatide1817 Terlipressin1818 Terodiline1819 Teropterin1820 Tesamorelin1821 Testolactone1822 Testosterone; except in medicines containing 1 milligram or less per litre or per

kilogram1823 Tetanus antitoxin1824 Tetanus toxoid1825 Tetanus vaccine1826 Tetrabenazine1827 Tetracosactrin1828 Tetracycline1829 Tetraethylammonium1830 Tetrahydrocannabinol1831 Tetrazepam1832 Tetroxoprim1833 Thalidomide


59

1834 Thenyldiamine1835 Theophylline; except in liquid form for oral use in medicines containing 2% or

less1836 Thevetia peruviana1837 Thevetin1838 Thiambutosine1839 Thiazosulfone1840 Thiethylperazine1841 Thioacetazone1842 Thiocarlide1843 Thioguanine1844 Thiomesterone1845 Thiopentone1846 Thiopropazate1847 Thioproperazine1848 Thioridazine1849 Thiotepa1850 Thiothixene1851 Thiouracil1852 Thiourea; except in medicines containing 0.1% or less1853 Thymoxamine1854 Thyroid1855 Thyrotrophin1856 Thyrotrophin-releasing factor1857 Thyroxine; except in medicines containing 10 micrograms or less per litre or

per kilogram1858 Tiagabine1859 Tiaprofenic acid1860 Tiaramide1861 Tibolone1862 Ticagrelor1863 Ticarcillin1864 Ticlopidine1865 Tiemonium1866 Tienilic acid


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1867 Tigecycline1868 Tigloidine1869 Tiletamine1870 Tilidine1871 Tiludronic acid1872 Timolol1873 Tinidazole1874 Tinzaparin1875 Tioconazole; except in medicines for vaginal or dermal use1876 Tiotropium1877 Tipepidine1878 Tiprinavir1879 Tirilazad1880 Tirofiban1881 Tobramycin1882 Tocainide1883 Tocilizumab1884 Tolazamide1885 Tolazoline1886 Tolbutamide1887 Tolcapone1888 Tolfenamic acid1889 Tolmetin1890 Tolonium1891 Tolpropamine1892 Tolrestat1893 Tolterodine1894 Tolvaptan1895 Topiramate1896 Topotecan1897 Torasemide1898 Toremifene1899 Toxoids; for injection1900 Tramadol1901 Trametinib dimethyl sulfoxide


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1902 Trandolapril1903 Tranexamic acid1904 Tranylcypromine1905 Trastuzumab1906 Trastuzumab emtansine1907 Travoprost1908 Trazodone1909 Trenbolone1910 Treosulphan1911 Treprostinil1912 Trestolone1913 Tretamine1914 Tretinoin1915 Triacetyloleandomycin1916 Triamcinolone; except when specified elsewhere in this schedule1917 Triamterene1918 Triaziquone1919 Triazolam1920 Trichlormethiazide1921 Trichloroacetic acid; except for external use in medicines containing 12.5% or

less for the treatment of warts other than anogenital warts1922 Trichloroethylene1923 Trichodesma africana; at all strengths1924 Triclofos1925 Tricyclamol1926 Tridihexethyl1927 Trifluoperazine1928 Trifluperidol1929 Triflupromazine1930 Trimeprazine; except when specified elsewhere in this schedule1931 Trimetaphan1932 Trimethoprim; except in medicines for oral use containing 300 milligrams or

less per dose unit when sold in a pack of 3 solid dosage units to a woman aged16–65 years for the treatment of an uncomplicated urinary tract infection by aregistered pharmacist who has successfully completed the New Zealand Col-lege of Pharmacists’ training in the treatment of urinary tract infections


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1933 Trimipramine1934 Trimustine1935 Trinitrophenol1936 Trioxysalen1937 Triparanol; at all strengths1938 Triple antigen vaccine1939 Triprolidine; except when specified elsewhere in this schedule1940 Triptorelin1941 Troglitazone1942 Trometamol; for injection in medicines containing more than 3%1943 Tropicamide; except when used in practice by an optometrist registered with

the Optometrists and Dispensing Opticians Board1944 Tropisetron1945 Trovafloxacin1946 Troxidone1947 Tryptophan; in medicines containing more than 100 milligrams per recommen-

ded daily dose except in parenteral nutrition replacement preparations1948 Tuberculin1949 Tuberculosis vaccine1950 Tubocurarine1951 Tulobuterol1952 Typhoid vaccine1953 Umeclidinium bromide1954 Unoprostone1955 Uracil1956 Urapidil1957 Urethane1958 Urofollitropin1959 Urokinase1960 Ursodeoxycholic acid1961 Ustekinumab1962 Vaccines; except when specified elsewhere in this schedule1963 Vaccinia virus vaccine1964 Valaciclovir1965 Valdecoxib


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1966 Valganciclovir1967 Valnoctamide1968 Valproic acid1969 Valsartan1970 Vancomycin1971 Vandetanib1972 Vardenafil and its structural analogues1973 Varenicline1974 Varicella vaccine; except when administered for the prevention of herpes zoster

(shingles) to a person 50 years of age or over by a registered pharmacist whohas successfully completed a vaccinator training course approved by the Minis-try of Health and who is complying with the immunisation standards of theMinistry of Health

1975 Vasopressin1976 Vecuronium1977 Vedolizumab1978 Velaglucerase alfa1979 Vemurafenib1980 Venlafaxine1981 Verapamil1982 Veratrum spp1983 Vernakalant1984 Verteporfin1985 Veruprevir1986 Vidarabine1987 Vigabatrin1988 Vilanterol1989 Vildagliptin1990 Viloxazine1991 Vinblastine1992 Vincamine1993 Vincristine1994 Vindesine1995 Vinflunine1996 Vinorelbine


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1997 Vinyl ether1998 Virginiamycin1999 Vismodegib2000 Visnadine2001 Vitamin A; for internal use in medicines containing more than 3 milligrams of

retinol equivalents per recommended daily dose except in parenteral nutritionreplacement preparations; for external use in medicines containing more than1%

2002 Vitamin D; for internal use in medicines containing more than 25 microgramsper recommended daily dose except in parenteral nutrition replacement prepar-ations

