Q1: What is the procedure to apply for a licence to import or sell Chinese Proprietary Medicines (CPM) by way of wholesale?

On-line application can be submitted via PRISM. As part of the application, supporting documents such as the store layout plan and Standard Operating Procedures (SOPs)/Records for GDP have to be submitted. For the applicationof 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-requisite for the approval of your application. The approval of the import licence is also contingent on the approval of the product listing.

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

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

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 contactyou to arrange for a suitable audit date. Alldeficiencies would have to be rectified and are-audit may be conducted to verify yourproposed corrective actions. The applicationwill be considered lapsed if your company isnot able to provide satisfactory responsewithin 3 months from the date of application.

Following approval of your licence, regular routine audit will be conducted to assess your compliance. The frequency of the routine audit would depend on your level of compliance. Unannounced audit may also be conducted should circumstances arise.

Q4: When do I need to renew my licence? 

The licence is valid for 1 year. You should remember to submit a renewal application before the licence expires. You may submit the application 2 months before the expiry of your 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 by that licence. Lapsed licence would not be renewed and a new application would have to be made.

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

If there is a change of warehouse, you should file an amendment application via “amend licence to import Chinese Proprietary Medicines” or “amend licence to sell Chinese Proprietary Medicines by wholesale” in the PRISM online system. For changes in company information, please submit the amendment via “amend company information” in PRISM.

Q6: If I leave the company, do I have to cancel the licence?

The Import Licence for Chinese Proprietary Medicines (CPMs) and Wholesale Dealer's Licence for CPMs are issued to your company. Cancellation of licences would only be done when the company decides not to import or sell CPMs by way of wholesale.