Importer's and wholesaler's licence

Application submission

Documents required

You need to submit the following documents in English:

1. Layout plan for the premises, specifying the storage areas.
2. Authorisation letter from the product registrant if your products are not registered under your company (only applicable for importer's licence application).

Good Distribution Practice audits

Compliance with the Good Distribution Practice (GDP) standard is a pre-requisite for the importer’s licence (full scope) and wholesaler’s licence.

When your licence application is received, we will contact your company to arrange for a pre-approval audit. The licence will only be approved and issued 10 working days from the date of audit close-out if your company is determined to have complied with the required GDP standard.

After licence approval, regular routine GDP audits will be conducted to assess your company's continued compliance. The frequency of the routine GDP audits will depend on risk factors like the activities conducted by your company, and your company's level of compliance with the regulatory requirements. Unannounced GDP audits may also be conducted.

Manufacturer's licence

Good Manufacturing Practice audits

Compliance to the HSA Guidelines on Good Manufacturing Practice (GMP) for CTGTP is mandatory for a manufacturer of a CTGTP, including those conducting secondary packaging.

Before submission of your application, your company should ensure that it is ready for the audit. Upon acceptance of your application, we will contact your company to arrange for a pre-approval audit within 3 months. A manufacturer's licence will be approved and issued 10 working days from the date of audit close-out.

Your company's Site Master File (SMF) should be prepared in accordance with the Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF) available from the PIC/S Publication website.

After licence approval, regular routine GMP audits will be conducted to assess your company's continued compliance. The frequency of the routine GMP audits will depend on risk factors like the activities conducted by your company, and your level of compliance with the regulatory requirements. Unannounced GMP audits may also be conducted.