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Frequently Asked Questions

Health Products Regulation

Manufacturing, Importation & Distribution > Chinese Proprietary Medicines > Import Licence and Wholesale Dealer's Licence for Chinese Proprietary Medicines

1.
When applying for the Import Licence and Wholesale Dealer’s Licence for Chinese Proprietary Medicines, do I need to apply for any other licences?

The licence is issued for you to deal in Chinese Proprietary Medicines (CPM). If you are dealing in Therapeutic Products, Controlled Drugs or other category of products, other relevant licences are required.

2.
For the Import Licence and Wholesale Dealer’s Licence for Chinese Proprietary Medicines, how should 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 was satisfactory, the licence 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). 

Following approval of the licence, regular routine audit will be conducted to assess your company’s continued compliance with the requirements in the HSA Guidance Notes On Good Distribution Practice. The frequency of the routine audit would depend on risk factors including the activities conducted by your company as well as your level of compliance. Unannounced audit may also be conducted should circumstances arise.

3.
When do I need to renew my Import Licence and Wholesale Dealer’s Licence for Chinese Proprietary Medicines?

The licence is valid for 1 year. Renewal notices and reminders will be sent to the licensee 60 days before expiry via the preferred mode of contact.

If your company has a GIRO account with HSA, the licence will be automatically renewed upon successful deduction of the licence fee. If your company does not wish to renew the licence, an application to opt-out of auto-renewal should be submitted at least 1 month before the expiry of the licence.

If your company does not have a GIRO account with HSA, you should remember to login PRISM and uses the ‘Renew Licence to Import Chinese Proprietary Medicines’ and/or ‘Renew Licence to Sell Chinese Proprietary Medicines by Wholesale’ modules under renew@prism on PRISM e-Services webpage to submit a renewal application before the licence expires. You may submit the application 2 months before the expiry of the licence.

If your licence is not renewed upon expiry, it would be considered lapsed and you would not be able to continue with the activities previously authorized under that licence. A lapsed licence would not be renewed and a new application would have to be made. You are encouraged to apply for a GIRO account with HSA and maintain sufficient funds for licence fee deductions, to prevent inadvertent lapses of licence validity.

4.
When do I need to file an amendment application to my Import Licence and Wholesale Dealer’s Licence for Chinese Proprietary Medicines?

An amendment (with site inspection) application must be submitted if your company wishes to add or relocate to a new warehouse. An amendment (without site inspection) application must be submitted if your company wishes to remove an existing warehouse from the licence.

Amendment application can be submitted via ‘Amend Licence to Import Chinese Proprietary Medicines’ and ‘Amend Licence to Sell Chinese Proprietary Medicines By Wholesale’ under amend@prism on PRISM e-Services webpage. Please refer to Guide on Amendment Application for Licence to Import Chinese Proprietary Medicines and Guide on Amendment Application for Chinese Proprietary Medicine Wholesale Dealer’s Licence when making an amendment application.

5.
How do I submit an amendment to change company information or applicant details for Import Licence and Wholesale Dealer’s Licence for Chinese Proprietary Medicines?

For changes to company’s business address or company name (but no change to the company’s Unique Entity Number, i.e. UEN), you can submit amendment via the‘Amend Company Information’ module under amend@prism on PRISM e-Services webpage.

For changes in the applicant’s detail, you can submit amendment via the ‘Amend Applicant’s Details For Licences And Applications’ module under amend@prism on PRISM e-Services webpage.

6.
If I leave the company, do I have to cancel the Import Licence and Wholesale Dealer’s Licence for Chinese Proprietary Medicines?

The Import Licence and Wholesale Dealer's Licence for Chinese Proprietary Medicines (CPM) are issued to your company. Cancellation of licence would only be required when the company decides not to import or supply CPMs by way of wholesale. You can submit a cancellation application via ‘Cancel Licence to Import Chinese Proprietary Medicines’ and/or ‘Cancel Licence to Sell Chinese Proprietary Medicines by Wholesale’ modules under cancel@prism on PRISM e-Services webpage.

7.
What is the procedure to apply for a licence to import or sell Chinese Proprietary Medicines (CPM) by way of wholesale?

The application can be submitted online via ‘Apply for Licence to Import Chinese Proprietary Medicines’ and/or ‘Apply for Licence to Sell Chinese Proprietary Medicines by Wholesale’ under apply@prism on PRISM e-Services webpage. Please refer to Guide on New Application for Licence to Import Chinese Proprietary Medicines and Guide on New Application for Chinese Proprietary Medicine Wholesale Dealer’s Licence when making an application. As part of the application, supporting documents such as the store layout plan and Standard Operating Procedures (SOPs)/Records/Forms that serve to demonstrate compliance with the requirements stipulated in the current HSA Guidance Notes On Good Distribution Practice should be submitted.

For the application of Import Licence for CPM, there must be a corresponding listing application for a CPM product. Completeness of these documents and a satisfactory outcome of the site audit are pre-requisites for the approval of your application. The approval of the Import Licence is also contingent on the approval of the product listing.

 

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