Apart from preparations listed in the First Schedule to the Misuse of Drugs Regulations, you will need a licence to sell controlled drugs by wholesale (CDWL) if you store and/or supply other controlled drugs by wholesale. You must be a pharmacist registered with the Singapore Pharmacy Council to apply and be the licence holder of a CDWL. A CDWL is required if you are manufacturing or importing controlled drugs for subsequent wholesale supply, or if you are exporting controlled drugs.
The CDWL is valid for 12 months and is specific to the controlled drugs listed in the approved licence. You can submit a renewal application for a CDWL before expiry.
You need the following information or items to complete your application:
- Site layout.
- List of controlled drugs.
- Standard Operating Procedures (SOPs) on handling of controlled drugs.
- Requisition form or signed order template.
- Controlled Drug Register Part I and Part 2 template.
- Pharmacist Practising Certificate issued by the Singapore Pharmacy Council.
When your licence application is received, we will inform you on the date for an audit of your premises. Any findings from the audit will have to be rectified before the audit can be closed out. The licence will be approved and issued 10 working days from date of audit close out, if your company has complied with the requirements.
After licence approval, regular routine audits will be conducted to assess your company’s continued compliance. The frequency of the routine audit would depend on risk factors like the activities conducted by your company and your compliance level with the regulatory requirements. Unannounced audits may also be conducted.