Q1: What is the procedure to apply for a licence to import or sell medicinal products 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 application of Import Licence (For Authorized Agent), a letter of authorization given by the product licence holder has to be submitted. 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 licence is issued for you to deal with medicinal products. If you are dealing with Chinese Proprietary Medicines, Controlled Drugs or other category of products, other relevant licences are required. In addition, the pharmacist must apply for a Form A Poisons Licence to deal in medicinal product containing substance included in the Poisons Act.

Q3: How should 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. All deficiencies would have to be rectified and a re-audit may be conducted to verify your proposed corrective actions. The application will be considered lapsed if your company is not able to provide satisfactory response within 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 dependon 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?

Amendment application of licence would be needed if there is a change of warehouse. Any changes to the list of products authorised for importation should also be made known via an amendment application. Similarly, wholesale dealers who intend to deal in different category of medicinal productnamely from General Sale List to Pharmacy Only medicines and/or Prescription Only medicines, they should file an amendment application.

For changes in company information, please submit amendment via “amend company information” in the PRISM online system.

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

The Import Licence For Medicinal Products (for Authorized Agent) and Wholesale Dealer's Licence For Medicinal Products are issued to your company. Cancellation of licences would only be done when the company decides not to import or sell medicinal products by way of wholesale.