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Information on the Regulations of Therapeutic Products under the Health Products Act




 

INFORMATION ON THE REGULATIONS OF THERAPEUTIC PRODUCTS UNDER THE HEALTH PRODUCTS ACT (FOR DOCTORS AND DENTISTS)

EXECUTIVE SUMMARY

  1. From 1 November 2016, pharmaceutical products will be regulated as “Therapeutic Products” (TP) under the Health Products Act (HPA), replacing existing controls under the Medicines Act (MA) and the Poisons Act (PA).
  2. Compounding of TP include repacking or relabelling of the TP, e.g. transferring the TP from its original container supplied by its manufacturer into another container before dispensing. New labelling requirements will apply to these compounded TP, i.e. (i) Name of TP and quantity of active ingredients (e.g. XYZ Tablet 500 mg), (ii) expiry date and (iii) batch number.
  3. Noting that time might be required to adjust clinic management systems to take in these new labelling requirements, HSA will allow a period of 6 months from 1 November 2016 to 30 April 2017 for practitioners to comply with the labelling requirements.
  4. Labelling requirements for dispensing of TP remain the same. As a good practice, the expiry dates should be available on the dispensed TP for patients’ information so that the TP is not used beyond this date.
  5. To facilitate prompt access to therapies fulfilling an unmet medical need, the import and supply of unregistered TP, commonly referred to as the ‘Named-patient exemption route’, will continue to be allowed. This special access route will be referred to as import and supply of TP ‘for patients’ use’ under the HPA.
  6. Advertisement controls of TP remain the same. Direct to consumer advertisements on Prescription only medicines (POM) will not be allowed and such materials should not be made available in publicly accessible areas e.g. patients’ waiting areas.
  7. General Sale List medicines (GSL), which currently can be purchased off the shelves and are deemed to be sufficiently safe to be used by public, will be allowed to be sold via vending machines.


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CONTACT HSA:
Should you have any enquiries on the Regulations of Therapeutic Products under the Health Products Act, please email us at HSA_TPPortOver@hsa.gov.sg.