Import and supply of registered Class 2 CTGTP on consignment basis

Importers who are neither the registrants nor authorised by the registrant and intend to import a registered Class 2 CTGTP under Regulation 9(a)(vi) of the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 are required to apply for approval from us.

Conditions for using this special access route (SAR)

• The Class 2 CTGTP to be imported must be the same in all respects as the Class 2 CTGTP that is currently registered in Singapore.
• Each application is limited to only one consignment of a specific batch of Class 2 CTGTP (registration number specific).  A separate application is required for each additional Class 2 CTGTP.
• Importation must be completed  within one year from the date of approval of the application and within the validity of your Wholesaler’s Licence.

Eligibility

Your company can apply to import registered Class 2 CTGTP via this SAR if it:

• Is registered in Singapore with the Accounting and Corporate Regulatory Authority (ACRA)
• Holds a valid wholesaler's licence for the wholesale of the Class 2 CTGTP

Documents required

• Documentary evidence (e.g., approval letter, register listing) issued by the regulatory authority of the exporting country, confirming that the exporting company is a licensed Class 2 CTGTP dealer in that country.
• Documentary evidence of the registration status of the Class 2 CTGTP in the exporting country.
• A copy of the supplier's invoice from the exporting country indicating the Class 2 CTGTP batch number.
• A certificate of analysis of the Class 2 CTGTP batch, from either:
  • The manufacturer of the Class 2 CTGTP; or
  • A testing laboratory accredited by the Singapore Accreditation Council
• Product labels, including outer and inner labels as well as package insert for the:
  • CTGTP to be imported
  • Locally-registered Class 2 CTGTP
• A letter of undertaking for assuming responsibility for the quality, safety and efficacy of the Class 2 CTGTP batch to be imported.

Fees and turnaround time

Refer to CTGTP fees and turnaround time for more information.

How to apply

Submit your applications through SHARE.