Retail Pharmacy Licensing - Singapore
In Singapore, running a retail pharmacy requires a license from the Health Sciences Authority (HSA). Here's a summary of the key points:
Who Needs a License?
Anyone who wants to supply certain health products at their retail pharmacy needs a license. This includes:
Prescription-only medicines (POM)
Pharmacy-only medicines (P)
Oral Dental Gums
Who Can Be In Charge?
The licensed pharmacy must be under the control and supervision of a designated pharmacist-in-charge (PIC) who meets these criteria:
Registered pharmacist with the Singapore Pharmacy Council
Holds a valid practicing certificate
Is actively practicing
License Application Process
You can find details and apply for a license on the Health Sciences Authority website. The website also includes information on:
Necessary documents and fees
Renewing or canceling a license
Amending an existing license
Apply for a License
Here's how to access details and apply for a retail pharmacy license in Singapore:
Applying Through HSA Website:
The Health Sciences Authority (HSA) offers an online portal called PRISM (Permit & Regulatory System for Medicines) for submitting license applications.
Before accessing PRISM, you'll need:
A CRIS (Company Registration Information System) company account. (https://www.acra.gov.sg/)
A Corppass or HSA PIN (Personal Identification Number). (https://www.corppass.gov.sg/)
Required Documents:
Along with the application form, you'll need to submit various documents like:
Pharmacy store layout plan specifying:
Dispensing counter
General sales areas
Storage area for Prescription-only medicines (POM) or Pharmacy-only medicines (P)
Other relevant areas
Valid Pharmacist Practising Certificate of the appointed pharmacist-in-charge (PIC). (PIC must be actively practicing)
Telepharmacy Declaration Form (if applicable) - signed by the PIC for providing telepharmacy services for Pharmacy-only medicines (P)
License Application Process:
Visit the HSA webpage on applying for a retail pharmacy license: [HSA retail pharmacy licence]
Ensure you have the required CRIS account and Corppass/HSA PIN.
Access PRISM and complete the online application form.
Attach the necessary documents electronically.
Submit the application and pay the associated fees.
Key Regulations
The Health Products (Licensing of Retail Pharmacies) Regulations 2016 govern retail pharmacy licensing. Here are some highlights:
The HSA may inspect the pharmacy before and after granting a license.
The HSA can conduct routine inspections to ensure compliance.
There are penalties for not following the regulations.
For more comprehensive information, refer to the resources provided by the Health Sciences Authority.
Fees
The current fees (as of June 16, 2024) for retail pharmacy licensing in Singapore are outlined on the Health Sciences Authority (HSA) website:
Application fee for, or renewal of, a pharmacy licence: $560
There are additional fees depending on the situation:
Application for the Authority's approval under Regulation 3(1)(b)(ii) or 4(1)(b) in respect of a retail pharmacy if made on a separate occasion from an application for a pharmacy licence in respect of that same retail pharmacy: $330 (This applies for special modes of supplying pharmacy-only medicines, like telepharmacy services)
Amending retail pharmacy licence:
With site inspection: $330 pen_spark
Without site inspection: $57
Important Note:
These fees are subject to change, so it's always best to confirm the latest charges on the HSA website: https://www.hsa.gov.sg/announcements/regulatory-updates/fee-revision2022 (Look for "Retail Pharmacy Licence" under "Therapeutic Products").
Additional Costs:
While not directly related to licensing fees, remember there might be other costs involved in setting up a retail pharmacy, such as:
Business registration fees
Rental costs for the pharmacy space
Renovations to meet pharmacy layout requirements
Sources
Additional Resources:
The HSA website offers comprehensive information on Retail Pharmacy Licensing, including:
Regulations and requirements: https://www.hsa.gov.sg/therapeutic-products/retail-pharmacy-licence
Renewing or canceling a license: https://www.hsa.gov.sg/therapeutic-products/retail-pharmacy-licence
Amending an existing license: Contact HSA for details.
For a more comprehensive understanding of the financial aspects of opening a retail pharmacy, it's recommended to consult with a business advisor or accountant.
How Bestar can Help
Bestar can assist with retail pharmacy licensing in Singapore. Here is how:
General Business Consulting:
Bestar is a general business consulting firm that offers guidance on starting a business in Singapore, which includes navigating the initial steps of setting up a retail pharmacy.
Focus on Different Areas:
Bestar specializes in areas that are helpful for obtaining a license, such as:
Business registration
Lease negotiations for your pharmacy location
General business plan development
Involvement in Licensing:
Bestar handles the entire licensing process for applications. We are able to provide guidance on the licensing process.
Search for Bestar's website or online presence to see our specific services related to retail pharmacy licensing in Singapore. Contact Bestar and inquire about our services related to retail pharmacy licensing.
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