Health Products (Therapeutic Products) (Amendment No. 2) Regulations 2023

Status:

Published in Subsidiary Legislation Supplement
on 25 Oct 2023

No. S 681

Health Products Act 2007

Health Products
(Therapeutic Products)
(Amendment No. 2) Regulations 2023

In exercise of the powers conferred by section 72 of the Health Products Act 2007, the Health Sciences Authority, with the approval of the Minister for Health, makes the following Regulations:

Citation and commencement

1. These Regulations are the Health Products (Therapeutic Products) (Amendment No. 2) Regulations 2023 and come into operation on 1 November 2023.

Amendment of First Schedule

2. In the Health Products (Therapeutic Products) Regulations 2016 (G.N. No. S 329/2016), in the First Schedule —

(a)

in paragraph 1, after the item “Alprazolam”, insert —

“Amineptine”;

(b)

in paragraph 1, after the item “Clonazepam”, insert —

“Clonazolam”;

(c)

in paragraph 1, after the item “Diazepam”, insert —

“Diclazepam”;

(d)

in paragraph 1, after the item “Etilamfetamine”, insert —

“Etizolam”;

(e)

in paragraph 1, after the item “Fenproporex”, insert —

“Flualprazolam

Flubromazolam”;

(f)

in paragraph 1, after the item “Pentobarbital”, insert —

“Phenazepam”; and

(g)

replace paragraph 2 with —

“2. The stereoisomeric forms or salts of the substances specified in paragraph 1, wherever the existence of such stereoisomeric forms or salts is possible.”.

Amendment of Second Schedule

3. In the Health Products (Therapeutic Products) Regulations 2016, in the Second Schedule —

(a)

in Part 1, after the item specified in the first column of the following table, insert the item specified opposite it in the second column of the table:

