Importer and wholesaler's licence
You need to submit the following documents in English:
- Current layout plan for the premises, specifying the storage areas.
- Pharmacist Practising Certificate, if the Responsible Person is a registered pharmacist.
- Authorisation letter from the product registrant, if your products are not registered under your company (only applicable for importer's licence application).
- List of products to wholesale (only applicable for wholesaler's licence application).
- Good Distribution Practice (GDP) standard operating procedures.
- GDP records or recording templates.
- Store approval letter.
- Other supporting documents, if applicable.
Good Distribution Practice audits
Compliance with the Good Distribution Practice (GDP) standard is mandatory for all importers and wholesalers of therapeutic products.
When your licence application is received, we will inform you of the date for a GDP audit of your premises, unless your company is only conducting the following restricted activities:
- Importing therapeutic products for supply or ships or aircraft leaving Singapore.
- Importing therapeutic products solely for export only.
- Importing therapeutic products for non-clinical use.
The licence will only be approved and issued 10 working days from the date of audit close out if your company is found to have complied with the required GDP standard.
After licence approval, regular routine audits will be conducted to assess your company's continued compliance. The frequency of the routine audits will depend on risk factors like the activities conducted by your company, and your level of compliance with the regulatory requirements. Unannounced audits may also be conducted.
While your company may only be conducting restricted activities and thus not subjected to routine GDP audits, you are still expected to comply with the legal obligations and duties of maintaining records of receipt and supply or use. Such records must be made available to us when requested.
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).