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. Curriculum Vitae (CV) of Responsible Persons.
3. Good Distribution Practice-related Standard Operating Procedures and forms [required only for importer’s licence (full scope) and wholesaler’s licence applications]. 

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 Inspections

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 inspection. Upon acceptance of your application, we will contact your company to arrange for a pre-approval inspection within 3 months. A manufacturer's licence will be approved and issued 10 working days from the date of inspection 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 inspections will be conducted to assess your company's continued compliance. The frequency of the routine GMP inspections will depend on risk factors like the activities conducted by your company, and your level of compliance with the regulatory requirements. Unannounced GMP inspections may also be conducted.