Audit and Licensing Of Retail Pharmacies
Under the Health Products (Licensing of Retail Pharmacies) Regulations 2016 , a retail pharmacy must be licensed by the Health Sciences Authority (HSA) for retail supply of specified health products listed in First Schedule in this regulations.
Specified Health Products refers to:
- Therapeutic Products (TP) except General Sales List Medicines
- Oral Dental Gums
The licensed retail pharmacy must be under the control and management of a qualified pharmacist registered with the Singapore Pharmacy Council, who holds a valid practising certificate and is in active practice.
The issuance of a Retail Pharmacy Licence would be considered when the retail pharmacy has been audited by HSA. HSA will inspect the retail pharmacy for compliance with the following requirements including:
- equipment used in pharmacy services
- facilities for storage, safekeeping and handling of Therapeutic Products
- professional reference/resources (e.g. Martindale, British National Formulary etc.)
- system for maintenance of records, procedures and other documentation relating to the supply of specified health products
Chain pharmacies (i.e. with several licensed retail pharmacies) who wish to register a new retail pharmacy may be eligible to apply for a new application for Retail Pharmacy Licence under the Simplified Registration Scheme. Under this scheme, a Retail Pharmacy Licence can be issued before an onsite audit is conducted if this new retail pharmacy adopts similar pharmacy operation as the other licensed retail pharmacies. However, a new retail pharmacy intending to provide additional services/activities (e.g. telepharmacy and compounding services etc.) will not be eligible for this Simplified Registration Scheme.
Under Regulation 49 of the Health Products (Therapeutic Products) Regulations 2016, the retail pharmacy licence holder may supply TP by wholesale in the following instances without a TP Wholesaler’s Licence, provided these wholesale activities of TP are confined to the following:
1. supply to a licensed healthcare institution;
2. supply for use on a ship or an aircraft in accordance with the requirements
a. under the Merchant Shipping (Medical Stores) Regulations (Cap.179, Rg 3),
the Merchant Shipping(Maritime Labour Convention)(Medicines and Medical Equipment)
Regulations 2014 (G.N. No. S181/2014) for the treatment of persons on board the ship; or
b. under the Air Navigation Order (Cap. 6, O 2) for the treatment of persons on board the aircraft;
3. supply for the purpose of scientific education or research and development, or for a non‑clinical purpose;
4. supply to a Government department or statutory board for the provision of public services;
5. supply between licensed retail pharmacy outlets under the same management chain; or
6. supply of registered therapeutic products to companies outside Singapore for the purpose of any business or trade carried out by those companies.
Oral Dental Gums
In the Health Products (Oral Dental Gums) Regulations, 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. Please click here to apply for Importer’s and/or Wholesaler’s Licence for ODG.
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 is subject to conditions as specified in Regulation 15 of the Health Products (Therapeutic Products) Regulations 2016.
Please refer to the GUIDE-MQA-029, Guidance Notes on Supply of Registered General Sale List (GSL) Therapeutic Products and Other Medicinal Products via Automatic Vending Machines for further 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.
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.
Form A Poisons Licence (FAPL)
Form A Poisons Licence (FAPL) is not required for dealing in TP. However, the FAPL will remain applicable to other products containing poisons such as Active Pharmaceutical Ingredients, laboratory reagents and veterinary products etc.
Target Processing Timelines
Issuance of new Retail Pharmacy Licence– 10 working days from date of audit close out (excluding any stop-clock time incurred by the applicant)