2003 Voriconazole2004 Vorinostat2005 Vortioxetine2006 Warfarin2007 Xamoterol2008 Xanthinol nicotinate2009 Ximelagatran2010 Xipamide2011 Yellow fever vaccine2012 Yohimbine2013 Zafirlukast2014 Zalcitabine2015 Zaleplon2016 Zanamivir2017 Zidovudine2018 Zimeldine2019 Zinc; for internal use in medicines containing more than 25 milligrams per rec-

ommended daily dose; except for internal use in medicines containing 50 milli-grams or less and more than 25 milligrams per recommended daily dose inpacks that have received the consent of the Minister or the Director-General totheir distribution as general sale medicines, when sold in the manufacturer’soriginal pack and when labelled with a statement that the product may be dan-gerous if taken in large amounts or for long periods; except in parenteral nutri-tion replacement preparations

2020 Ziprasidone2021 Zoledronic acid


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2022 Zolmitriptan; except when specified elsewhere in this schedule2023 Zolpidem2024 Zonisamide2025 Zopiclone2026 Zoster immunoglobulin, human2027 Zoxazolamine2028 Zuclopenthixol

Part 2Restricted medicines

1 Adrenaline; in medicines containing 1% or less except in medicines for injec-tion containing 0.02% or less

2 Alclometasone; for dermal use in medicines containing 0.05% or less and inpacks containing not more than 30 grams that have received the consent of theMinister or the Director-General to their distribution as restricted medicines,when sold in the manufacturer’s original pack

3 Aminophylline; for oral use in liquid form in medicines containing 2% or less4 Amorolfine; for external use in medicines containing more than 0.25%5 Aspirin; in slow-release forms; in enteric coated forms containing more than

300 milligrams per dose form; except when specified elsewhere in this sched-ule

6 Azatadine; for oral use in adults and children over 2 years of age7 Azelastine; in medicines for ophthalmic use containing 0.05% or less8 Brompheniramine; for oral use in medicines for adults or children over 2 years

of age other than in medicines used for the treatment of anxiety or insomnia;for oral use for the treatment of anxiety or insomnia when sold in the manufac-turer’s original pack containing not more than 10 dosage units

9 Buclizine; for oral use10 Butoconazole; for vaginal use11 Chloramphenicol; for ophthalmic use; except when sold in practice by an

optometrist registered with the Optometrists and Dispensing Opticians Board12 Chlorbutol; in medicines containing more than 5%13 Chlorpheniramine; for oral use in medicines for adults or children over 2 years


14 Ciclopirox; for external use in medicines containing more than 2%; in prepar-ations for application to the nails containing more than 8%


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15 Cimetidine; in medicines for the symptomatic relief of heartburn, dyspepsia,and hyperacidity or to be used on the recommendation of a registered medicalpractitioner, when sold in the manufacturer’s original pack containing not morethan 14 days’ supply

16 Clemastine; for oral use17 Clobetasone; for dermal use in medicines containing 0.05% or less and in

packs containing not more than 30 grams that have received the consent of theMinister or the Director-General to their distribution as restricted medicines,when sold in the manufacturer’s original pack

18 Clotrimazole; for vaginal use19 Codeine; in medicines for oral use containing not more than 15 milligrams of

codeine per solid dosage unit or per dose of liquid with a maximum daily dosenot exceeding 100 milligrams of codeine, when combined with 1 or moreactive ingredients in such a way that the substance cannot be recovered byreadily applicable means or in a yield that would constitute a risk to health, foruse as an analgesic and when sold in a pack of not more than 5 days’ supply,approved by the Minister or the Director-General for distribution as a restrictedmedicine

20 Cyclizine; for oral use other than in medicines used for the treatment of anxietyor insomnia; for oral use for the treatment of anxiety or insomnia when sold inthe manufacturer’s original pack containing not more than 10 dosage units

21 Cyproheptadine; for oral use22 Dexchlorpheniramine; for oral use in medicines for adults or children over 2

years of age other than in medicines used for the treatment of anxiety or insom-nia; for oral use for the treatment of anxiety or insomnia when sold in the man-ufacturer’s original pack containing not more than 10 dosage units

23 Di-iodohydroxy quinoline; for vaginal use24 Diclofenac; in solid dose form in medicines containing 25 milligrams or less

and more than 12.5 milligrams per dose form in packs containing not morethan 30 tablets or capsules

25 Dimenhydrinate; for oral use in medicines for adults and children over 2 yearsof age; except when specified elsewhere in this schedule

26 Dimethindene; for oral use27 Diphenhydramine; for oral use in medicines for adults or children over 2 years


28 Dithranol29 Doxylamine; for oral use in medicines for adults or children over 2 years of age

other than in medicines used for the treatment of anxiety or insomnia; for oral


67

use for the treatment of anxiety or insomnia when sold in the manufacturer’soriginal pack containing not more than 10 dosage units

30 Econazole; for vaginal use31 Erythrityl tetranitrate32 Famciclovir; in divided solid dosage forms for oral use containing 500 milli-

grams or less for the treatment of recurrent herpes labialis when sold in themanufacturer’s original pack containing up to 3 dosage units

33 Flavoxate34 Fluconazole; for oral use in medicines that have received the consent of the

Minister or the Director-General to their distribution as restricted medicines,when sold in the manufacturer’s original pack containing 150 milligrams orless as a single dose for the treatment of vaginal candidiasis

35 Fluorides; for external use in liquid form in medicines containing 5.5 grams orless and more than 1 gram per litre or per kilogram and when sold in packsapproved by the Minister or the Director-General for distribution as restrictedmedicines; for external use in non-liquid form in medicines containing 5.5grams or less and more than 1 gram per litre or per kilogram, except in medi-cines containing 1.5 grams or less and more than 1 gram per litre or per kilo-gram; except when supplied to a dental professional registered with the DentalCouncil

36 Glucagon; except in medicines containing 100 micrograms or less per litre orper kilogram

37 Glyceryl trinitrate; for oral or sublingual use; for rectal use38 Guaiphenesin; for oral use in modified release form with a maximum recom-

mended daily dose of not more than 2.4 grams when sold in the manufacturer’soriginal pack containing more than 10 days’ supply but not more than 30 days’supply

