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Licensing and Certification of Importers and Wholesalers

  1. Good Distribution Practice Certification

Good Distribution Practice Certification

Find out what types of certification we offer for local importers and wholesalers.

Overview

Good Distribution Practice (GDP) certification is a voluntary scheme offered to local dealers of therapeutic products interested to be certified for conformity with relevant GDP standards by us. Interested parties may include third party logistics companies etc.

Good Distribution Practice audits

When your application is received, we will review your application to assess audit readiness before arranging for a GDP audit. A GDP certificate is issued when your company's quality system has been audited and found to comply with our Guidance Notes on Good Distribution Practice263 KB, and is valid for 3 years from the date of audit.

The certificate cannot be renewed or re-issued. Upon expiry, you will need to submit a new application if you are still interested in re-certification. GDP audits will apply.

Documents required

You will need the following items to complete the form:

  • 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.
  • Good Distribution Practice Standard Operating Procedures.
  • Good Distribution Practice records or recording templates.
  • Site Master File (Refer to Guidance Notes on Preparation of a Site Master File for Good Distribution Practice Certification218 KB).
  • Other supporting documents, if any.

Fees and turnaround time

Refer to active ingredient licence and certificate fees and turnaround time for more information.

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).

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