You need to submit the following in English:
- Current layout plan for the premises, specifying the storage areas.
- Good Distribution Practice (GDP) Standard Operating Procedures, applicable if your core business is in wholesale dealing of active pharmaceutical ingredients containing poisons intended for local clinical use.
- GDP records or recording templates, applicable if your core business is in wholesale dealing of active pharmaceutical ingredients containing poisons intended for local clinical use.
- Other supporting documents, if applicable.
Fees and turnaround time
Refer to Form A Poisons Licence fees and turnaround time for more information.
Form A Poisons Licence audits
Compliance with Good Distribution Practice (GDP) standard is mandatory if your core business is in wholesale of active pharmaceutical ingredients containing poisons intended for local clinical use.
When your licence application is received, we will inform you on the date for a GDP audit of your premises. If your company is not dealing in the above-mentioned activity, a regulatory audit would be conducted according to the requirements stipulated in the Poisons Act and Rules.
The licence will only be approved and issued 10 working days from date of audit close out, if your company has been found to have complied with the relevant 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.
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).
Refer to our guide on the New Application for Form A Poisons Licence1221 KB for more details when making an application