39 Haemophilus influenzae vaccine; in oral vaccines for the prophylaxis of bacte-rial complications of colds

40 Hydrocortisone and hydrocortisone acetate but no other esters of hyrocorti-sone; for dermal use in medicines containing 1% or less but more than 0.5% byweight of hydrocortisone base with no other active ingredient except an anti-fungal and in a quantity of 30 grams or less or 30 millilitres or less per con-tainer; in rectal medicines containing 1% or less but more than 0.5% by weightof hydrocortisone base and in combination with a local anaesthetic and in aquantity of 35 grams or less per container or up to 12 suppositories per pack

41 Hyoscine butylbromide; for oral use in medicines containing not more than 20milligrams per dose form and in packs containing not more than 10 tablets orcapsules for the relief of muscle spasm of the gastrointestinal tract

42 Ibuprofen; for oral use in tablets or capsules containing up to 400 milligramsper dose form and in packs containing not more than 50 dose units and that


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have received the consent of the Minister or the Director-General to their distri-bution as restricted medicines, when sold in the manufacturer’s original packlabelled for use by adults or children over 12 years of age

43 Inositol nicotinate44 Isoconazole; for vaginal use45 Ketoprofen; in solid dose form containing 25 milligrams or less per dose form

in packs of not more than 30 capsules or tablets46 Lansoprazole; in divided solid dosage forms for oral use containing 15 milli-

grams or less with a maximum daily dose of 15 milligrams for the short-termsymptomatic relief of gastric reflux-like symptoms in sufferers aged 18 yearsand over for the relief of heartburn when sold in the manufacturer’s originalpack containing not more than 14 dosage units

47 Levonorgestrel; in medicines for use as emergency post-coital contraceptionwhen in packs containing not more than 1.5 milligrams except when sold bynurses recognised by their professional body as having competency in the fieldof sexual and reproductive health

48 Macrogols; in oral preparations for bowel cleansing prior to diagnostic, med-ical, or surgical procedures

49 Malathion; for external use in medicines containing more than 2%50 Mannityl hexanitrate51 Meclozine; in a pack size of up to 10 dosage units for the treatment of anxiety

or insomnia52 Mepyramine; for oral use in medicines for adults or children over 2 years of

age other than in medicines used for the treatment of anxiety or insomnia; fororal use for the treatment of anxiety or insomnia when sold in the manufactur-er’s original pack containing not more than 10 dosage units

53 Methdilazine; for oral use54 Metoclopramide; when compounded with paracetamol in packs of not more

than 10 tablets or capsules for the treatment of nausea associated with migraine55 Miconazole; for the treatment of oral candidiasis; for vaginal use56 Nicotinic acid except nicotinamide; in medicines containing 250 milligrams or

less but more than 100 milligrams per dose form57 Nicotinyl alcohol; in medicines containing more than 100 milligrams per dose

form58 Nystatin; for the treatment of oral candidiasis; for vaginal use59 Omeprazole; in tablets or capsules containing 20 milligrams or less when sold

in a pack approved by the Minister or the Director-General for distribution as arestricted medicine


69

60 Orlistat; in medicines for weight control containing 120 milligrams or less perdose form

61 Oseltamivir; in solid dosage forms for oral use containing 75 milligrams in apack size of up to 10 dosage units for the treatment or prophylaxis of influenzain adults and children aged 13 years and older who have been exposed to theinfluenza virus

62 Oxiconazole; for vaginal use63 Pantoprazole; in tablets or capsules containing 20 milligrams or less of panto-

prazole when sold in a pack approved by the Minister or the Director-Generalfor distribution as a restricted medicine

64 Pheniramine; for oral use in medicines for adults or children over 2 years ofage other than in medicines used for the treatment of anxiety or insomnia; fororal use for the treatment of anxiety or insomnia when sold in the manufactur-er’s original pack containing not more than 10 dosage units

65 Pneumococcal vaccine; in oral vaccines for the prophylaxis of bacterial com-plications of colds

66 Podophyllotoxin; for external use for the treatment of warts other than anogeni-tal warts in medicines containing 1% or less and more than 0.5%; except inmedicines containing 1 milligram or less of podophyllin per litre or per kilo-gram

67 Podophyllum emodi; for external use for the treatment of warts other than ano-genital warts in medicines containing 20% or less and more than 10% of podo-phyllin; except in medicines containing 1 milligram or less of podophyllin perlitre or per kilogram

68 Podophyllum peltatum; for external use for the treatment of warts other thananogenital warts in medicines containing 20% or less and more than 10% ofpodophyllin; except in medicines containing 1 milligram or less of podophyllinper litre or per kilogram

69 Prochlorperazine; in packs containing not more than 10 tablets or capsules forthe treatment of nausea associated with migraine

70 Promethazine; for oral use in medicines for adults or children over 2 years ofage other than in medicines used for the treatment of anxiety or insomnia; fororal use for the treatment of anxiety or insomnia when sold in the manufactur-er’s original pack containing not more than 10 dosage units

71 Rizatriptan; for oral use in medicines for the acute relief of migraine attackswith or without aura in patients who have a stable, well-established pattern ofsymptoms, when in wafers containing 5 milligrams or less per wafer and whensold in a pack containing not more than 2 wafers approved by the Minister orthe Director-General for distribution as a restricted medicine

72 Salicylic acid; except in medicines for dermal use containing 40% or less73 Santonin


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74 Sodium phosphate; in oral preparations for bowel cleansing prior to diagnostic,medical, or surgical procedures

75 Sodium picosulphate; in oral preparations for bowel cleansing prior to diagnos-tic, medical, or surgical procedures

76 Staphyloccocus aureus vaccine; in oral vaccines for the prophylaxis of bacterialcomplications of colds

77 Stramonium; for oral use in liquid form; in solid dose form in medicines con-taining more than 0.3 milligrams per dose or more than 1.2 milligrams per rec-ommended daily dose

78 Streptococcus beta-haemolyticus vaccine; in oral vaccines for the prophylaxisof bacterial complications of colds

79 Sulfacetamide; for ophthalmic use in medicines containing 10% or less80 Sumatriptan; for oral use in medicines for the acute relief of migraine attacks

with or without aura in patients who have a stable, well-established pattern ofsymptoms when in tablets containing 50 milligrams or less per tablet and whensold in a pack containing not more than 2 tablets that has received the consentof the Minister or the Director-General to its sale as a restricted medicine

