Wednesday, 29 May 2013

Frequently asked questions regarding regulatory classification?


1. What is legal classification for medication in Singapore?
Legal classification or Regulatory classification is how Health Science Authority (HSA) categorize medicine in Singapore so that medications are supplied appropriately to the public.

High risk medications that require medical supervision by physician can only be supplied when a licensed doctor has written a valid prescription to treat a specific condition for a patient. These medications are known as POM (Prescription Only Medicine).

Without prescription, pharmacists can still assess and supply medications to treat minor ailments such as diarrhea, motion sickness, runny nose, nausea vomiting, pain killers etc. These medications are called P (Pharmacy Only Medicine). On top of that, pharmacists can supply certain medicines in restricted quantity and for specific duration (e.g. 2 week or 10 day depending on the medicine). These medications are called P+, POM (Pharmacy Only Medicine, 2nd Schedule)

The least restricted class of medication is G or GSL (General Sales List), which can be sold or supplied to the public without restriction. Customers can buy these medicines from supermarket, pharmacies even without doctors’ or pharmacists’ supervision.

2. How are medical devices classified in Singapore?
Refer to www.hsa.gov.sg for GN-13 on the risk classification system for medical devices. Medical devices are generally categorized from class A to class D, with Class A being the lowest Risk and Class D being the highest risk

3. Why must medicines be legally classified?
Unlike in some countries where antibiotics and other POM medications can be bought even without prescriptions, Singapore health system restricts supply of medication to ensure that patients are properly diagnosed and treated by trained medical professionals before they consume any medications. This prevents inappropriate use and abuse of medication.