Regulatory Guidelines and Standards
Importer's Licence (IL) and Wholesaler's Licence (WL) for Therapeutic Products (TP)
Under the Health Products Act, the activity-based licensing framework requires companies to hold the relevant licences if they are involved in the import and/or wholesale of TP in Singapore.
The following points highlight the licensing requirements for companies involved in the respective activities:
- IL and/or WL will be required for companies with product registration (‘Product Registrants’) if they are importing and/or wholesaling their own registered TP. Companies will be subject to GDP compliance before they can be granted these licences. However if the company outsources the import and wholesale activity including invoicing, IL, WL as well as GDP compliance are not required.
- IL and WL will be required for companies importing and/or wholesaling unregistered TP for patients’ use only. Companies will be subjected to GDP compliance. Consignment approval from Therapeutic Products Branch of Health Sciences Authority is required.
- IL will be required for companies conducting the following restricted activities. Consignment notification to Therapeutic Products Branch of Health Sciences Authority is no longer required for these restricted activities:
o Importing TP for supply to ships/aircraft leaving Singapore
o Importing TP solely for export only
o Importing TP for non-clinical use
Companies can choose to apply for term (annual) or consignment (one-time only) licences according to their operational needs.
Companies should ensure the above activities are included into their licences if they are involved in conducting these activities.
Companies applying for new TPIL and/or TPWL for the import and wholesale of TP for patients’ use, or import of TP for restricted activities will be given a fee waiver for a period of 3 years, from 1 November 2016 – 31 October 2019.
Bundled Application Fee
Companies involved in both import and wholesale of TP can consider bundling the applications for both TPIL and TPWL so that a lower bundled application fee can be applied. This is not applicable if the company’s IL is for restricted activity only.
Requirement to Appoint a ‘Responsible Person’
Therapeutic Products IL and WL holders (the ‘licensee’) will be required to name at least one Responsible Person (RP) in their respective IL and WL. The RP is a person employed and appointed by the licensee to implement and maintain an effective quality system that meets Good Distribution Practice (GDP) standard. Details on the duties and responsibilities of the RP are found in Regulation 39 of the Health Products (Therapeutic Products) Regulations 2016 (the ‘TP Regulations’).
For companies dealing in pharmacy-only medicines (P-only), prescription-only medicines (POM) for local supply and/or unregistered TP for patients’ use, the RP named in the IL and/or WL must be a registered pharmacist. For more information, please refer to the Guidance Notes on Duties of Responsible Persons Named In The Importer’s Licence and Wholesaler’s Licence.
Import and/or wholesale of health products by licensed manufacturer without Importer’s Licence and/or Wholesaler’s Licence
A holder of a Manufacturer’s Licence for Therapeutic Products may import any health product without holding an Importer’s Licence, if the health product is required for the purpose of carrying out the manufacture of a therapeutic product in accordance with the conditions of the Manufacturer’s Licence.
The holder of a Manufacturer’s Licence may also supply by wholesale any therapeutic product manufactured by the holder under the Manufacturer’s Licence without holding a Wholesaler’s Licence. The holder of the Manufacturer Licence must provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the distribution of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the holder’s ownership, possession or control.
Therapeutic Products (TP) prescribed for veterinary use
HSA-licensed retail pharmacies and wholesalers may continue to supply TP for animal use based on valid veterinary prescriptions and signed (purchase) orders from Agri-Food & Veterinary Authority (AVA)-licensed veterinarians, veterinary clinics, feedmills, farms and AVA-registered wholesalers which are supplying TP solely for veterinary use.
For any enquiry or feedback relating to veterinary products, please contact AVA at email: AVA_Import&Export_Animals@ava.gov.sg or Tel: 6805 2991.
Good Distribution Practice Standard
Good Distribution Practice (GDP) is a quality system which ensures that products are stored and handled consistently under appropriate conditions as required by the marketing authorization or product specification so that the quality of the products will be maintained during storage, transportation and distribution.
Importers and wholesalers of TP are required to comply with HSA's GDP requirements to ensure that products are handled, stored and distributed in a proper manner to assure their quality and integrity throughout the supply chain. The HSA's auditors will audit the company in accordance with the HSA Guidance Notes On Good Distribution Practice.
REVISION OF GUIDANCE NOTES ON GOOD DISTRIBUTION PRACTICE
The Health Sciences Authority (HSA) reviews and revises the Guidance Notes on Good Distribution Practice as needed to provide clarity to the existing requirements.
For easy reference, the latest version of Guidance Notes with track changes is available at the following hyperlink:
If further clarification(s) is/are required on the revised Guidance Notes on Good Distribution Practice, please write to us here or contact us at Tel: 6866 1111.