Singapore: Consignment Therapeutic Product Importation Application Guidance

All non-registrant importers or non-authorized importers will need to apply for importation approval before importing registered therapeutic products under Regulation 5(1)(b)(vii) of Health Products (Therapeutic Products) Regulations 2016. The guidance update has been published publicly on 1 June 2023.

Before receiving approval for the importation procedure, importers are needed to ensure that their consignments adhere to all of the conditions specified below:

1. The Chemistry, Manufacturing, and Controls (CMC) standards and package insert supply of the therapeutic product must be the same as the existing products registered in Singapore.

2. No controlled drugs in the products as stated under the Misuse of Drugs Act and its Regulations.

3. Starting from the approval date, the importers were given 6 months to execute the importation.

4. The approval validity can be applied constantly if the therapeutic products are continued to be registered in Singapore.

5. HSA may conduct testing under Program Quality Surveillance Programme and HSA has the authority to cancel the consignment approval if the CMC standards are not fulfilled.

6. The applicants must be currently registered with Accounting and Corporate Regulatory Authority (ACRA) and also has an active CRIS account.

7. The applicants are also required to own a valid Therapeutic Product Importer’s License and Therapeutic Product Wholesaler’s License.

Once all the requirements were completed, the importers are required to prepare all the supporting documents as below:

1. Documentary evidence issued by exporting country regulatory authority (color scanned copy)

2. Approval proof from the exporting country: Regulatory authority approval letter; registered under / published listing by the authority in the website (website screenshot and URL of the website)

3. Copy of supplier invoice with the imported therapeutic product batch number

4. Certificate of Analysis (CoA) of the consignment batch by: finished therapeutic product manufacturer; or testing laboratory certified by the Singapore Accreditation Council; or overseas testing laboratory certified by International Laboratory Accreditation Cooperation (ILAC)

5. Evidence documentation of the therapeutic product imported by the same Container Closure System (CCS) in the form of: product label with type of CCS; or Approval proof from exporting country with CCS statement.

6. Evidence documentation to prove the shelf-life of the imported therapeutic products are the same with the registered products in the form of: product carton with expiry dates; or Approval proof from exporting country with statement of the shelf-life; or CoA issued with the manufacturing date and expiry date on the product’s carton.

The applicants may submit the application of importing therapeutic products via Apply@PRISM. The application is only applicable for one consignment with a specific registration therapeutic product number.

Please refer to HSA website for the current fee chargeable. The application fees is paid at the point of application submission and is non-refundable. The application turn-around time is 14 working days, excluding stop clock.

Source: Health Science Authority (HSA)