Licence to sell controlled drugs
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, such as:
- Inclusion of new warehouse or change in location or address of current warehouse for the storage of controlled drugs.
- Inclusion of new storage conditions (e.g. cold chain) to the warehouse.
- Renovation of warehouse which involves a change in layout and infrastructure namely with respect to security and storage facilities.
Amendments not requiring site inspection
The following amendments do not require a site inspection:
- Deletion of existing warehouse.
- Addition or deletion of controlled drugs to be sold.
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 the following information or items to complete your application, where applicable:
- Site layout.
- Standard Operating Procedures (SOPs) on handling of controlled drugs.
- List of controlled drugs.
- The name of the product.
- The strength, concentration and volume of each controlled drug contained within each product.