Dealer’s Licences to Import and Wholesale Therapeutic Products in Singapore
In Singapore, any company dealing with importing and wholesaling therapeutic products, also known as pharmaceuticals, needs to acquire licenses from the Health Sciences Authority (HSA) to ensure adherence to safety regulations. These licenses are:
Therapeutic Product Importer's License (TPIL): This license is required for any company that intends to import therapeutic products into Singapore.
Therapeutic Products Wholesaler's License (TPWL): This license is required for any company that intends to wholesale therapeutic products within Singapore. This includes exporting these products.
It's important to note that companies that manufacture therapeutic products under a valid Therapeutic Product Manufacturer's License (TPML) do not need a separate TPIL or TPWL license for the products they manufacture themselves.
Here's a summary table for the different licenses:
License | Description |
Therapeutic Product Manufacturer's License (TPML) | Required to manufacture or assemble therapeutic products |
Therapeutic Product Importer's License (TPIL) | Required to import therapeutic products |
Therapeutic Products Wholesaler's License (TPWL) | Required to wholesale therapeutic products within Singapore |
Before HSA grants a TPIL or TPWL license, they will assess the company's compliance with Good Distribution Practice (GDP) requirements. GDP refers to a quality management system that ensures the safe and quality distribution of therapeutic products.
Application Process
The application process for a Dealer's License to import or wholesale therapeutic products in Singapore is handled electronically through the Health Sciences Authority's (HSA) Product Regulation Information System (PRISM).
Here's a breakdown of the key steps involved:
Preparation:
CRIS Company Account: You'll need a valid Corppass or HSA PIN to access PRISM. If you don't have a CRIS account, you'll need to register your company with Singapore's Accounting and Corporate Regulatory Authority (ACRA) first.
Required Documents: Gather the necessary documents as outlined by HSA. These typically include:
Current layout plan of your company premises, specifying storage areas for the products.
Pharmacist Practising Certificate (if your Responsible Person is a pharmacist).
Authorization letter from the product registrant (needed for TPIL applications if the products aren't registered under your company).
List of products you intend to wholesale (applicable for TPWL applications).
Good Distribution Practice (GDP) standard operating procedures along with relevant records or recording templates.
Store approval letter (depending on storage arrangements).
Application Submission through PRISM:
Access PRISM using your Corppass or HSA PIN.
Locate the specific application for a Therapeutic Product Importer's License (TPIL) or Therapeutic Products Wholesaler's License (TPWL).
Fill out the application form electronically and upload the required documents.
Submit the completed application and pay the necessary fees.
Processing and Approval:
HSA will review your application and may request additional information if needed.
Once approved, you'll receive notification from HSA with your official Dealer's License.
Additional Tips:
It's recommended to thoroughly review the information on the HSA website regarding Dealer's Licenses and Good Distribution Practices (GDP) to ensure you meet all the requirements before applying https://www.hsa.gov.sg/therapeutic-products.
How Bestar can Help
Bestar can assist with acquiring Dealer's Licences to Import and Wholesale Therapeutic Products in Singapore. Here is how:
Consulting: Bestar specializes in helping companies navigate the process of obtaining HSA licenses, including TPIL and TPWL licenses. They offer guidance on:
Completing the application process
Ensuring compliance with GDP requirements
Liaising with HSA
Licensing: Bestar acts as a liaison between businesses and the HSA to expedite the licensing process.
Regulatory Compliance: Bestar helps ensure companies comply with regulations set forth by HSA, including those related to GDP.
To determine how Bestar can specifically assist you, contact us. Our website or social media pages have information on the services we offer related to HSA licensing and regulatory compliance for therapeutic products.
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