Q1: What is the procedure to apply for a Good Distribution Practice Certificate?

On-line application can be submitted via PRISM. As part of the application, supporting documents such as store layout plan and Standard Operating Procedures (SOPs)/Records for GDP have to be submitted. The completeness of these documents and a satisfactory outcome of the site audit are pre-requisite for the approval of your application.

Q2: Do I need to apply for any other licences?

The certificate is issued under a voluntary scheme and do not confer any legal rights to operate a business. If you are dealing with Medicinal Products, Chinese Proprietary Medicines, Controlled Drugs or other category of products, the relevant licences are needed.

Q3: How do we prepare for the audit and how are audits conducted?

Please familiarize yourselves with the HSA Guidance Notes On Good Distribution Practice prior to the audit. We will contact you to arrange for a suitable audit date. Any deficiencies would have to be rectified and a re-audit may be conducted to verify your proposed corrective actions. Application will be considered lapsed if your company is not able to provide satisfactory response within 3 months from the date of application.

Q4: When do I need to renew my certificate?

The certificate is valid for 3 years and there is no renewal of an expired certificate. If you wish to continue with the GDP certification, please submit a new application for the GDP certificate.

Q5: When do I need to file an amendment application?

There is no amendment function for the certificate as the certificate reflects the observed situation during the time of audit. If there is a change of warehouse or operations and you are interested in having the new warehouse/operations certified, please apply for a new GDP certificate.