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No. S 189

Poisons Act

(Chapter 234)

Poisons (Amendment) Rules 2004

In exercise of the powers conferred by section 20(1) of the Poisons Act, Mr Khaw Boon Wan, Senior Minister of State, Ministry of Finance, charged with the responsibility of the Minister for Health, hereby makes the following Rules:

Citation and commencement

1. These Rules may be cited as the Poisons (Amendment) Rules 2004 and shall come into operation on 14th April 2004.

Amendment of First Schedule

2. The First Schedule to the Poisons Rules (R 1) is amended —

(a)

by inserting, immediately below the item “Acyclovir”, the following item:

“Adalimumab”;

(b)

by inserting, immediately below the item “Adapalene”, the following item:

“Adefovir dipivoxil”;

(c)

by inserting, immediately below the item “Aldosterone”, the following item:

“Alemtuzumab”;

(d)

by inserting, immediately below the item “Amylocaine; its salts”, the following item:

“Anagrelide; its salts”;

(e)

by inserting, immediately below the item “Apramycin; its salts”, the following item:

“Aprepitant”;

(f)

by inserting, immediately below the item “Aprotinin”, the following item:

“Aripiprazole”;

(g)

by inserting, immediately below the item “Astemizole”, the following item:

“Atazanavir; its salts”;

(h)

by inserting, immediately below the item “Bifonazole”, the following item:

“Bimatoprost”;

(i)

by inserting, immediately below the item “Boric acid; sodium borate”, the following item:

“Bosentan; its salts”;

(j)

by inserting, immediately below the item “Calcium carbimide”, the following item:

“Calcium dobesilate”;

(k)

by inserting, immediately below the item “Carbenoxolone; its salts”, the following item:

“Carbetocin”;

(l)

by inserting, immediately below the item “Chlorothiazide and other derivatives of benzo-1,2,4-thiadiazine-7-sulphonamide 1,1-dioxide, whether hydrogenated or not”, the following item:

“Chlorpheniramine; its salts; its isomers; their salts”;

(m)

by deleting the item “Citalopram; its salts” and substituting the following item:

“Citalopram; its salts; its isomers; their salts Citicoline”;

(n)

by inserting, immediately below the item “Clebopride”, the following item:

“Clenbuterol”;

(o)

by inserting, immediately below the item “Clostebol; its salts”, the following item:

“Clostridiopeptidase A”;

(p)

by inserting, immediately below the item “Dexfenfluramine; its salts”, the following item:

“Dexrazoxane”;

(q)

by inserting, immediately below the item “Drotebanol”, the following items:

“Drotrecogin alpha

Dutasteride”;

(r)

by inserting, immediately below the item “Epithiazide”, the following item:

“Eplerenone; its salts”;

(s)

by inserting, immediately below the item “Eptifibatide”, the following item:

“Erdosteine; its salts”;

(t)

by inserting, immediately below the item “Ergotoxine; its salts”, the following item:

“Ertapenem; its salts”;

(u)

by inserting, immediately below the item “Etryptamine; its salts; its esters; their salts”, the following item:

“Ezetimibe”;

(v)

by inserting, immediately below the item “Gatifloxacin; its salts; its isomers; its esters; their salts”, the following item:

“Gefitinib”;

(w)

by inserting, immediately below the item “Glyceryl trinitrate”, the following item:

“Glycopyrrolate”;

(x)

by inserting, immediately below the item “Ifosfamide”, the following item:

“Iloprost; its salts; its esters; their salts”;

(y)

by inserting, immediately below the item “Indomethacin; its salts”, the following item:

“Infliximab”;

(z)

by inserting, immediately below the item “Isradipine”, the following item:

“Itopride; its salts”;

(za)

by deleting the item “Ketoprofen” and substituting the following item:

“Ketoprofen; its isomers”;

(zb)

by inserting, immediately below the item “Lacidipine”, the following item:

“Lafutidine”;

(zc)

by deleting the item “Loratadine” and substituting the following item:

“Loratadine; its isomers”;

(zd)

by inserting, immediately below the item “Losartan; its salts”, the following item:

“Loteprednol; its salts”;

(ze)

by inserting, immediately below the item “Luteinising hormones”, the following item:

“Lutropin alpha”;

(zf)

by inserting, immediately below the item “Melphalan”, the following item:

“Memantine; its salts”;

(zg)

by inserting, immediately below the item “Moxalactam; its salts”, the following item:

“Moxifloxacin; its salts”;

(zh)

by inserting, immediately below the item “Nadolol”, the following item:

“Nadroparin; its salts”;

(zi)

by inserting, immediately below the item “Nandrolone; its salts; its esters and ethers; their salts”, the following item:

“Naphazoline; its salts; when contained in eye preparations”;

(zj)

by inserting, immediately below the item “Nordazepam”, the following item:

“Norelgestromin”;

(zk)

by inserting, immediately below the item “Paramethoxyamphetamine”, the following item:

“Parecoxib; its salts”;

(zl)

by inserting, immediately below the item “Pilocarpine; its salts”, the following item:

