Conditions for using this special access route (SAR)
Under the Health Products Act, the import and supply of registered Class 2 CTGTP must be conducted by licensed dealers authorised by the CTGTP registrants. Dealers intending to import or wholesale a registered Class 2 CTGTP, but are not authorised by the registrant to do so, are required to apply for approval from us.
Applications are approved on a case by case basis, and the Class 2 CTGTP can be imported and supplied only upon successful approval.
Each application is restricted to only one Class 2 CTGTP, and is registration number specific. A separate application is required for each additional Class 2 CTGTP. The Class 2 CTGTP to be imported must be, in all aspects, the same as the Class 2 CTGTP that is currently registered and marketed in Singapore.
Each approval is granted to a single consignment of the specified batch of the Class 2 CTGTP made in the application. Importation must be carried out within one year from the date of the approval, subject to the validity of the corresponding Importer’s Licence.
A supplier may continue to supply the Class 2 CTGTP by retail sale after its registration is cancelled, before its product expiry date, if:
- The Class 2 CTGTP registration is cancelled due to a failure to pay the retention fee within the prescribed time.
- The application for the cancellation of the Class2 CTGTP registration has been approved by us.
- You took possession of the Class 2 CTGTP before the registration cancellation.
- We do not direct a recall of the Class 2 CTGTP from the market.
- A declaration by the exporting company indicating its status as a licensed Class 2 CTGTP dealer in the exporting country.
- Documentary evidence that the Class 2 CTGTP to be imported is registered in the exporting country.
- A copy of the supplier's invoice from the exporting country indicating the batch number of the Class 2 CTGTP to be imported.
- A certificate of analysis of the Class 2 CTGTP batch to be imported, from either of the following:
- Packaging and labelling of the following:
- Pharmaceutical drug to be imported.
- Locally-registered Class 2 CTGTP.
- A letter of undertaking to assume responsibility for the quality, safety and efficacy of the Class 2 CTGTP batch to be imported.
Fees and turn-around-time
Refer to CTGTP fees and turn-around-time for more information.
How to apply
Submit your application through the relevant application form. Ensure you have the following before submitting your application:
You will be notified of the outcome of your application via email. For approved applications, the approval number would also serve as the import licence number for the import.