81 Theophylline; in liquid form for oral use in medicines containing 2% or less82 Tioconazole; for vaginal use83 Triamcinolone; for buccal use in medicines containing 0.1% or less of triamci-

nolone acetonide and in pack sizes of 5 grams or less84 Trimeprazine; for oral use in medicines for adults or children over 2 years of

age other than in medicines used for the treatment of anxiety or insomnia; fororal use for the treatment of anxiety or insomnia when sold in the manufactur-er’s original pack containing not more than 10 dosage units

85 Triprolidine; for oral use in medicines for adults and children over 2 years ofage; except when specified elsewhere in this schedule

86 Zolmitriptan; in a pre-filled nasal spray device containing not more than 5 mil-ligrams of zolmitriptan, for the acute relief of migraine attacks with or withoutaura in patients who have a stable, well-established pattern of symptoms andwhen sold in a pack of not more than 2 devices approved by the Minister or theDirector-General for distribution as a restricted medicine

Part 3Pharmacy-only medicines

1 8-hydroxyquinoline and its non-halogenated derivatives; in medicines contain-ing more than 1% of such substances

2 Acetic acid and preparations containing more than 80% of acetic acid(CH3COOH); excluding its salts and derivatives


71

3 Acetylcysteine; for oral use in medicines containing more than 1 gram per rec-ommended daily dose

4 Aciclovir; for external use for the treatment of herpes labialis except in medi-cines containing 5% or less and in tubes containing 10 grams or less

5 Aconitum spp; for oral use in packs containing 0.2 milligrams or less and morethan 0.02 milligrams of total alkaloids; for dermal use in concentrations of0.02% or less and in packs containing 0.2 milligrams or less and more than0.02 milligrams of total alkaloids

6 Aloes; for internal use; except when obtained solely from the mucilaginous gelof the leaf

7 Aloin8 Aloxiprin9 Amethocaine; for external use in medicines containing 10% or less and more

than 2%10 Amorolfine; in preparations for topical use except in preparations for the treat-

ment of tinea pedis only or when sold in practice by a podiatrist registered withthe Podiatrists Board

11 Antazoline; for ophthalmic use except when sold in practice by an optometristregistered with the Optometrists and Dispensing Opticians Board

12 Atropa belladonna; for external use in medicines containing 0.03% or less ofthe alkaloids of belladonna; for oral use in liquid form in medicines containing0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milli-grams per recommended daily dose of the alkaloids of belladonna or in soliddose form in medicines containing 0.3 milligrams or less per dose form and notmore than 1.2 milligrams per recommended daily dose of the alkaloids of bel-ladonna

13 Atropine; for oral use in liquid form in medicines containing 0.03% or less and0.3 milligrams or less per dose and not more than 1.2 milligrams per recom-mended daily dose or in solid dose form in medicines containing 0.3 milli-grams or less per dose form and not more than 1.2 milligrams per recommen-ded daily dose; in medicines containing atropine sulphate for the treatment oforganophosphorus poisoning either in packs of not more than 20 dose unitscontaining 0.6 milligrams or less per dose unit or in injections in packs of notmore than 5 vials containing 0.6 milligrams per millilitre; except when sold asan antidote in a device designed for self-injection from outlets licensed to sellorganophosphorus poisons; except in medicines containing 300 micrograms orless per litre or per kilogram

14 Azelaic acid; for dermal use15 Azelastine; for nasal use; in topical eye preparations containing 0.05% or less16 Beclomethasone; for the treatment or prophylaxis of allergic rhinitis in adults

and children over 12 years of age in aqueous nasal sprays delivering up to 50


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micrograms per actuation when the maximum recommended daily dose is nogreater than 400 micrograms (200 micrograms per nostril) in a pack containing200 actuations or less

17 Benzocaine; in preparations for topical use, other than eye drops, containing10% or less of total anaesthetic substances except in dermal preparations con-taining 2% or less of total anaesthetic substances; in divided preparations con-taining 200 milligrams or less of total anaesthetic substances per dosage unitexcept in lozenges containing 30 milligrams or less of total anaesthetic sub-stances per dosage unit

18 Benzoyl peroxide; for external use in medicines containing more than 5% andnot more than 10%

19 Benzydamine; for external use except for dermal use20 Bephenium21 Bifonazole; for dermal use except in medicines for tinea pedis only or in sham-

poos containing 1% or less22 Bisacodyl23 Bromhexine24 Brompheniramine; for oral use in medicines for adults and children over 6

years of age when combined in the same container with 1 or more other thera-peutically active ingredients either when in the bedtime dose of a day/nightpack containing brompheniramine or when at least 1 of the other active ingre-dients is a sympathomimetic decongestant

25 Budesonide; for the treatment or prophylaxis of allergic rhinitis in adults andchildren over 12 years of age in aqueous nasal sprays delivering up to 50micrograms per actuation and when the maximum recommended daily dose isno greater than 400 micrograms (200 micrograms per nostril) in a pack con-taining 200 actuations or less

26 Carbetapentane; in medicines containing more than 0.5%27 Carbocisteine28 Cetirizine; for oral use except in divided solid dosage forms for oral use con-

taining 10 milligrams or less of cetirizine hydrochloride per dose form for thetreatment of seasonal allergic rhinitis when sold in the manufacturer’s originalpack containing not more than 5 days’ supply

29 Chlophedianol30 Chlorbutol; in medicines containing 5% or less and more than 0.5%31 Chloroform; in medicines other than for anaesthesia containing more than

0.5%32 Chlorpheniramine; for oral use in medicines for adults and children over 6

years of age when combined in the same container with 1 or more other thera-peutically active ingredients either when in the bedtime dose of a day/night


73

pack containing chlorpheniramine or when at least 1 of the other active ingredi-ents is a sympathomimetic decongestant

33 Ciclopirox; for external use in medicines containing 2% or less except whenfor the treatment of tinea pedis only or when sold in practice by a podiatristregistered with the Podiatrists Board; in preparations for application to the nailscontaining 8% or less

