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This application is a service of the Singapore Government.

Health Sciences Authority

Key Changes to Regulatory Controls (HPA)

TRANSFER OF LEGISLATIVE CONTROL FOR PHARMACEUTICAL PRODUCTS FROM MEDICINES ACT AND POISONS ACT TO THE HEALTH PRODUCTS ACT

Item Description of changes
Western Medicines

Renamed as Therapeutic Products

Product Licence

  • The requirement for a Product Licence under Section 5(1) of the Medicines Act is replaced by Product Registration under Section 15(1) of the Health Products Act
  • The Register of Therapeutic Products is published on HSA website.
  • There is no change to the product registration process. Nonetheless, there are administrative changes to the PRISM application form, as below:
    • Existing product registration records have been updated to indicate “cold chain” or “non-cold chain” for each container closure system (CCS) in the PRISM form, based on the current approved storage condition of the registered product.
    • The PRISM application form for new drug application has been amended to allow the option for auto-inclusion of product registration into Importer’s Licence held by the same applicant company. This is not applicable to variation applications, and new drug applications that were submitted prior to the implementation date.
  • Product Registrants are required to hold an Importer’s Licence (IL) and/or Wholesalers’ Licence (WL) if they intend to import and/or wholesale their own registered TP.

    The Guidance on Therapeutic Product Registration will be available soon.

    Click here for more information on IL/WL.

Licence Renewal

  • Each therapeutic product on the register has a retention fee due date.
  • For products which have obtained a Product Licence under the Medicines Act, the retention fee due date corresponds to the date of expiry of the Product Licence.
  • For new Product Registrations, the retention fee due date will be on each anniversary of the date of registration of the therapeutic product. 
  • All registered therapeutic products will remain on the Register, unless:
    • The registration is suspended or cancelled by HSA, or
    • The registration is cancelled by the registrant, or
    • The registrant has failed to make a payment for an annual retention fee within 60 calendar days after the retention fee due date.

    Please refer to the Guidance for Retention of Therapeutic Product on the Product Register for more information.

Online Infosearch

Renamed as Infosearch - Register of Therapeutic Products

Import for Re-export

  • Companies are no longer required to submit notification for each consignment imported for re-exporting purpose. 
  • Companies with existing Import for Re-export notifications (with outstanding export clearance) will not need to submit any export clearance notification after the implementation date.
  • Companies without an existing IL are required to apply for an Importer’s Licence for Restricted Activities prior to carrying out the import and export activity after the implementation date.

    Click here for more information on IL/WL.

Import and Supply of Unregistered TP for Patients' Use

  • Companies importing unregistered therapeutic products on behalf of healthcare institutions for patients’ use are required to hold a valid IL and WL, in addition to obtaining approval for the specific consignment.

    Click here for more information on IL/WL.

  • Healthcare institutions are not subject to the IL for importing an unregistered therapeutic product for patients’ use. However, consignment approval is required prior to importation.
  • Healthcare institutions are not required to seek prior approval from HSA for the transfer of stocks imported under “Unregistered TP for Patients’ Use” between healthcare institutions

Import and Supply of Registered Therapeutic Product on Consignment Basis

Companies importing a registered therapeutic product on consignment basis for local supply (i.e. parallel import) are required to hold a valid IL and WL, in addition to obtaining approval for the specific consignment.

Please refer to the Guidance for Application to Import a Therapeutic Product on Consignment Basis.

Other importation for non-clinical use,and import for supply to vessels and aircraft

Companies without an existing IL are required to apply for an Importer’s Licence for Restricted Activities prior to carrying out the import activity.

Click here for more information on IL/WL.