First column

Second column

Item

Abciximab

Abemaciclib

Abiraterone

Abrocitinib

Acalabrutinib

Acitretin

Aclidinium

Aflibercept

Agalsidase alfa

Alatrofloxacin

Albutrepenonacog alfa

Aldosterone

Alectinib

Alglucosidase alfa

Alirocumab

Alosetron

Alpelisib

Ambenonium

Ambrisentan

Aminoglutethimide

Aminolevulinic acid

Amitriptyline

Amivantamab

Antazoline

Apalutamide

Apramycin

Apremilast

Arotinolol

Arsenic trioxide

Articaine

Asciminib

Atenolol

Atezolizumab

Auranofin

Avanafil

Avelumab

Avibactam

Baclofen

Baloxavir marboxil

Barbituric acid

Baricitinib

Bekanamycin

Belantamab mafodotin

Benperidol

Benralizumab

Bleomycin

Blinatumomab

Bretylium

Brexipiprazole

Brigatinib

Bupropion

Burosumab

Cabimicina

Cabotegravir

Cabozantinib

Capecitabine

Capmatinib

Carfentanil

Carfilzomib

Cariprazine

Ceftizoxime

Ceftolozane

Clonazepam

Clonazolam

Cobicistat

Cobimetinib

Cortisone

Crisaborole

Daclizumab

Dacomitinib

Daptomycin

Daratumumab

Darbepoetin alfa

Darolutamide

Daunorubicin

Davesomeran

Denosumab

Deoxycholic acid

Dichlorphenamide

Diclazepam

Diethylthiambutene

Difelikefalin

Dimethyl 4‑sulphamoylphenyl phosphorothioate

Dimethyl fumarate

Dopamine

Doravirine

Dorzolamide

Dostarlimab

Drotrecogin alfa

Dulaglutide

Duloxetine

Dupilumab

Durvalumab

Eculizumab

Edoxaban

Efavirenz

Elasomeran

Elbasvir

Emepronium

Emicizumab

Empagliflozin

Enflurane

Enfortumab vedotin

Entecavir

Entrectinib

Eptifibatide

Eptinezumab

Eravacycline

Erdafitinib

Erdosteine

Erenumab

Ertapenem

Ertugliflozin

Escitalopram

Esketamine

Etanercept

Etelcalcetide

Etilamfetamine

Etizolam

Everolimus

Evolocumab

Famprofazone

Famtozinameran

Faricimab

Febuxostat

Fedratinib

Ferric carboxymaltose

Ferric derisomaltose

Filgrastim

Fimasartan

Finasteride

Finerenone

Floxuridine

Flualprazolam

Fluanisone

Flubromazolam

Flutamide

Flutemetamol

Follitropin alfa

Follitropin delta

Framycetin

Fremanezumab

Galantamine

Galcanezumab

Gestronol

Gilteritinib

Glafenine

Glecaprevir

Granisetron

Grazoprevir

Guanoxan

Guselkumab

Idarubicin

Idarucizumab

Imiquimod

Inclisiran

Infliximab

Inotuzumab ozogamicin

Iodine-131

Ioflupane

Irinotecan

Isatuximab

Isavuconazonium

Ixabepilone

Ixazomib

Ixekizumab

Laropiprant

Larotrectinib

Latanoprost

Latanoprostene

Leflunomide

Lemborexant

Lenograstim

Lenvatinib

Lercanidipine

Letermovir

Linezolid

Lipegfilgrastim

Liraglutide

Lisdexamfetamine

Lonazolac

Lonoccog alfa

Lorazepam

Lorlatinib

L-Pyroglutamyl-L-histidyl-L-proline amide

Lubiprostone

Luliconazole

Lumefantrine

Lurasidone

Lurbinectedin

Luspatercept

Luteinising hormone

Lutetium-177

Maraviroc

Mavacamten

Mepivacaine

Mepolizumab

Methyltestosterone

Methylthioninium

Midodrine

Midostaurin

Mifepristone

Nebivolol

Necitumumab

Nepafenac

Neratinib

Netarsudil

Netilmicin

Netupitant

Nintedanib

Niraparib

Nitroxoline

Nivolumab

Noxythiolin

Nusinersen

Olanzapine

Olaparib

Omeprazole

Omidenepag

Orciprenaline

Orelabrutinib

Oseltamivir

Osimertinib

Ospemifene

Oxytocin

Ozanimod

Paclitaxel

Palbociclib

Panitumumab

Panobinostat

Pegaptanib

Pegaspargase

Pegvisomant

Pemafibrate

Perampanel

Perfluorobutane

Phenaglycodol

Phenazepam

Physostigmine

Pibrentasvir

Pirenzepine

Pirfenidone

Pirprofen

Pitavastatin

Plerixafor

Polatuzumab vedotin

Pomalidomide

Ponatinib

Pralidoxime

Pralsetinib

Ramipril

Ramucirumab

Ranolazine

Rasagiline

Raubasine

Raxtozinameran

Regorafenib

Remdesivir

Retinoic acid

Revefenacin

Ribavirin

Ribociclib

Rifampicin

Rifapentine

Riluzole

Rimegepant

Riociguat

Ripasudil

Ripretinib

Risankizumab

Risdiplam

Romiplostim

Romosozumab

Roxithromycin

Rufinamide

Rupatadine

Rurioctocog alfa pegol

Ruxolitinib

Sacituzumab govitecan

Sacubitril

Safinamide

Saquinavir

Sarilumab

Satralizumab

Selegiline

Selexipag

Selinexor

Selumetinib

Semaglutide

Silver sulphadiazine

Simeprevir

Simfibrate

Simoctocog alfa

Simvastatin

Siponimod

Sodium picosulphate

Sodium pyrophosphate

Sodium valproate

Sodium zirconium

Sotalol

Sotorasib

Tadalafil

Tafamidis

Talampicillin

Talazoparib

Taliglucerase alfa

Tegaserod

Tegoprazan

Tenoxicam

Tepotinib

Tetrofosmin

Tezepelumab

Tiotropium

Tipiracil

Tirofiban

Tirzepatide

Tolterodine

Tolvaptan

Tosufloxacin

Tozinameran

Tramadol

Trametinib

Trientine

Trifarotene

Tubocurarine

Tucatinib

Turoctocog alfa

Unoprostone

Upadacitinib

Valaciclovir

Valbenazine

Vedolizumab

Velaglucerase alfa

Velpatasvir

Vemurafenib

Venetoclax

Verapamil

Vericiguat

Vigabatrin

Vilanterol

Vismodegib

Vonoprazan

Vortioxetine

Voxilaprevir

Zanamivir

Zanubrutinib

;