34 Cinchocaine; for external use in medicines containing 0.5% or less35 Cinnamedrine36 Clotrimazole; for external use except in medicines for tinea pedis only or when

sold in practice by a podiatrist registered with the Podiatrists Board37 Cocaine; in medicines for oral use, containing not more than 0.1% of cocaine,

when combined with 1 or more active ingredients in such a way that the sub-stance cannot be recovered by readily applicable means or in a yield that wouldconstitute a risk to health, and when sold in a pack approved by the Minister orthe Director-General for distribution as a pharmacy-only medicine

38 Codeine; in medicines for oral use, containing not more than 15 milligrams ofcodeine per solid dosage unit or per dose of liquid with a maximum daily dosenot exceeding 100 milligrams of codeine, when combined with 1 or moreactive ingredients in such a way that the substance cannot be recovered byreadily applicable means or in a yield that would constitute a risk to health, forthe treatment of the symptoms of cough and cold and when sold in a pack ofnot more than 6 days’ supply, approved by the Minister or the Director-Generalfor distribution as a pharmacy-only medicine

39 Colocynth40 Creosote; in medicines containing more than 10%41 Cresols; in medicines containing more than 3%42 Datura spp; for oral use in liquid form in medicines containing 0.03% or less

and 0.3 milligrams or less per dose and not more than 1.2 milligrams per rec-ommended daily dose of total solanaceous alkaloids; in solid dose form inmedicines containing 0.3 milligrams or less per dose form and not more than1.2 milligrams per recommended daily dose of total solanaceous alkaloids

43 Delphinium staphisagria; in medicines containing more than 0.2%44 Desloratadine; for oral use45 Dexchlorpheniramine; for oral use in medicines for adults and children over 6

years of age when combined in the same container with 1 or more other thera-peutically active ingredients either when in the bedtime dose of a day/nightpack containing dexchlorpheniramine or when at least 1 of the other activeingredients is a sympathomimetic decongestant

46 Dextromethorphan; in liquid form containing more than 0.25% or in solid doseform containing more than 15 milligrams per dose form when in packs contain-


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ing not more than 600 milligrams and with a recommended daily dose of notmore than 120 milligrams; in medicines for the treatment of the symptoms ofcough and cold in children aged 6–12 years

47 Dibrompropamidine; for ophthalmic use except when sold in practice by anoptometrist registered with the Optometrists and Dispensing Opticians Board

48 Diclofenac; in solid dose form in medicines containing 12.5 milligrams or lessper dose form in packs containing not more than 30 tablets or capsules andwith a recommended daily dose of not more than 75 milligrams

49 Diphenoxylate; in liquid form containing in each millilitre not more than 0.5milligrams of diphenoxylate calculated as base and not less than 5 microgramsof atropine sulphate; in solid dose form containing not more than 2.5 milli-grams of diphenoxylate calculated as base and not less than 5 micrograms ofatropine sulphate

50 Dimenhydrinate; for oral use in a sealed container of not more than 10 tabletsor capsules for the prevention or treatment of motion sickness in adults or chil-dren over 2 years of age except when sold at a transport terminal or aboard aship or aircraft

51 Diphenhydramine; for oral use in medicines for adults and children over 6years of age when combined in the same container with 1 or more other thera-peutically active ingredients either when in the bedtime dose of a day/nightpack containing diphenhydramine or when at least 1 of the other active ingredi-ents is a sympathomimetic decongestant; for oral use in a sealed container ofnot more than 10 tablets or capsules for the prevention or treatment of motionsickness in adults and children over 2 years of age except when sold at a trans-port terminal or aboard a ship or aircraft

52 Doxylamine; for oral use in medicines for adults and children over 6 years ofage when combined in the same container with 1 or more other therapeuticallyactive ingredients either when in the bedtime dose of a day/night pack contain-ing doxylamine or when at least 1 of the other active ingredients is a sympatho-mimetic decongestant

53 Duboisia leichhardtii; for oral use in liquid form in medicines containing0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milli-grams per recommended daily dose of total solanaceous alkaloids; in solid doseform in medicines containing 0.3 milligrams or less per dose form and notmore than 1.2 milligrams per recommended daily dose of total solanaceousalkaloids

54 Duboisia myoporides; for oral use in liquid form in medicines containing0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milli-grams per recommended daily dose of total solanaceous alkaloids; in solid doseform in medicines containing 0.3 milligrams or less per dose form and notmore than 1.2 milligrams per recommended daily dose of total solanaceousalkaloids


75

55 Econazole; for dermal use except in medicines for tinea pedis only or whensold in practice by a podiatrist registered with the Podiatrists Board

56 Etafedrine57 Ether; in medicines containing more than 10%58 Etofenamate; for external use59 Famotidine; for the symptomatic relief of heartburn, dyspepsia, and hyperacid-

ity or to be used on the recommendation of a registered medical practitioner,when sold in the manufacturer’s original pack containing not more than 14days’ supply

60 Felbinac; for external use61 Fexofenadine; for oral use except for the treatment of seasonal allergic rhinitis

in adults and children 12 years of age and over when in capsules containing 60milligrams or less of fexofenadine hydrochloride or in tablets containing 120milligrams or less of fexofenadine hydrochloride with a maximum daily doseof 120 milligrams when sold in the manufacturer’s original pack containing 10dosage units or less and not more than 5 days’ supply

62 Fluorides; for internal use in medicines containing 0.5 milligrams or less perdose unit; except in parenteral nutrition replacement preparations; for externaluse in liquid form in medicines containing 1 gram or less per litre or per kilo-gram and when sold in packs approved by the Minister or the Director-Generalfor distribution as pharmacy-only medicines except in medicines containing220 milligrams or less per litre or per kilogram and in packs containing notmore than 120 milligrams of total fluoride; except when supplied to any dentalprofessional registered with the Dental Council; except in medicines containing15 milligrams or less per litre or per kilogram

63 Flurbiprofen; in locally acting oromucosal preparations containing 10 milli-grams or less per dosage unit

64 Fluticasone; for the treatment or prophylaxis of allergic rhinitis in adults andchildren over 12 years of age when in aqueous nasal sprays delivering up to 50micrograms per actuation with a maximum recommended daily dose of 200micrograms (as a single dose) in a pack containing 200 actuations or less

