Importer and wholesaler's licence
If you intend to change your importer's licence granted for full scope activities to one that is solely for restricted activities, or vice versa, you will need to
cancel your existing licence and submit a new licence application.
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. The following are examples of amendments that require site inspection:
- Inclusion of new warehouse or change in location or address of the current warehouse for the storage of therapeutic products.
- Inclusion of new storage conditions to the warehouse, such as cold chain storage.
Amendments not requiring site inspection
The following amendments do not require site inspection:
- Deletion of existing warehouse.
- Addition or deletion of aspect of activities.
- Addition or deletion of products (only for importer's licence).
- Addition or deletion of Responsible Person.
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.
Documents required
You need to submit the following documents in English, where applicable:
Supporting documents |
Details |
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. |
Pharmacist Practising Certificate, only applicable when the Responsible Person is a registered pharmacist.
|
Compulsory for addition of a new Responsible Person or change of the current Responsible Person to a new person who is a registered pharmacist. |
Authorisation Letter from the product registrant, only applicable for products that are not registered under your company (only for importer's licence).
|
Compulsory for addition of a new product not registered under your company. |
Good Distribution Practice (GDP) standard operating procedures, which must be up-to-date. |
If applicable. |
GDP records or recording templates, which must be up-to-date. |
If applicable. |
Store approval letter. |
If applicable. |
Other supporting documents. |
If applicable. |
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).