Product notification (new and updates)

Submit your new product notification or update notification through SHARE.

Useful links:

• HSA SHARE Applicant User Manual4471 KB
• Appendix 1 Documentary Requirements for Class 1 Cell Tissue and Gene Therapy Products Notification191 KB

Product registration

How to apply

1. Complete and submit the online application form via the FORMSG link below.
2. Upon successful submission, an application reference number will be sent to your email. Please cite this reference number for your payment transaction and future enquiries pertaining to the application. 
3. Submit the supporting document(s) via CD/DVD or email, indicating the product name and application reference number.

Online application forms (FORMSG links)

• Pre-market consultation for Class 2 cell, tissue or gene therapy product registration
• Registration of Class 2 cell, tissue or gene therapy product 
• Submission of documents to fulfil Class 2 cell, tissue or gene therapy product registration conditions

Variation applications

How to apply

1. Complete and submit the online application form via the FORMSG link below.
2. Upon successful submission, an application reference number will be sent to your email. Please cite this reference number for your payment transaction and future enquiries pertaining to the application. 
3. Submit the supporting document(s) via CD/DVD or email, indicating the product name and application reference number.

Online application forms (FORMSG links)

• Major variation (MAV-1) application for registered Class 2 cell, tissue or gene therapy products
• Minor variation 1 (MIV-1) application for registered Class 2 cell, tissue or gene therapy products

• Minor variation 2 (MIV-2) application for registered Class 2 cell, tissue or gene therapy products

Special Access Route (SAR)

How to apply

1. Complete the relevant request form digitally.
   
   • Request form for Import and Supply of an Unregistered Class 2 CTGTP375 KB
   • Request form for Import and Supply of a Registered Class 2 CTGTP176 KB 
2. Complete the relevant online application form via the FORMSG link below, attach the completed request form from step 1 and submit the application.
3. Upon successful submission, an application reference number will be sent to your email. Please cite this reference number for your payment transaction and future enquiries pertaining to the application. 
4. Submit the supporting document(s) via CD/DVD or email, indicating the product name and application reference number.

Online application forms (FORMSG links)

• Import and supply of an Unregistered Class 2 Cell, Tissue or Gene Therapy Product
• Import and supply of a Registered Class 2 Cell, Tissue or Gene Therapy Product on Consignment Basis

Application Withdrawal

How to apply

1. Complete and submit the Withdraw an application for a Cell, Tissue or Gene Therapy form.

Dealer's notice (new or changes to dealer's notice)

Submit your new dealer's notice or update notice through SHARE.

Useful links: HSA SHARE Applicant User Manual4471 KB

Dealer's licence or certificate

Application forms

New applications

• Application for CTGTP GMP Certificate96 KB
• Application for CTGTP Manufacturer’s Licence 114 KB
• Application for CTGTP Importer’s Licence and/or Wholesaler’s Licence 291 KB
• Application for a CTGTP Good Distribution Practice Certificate 167 KB
• Application for a Certificate of a Pharmaceutical Product for a CTGTP 744 KB

 Amendment applications

• Amendment Application for CTGTP Manufacturer's Licence 140 KB
• Amendment Application for CTGTP Importer’s or Wholesaler’s Licence 323 KB

How to apply

1. Complete the application form digitally and save a copy for your reference.
2. Attach your PDF and submit your application via CTGTP Dealer's Submission.

3. An acknowledgement email with the application reference number will be sent to your email indicated in your submission. Please cite this reference number in your payment transaction and future enquiries pertaining to the application.

Withdraw a dealer's application

You can withdraw your application before it is approved or rejected by submitting a request through CTGTP Dealer’s Submission indicating the reason(s) for the withdrawal.

A refund of the application fee may not be granted in the case whereby substantial work has already been done in the evaluation/technical assessment of the application.

Possible reasons for withdrawal include the following:

• Licence or certificate not applicable or not required
• Company is not ready for inspection
• Change of business decision
• Duplicate application

Renew a dealers licence

Submit your dealer's licence renewal application via the CTGTP Dealer’s Submission at least one month before your licence’s expiry date to allow sufficient time for the renewal fee to be cleared for the licence to be renewed.

Upon successful renewal, the licence will be valid for 12 months from the last licence expiry date.

Cancel a dealers licence

Submit your dealer's licence cancellation request via CTGTP Dealer’s Submission.

Change to business or applicant details

Please inform HSA by writing in to email at HSA_ALD_Appl@hsa.gov.sg if you have changes in  company’s Accounting and Corporate Regulatory Authority (ACRA) registered name and business address and applicant details. In addition, please use the e-service Change of Business Information to change company particulars such as company’s ACRA registered name and business address, provided there is no change to the company's Unique Entity Number (UEN).

The company’s UEN, as issued by ACRA, is used as the standard identification of a legal entity. For a change in UEN, the company is considered a new business entity. Licences or certificates issued to the company under the old UEN will not be valid anymore. The company will need to apply for a new CRIS account using the new UEN and thereafter submit new licence or certificate applications if the licence(s) or certificate(s) are required under the new business entity.