From 13 September 2016, Audit & Licensing Division has now relocated to 11 Biopolis Way #11-01 Helios Singapore 138667.
The Audit & Licensing Division (ALD) comprises the Audits Branch (AB) and Licensing & Certification Branch (LCB). The main function of the ALD is to audit and license pharmaceutical manufacturers and importers/wholesalers of Health Products in accordance with current international Good Manufacturing Practice (GMP) and the relevant Good Distribution Practice (GDP) standards respectively.
This is to ensure the manufacture of good quality medicines and the preservation of product quality throughout the supply chain from manufacturers to distributors and retail pharmacies.
Health Products (Therapeutic Products) Regulations 2016
As part of HSA’s ongoing initiative to update and streamline the regulatory controls for health products, pharmaceutical products, commonly referred to as chemical and biologic drugs, has been introduced as “therapeutic products” under the Health Products Act (HPA) on 15 July 2016.
The regulatory controls of the HPA on TP, including changes to the licensing framework take effect from 1 November 2016.
HOW WILL THIS IMPLEMENTATION AFFECT YOUR COMPANY?
Importer's Licence (IL) and Wholesaler's Licence (WL) for Therapeutic Products (TP)
Under the Health Products Act, the activity-based licensing framework will require your company to hold the relevant licences if you are involved in the import and/or wholesale of TP in Singapore.
The following points highlight new licensing requirements for companies involved in the respective activities:
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.
To apply for Therapeutic Products Importer’s Licence and/or Wholesaler’s Licence, click Applications @ e-Services.
Form A Poisons Licence
Form A Poisons Licence (FAPL) is not required for dealings in TP. However, the Poisons Act remains applicable to other products containing poisons such as Active Pharmaceutical Ingredients (API), laboratory reagents and veterinary products.
FAPL is not required for licensed manufacturers of TP for the import of substance containing poisons (i.e. API or reagents) for use in manufacture of their own TP, including QC testing pertaining to the manufacture of TP.
Retail sale of General Sale List (GSL) by Vending Machine
The use of vending machines as an alternative supply channel for General Sale List (GSL) therapeutic products will be allowed, subject to conditions as specified in regulation 15 of the Health Products (Therapeutic Products) Regulations 2016.
Please refer to the GUIDE-29, Guidance Notes on Supply of Registered General Sale List (GSL) Therapeutic Products and Other Medicinal Products Via Automatic Vending Machines for futher details.
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.
*The “List of Registered Wholesalers of Therapeutic Products for Veterinary Purposes” can be located by selecting “Circulars” and “Pets & Animals” under the search function in the AVA newsroom webpage.
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.
Compounding of Therapeutic Products at Hospitals and Medical Clinics
A component of pharmaceutical services typically includes compounding of therapeutic products under the supervision of a qualified pharmacist and/or qualified practitioner and with the written instructions of a qualified practitioner if compounding prescription TPs. Compounded therapeutic products serve an important role for patients whose clinical needs cannot be met by currently approved therapeutic products. Compounding and distribution practices in a hospital or medical clinic may vary. For example, some hospital pharmacies compound only for use in the hospital in which the pharmacy is located, while others may compound and supply to other facilities within the national healthcare system (i.e., to other hospitals, medical clinics or nursing homes).
Transfer of compounded therapeutic products within the national healthcare system
A hospital pharmacy or medical clinic may compound and transfer therapeutic products compounded at a hospital or a medical clinic to another hospital or medical clinic without holding a wholesaler’s licence. In the case of a medical clinic, prior approval from HSA must be obtained before the medical clinic can transfer compounded therapeutic products to other institutions within the national healthcare system.
A medical clinic that intends to transfer therapeutic products that they have compounded to other institutions may write in to the Audit & Licensing Division of HSA at HSA_GMP@hsa.gov.sg, with the following information:
Please note that additional information and documents may be requested where necessary to provide a complete understanding of the compounding practice.
Note: Compounded products can serve an important need in the healthcare setting. However, these products have not undergone HSA pre-market review for safety, efficacy and quality. The oversight and regulation of the practice of pharmaceutical services (including compounding) in a hospital or medical clinic remains largely under the Private Hospitals and Medical Clinics (PHMC) Act, its regulations and the Singapore Pharmacy Council, a statutory board under the Ministry of Health.
HEALTH PRODUCTS (LICENSING OF RETAIL PHARMACIES) REGULATIONS 2016
A pharmacy must be licensed by Health Sciences Authority (HSA) for retail supply of specified health products listed in First Schedule in this regulations.
Specified Health Products refers to:
Oral Dental Gums (ODG)
The supply of ODG from a licensed retail pharmacy by a qualified pharmacist remains unchanged. There is no impact on the retail operation for the supply of ODG.
Companies importing and wholesaling ODG need to continue to hold the Importer’s Licence and/or Wholesaler’s Licence for ODG under the Health Products (Oral Dental Gums) Regulations.
Have a Question?
If you have enquiries on TPIL, TPWL and Pharmacy Licence, please contact HSA at: