You need to submit the following documents in English:
- Current layout plan for the premises, specifying the storage areas. The layout floor plan will need to have the following information:
(i)The full address of the warehouse
(ii) The dimensions (length and width) of the warehouse
(iii) Indication of various storage areas, e.g. receiving bay, quarantined product area, released product area, rejected product area, returned product area, recalled product area, outgoing staging area, etc.
- Pharmacist Practising Certificate, if the Responsible Person is a registered pharmacist.
- List of active ingredient(s) handled by the company.
- Material Safety Data Sheet or Safety Data Sheet of the active ingredient(s) handled by the company, if available.
- Good Distribution Practice (GDP) standard operating procedures.
- GDP records or recording templates.
- Store approval letter.
- Contract with contract acceptor for outsourced activity which clearly establishes the roles and responsibilities of each party, if applicable.
- 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 active ingredients used for manufacturing of relevant health products for local clinical use.
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 active ingredients solely for export only.
- Importing active ingredients for manufacturing relevant health product(s) for non-clinical purposes.
Importing active ingredients for purposes other than for the manufacture of relevant health products (e.g., for research, reference standards, etc.).
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).