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This application is a service of the Singapore Government.

Health Sciences Authority

Introduction

Good Manufacturing Practice & Licensing of Premises

The Good Manufacturing Practice Unit was formed in April 1997 within the National Pharmaceutical Administration (NPA) of the Ministry of Health to centralise the inspection of manufacturers of medicinal and cosmetic products under one specialised unit.

images.Par.71497.ImagePharmaceutical manufacturing in Singapore: The Unit is actively assisting local manufacturers to upgrade their operations, to attain internationally-recognised GMP standards.

The Unit has been referred to as the GMP and Licensing Unit, when its scope of work expanded considerably to include the licensing of pharmacies, dealers of therapeutic products, Chinese Proprietary Medicines (CPM), the regulating of psychotropic substances and narcotic drugs in accordance with international drug conventions, and the granting of the Certificate of a Pharmaceutical Product under the World Health Organisation (WHO) Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.

With effect from April 2001, Good Manufacturing Practice and Licensing Unit has been upgraded to become the Division of Manufacturing and Quality Audit (MQA) and subsequently in August 2008, the MQA Division had expanded with a GMP Audit Branch, Certification Unit and Good Distribution Practice Audit Unit. The GMP Audit Branch was further divided into Pharmaceuticals Audit Unit, Biologics & Cell and Tissue Therapy Audit Unit, Natural Health Products Audit Unit and Overseas Audit Unit. 

In 2010, MQA has been renamed as Audit & Licensing Division (ALD) and comprises of Audit Branch (AB) and Licensing & Certification Branch (LCB). AB comprises of GMP Unit, GDP Unit and Overseas Audit Unit.

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