65 Folic acid; for oral use in medicines containing more than 500 micrograms perrecommended daily dose

66 Folinic acid; for oral use in medicines containing more than 500 microgramsper recommended daily dose

67 Formaldehyde; in medicines containing more than 5%68 Gelsemium sempervirens; except in medicines containing 1 milligram or less

per litre or per kilogram69 Glutaraldehyde70 Hexachlorophane; in medicines containing 3% or less but more than 0.75%


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71 Hydrocortisone and hydrocortisone acetate but no other esters of hydrocorti-sone; for dermal use in medicines containing 0.5% or less by weight of hydro-cortisone base with no other active ingredient except an antifungal and in aquantity of 30 grams or less or 30 millilitres or less per container; in rectalmedicines containing 0.5% or less by weight of hydrocortisone base and incombination with a local anaesthetic and in a quantity of 35 grams or less percontainer or 12 suppositories or fewer per pack

72 Hydrocyanic acid; for oral use in packs containing 5 milligrams or less andmore than 0.5 milligrams; except in medicines containing 1 microgram or lessper litre or per kilogram

73 Hydroquinone; for external use in medicines containing 2% or less except inhair preparations containing 1% or less

74 Hyoscine; for transdermal use in medicines containing 2 milligrams or less oftotal solanaceous alkaloids per dose unit; for oral use in liquid form in medi-cines containing 0.03% or less and 0.3 milligrams or less per dose and notmore than 1.2 milligrams per recommended daily dose of total solanaceousalkaloids; in solid dose form in medicines containing 0.3 milligrams or less perdose form and not more than 1.2 milligrams per recommended daily dose oftotal solanaceous alkaloids

75 Hyoscyamine; for external use in medicines containing 0.03% or less of totalsolanaceous alkaloids; for oral use in liquid form in medicines containing0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milli-grams per recommended daily dose of total solanaceous alkaloids; in solid doseform in medicines containing 0.3 milligrams or less per dose form and notmore than 1.2 milligrams per recommended daily dose of total solanaceousalkaloids

76 Hyoscyamus niger; for oral use in liquid form in medicines containing 0.03%or less and 0.3 milligrams or less per dose and not more than 1.2 milligramsper recommended daily dose of total solanaceous alkaloids or in solid doseform in medicines containing 0.3 milligrams or less per dose form and notmore than 1.2 milligrams per recommended daily dose except in packs contain-ing 30 micrograms or less of total solanaceous alkaloids

77 Ibuprofen; for oral use in liquid form with a recommended daily dose of notmore than 1.2 grams for the relief of pain and reduction of fever or inflamma-tion when sold in the manufacturer’s original pack containing not more than 8grams; for oral use in solid dose form containing not more than 200 milligramsper dose form and with a recommended daily dose of not more than 1.2 gramswhen sold in the manufacturer’s original pack containing not more than 100dose units; except in divided solid dosage forms for oral use containing 200milligrams or less per dose form with a recommended daily dose of not morethan 1.2 grams and when sold in the manufacturer’s original pack containingnot more than 25 dose units


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78 Indanazoline79 Indomethacin; for external use in medicines containing 1% or less; except in

medicines containing 1 milligram or less per litre or per kilogram80 Iodine; for external use in medicines containing more than 2.5%; for internal

use in medicines containing 300 micrograms or more per recommended dailydose

81 Ipecacuanha; in medicines containing 0.2% or less of emetine and 40 micro-grams or more of ipecacuanha alkaloids per recommended dose for the treat-ment of the symptoms of cough and cold in children aged 6–12 years

82 Ipomoea spp; except ipomoea batatas83 Ipratropium; for nasal use84 Iron; for oral use either in medicines containing more than 24 milligrams per

recommended daily dose or in medicines containing more than 5 milligramsper dose unit and more than 750 milligrams of iron per pack; except in paren-teral nutrition replacement preparations

85 Isoconazole; for dermal use except when sold in practice by a podiatrist regis-tered with the Podiatrists Board

86 Isopropamide; for dermal use in preparations containing 2% or less87 Jalap resin88 Ketoconazole; for dermal use except in medicines for tinea pedis only or when

sold in practice by a podiatrist registered with the Podiatrists Board; except inmedicines for treatment of the scalp containing 1% or less

89 Ketotifen; for ophthalmic use in medicines containing 0.025% or less exceptwhen sold in practice by an optometrist registered with the Optometrists andDispensing Opticians Board

90 Leucovorin; in medicines containing more than 500 micrograms per recom-mended daily dose

91 Levocabastine; for nasal use; for ophthalmic use except when sold in practiceby an optometrist registered with the Optometrists and Dispensing OpticiansBoard

92 Levocetirizine; for oral use93 Lignocaine; for urethral use; for external use in medicines containing 10% or

less and more than 2%94 Lindane; for external use in medicines containing 2% or less95 Lithium; for dermal use in medicines containing 1% or less but more than

0.01%; except when present as an excipient in dermal medicines containing0.25% or less

96 Lobelia inflata; except in medicines for smoking or burning97 Lobeline; except when in medicines for smoking or burning


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98 Lodoxamide; for ophthalmic use except when sold in practice by an optomet-rist registered with the Optometrists and Dispensing Opticians Board

99 Loperamide; in packs containing not more than 20 tablets or capsules; exceptin divided solid dosage forms for oral use containing 2 milligrams or less ofloperamide per dosage form when sold in a pack containing not more than 8dosage forms approved by the Minister or the Director-General for distributionas a general sales medicine for the symptomatic treatment of acute non-specificdiarrhoea

100 Loratadine; for oral use except in divided solid dosage forms for oral use con-taining 10 milligrams or less per dose form for the treatment of seasonal aller-gic rhinitis when sold in the manufacturer’s original pack containing not morethan 5 days’ supply

101 Mebendazole102 Meclozine; in a sealed container of not more than 12 tablets or capsules for the

prevention or treatment of travel sickness except when sold at a transport ter-minal or aboard a ship or aircraft

103 Mefenamic acid; in solid dose form in packs containing not more than 30 tab-lets or capsules for the treatment of dysmenorrhoea

