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

Importers or wholesalers who are neither registrants nor authorised by the registrant, need approval to import and supply a registered Class 2 CTGTP.

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

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:
  • 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:

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.

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