Import and supply of registered Class 2 Cell, Tissue and Gene Therapy Products (CTGTP) on consignment basis

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.

Eligibility

• Your company needs to be registered in Singapore with the Accounting and Corporate Regulatory Authority (ACRA) to apply for this SAR.
• Your company must hold a valid wholesaler's licence for the wholesale of the Class 2 CTGTP.

Documents required

• 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:
  • The manufacturer of the Class 2 CTGTP to be imported.
  • Any testing laboratory accredited by the Singapore Accreditation Council.
• Packaging and labelling of the following:
  • CTGTP 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:

• CRIS company account
• CorpPass

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.