Q1: What is the procedure to set up a retail pharmacy in Singapore?

The premises for conducting retail pharmacy business must be licensed by HSA. The retail pharmacy must be under the control and management of a qualified pharmacist registered with the Singapore Pharmacy Board. The pharmacy will be audited before a Certificate of Registration of Pharmacy is issued. Please note that the pharmacist must apply for a Form A Poisons Licence to conduct wholesale sales of medicinal products containing any scheduled poisons (include export sales and supply to medical clinics & ships) at a registered pharmacy. You may apply for the licence and certificate from “Audit And Licensing Of Pharmacies”.

Q2: Are the pharmacists required to record wholesale sale transaction of Pharmacy Only Medicines in the Form E records?

Yes, as required under the Poisons Act and Rules, the maintenance of a Form E record is required for the wholesale sale of any poison or medicinal product containing poison(s) regardless of whether the product is classified as a prescription or pharmacy-only medicine. Additionally, you should also note that under the Medicines Act, the maintenance of a Sales Record is required for the wholesale dealing of any medicinal product. You may combine the two records (i.e. Form E record and Sales Record) into one as long as the consolidated record contains all required information.

Q3: What are the correct disposal methods for medicinal products?

Please refer to the section on toxic waste control at the National Environment Agency (NEA) website for the requirements for the proper disposal method. However, you should note that product containing Controlled Drugs must be destroyed or disposed of in accordance, with provisions of the Misuse of Drugs Regulations, in addition to the requirements of NEA.

Q4: What are the professional reference books to be kept in a pharmacy?

References such as Martindale, BNF, MIMS, current government gazettes Medicines (General Sale List) Order, Medicines (Sale and Supply By Pharmacy) Notification, Medicines (Prescription Only) Order and the lists of currently registered medical and dental practitioners should be made available.

Q5: When do I need to renew the Certificate Of Registration Of A Pharmacy?

The Certificate Of Registration Of A Pharmacy is valid for 1 year. You should remember to submit a renewal application before the licence expires. You may submit the application 2 months before the expiry of your licence. If your licence is not renewed upon expiry, it would be considered lapsed and you would not be able to continue with the activities previously authorized by that licence. Lapsed licence would not be renewed and a new application would have to be made.

Q6: When do I need to file an amendment application?

Please refer to Guidelines On Amendment Application For A Certificate Of Registration Of A Pharmacy. For changes in company information, please submit amendment via “amend company information” in the PRISM online system.