Importing clinical trial materials (CTMs) into Singapore requires strict adherence to regulations set by Singapore Customs and the Health Sciences Authority (HSA). Failure to comply can lead to delays, penalties, or rejection of goods. At Declarators, we specialize in guiding businesses through the complexities of importing CTMs, ensuring smooth and compliant operations.
What Are Clinical Trial Materials (CTMs)?
CTMs encompass medicinal products, Class 2 cell, tissue, and gene therapy (CTGT) products, therapeutic products, and their placebos intended for clinical trials. These materials are subject to specific import procedures to ensure safety and compliance with local regulations.
GST Relief for CTMs
Under the GST (Imports Relief) Order, GST relief is granted for the import of CTMs under the following conditions:
- Medicinal products, Class 2 CTGT products, and therapeutic products, including placebos, for regulated clinical trials in Singapore.
- Medicinal products, Class 2 CTGT products, and therapeutic products, including placebos, for use in clinical trials outside Singapore and imported for destruction or disposal.
- Class 2 CTGT products and therapeutic products, including placebos, for use in clinical trials outside Singapore and imported for the purpose of being exported for such intended use.
To qualify for GST relief, importers must:
- Obtain necessary approvals or notifications from the HSA for the import of these trial materials.
- Register for a claimant account with Singapore Customs.
Application Process
When applying for GST relief for CTMs, the following steps must be taken:
- Obtain the necessary approvals from the HSA and, if applicable, the National Environment Agency (NEA) for destruction or disposal.
- Register for a claimant account with Singapore Customs.
- Submit a TradeNet permit with the Message Type “In-Non Payment” and Declaration Type “GTR – GST Relief” for each importation.
- Declare the Place of Receipt code as “CTM”.
- Ensure the HS Code(s) declared fall under the list specified by Singapore Customs.
- Prefix the item description with “CTM”.
- Itemize different CTM goods in the same shipment under separate line items.
- Do not include non-CTM goods in the same permit application; they require a separate In-Payment (GST) permit
Why Compliance Matters
Strict adherence to these procedures ensures:
- Smooth Customs Clearance: Proper documentation and compliance prevent delays at the border.
- Avoidance of Penalties: Non-compliance can lead to fines, seizure of goods, or other legal consequences.
- Regulatory Approval: Ensures that clinical trials proceed without regulatory hindrances.
How Declarators Can Assist
At Declarators, we offer comprehensive services to ensure your CTM imports are compliant:
- Guidance on Regulatory Requirements: We help you understand and navigate the necessary approvals and documentation.
- Assistance with TradeNet Applications: Our experts assist in preparing and submitting accurate TradeNet permits.
- Liaison with Authorities: We coordinate with the HSA and NEA on your behalf to secure the required approvals.
- Compliance Audits: We conduct thorough checks to ensure all aspects of your import process meet regulatory standards.
Contact Declarators
Ensure your CTM imports are handled efficiently and compliantly. Reach out to Declarators for expert assistance:
📧 Email: group@declarators.com.sg
📞 Phone: +65 6385 2155
🌐 Website: www.declarators.com.sg