“Pimecrolimus”;

(zm)

by inserting, immediately below the item “Pinazepam”, the following item:

“Pioglitazone; its salts”;

(zn)

by inserting, immediately below the item “Propiram; its salts”, the following item:

“Propiverine; its salts”;

(zo)

by inserting, immediately below the item “13-cis Retinoic acid”, the following item:

“Reviparin; its salts”;

(zp)

by inserting, immediately below the item “Rosoxacin”, the following item:

“Rosuvastatin”;

(zq)

by inserting, immediately below the item “Secbutobarbitone; its salts”, the following item:

“Secnidazole”;

(zr)

by inserting, immediately below the item “Tacrolimus; its salts”, the following item:

“Tadalafil; its salts”;

(zs)

by inserting, immediately below the item “Tamoxifen; its salts”, the following item:

“Tazarotene”;

(zt)

by inserting, immediately below the item “Tegafur”, the following item:

“Tegaserod; its salts”;

(zu)

by inserting, immediately below the item “Terfenadine”, the following item:

“Teriparatide”;

(zv)

by inserting, immediately below the item “Trifluridine; its salts; its esters; their salts”, the following item:

“Triflusal; its salts; its esters; their salts”;

(zw)

by inserting, immediately below the item “Trimebutine; its salts”, the following item:

“Trimegestone”;

(zx)

by inserting, immediately below the item “Tropisetron; its salts”, the following item:

“Trospium; its salts”;

(zy)

by inserting, immediately below the item “Tyrothricin; its salts; its esters; their salts”, the following item:

“Unoprostone; its salts; its esters and their salts”;

(zz)

by deleting the item “Urea, when contained in preparations intended for treatment of human ailments and containing more than 10% of urea” and substituting the following item:

“Urea, when contained in preparations intended for human consumption, except external preparations containing not more than 10% of urea”;

(zza)

by inserting, immediately below the item “Valaciclovir; its salts”, the following items:

“Valdecoxib

Valganciclovir; its salts”;

(zzb)

by inserting, immediately below the item “Vancomycin; its salts; its esters; their salts”, the following item:

“Vardenafil; its salts; its active derivatives”;

(zzc)

by inserting, immediately below the item “Virginiamycin; its salts; its esters; their salts”, the following item:

“Voriconazole”; and

(zzd)

by inserting, immediately below the item “Ziprasidone; its salts”, the following item:

“Zofenopril; its salts”.

Amendment of Second Schedule

3. The Second Schedule to the Poisons Rules is amended —

(a)

by inserting, immediately below the item “Sodium nitrite”, the following item:

“

Terbinafine

Preparations intended for dermatological uses, containing not more than 1% of terbinafine calculated as its free base.

”; and

(b)

by inserting, immediately below the item “Thiouracil; its alkyl derivatives”, the following item:

“

Tolnaftate

Preparations intended for dermatological uses, containing not more than 1% of tolnaftate.

”.

Amendment of Third Schedule

4. The Third Schedule to the Poisons Rules is amended —

(a)

by inserting, immediately below the item “Acyclovir; except in dermatological preparations containing not more than 5% of acyclovir”, the following item:

“Adalimumab”;

(b)

by inserting, immediately below the item “Adapalene”, the following item:

“Adefovir dipivoxil”;

(c)

by inserting, immediately below the item “Aldosterone”, the following item:

“Alemtuzumab”;

(d)

by deleting the item “Ambroxol; its salts”;

(e)

by inserting, immediately below the item “Amylobarbitone; its salts”, the following item:

“Anagrelide; its salts”;

(f)

by inserting, immediately below the item “Apramycin; its salts”, the following item:

“Aprepitant”;

(g)

by inserting, immediately below the item “Aprotinin”, the following item:

“Aripiprazole”;

(h)

by inserting, immediately below the item “Astemizole”, the following item:

“Atazanavir; its salts”;

(i)

by inserting, immediately below the item “Bicalutamide”, the following item:

“Bimatoprost”;

(j)

by inserting, immediately below the item “Boric acid; sodium borate”, the following item:

“Bosentan; its salts”;

(k)

by deleting the item “Bromhexine; its salts”;

(l)

by inserting, immediately below the item “Calcium carbimide”, the following item:

“Calcium dobesilate”;

(m)

by inserting, immediately below the item “Carbenoxolone; its salts”, the following item:

“Carbetocin”;

(n)

by deleting the item “Citalopram; its salts” and substituting the following items:

“Citalopram; its salts; its isomers; their salts

Citicoline”;

(o)

by inserting, immediately below the item “Clebopride”, the following item:

“Clenbuterol”;

(p)

by inserting, immediately below the item “Clostebol; its salts”, the following item:

“Clostridiopeptidase A”;

(q)

by inserting, immediately below the item “Dexfenfluramine; its salts”, the following item:

“Dexrazoxane”;

(r)

by inserting, immediately below the item “Dihydroartemisin”, the following item:

“Dihydrocodeine; its salts; its esters and ethers; their salts”;

