The following documents are required in your application for a licence for a new retail pharmacy:
- Pharmacy store layout plan, specifying the dispensing counter, general sales areas, area for storing Prescription-only medicines (POM) or Pharmacy-only medicines (P), and other ancillary areas.
- Valid Pharmacist Practising Certificate of the appointed pharmacist-in-charge (PIC). The PIC must be active in practice.
- Telepharmacy Declaration Form, signed and dated by the PIC for the provision of telepharmacy service for Pharmacy-only medicines (P), if applicable.
- Company's standard operating procedures and related recording forms for additional activities or services, if applicable. Additional activities or services can include compounding of non-sterile preparations in accordance with a patient’s valid prescription, telepharmacy service, medication delivery service and provision of e-pharmacy service* etc.
- Contractual agreement with contract acceptor for the outsourced activity (e.g. engaging 3rd party to deliver the medication) with clear roles and responsibilities between contract giver and contract acceptor.
- Validation documents of the computerised system to support e-pharmacy service, if applicable
*Refer to the Explanation Note on Application of a Pharmacy Licence and Guidance Notes on Supply of Registered Therapeutic Products through e-pharmacy service, for details on the considerations in the application of a retail pharmacy licence and the regulatory requirements for operating an e-pharmacy, respectively.
Fees and turn-around-time
Refer to therapeutic product fees and turn-around-time for more information.
Retail pharmacy audit
When your new application for a pharmacy licence is received, we will inform you on the audit date. We will audit for compliance with the current regulations such as Health Products (Licensing of Retail Pharmacies) Regulations 2016 and the Health Products (Therapeutic Products) Regulations 2016. Aspects covered during the audit may include, but are not limited to the following:
- Equipment used in the provision of pharmacy services.
- Facilities for storage, safekeeping and handling of therapeutic products.
- Professional references or resources, such as Martindale, British National Formulary etc.
- System for maintenance of records, procedures and other documentation relating to the supply of specified health products.
Licensing of new outlets in chain pharmacies
Licensed chain pharmacies that wish to operate a new retail pharmacy outlet may be eligible to apply for a pharmacy licence for the new outlet under the Simplified Registration Scheme.
Under this scheme, a pharmacy licence can be issued to the new outlet before an onsite audit is conducted, provided this new outlet adopts a similar pharmacy operation as the pharmacy chain's other licensed retail pharmacy outlets. However, a new outlet which intends to provide additional services or activities such as compounding, medication delivery services, telepharmacy services and supply through any special mode will not be eligible for this scheme.
How to apply
Submit your application through PRISM. Ensure you have the following before you access the e-service:
If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).