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Frequently Asked Questions

Health Products Regulation

Manufacturing, Importation & Distribution > Certification Of Manufacturers and Dealers

1.
What is the Good Distribution Practice (GDP) Certificate?

The Good Distribution Practice (GDP) Certificate issued by HSA is a certificate relating to the storage and distribution of Therapeutic Products, Chinese Proprietary Medicines and/or Active Pharmaceutical Ingredients, attesting to its conformity with GDP requirements. The GDP Certificate is issued when the company’s quality system and premises have been assessed and found to comply with the requirements prescribed in the HSA Guidance Notes on Good Distribution Practice. This is a voluntary certification scheme.

2.
What is the difference between GDP Certification, and Importer’s Licence and/or Wholesaler’s Licence?

Both the Importer’s Licence and Wholesaler’s Licence are mandatory licences which allow licensees to import and/or supply by wholesale Therapeutic Products. Similarly, the Import Licence and Wholesale Dealer’s Licence are mandatory licences which allow licensees to import and/or supply by wholesale Chinese Proprietary Medicines. Prior to the issuance of these licences, applicants must demonstrate compliance with GDP requirements as prescribed in the HSA Guidance Notes on Good Distribution Practice.

On the other hand, the GDP Certificate is a voluntary certification scheme. Companies that are involved in the storage and handling of Therapeutic Products, Chinese Proprietary Medicines and/or Active Pharmaceutical Ingredients on their clients’ behalf (i.e. logistic service providers etc.) may apply for the GDP Certificate as an attestation of compliance with GDP requirements. Prior to the issuance of the certificate, applicants must demonstrate compliance with GDP requirements as prescribed in the HSA Guidance Notes on Good Distribution Practice.

3.
What is the procedure to apply for a Good Distribution Practice (GDP) Certificate?

The application for voluntary GDP certification can be submitted online via ‘Apply for Good Distribution Practice Certificate’ module under apply@prism on the PRISM e-Services webpage. As part of the application, supporting documents such as the warehouse layout plan, Site Master File (SMF) and Standard Operating Procedures (SOPs)/Records/Forms that serve to demonstrate compliance with the requirements described in current HSA Guidance Notes on Good Distribution Practice should be submitted. You may wish to refer to the HSA Guidance Notes on Preparation of a Site Master File for Good Distribution Practice Certificate for the requirements on the preparation of a Site Master File (SMF).

If the outcome of the audit is satisfactory, the GDP certificate will be issued within 10 working days from the date of close-out of the audit (excluding any stop-clock time incurred by the applicant).

4.
When applying for the Good Distribution Practice (GDP) Certificate, do I need to apply for any other licences?

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

5.
For GDP certification, how do we prepare for the audit and how are audits conducted?

During the audit, your company’s quality system and premises would be assessed for compliance with the GDP requirements. As such, you are advised to be familiar with the HSA Guidance Notes on Good Distribution Practice and ensure that the premises and quality system (Standard Operating Procedures, Records, Forms, etc.) are available for the audit.

Upon receiving the application via PRISM, an officer will contact you to arrange for a suitable date for the audit. All deficiencies raised during the audit would have to be satisfactorily addressed and a follow-up audit may be conducted to verify your proposed corrective actions. If the outcome of the audit is satisfactory, the approval of the GDP Certificate will be granted within 10 working days from the date of close-out of the audit (excluding any stop-clock time incurred by the applicant), and an officer will contact you for the collection of the GDP Certificate.

6.
When do I need to renew my GDP certificate?

The certificate is valid for 3 years from the date of the audit, and there is no renewal of an expired certificate. If you wish to continue with the GDP certification, a new application must be submitted before the expiry of the existing GDP Certificate.

7.
When do I need to file an amendment application to GDP Certificate?

Once issued, amendments can no longer be made to the GDP Certificate as the certificate serves to attest your company’s compliance with GDP requirements as determined at the time of audit and assessment. If there is a change of warehouse, storage/distribution operations or categories of products to be covered under the certification scheme, please apply for a new GDP certificate.

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