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This application is a service of the Singapore Government.

Health Sciences Authority

Introduction

 

Audit & Licensing Division - GMP and GDP Audit

The principal function of the ALD is to audit and license pharmaceutical manufacturers and importers/wholesale dealers of Health Products in accordance with current international Good Manufacturing Practice (GMP) and the relevant Good Distribution Practice (GDP) standard respectively.

The objective of audit and licensing activities is to ensure the production of good quality health products and the preservation of product quality down the supply chain from the manufacturers to the distributors and pharmacies.

Licences & Certificates

The types of licences and certificates under the purview of Audit & Licensing Division include:

  • Manufacturer's Licence
  • Wholesaler's Licence
  • Importer's Licence
  • Controlled Drug Licences – Import, Export, Wholesale, Manufacture
  • Import Authorisation for Psychotropic Substances
  • Approval to Import Therapeutic Products Containing Psychotropic Substances
  • Export Licence for Psychotropic Substances
  • Approval to Export Therapeutic Products Containing Psychotropic Substances
  • Restricted Substance Import Authorisation
  • Certificate of Approval for Import of a Therapeutic Product
  • Retail Pharmacy Licence
  • Certificate Of A Pharmaceutical Product and Free Sale Certificate
  • Statement Of Licensing Status
  • GMP Certificate
  • GDP Certificate
  • Form A Poisons Licence