Regulations and Requirements for Therapeutic Products in Singapore
Classified in Medicine & Health
Written at on 
English with a size of 23.96 KB.
| Therapeutic products | Cometic products(2type)ivd+general | Medical devices | oral dental gums | Chinese proprietary medicine | traditional Medicine | Quasimedicinal products | medicated oil and balms | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Examples | Paracetemol,antibiotics,bloodpressure medication | makeup,thoothpaste,cleanser, bodysoap(+medicatedsoap) ,shampoo(+antidandruff),anti-achne prep | generalmedicaldevice(thermometer/Bpmeter/contactlens/condoms) IVD(Bloodglucosemeter.Pregnancykit).Massagers,bodytoning.Magnet. accessoriesnotmedicaldeviceastheyarenotforpreventingdiagnosingcuringoralleviatingdiseaseorhaveanymedicalpurpose | Xylitol/orbit.Dentalgums | lingzhitablets.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 off | Healthproducts | Healthproducts | Healthproducts | Healthproducts | medicinal product | medicinal product | medicinal product | medicinal product | ||
| mainlyregulatedunder(referforlicenseact) | Healthproductsact | Healthproductsact | Healthproductsact | Healthproductsact | medicineact | medicineact | medicineact | medicineact | ||
| needtoregisterprodyctwithHSAbeforeit canbesoldinSg(premarketingapproval) | YcanbefoundonHSAonlineinfosearchforTherapeuticproducts | N | Y/exceptnonsterileclassAgeneralmedicaldevice) foundinHSAsingaporemedicaldeviceregister(SMDR) | Y | N | N | N | N | ||
| needmanufacturerlicese(tomakeproductinSG) | Y | N | Y | Y | Y | N | N | N | ||
| needlicensetoimport(bringintoSG) | Y(Importerlicense) | N | Y(Importerlicense) | Y | Y(IMPORTlicense) | N | N | N | ||
| needlicencetosellviawholesaleinSG | Y(wholesalerlicense) | N | Y(wholesalerlicense) | Y | Y(wholesalerDEALERlicense) | N | N | N | ||
| needresponsiblepersonformanufacture's,licence,importer's | Y(RPformanufacturerlicence;donotneedtobeapharmacis;mustbesomeonewith experienceinmanufacturingRPforimporterlicenseandwholesalerlicensepreferablyapharmacist | N | N | N | N | N | N | N | ||
| QualityRegulatedby | HealthProductAct/SaleofDrugAct | HealthProductAct | HealthProductAct | HealthProductAct | medicineact | medicineact | medicineact | medicineact | ||
| Advertismentregulatedby | Healthproductact | HealthProductAct | HealthProductAct | HealthProductAct | medicineact/medicineadvertismentandsaleact | medicineact/medicineadvertismentandsaleact | medicineact/medicineadvertismentandsaleact | medicineact/medicineadvertismentandsaleact | ||
| NeedtogetpermitfromHSAforAdvertisment | N |
| N | N | Y | Y | Y | Y | ||
| 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) | Y | Y | Not 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) | ||
| Canbesoldas | GSL, 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) | Overthecounter | Overthecounter | Pharmacyonly | overthecounter | overthecounter | overthecounter | overthecounter | ||
| Clinicaltrailregulatedunder | Healthproductsact/Clinicaltrailauthorisation-clnicaltrailnotification(CTA-CTN)system | NA | HealthproductsactbutnotregulatedbyHSA | NA | Medicinesact/Clinicaltrailcertificate(CTC)system | Medicinesact/Clinicaltrailcertificate(CTC)system | Medicinesact/Clinicaltrailcertificate(CTC)system | Medicinesact/Clinicaltrailcertificate(CTC)system | ||
| Productrecall | Class1recall: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 | sameastherapeuticproducts | sameastherapeuticproducts | sameastherapeuticproducts | sameastherapeuticproducts | sameastherapeuticproducts | sameastherapeuticproducts | sameastherapeuticproducts | ||
| 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. | sameastherapeuticproducts | 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. | sameastherapeuticproducts | sameastherapeuticproducts | sameastherapeuticproducts | sameastherapeuticproducts | sameastherapeuticproducts | ||