Regulations and Requirements for Therapeutic Products in Singapore

Classified in Medicine & Health

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Therapeutic productsCometic products(2type)ivd+generalMedical devicesoral dental gumsChinese proprietary medicinetraditional MedicineQuasimedicinal productsmedicated oil and balms
ExamplesParacetemol,antibiotics,bloodpressure medicationmakeup,thoothpaste,cleanser,
bodysoap(+medicatedsoap) ,shampoo(+antidandruff),anti-achne prep
generalmedicaldevice(thermometer/Bpmeter/contactlens/condoms)
IVD(Bloodglucosemeter.Pregnancykit).Massagers,bodytoning.Magnet.
accessoriesnotmedicaldeviceastheyarenotforpreventingdiagnosingcuringoralleviatingdiseaseorhaveanymedicalpurpose
Xylitol/orbit.Dentalgumslingzhitablets.Ginseng+pochaipill/
DoesnotincludeCPMininjectionform.CPMclassifiedasTP
ginseng(original).Traditionaljavamedicinejamu. Nonchingherbalmeds.medicatedplaster/toothpaste/soap/beverage(ensure).
sun/screen.Tan.Anti/dandruff/acneprep.Sweetsforcoughnthroat.Vitamins/supplements
axebrand
It’s a type offHealthproductsHealthproductsHealthproductsHealthproductsmedicinal productmedicinal productmedicinal productmedicinal product
mainlyregulatedunder(referforlicenseact)HealthproductsactHealthproductsactHealthproductsactHealthproductsactmedicineactmedicineactmedicineactmedicineact
needtoregisterprodyctwithHSAbeforeit
canbesoldinSg(premarketingapproval)
YcanbefoundonHSAonlineinfosearchforTherapeuticproductsNY/exceptnonsterileclassAgeneralmedicaldevice)
foundinHSAsingaporemedicaldeviceregister(SMDR)
YNNNN
needmanufacturerlicese(tomakeproductinSG)YNYYYNNN
needlicensetoimport(bringintoSG)Y(Importerlicense)NY(Importerlicense)YY(IMPORTlicense)NNN
needlicencetosellviawholesaleinSGY(wholesalerlicense)NY(wholesalerlicense)YY(wholesalerDEALERlicense)NNN
needresponsiblepersonformanufacture's,licence,importer'sY(RPformanufacturerlicence;donotneedtobeapharmacis;mustbesomeonewith
experienceinmanufacturingRPforimporterlicenseandwholesalerlicensepreferablyapharmacist
NNNNNNN
QualityRegulatedbyHealthProductAct/SaleofDrugActHealthProductActHealthProductActHealthProductActmedicineactmedicineactmedicineactmedicineact
AdvertismentregulatedbyHealthproductactHealthProductActHealthProductActHealthProductActmedicineact/medicineadvertismentandsaleactmedicineact/medicineadvertismentandsaleactmedicineact/medicineadvertismentandsaleactmedicineact/medicineadvertismentandsaleact
NeedtogetpermitfromHSAforAdvertismentN
N
N

N

YYYY
Artisement allowed?Artisement Depends on legal/forensic classsification. GSL: Allowed as long it is not misleading or false and does not compare itself to other products and does not claim to treat any of the 19 diseases
specified in the Second Schedule of the Health Products (Advertisement of Therapeutic Products) Regulations 2016 P: Allowed only if it advises consumers to read PIL or consult healthcare professionals on the use of the medicine of if symptoms persists
POM: Not allowed unless it is directed at healthcare professions (not accessible to public) or for trade advertisement (found in catalogue, price list) TP: Not allowed unless it is in the form of a journal article or at trade fair (not accessible to public)
UnregisteredProduct : Not allowed unless it is in the form of a journalarticle or as tradefair(notaccessibletopublic)
YYNot allowed unless it is directed at healthcare professions (not accessible to public)
or for trade advertisement (found in catalogue, price list)
Y when it is not false or misleading and does not claim ot to treat any of the
19 diseases specified in First Schedule of the Medicines Act (blind, cancer etc)
Y when it is not false or misleading and does not claim ot to treat any of the
19 diseases specified in First Schedule of the Medicines Act (blind, cancer etc)
Y when it is not false or misleading and does not claim ot to treat any of the
19 diseases specified in First Schedule of the Medicines Act (blind, cancer etc)
Y when it is not false or misleading and does not claim ot to treat any of the
19 diseases specified in First Schedule of the Medicines Act (blind, cancer etc)
CanbesoldasGSL, P or POM. O Depends classification found in Poisons Act GSL- specified in 2nd Schedule of Poison Act
P- specified in 1 schedule of Poisons Act POM-specified in 1st and 3rd schedule of Poisons Act. NOTE to refer to POMS with exemption PDF(criteriawhichPOMcanbesoldasP) and reclassified products PDF(POMcanbereclassifiedasGSLorPOMetc)
OverthecounterOverthecounterPharmacyonlyoverthecounteroverthecounteroverthecounteroverthecounter
ClinicaltrailregulatedunderHealthproductsact/Clinicaltrailauthorisation-clnicaltrailnotification(CTA-CTN)systemNAHealthproductsactbutnotregulatedbyHSANAMedicinesact/Clinicaltrailcertificate(CTC)systemMedicinesact/Clinicaltrailcertificate(CTC)systemMedicinesact/Clinicaltrailcertificate(CTC)systemMedicinesact/Clinicaltrailcertificate(CTC)system
ProductrecallClass1recall:criticaldefect - Cause life- threatening conditions - Report within 2 days (not including Sunday and PH) -
Complete recall in 1 week Class 2 recall: - Non-critical defect - Does not cause life- threatening conditions Report within 15 calendar days Complete recall in 3 weeks *notify HSA atleast24hoursb4startrecall
sameastherapeuticproductssameastherapeuticproductssameastherapeuticproductssameastherapeuticproductssameastherapeuticproductssameastherapeuticproductssameastherapeuticproducts
Adverse event reporting Recall: Adverse event is unexpected but may or may not be caused by drug.
Does not include prescribing, dispensing and administration errors. It is not the same as
adverse drug event → injury due to drug- related interventions such as prescribing errors,
dispensing errors and medication administration errors
Healthcare professional/ dealers: Fill in AE reporting form / Forms to be submitted to Vigilance Branch
under the post- market cluster of the Health Products Regulation Group in HSA.
sameastherapeuticproductsHealthcare professional/ dealers: Fill in AE reporting form Forms to be submitted to Vigilance Branch under the post- market cluster of the Health Products Regulation Group in HSA.sameastherapeuticproductssameastherapeuticproductssameastherapeuticproductssameastherapeuticproductssameastherapeuticproducts

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