(s)

by inserting, immediately below the item “Drostanolone; its salts”, the following items:

“Drotrecogin alpha

Dutasteride”;

(t)

by inserting, immediately below the item “Ergotoxine; its salts”, the following item:

“Ertapenem; its salts”;

(u)

by inserting, immediately below the item “Etryptamine; its salts; its esters; their salts”, the following item:

“Ezetimibe”;

(v)

by inserting, immediately below the item “Gatifloxacin; its salts; its isomers; its esters; their salts”, the following item:

“Gefitinib”;

(w)

by inserting, immediately below the item “Glyceryl trinitrate; except when contained in sublingual preparations or transdermal patches”, the following item:

“Glycopyrrolate”;

(x)

by inserting, immediately below the item “Ifosfamide”, the following item:

“Iloprost; its salts; its esters; their salts”;

(y)

by inserting, immediately below the item “Indomethacin; its salts” the following item:

“Infliximab”;

(z)

by inserting, immediately below the item “Isradipine”, the following item:

“Itopride; its salts”;

(za)

by deleting the item “Ketoprofen; except when contained in dermatological preparations” and substituting the following item:

“Ketoprofen; its isomers; except when contained in dermatological preparations”;

(zb)

by inserting, immediately below the item “Lacidipine”, the following item:

“Lafutidine”;

(zc)

by inserting, immediately below the item “Losartan; its salts”, the following item:

“Loteprednol; its salts”;

(zd)

by inserting, immediately below the item “Luteinising hormones”, the following item:

“Lutropin alpha”;

(ze)

by inserting, immediately below the item “Melphalan”, the following item:

“Memantine; its salts”;

(zf)

by inserting, immediately below the item “Moxalactam; its salts”, the following item:

“Moxifloxacin; its salts”;

(zg)

by inserting, immediately below the item “Nadolol”, the following item:

“Nadroparin; its salts”;

(zh)

by deleting the item “Naproxen; its salts”;

(zi)

by deleting the item “Nicotine; its salts; its quarternary compounds; their salts; except when contained in transdermal patches or inhalers”;

(zj)

by inserting, immediately below the item “Nordazepam”, the following item:

“Norelgestromin”;

(zk)

by inserting, immediately below the item “Paramethoxyamphetamine”, the following item:

“Parecoxib; its salts”;

(zl)

by inserting, immediately below the item “Phthalylsulphathiazole; its salts”, the following item:

“Pimecrolimus”;

(zm)

by inserting, immediately below the item “Pinazepam”, the following item:

“Pioglitazone; its salts”;

(zn)

by inserting, immediately below the item “Propiomazine; its salts”, the following item:

“Propiverine; its salts”;

(zo)

by inserting, immediately below the item “13-cis Retinoic acid”, the following item:

“Reviparin; its salts”;

(zp)

by inserting, immediately below the item “Rosoxacin”, the following item:

“Rosuvastatin”;

(zq)

by inserting, immediately below the item “Secbutobarbitone; its salts”, the following item:

“Secnidazole”;

(zr)

by inserting, immediately below the item “Tacrolimus; its salts”, the following item:

“Tadalafil; its salts”;

(zs)

by inserting, immediately below the item “Tamoxifen; its salts”, the following item:

“Tazarotene”;

(zt)

by inserting, immediately below the item “Tegafur”, the following item:

“Tegaserod; its salts”;

(zu)

by inserting, immediately below the item “Terfenadine”, the following item:

“Teriparatide”;

(zv)

by inserting, immediately below the item “Trifluridine; its salts; its esters; their salts”, the following item:

“Triflusal; its salts; its esters; their salts”;

(zw)

by inserting, immediately below the item “Trimebutine; its salts”, the following item:

“Trimegestone”;

(zx)

by inserting, immediately below the item “Tropisetron; its salts”, the following item:

“Trospium; its salts”;

(zy)

by inserting, immediately below the item “Tyrothricin; its salts; its esters; their salts; except when contained in lozenges”, the following item:

“Unoprostone; its salts; its esters and their salts”;

(zz)

by inserting, immediately below the item “Valaciclovir; its salts”, the following item:

“Valdecoxib Valganciclovir; its salts”;

(zza)

by inserting, immediately below the item “Vancomycin; its salts; its esters; their salts”, the following item:

“Vardenafil; its salts; its active derivatives”;

(zzb)

by inserting, immediately below the item “Virginiamycin; its salts; its esters; their salts”, the following item:

“Voriconazole”; and

(zzc)

by inserting, immediately below the item “Ziprasidone; its salts”, the following item:

“Zofenopril; its salts”.

[G.N. Nos. S 632/98; S51/99; S 177/99; S 279/99; S 68/2000; S 238/2001; S473/2002]

Made this 2nd day of April 2004.

MOSES LEE

Permanent Secretary,
Ministry of Health,
Singapore.

[CPA (PER): 78:01 Vol. 5; AG/LEG/SL/234/2002/1 Vol. 1]

(To be presented to Parliament under section 20(2) of the Poisons Act).