(b)

in Part 1, before “Bifonazole”, insert “Bictegravir”;

(c)

in Part 1, replace each item specified in the first column of the following table with the item specified opposite it in the second column of the table:

First column

Second column

Item

Acetanilide; alkyl acetanilides

Acetanilide

Benactyzine; its quarternary compounds

Benactyzine

Bendamustine hydrochloride

Bendamustine

Benztropine and its homologues

Benztropine

Bevonium methyl sulphate

Bevonium

Bicisate dihydrochloride

Bicisate

Buphenine hydrochloride

Buphenine

Butropium bromide

Butropium

Chromium [51CR] Edetate

Chromium [51CR]

Dabigatran etexilate mesylate

Dabigatran

Dextrothyroxine sodium

Dextrothyroxine

Dithienylallylamines; dithienyl-alkylallylamines

Dithienylallylamines

Ecothiopate iodide

Ecothiopate

Eltrombopag olamine

Eltrombopag

Ephedrine; its optical isomers

Ephedrine

Eribulin mesylate

Eribulin

Etofylline clofibrate

Etofylline

Fludarabine phosphate

Fludarabine

Fosaprepitant dimeglumine

Fosaprepitant

Gadobenate dimeglumine

Gadobenic acid

Lanthanum carbonate hydrate

Lanthanum carbonate

Liothyronine sodium

Liothyronine

Mercaptopurine; derivatives of mercaptopurine

Mercaptopurine

Methadone (amidone)

Methadone

Methanthelinium bromide

Methantheline

Methyl 5-aminolevulinate hydrochloride

Methyl aminolevulinate

Methylnaltrexone bromide

Methylnaltrexone

Minoxidil

Minoxidil (other than topical preparations)

Morphine methylbromide; morphine N-oxide and other pentavalent nitrogen morphine derivatives

Morphine

N-Acetylaspartyl glutamic acid sodium salt

N-Acetylaspartyl glutamic acid; spaglumic acid

Poldine methylsulphate

Poldine

Protamine sulphate

Protamine

Radium-223 chloride

Radium-223

Sodium molybdate

Sodium molybdate [99Mo]

Streptomycin and its derivatives

Streptomycin

Sulphonal; alkyl sulphonals

Sulphonal

Thiazinamium methylsulphate

Thiazinamium

Thiouracil; its alkyl derivatives

Thiouracil

Urea

Urea [13C]

Urea [14C]

Yttrium-90 chloride

Yttrium-90

;

(d)

in Part 1, delete the following items:

Alphacalcidol

Desferrioxamine mesylate

Dextromethorphan

Diethanolamine fusidate

Gadoxetate

Histrelin

Isoconazole

Leucovorin

Meglumine gadoterate

Miconazole

N-Benzoyl sulphanilamide

Nicotinic acid

p-Aminobenzene-sulphonamide

Thyroid gland, the active principles of;

(e)

in Part 1, at the end, insert —

“Note: The stereoisomeric forms or salts of the substances specified in Part 1, wherever the existence of such stereoisomeric forms or salts is possible, are also active ingredients for the purpose of this Part.”;

(f)

in Part 2, replace item 6 with —

“6.	Vaccine antigens”;

(g)

in Part 3, after the item “Dexchlorpheniramine”, insert “Dextromethorphan”;

(h)

in Part 3, after the item “Flunarizine”, insert “Isoconazole”;

(i)

in Part 3, after the item “Mebeverine”, insert “Miconazole”; and

(j)

in Part 3, at the end, insert —

“Note: The stereoisomeric forms or salts of the substances specified in Part 3, wherever the existence of such stereoisomeric forms or salts is possible, are also active ingredients for the purpose of this Part.”.

[G.N. Nos. S 219/2017; S 119/2018; S 92/2019; S 969/2020; S 732/2021; S 1081/2021; S 458/2022; S 436/2023]

Made on 18 October 2023.

BENJAMIN ONG

Chairperson,
Health Sciences Authority,
Singapore.

[401:04/01-000; AG/LEGIS/SL/122D/2020/4 Vol. 2]

(To be presented to Parliament under section 72(5) of the Health Products Act 2007).

Search within Legislation