104 Mepyramine; for dermal use105 Mercuric oxide; for ophthalmic use106 Mercurochrome; in preparations for external use containing 2% or less107 Mercury; for external use in medicines containing 0.5% or less108 Methoxamine; for external use in medicines containing more than 1%109 Methoxyphenamine110 Methylephedrine111 Miconazole; for external use except in medicines for tinea pedis only or when

sold in practice by a podiatrist registered with the Podiatrists Board112 Minoxidil; for dermal use in medicines containing 5% or less113 Mometasone; for the treatment or prophylaxis of allergic rhinitis in adults and

children over 12 years of age in aqueous nasal sprays delivering up to 50micrograms per actuation when the maximum recommended daily dose is nogreater than 200 micrograms (as a single dose) in a pack containing 200 actua-tions or less

114 Morphine; in medicines for oral use containing not more than 0.2% of mor-phine, when combined with 1 or more active ingredients in such a way that thesubstance cannot be recovered by readily applicable means or in a yield thatwould constitute a risk to health, when sold in a pack approved by the Ministeror the Director-General for distribution as a pharmacy-only medicine

115 Naphazoline; except for ophthalmic use when sold in practice by an optomet-rist registered with the Optometrists and Dispensing Opticians Board


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116 Naproxen; in solid dose form containing 250 milligrams or less per dose formin packs of not more than 30 tablets or capsules

117 Niclosamide118 Nicotine; for inhalation except when sold from a smoking cessation clinic run

under the auspices of a registered medical practitioner, nurse, pharmacist, orpsychologist

119 Nizatidine; in medicines for the symptomatic relief of heartburn, dyspepsia,and hyperacidity or to be used on the recommendation of a registered medicalpractitioner, when sold in the manufacturer’s original pack containing not morethan 14 days’ supply

120 Noscapine121 Nystatin; for dermal use except when sold in practice by a podiatrist registered

with the Podiatrists Board122 Omeprazole; in divided solid dosage forms for oral use containing 20 milli-

grams or less with a maximum daily dose of 20 milligrams for the short-termsymptomatic relief of gastric reflux-like symptoms in sufferers aged 18 yearsand over when sold in the manufacturer’s original pack containing not morethan 28 dosage units

123 Opium; in medicines for oral use containing not more than 0.2% of morphine,when combined with 1 or more active ingredients in such a way that the sub-stance cannot be recovered by readily applicable means, or in a yield thatwould constitute a risk to health, when sold in a pack approved by the Ministeror the Director-General for distribution as a pharmacy-only medicine

124 Oxetacaine; for internal use125 Oxiconazole; for dermal use except in medicines for tinea pedis only126 Oxymetazoline; except for nasal use when sold at an airport; except for oph-

thalmic use when sold in practice by an optometrist registered with the Optom-etrists and Dispensing Opticians Board; except for nasal use in medicines con-taining 0.05% or less when sold in the manufacturer’s original pack with apack size of 20 millilitres or less

127 Pantoprazole; in divided solid dosage forms for oral use containing 20 milli-grams or less with a maximum daily dose of 20 milligrams for the short-termsymptomatic relief of gastric reflux-like symptoms in sufferers aged 18 yearsand over when sold in the manufacturer’s original pack containing not morethan 28 dosage units

128 Papaverine; except for injection129 Paracetamol; in liquid form; in suppositories; in tablets or capsules containing

500 milligrams or less and in packs containing more than 10 grams; in slow-release forms containing 665 milligrams or less and more than 500 milligrams;in powder form containing not more than 1 gram per sachet and more than 10grams per pack


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130 Paraformaldehyde; in medicines containing more than 5%131 Penciclovir; for external use for the treatment of herpes labialis132 Phedrazine133 Phenazone; for external use134 Pheniramine; for ophthalmic use except when sold in practice by an optomet-

rist registered with the Optometrists and Dispensing Opticians Board; for oraluse in medicines for adults and children over 6 years of age when combined inthe same container with 1 or more other therapeutically active ingredientseither when in the bedtime dose of a day/night pack containing pheniramine orwhen at least 1 of the other active ingredients is a sympathomimetic decongest-ant

135 Phenol; in medicines other than for injection containing more than 3%136 Phenylephrine; for nasal use in medicines containing more than 1%; for oph-

thalmic use in medicines containing 5% or less and more than 1%; for oral usein medicines containing more than 50 milligrams per recommended daily doseor in packs containing more than 250 milligrams of phenylephrine per pack; inmedicines for the treatment of the symptoms of cough and cold in childrenaged 6–12 years

137 Pholcodine; in medicines for oral use containing not more than 15 milligramsof pholcodine per solid dosage unit or per dose of liquid with a maximum dailydose not exceeding 100 milligrams of pholcodine, when combined with 1 ormore active ingredients in such a way that the substance cannot be recoveredby readily applicable means, or in a yield that would constitute a risk to health,when sold in a pack approved by the Minister or the Director-General for dis-tribution as a pharmacy-only medicine

138 Piperazine139 Podophyllotoxin; for external use for the treatment of warts other than anogeni-

tal warts in medicines containing 0.5% or less; except in medicines containing1 milligram or less of podophyllin per litre or per kilogram

140 Podophyllum emodi; for external use for the treatment of warts other than ano-genital warts in medicines containing 10% or less of podophyllin; except inmedicines containing 1 milligram or less of podophyllin per litre or per kilo-gram

141 Podophyllum peltatum; for external use for the treatment of warts other thananogenital warts in medicines containing 10% or less of podophyllin; except inmedicines containing 1 milligram or less of podophyllin per litre or per kilo-gram

142 Potassium; for internal use: in slow-release or enteric coated forms; in medi-cines containing more than 100 milligrams per recommended dose except inmedicines for oral rehydration therapy, parenteral nutrition replacement, or


81

dialysis; except in glucosamine sulphate complexed products containing 600milligrams or less of potassium chloride per recommended dose

