Import and wholesale dealer's licence
Amendments requiring site inspection
Site inspections may be conducted by us for certain amendments such as those that would have direct impact on the product's quality.
An example of an amendment that requires site inspection is the inclusion of a new warehouse or change in location or address of the current warehouse for the storage of Chinese Proprietary Medicines.
Amendments not requiring site inspection
An amendment that does not require site inspection is the deletion of an existing warehouse.
Note: While these amendments generally do not require site inspection, there may be cases where we may still conduct one if it is deemed necessary.
You need to submit the following documents in English, where applicable:
|Current layout plan for the premises, specifying the storage areas.
Compulsory for addition of a new warehouse or change in location or address of current warehouse.
The layout floor plan will need to have the following information:
(i) The full address of the warehouse
(ii) The dimensions (length and width) of the warehouse
(iii) Indication of various storage areas, e.g. receiving bay, quarantined product area, released product area, rejected product area, returned product area, recalled product area, outgoing staging area, etc.
|Good Distribution Practice (GDP) standard operating procedures, which must be up-to-date.
|GDP records or recording templates, which must be up-to-date.
| Contract with contract acceptor for outsourced activity which clearly establishes the roles and responsibilities of each party
|| If there is change in contract acceptor or outsourced activity.
How to apply
Submit your application through PRISM. Ensure you have the following before you access the e-service:
If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).