143 Potassium chlorate; except in medicines containing 10% or less144 Prilocaine; for dermal use in medicines containing 10% or less of local anaes-

thetic substances145 Procyclidine; for dermal use in medicines containing 5% or less146 Promethazine; for oral use in medicines for adults and children over 6 years of

age when combined in the same container with 1 or more other therapeuticallyactive ingredients either when in the bedtime dose of a day/night pack contain-ing promethazine or when at least 1 of the other active ingredients is a sympa-thomimetic decongestant; for oral use in a sealed container of not more than 10tablets or capsules for the prevention or treatment of motion sickness in adultsand children over 2 years of age except when sold at a transport terminal oraboard a ship or aircraft

147 Propamidine; for ophthalmic use except when sold in practice by an optomet-rist registered with the Optometrists and Dispensing Opticians Board

148 Pyrantel149 Pyrethrins; in medicines containing more than 10%150 Pyrithione zinc; except in medicines for treatment of the scalp containing 2%

or less151 Ranitidine; in medicines for the symptomatic relief of heartburn, dyspepsia,

and hyperacidity or to be used on the recommendation of a registered medicalpractitioner, when sold in the manufacturer’s original pack containing not morethan 14 days’ supply; except in medicines containing 150 milligrams or lessper dose unit when sold in the manufacturer’s original pack containing notmore than 7 days’ supply

152 Salicylamide153 Selenium; for oral use in medicines containing 300 micrograms or less and

more than 150 micrograms per recommended daily dose; for external useexcept in medicines containing 3.5% or less of selenium sulphide

154 Sennosides155 Silver; except in oral solutions containing 0.3% or less or other medicines con-

taining 1% or less156 Silver sulfadiazine; for external use in pack sizes of 50 grams or less157 Sodium cromoglycate; for nasal use; for ophthalmic use except when sold in

practice by an optometrist registered with the Optometrists and DispensingOpticians Board

158 Sodium nitrite; except for use as an excipient159 Sodium picosulphate; in oral laxative preparations


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160 Squill; in medicines containing more than 1%161 Stramonium; for oral use in liquid form in medicines containing 0.03% or less

and 0.3 milligrams or less per dose and not more than 1.2 milligrams per rec-ommended daily dose of total solanaceous alkaloids; in solid dose form inmedicines containing 0.3 milligrams or less per dose form and not more than1.2 milligrams per recommended daily dose of total solanaceous alkaloids

162 Sulconazole; for dermal use163 Sulfadiazine, silver; for external use in pack sizes of 50 grams or less164 Terbinafine; for dermal use except in medicines for tinea pedis only or when

sold in practice by a podiatrist registered with the Podiatrists Board165 Tetrachloroethylene166 Tetrahydrozoline; except for ophthalmic use when sold in practice by an

optometrist registered with the Optometrists and Dispensing Opticians Board167 Thiabendazole168 Tioconazole; for dermal use except in medicines for tinea pedis only or when

sold in practice by a podiatrist registered with the Podiatrists Board169 Tramazoline170 Triamcinolone; for the treatment or prophylaxis of allergic rhinitis in adults and

children over 12 years of age and when in aqueous nasal sprays delivering upto 55 micrograms per actuation when the maximum recommended daily dose isno greater than 220 micrograms and the medicine has received the consent ofthe Minister or the Director-General to its distribution as a pharmacy-onlymedicine

171 Trimeprazine; for oral use in medicines for adults and children over 6 years ofage when combined in the same container with 1 or more other therapeuticallyactive ingredients either when in the bedtime dose of a day/night pack contain-ing trimeprazine or when at least 1 of the other therapeutically active ingredi-ents is a sympathomimetic decongestant

172 Triprolidine; for oral use in medicines for adults and children over 6 years ofage when combined in the same container with 1 or more other therapeuticallyactive ingredients either when in the bedtime dose of a day/night pack contain-ing triprolidine or when at least 1 of the other active ingredients is a sympatho-mimetic decongestant

173 Tuaminoheptane174 Tymazoline175 Xylenols; in medicines containing more than 3%176 Xylometazoline; except for nasal use when sold at an airport; except for oph-

thalmic use when sold in practice by an optometrist registered with the Optom-etrists and Dispensing Opticians Board

177 Zinc chloride; for dermal use in medicines containing more than 5%


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Michael Webster,Clerk of the Executive Council.

Explanatory noteThis note is not part of the regulations, but is intended to indicate their general effect.These regulations, which come into force on 6 August 2015, replace Schedule 1 ofthe Medicines Regulations 1984 (the principal regulations). New Schedule 1 sets outan updated list of specified medicines and classes of medicines that are declared to beprescription medicines, restricted medicines, or pharmacy-only medicines under theMedicines Act 1981 (the Act).The updated list includes medicines that the Minister of Health has previously classi-fied as prescription medicines, etc, by Gazette notice made under section 106 of theAct (see Classification of Medicines (Gazette 2015-go984) and Classification ofMedicines (Gazette 2014-go7770)). Gazette notices made under section 106 overrideany inconsistent classification of medicines in the principal regulations, but they donot amend the principal regulations and they cease to have effect after a period of 6months (if not revoked sooner).

Issued under the authority of the Legislation Act 2012.Date of notification in Gazette: 30 July 2015.

Explanatory note Medicines Amendment Regulations (No 2) 2015Reprinted as at

25 October 2018

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Reprints notes

1 GeneralThis is a reprint of the Medicines Amendment Regulations (No 2) 2015 thatincorporates all the amendments to those regulations as at the date of the lastamendment to them.

2 Legal statusReprints are presumed to correctly state, as at the date of the reprint, the lawenacted by the principal enactment and by any amendments to that enactment.Section 18 of the Legislation Act 2012 provides that this reprint, published inelectronic form, has the status of an official version under section 17 of thatAct. A printed version of the reprint produced directly from this official elec-tronic version also has official status.

3 Editorial and format changesEditorial and format changes to reprints are made using the powers under sec-tions 24 to 26 of the Legislation Act 2012. See also http://www.pco.parlia-ment.govt.nz/editorial-conventions/.

4 Amendments incorporated in this reprintMedicines Amendment Regulations 2018 (LI 2018/179): regulation 5

Wellington, New Zealand:

Published under the authority of the New Zealand Government—2018

Reprinted as at25 October 2018 Medicines Amendment Regulations (No 2) 2015 Notes

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http://www.pco.parliament.govt.nz/editorial-conventions/

http://www.pco.parliament.govt.nz/editorial-conventions/

http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=LMS69432

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